Diabetes guidelines recommend sodium-glucose transport protein 2 (SGLT2) inhibitors to reduce kidney disease progression in patients with type 2 diabetes (T2D) and moderate-to-severe albuminuric kidney disease on the basis of renal outcomes trials, such as CREDENCE and DAPA-CKD. However, these trials did not include patients who are at low risk for kidney disease progression.

Mozenson and colleagues published a post hoc analysis of the DECLARE-TIMI 58 trial and focused on patients with low kidney risk. They demonstated that dapagliflozin slowed the progression of kidney disease in patients with T2D at high cardiovascular risk, including those who are at low risk for kidney progression. The absolute benefit for slowing kidney progression was much lower in patients with low kidney risk compared with those who are at high or very high risk (number needed to treat 177 vs 13-23). Though dapagliflozin does provide kidney protection across a spectrum of patients with kidney risk, clinicians should consider the level of risk when starting an SGLT2 inhibitor for slowing kidney disease.

SGLT2 inhibitor outcome trials and meta-analyses have mainly shown neutral results for ischemic stroke, except for sotagliflozin vs placebo in the SCORED trial. In this trial, sotagliflozin was shown to reduce total stroke. Recently, in a retrospective longitudinal cohort study of patients with T2D in Taiwan, Lin and colleagues have shown a significant reduction in new onset stroke among those who use SGLT2 inhibitor compared with those who don't. A 15% relative risk reduction in stroke was shown in an analysis that adjusted for age, sex, and duration of T2D, with a similar reduction in a propensity score-matched analysis. Although limited by its observational design, this study suggests that further research should be continued regarding the impact of SGLT2 inhibitors on stroke outcomes.

Severe hypoglycemia is a serious complication of insulin and insulin secretagogue therapy. There have been few studies regarding the association between long-term glycemic variability of A1c and fasting plasma glucose (FPG) and the risk for severe hypoglycemia. Long and colleagues performed a post hoc analysis of the ACCORD study and found that both A1c and FPG variability were associated with a greater risk for severe hypoglycemia in T2D, with FPG being a more sensitive indicator than is A1c variability. Clinicians need to be aware that A1c and FPG variability in insulin- or insulin secretagogue–treated patients with T2D places them at greater risk for severe hypoglycemia and such variability should be considered a potential target of treatment.

Although a higher mean A1c has been linked to diabetes microvascular and macrovascular complications, there is a paucity of data comparing mean A1c and A1c variability and diabetes complications. In a prospective study from Taiwan, Wu and colleagues demonstrated that both mean A1c and A1c variability predicted most diabetes-related complications, with mean A1c being more effective at predicting retinopathy and A1c variability being more effective at predicting a decline in kidney function and cardiovascular and total mortality. Perhaps physicians need to pay more attention to A1c variability and not just the mean A1c over time when assessing an individual and their overall risk for diabetes complications.

Diabetes guidelines recommend sodium-glucose transport protein 2 (SGLT2) inhibitors to reduce kidney disease progression in patients with type 2 diabetes (T2D) and moderate-to-severe albuminuric kidney disease on the basis of renal outcomes trials, such as CREDENCE and DAPA-CKD. However, these trials did not include patients who are at low risk for kidney disease progression.

Mozenson and colleagues published a post hoc analysis of the DECLARE-TIMI 58 trial and focused on patients with low kidney risk. They demonstated that dapagliflozin slowed the progression of kidney disease in patients with T2D at high cardiovascular risk, including those who are at low risk for kidney progression. The absolute benefit for slowing kidney progression was much lower in patients with low kidney risk compared with those who are at high or very high risk (number needed to treat 177 vs 13-23). Though dapagliflozin does provide kidney protection across a spectrum of patients with kidney risk, clinicians should consider the level of risk when starting an SGLT2 inhibitor for slowing kidney disease.

SGLT2 inhibitor outcome trials and meta-analyses have mainly shown neutral results for ischemic stroke, except for sotagliflozin vs placebo in the SCORED trial. In this trial, sotagliflozin was shown to reduce total stroke. Recently, in a retrospective longitudinal cohort study of patients with T2D in Taiwan, Lin and colleagues have shown a significant reduction in new onset stroke among those who use SGLT2 inhibitor compared with those who don't. A 15% relative risk reduction in stroke was shown in an analysis that adjusted for age, sex, and duration of T2D, with a similar reduction in a propensity score-matched analysis. Although limited by its observational design, this study suggests that further research should be continued regarding the impact of SGLT2 inhibitors on stroke outcomes.

Severe hypoglycemia is a serious complication of insulin and insulin secretagogue therapy. There have been few studies regarding the association between long-term glycemic variability of A1c and fasting plasma glucose (FPG) and the risk for severe hypoglycemia. Long and colleagues performed a post hoc analysis of the ACCORD study and found that both A1c and FPG variability were associated with a greater risk for severe hypoglycemia in T2D, with FPG being a more sensitive indicator than is A1c variability. Clinicians need to be aware that A1c and FPG variability in insulin- or insulin secretagogue–treated patients with T2D places them at greater risk for severe hypoglycemia and such variability should be considered a potential target of treatment.

Although a higher mean A1c has been linked to diabetes microvascular and macrovascular complications, there is a paucity of data comparing mean A1c and A1c variability and diabetes complications. In a prospective study from Taiwan, Wu and colleagues demonstrated that both mean A1c and A1c variability predicted most diabetes-related complications, with mean A1c being more effective at predicting retinopathy and A1c variability being more effective at predicting a decline in kidney function and cardiovascular and total mortality. Perhaps physicians need to pay more attention to A1c variability and not just the mean A1c over time when assessing an individual and their overall risk for diabetes complications.

Diabetes guidelines recommend sodium-glucose transport protein 2 (SGLT2) inhibitors to reduce kidney disease progression in patients with type 2 diabetes (T2D) and moderate-to-severe albuminuric kidney disease on the basis of renal outcomes trials, such as CREDENCE and DAPA-CKD. However, these trials did not include patients who are at low risk for kidney disease progression.

Mozenson and colleagues published a post hoc analysis of the DECLARE-TIMI 58 trial and focused on patients with low kidney risk. They demonstated that dapagliflozin slowed the progression of kidney disease in patients with T2D at high cardiovascular risk, including those who are at low risk for kidney progression. The absolute benefit for slowing kidney progression was much lower in patients with low kidney risk compared with those who are at high or very high risk (number needed to treat 177 vs 13-23). Though dapagliflozin does provide kidney protection across a spectrum of patients with kidney risk, clinicians should consider the level of risk when starting an SGLT2 inhibitor for slowing kidney disease.

SGLT2 inhibitor outcome trials and meta-analyses have mainly shown neutral results for ischemic stroke, except for sotagliflozin vs placebo in the SCORED trial. In this trial, sotagliflozin was shown to reduce total stroke. Recently, in a retrospective longitudinal cohort study of patients with T2D in Taiwan, Lin and colleagues have shown a significant reduction in new onset stroke among those who use SGLT2 inhibitor compared with those who don't. A 15% relative risk reduction in stroke was shown in an analysis that adjusted for age, sex, and duration of T2D, with a similar reduction in a propensity score-matched analysis. Although limited by its observational design, this study suggests that further research should be continued regarding the impact of SGLT2 inhibitors on stroke outcomes.

Severe hypoglycemia is a serious complication of insulin and insulin secretagogue therapy. There have been few studies regarding the association between long-term glycemic variability of A1c and fasting plasma glucose (FPG) and the risk for severe hypoglycemia. Long and colleagues performed a post hoc analysis of the ACCORD study and found that both A1c and FPG variability were associated with a greater risk for severe hypoglycemia in T2D, with FPG being a more sensitive indicator than is A1c variability. Clinicians need to be aware that A1c and FPG variability in insulin- or insulin secretagogue–treated patients with T2D places them at greater risk for severe hypoglycemia and such variability should be considered a potential target of treatment.

Although a higher mean A1c has been linked to diabetes microvascular and macrovascular complications, there is a paucity of data comparing mean A1c and A1c variability and diabetes complications. In a prospective study from Taiwan, Wu and colleagues demonstrated that both mean A1c and A1c variability predicted most diabetes-related complications, with mean A1c being more effective at predicting retinopathy and A1c variability being more effective at predicting a decline in kidney function and cardiovascular and total mortality. Perhaps physicians need to pay more attention to A1c variability and not just the mean A1c over time when assessing an individual and their overall risk for diabetes complications.

Patients with inflammatory bowel disease (IBD) are 70% more likely to use benzodiazepines and “Z-drugs” than are the general population, a large study from Canada suggests. 

Mood/anxiety disorders and sleep disorders are common in patients with IBD, but few studies have looked at use of benzodiazepines and Z-drugs (such as zolpidem, zaleplon, and eszopiclone) in this patient population.

The results are “concerning, and especially as the IBD population ages, these drugs are associated with health risks, including something as simple as falls,” first author Charles Bernstein, MD, of the IBD clinical and research centre, University of Manitoba, Winnipeg, told this news organization.

“Clinicians need to find better strategies to deal with anxiety disorders and sleep disorders in the IBD population,” Dr. Bernstein said.

The study was published online in the American Journal of Gastroenterology.
 

High burden of use

Using administrative data from Manitoba, Dr. Bernstein and colleagues identified 5,741 patients with IBD (2,381 with Crohn’s disease and 3,360 with ulcerative colitis) and matched them (1:5) to 28,661 population controls without IBD.

Over a 20-year period (1997-2017), there was a “high burden” of benzodiazepine and Z-drug use in the IBD population. In 2017, roughly 20% of Manitobans with IBD were using benzodiazepines, and 20% were using Z-drugs, the study team reports.

The benzodiazepine use rate (per 1,000) was 28.06 in the IBD cohort vs. 16.83 in the non-IBD population (adjusted rate ratio, 1.67). The use rate for Z-drugs was 21.07 in the IBD cohort vs. 11.26 in the non-IBD population (adjusted RR, 1.87).

Benzodiazepine use declined from 1997 to 2016, but it remained at least 50% higher in patients with IBD than in the general population over this period, the researchers found. The rate of Z-drug use also was higher in the IBD population than in the general population but remained stable over the 20-year study period.

Regardless of age, men and women had similarly high use rates for benzodiazepines, Z-drugs, and joint use of benzodiazepines and Z-drugs. The highest incidence rates for joint benzodiazepine and Z-drug use were in young adults (age 18-44 years), and these rates were similar among men and women.

Patients with IBD and a mood/anxiety disorder also were more likely to use benzodiazepines and Z-drugs and to be continuous users than were those without a mood/anxiety disorder.
 

Mental health and IBD go hand in hand

“The results are not very surprising, but they highlight the importance of mental health and mood disturbances in patients with IBD,” Ashwin Ananthakrishnan, MBBS, MPH, with Massachusetts General Hospital and Harvard Medical School in Boston, who wasn’t involved in the study, told this news organization.

“It is important for treating physicians to be aware of the important mental health implications of IBD diagnosis and disease activity, to screen patients for these disturbances, and to institute early effective interventions,” Dr. Ananthakrishnan said.

Also offering perspective, Laurie Keefer, PhD, academic health psychologist and director of psychobehavioral research within the division of gastroenterology, Mount Sinai Health System, New York, said that she is “concerned but not surprised” by the results of this study.

“One in three patients with IBD meets criteria for an anxiety disorder,” Dr. Keefer told this news organization.

And with the ongoing mental health crisis and shortage of mental health providers, “gastroenterologists are, unfortunately, in the position where they may have to manage these issues,” she said.

Dr. Keefer noted that when patients are first diagnosed with IBD, they will likely be on prednisone, and “an antidote” for the side effects of prednisone are benzodiazepines and sleeping medications because prednisone itself causes insomnia. “However, that’s really just a band-aid,” she said.

A major concern, said Dr. Keefer, is that young men and women who are diagnosed with IBD in their 20s may start using these drugs and become reliant on them.

“People do build up a tolerance to these drugs, so they need more and more to receive the same effect,” she said.

A better approach is to figure out why patients are so anxious and teach them skills to manage their anxiety and sleep problems so that they’re not dependent on these drugs, Dr. Keefer said.

“There are behavioral strategies that can help. These are harder to do, and they’re not a quick fix. However, they are skills you can learn in your 20s and so when you have an IBD flare at 50, you have the skills to deal with it,” she said.

“We just have to be a little more proactive in really encouraging patients to learn disease management skills,” Dr. Keefer added.

The study was funded by the Canadian Institutes of Health Research and Crohn’s and Colitis Canada. Dr. Bernstein has disclosed relationships with AbbVie Canada, Amgen Canada, Bristol-Myers Squibb Canada, Roche Canada, Janssen Canada, Sandoz Canada, Takeda and Takeda Canada, Pfizer Canada, Mylan Pharmaceuticals, and Medtronic Canada. Dr. Ananthakrishnan and Dr. Keefer report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Patients with inflammatory bowel disease (IBD) are 70% more likely to use benzodiazepines and “Z-drugs” than are the general population, a large study from Canada suggests. 

Mood/anxiety disorders and sleep disorders are common in patients with IBD, but few studies have looked at use of benzodiazepines and Z-drugs (such as zolpidem, zaleplon, and eszopiclone) in this patient population.

The results are “concerning, and especially as the IBD population ages, these drugs are associated with health risks, including something as simple as falls,” first author Charles Bernstein, MD, of the IBD clinical and research centre, University of Manitoba, Winnipeg, told this news organization.

“Clinicians need to find better strategies to deal with anxiety disorders and sleep disorders in the IBD population,” Dr. Bernstein said.

The study was published online in the American Journal of Gastroenterology.
 

High burden of use

Using administrative data from Manitoba, Dr. Bernstein and colleagues identified 5,741 patients with IBD (2,381 with Crohn’s disease and 3,360 with ulcerative colitis) and matched them (1:5) to 28,661 population controls without IBD.

Over a 20-year period (1997-2017), there was a “high burden” of benzodiazepine and Z-drug use in the IBD population. In 2017, roughly 20% of Manitobans with IBD were using benzodiazepines, and 20% were using Z-drugs, the study team reports.

The benzodiazepine use rate (per 1,000) was 28.06 in the IBD cohort vs. 16.83 in the non-IBD population (adjusted rate ratio, 1.67). The use rate for Z-drugs was 21.07 in the IBD cohort vs. 11.26 in the non-IBD population (adjusted RR, 1.87).

Benzodiazepine use declined from 1997 to 2016, but it remained at least 50% higher in patients with IBD than in the general population over this period, the researchers found. The rate of Z-drug use also was higher in the IBD population than in the general population but remained stable over the 20-year study period.

Regardless of age, men and women had similarly high use rates for benzodiazepines, Z-drugs, and joint use of benzodiazepines and Z-drugs. The highest incidence rates for joint benzodiazepine and Z-drug use were in young adults (age 18-44 years), and these rates were similar among men and women.

Patients with IBD and a mood/anxiety disorder also were more likely to use benzodiazepines and Z-drugs and to be continuous users than were those without a mood/anxiety disorder.
 

Mental health and IBD go hand in hand

“The results are not very surprising, but they highlight the importance of mental health and mood disturbances in patients with IBD,” Ashwin Ananthakrishnan, MBBS, MPH, with Massachusetts General Hospital and Harvard Medical School in Boston, who wasn’t involved in the study, told this news organization.

“It is important for treating physicians to be aware of the important mental health implications of IBD diagnosis and disease activity, to screen patients for these disturbances, and to institute early effective interventions,” Dr. Ananthakrishnan said.

Also offering perspective, Laurie Keefer, PhD, academic health psychologist and director of psychobehavioral research within the division of gastroenterology, Mount Sinai Health System, New York, said that she is “concerned but not surprised” by the results of this study.

“One in three patients with IBD meets criteria for an anxiety disorder,” Dr. Keefer told this news organization.

And with the ongoing mental health crisis and shortage of mental health providers, “gastroenterologists are, unfortunately, in the position where they may have to manage these issues,” she said.

Dr. Keefer noted that when patients are first diagnosed with IBD, they will likely be on prednisone, and “an antidote” for the side effects of prednisone are benzodiazepines and sleeping medications because prednisone itself causes insomnia. “However, that’s really just a band-aid,” she said.

A major concern, said Dr. Keefer, is that young men and women who are diagnosed with IBD in their 20s may start using these drugs and become reliant on them.

“People do build up a tolerance to these drugs, so they need more and more to receive the same effect,” she said.

A better approach is to figure out why patients are so anxious and teach them skills to manage their anxiety and sleep problems so that they’re not dependent on these drugs, Dr. Keefer said.

“There are behavioral strategies that can help. These are harder to do, and they’re not a quick fix. However, they are skills you can learn in your 20s and so when you have an IBD flare at 50, you have the skills to deal with it,” she said.

“We just have to be a little more proactive in really encouraging patients to learn disease management skills,” Dr. Keefer added.

The study was funded by the Canadian Institutes of Health Research and Crohn’s and Colitis Canada. Dr. Bernstein has disclosed relationships with AbbVie Canada, Amgen Canada, Bristol-Myers Squibb Canada, Roche Canada, Janssen Canada, Sandoz Canada, Takeda and Takeda Canada, Pfizer Canada, Mylan Pharmaceuticals, and Medtronic Canada. Dr. Ananthakrishnan and Dr. Keefer report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Patients with inflammatory bowel disease (IBD) are 70% more likely to use benzodiazepines and “Z-drugs” than are the general population, a large study from Canada suggests. 

Mood/anxiety disorders and sleep disorders are common in patients with IBD, but few studies have looked at use of benzodiazepines and Z-drugs (such as zolpidem, zaleplon, and eszopiclone) in this patient population.

The results are “concerning, and especially as the IBD population ages, these drugs are associated with health risks, including something as simple as falls,” first author Charles Bernstein, MD, of the IBD clinical and research centre, University of Manitoba, Winnipeg, told this news organization.

“Clinicians need to find better strategies to deal with anxiety disorders and sleep disorders in the IBD population,” Dr. Bernstein said.

The study was published online in the American Journal of Gastroenterology.
 

High burden of use

Using administrative data from Manitoba, Dr. Bernstein and colleagues identified 5,741 patients with IBD (2,381 with Crohn’s disease and 3,360 with ulcerative colitis) and matched them (1:5) to 28,661 population controls without IBD.

Over a 20-year period (1997-2017), there was a “high burden” of benzodiazepine and Z-drug use in the IBD population. In 2017, roughly 20% of Manitobans with IBD were using benzodiazepines, and 20% were using Z-drugs, the study team reports.

The benzodiazepine use rate (per 1,000) was 28.06 in the IBD cohort vs. 16.83 in the non-IBD population (adjusted rate ratio, 1.67). The use rate for Z-drugs was 21.07 in the IBD cohort vs. 11.26 in the non-IBD population (adjusted RR, 1.87).

Benzodiazepine use declined from 1997 to 2016, but it remained at least 50% higher in patients with IBD than in the general population over this period, the researchers found. The rate of Z-drug use also was higher in the IBD population than in the general population but remained stable over the 20-year study period.

Regardless of age, men and women had similarly high use rates for benzodiazepines, Z-drugs, and joint use of benzodiazepines and Z-drugs. The highest incidence rates for joint benzodiazepine and Z-drug use were in young adults (age 18-44 years), and these rates were similar among men and women.

Patients with IBD and a mood/anxiety disorder also were more likely to use benzodiazepines and Z-drugs and to be continuous users than were those without a mood/anxiety disorder.
 

Mental health and IBD go hand in hand

“The results are not very surprising, but they highlight the importance of mental health and mood disturbances in patients with IBD,” Ashwin Ananthakrishnan, MBBS, MPH, with Massachusetts General Hospital and Harvard Medical School in Boston, who wasn’t involved in the study, told this news organization.

“It is important for treating physicians to be aware of the important mental health implications of IBD diagnosis and disease activity, to screen patients for these disturbances, and to institute early effective interventions,” Dr. Ananthakrishnan said.

Also offering perspective, Laurie Keefer, PhD, academic health psychologist and director of psychobehavioral research within the division of gastroenterology, Mount Sinai Health System, New York, said that she is “concerned but not surprised” by the results of this study.

“One in three patients with IBD meets criteria for an anxiety disorder,” Dr. Keefer told this news organization.

And with the ongoing mental health crisis and shortage of mental health providers, “gastroenterologists are, unfortunately, in the position where they may have to manage these issues,” she said.

Dr. Keefer noted that when patients are first diagnosed with IBD, they will likely be on prednisone, and “an antidote” for the side effects of prednisone are benzodiazepines and sleeping medications because prednisone itself causes insomnia. “However, that’s really just a band-aid,” she said.

A major concern, said Dr. Keefer, is that young men and women who are diagnosed with IBD in their 20s may start using these drugs and become reliant on them.

“People do build up a tolerance to these drugs, so they need more and more to receive the same effect,” she said.

A better approach is to figure out why patients are so anxious and teach them skills to manage their anxiety and sleep problems so that they’re not dependent on these drugs, Dr. Keefer said.

“There are behavioral strategies that can help. These are harder to do, and they’re not a quick fix. However, they are skills you can learn in your 20s and so when you have an IBD flare at 50, you have the skills to deal with it,” she said.

“We just have to be a little more proactive in really encouraging patients to learn disease management skills,” Dr. Keefer added.

The study was funded by the Canadian Institutes of Health Research and Crohn’s and Colitis Canada. Dr. Bernstein has disclosed relationships with AbbVie Canada, Amgen Canada, Bristol-Myers Squibb Canada, Roche Canada, Janssen Canada, Sandoz Canada, Takeda and Takeda Canada, Pfizer Canada, Mylan Pharmaceuticals, and Medtronic Canada. Dr. Ananthakrishnan and Dr. Keefer report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Doctors caring for patients taking steroids now have broader flexibility for which drugs to use to prevent osteoporosis associated with the medications.

The American College of Rheumatology (ACR) has released an updated guideline that advises treatment providers on when and how long to prescribe therapies that prevent or treat glucocorticoid-induced osteoporosis (GIOP). Since the ACR last updated the guideline in 2017, the Food and Drug Administration has approved new treatments for osteoporosis, which are now included in the recommendations.

The new guideline also advises physicians that they may need to transition patients to a second treatment after concluding a first course – so-called sequential therapy – to better protect them against bone loss and fracture. It also offers detailed instructions for which drugs to use, when, and how long these medications should be administered for patients taking glucocorticoids over a long period of time.

The guideline’s inclusion of sequential therapy is significant and will be helpful to practicing clinicians, according to S.B. Tanner IV, MD, director of the Osteoporosis Clinic at Vanderbilt Health, Nashville, Tenn.

“For the first time, the ACR has offered guidance for starting and stopping treatments,” Dr. Tanner said. “This guideline supports awareness that osteoporosis is lifelong – something that will consistently need monitoring.”

An estimated 2.5 million Americans use glucocorticoids, according to a 2013 study in Arthritis Care & Research. Meanwhile, a 2019 study of residents in Denmark found 3% of people in the country were prescribed glucocorticoids annually. That study estimated 54% of glucocorticoid users were female and found the percentage of people taking glucocorticoids increased with age.

Glucocorticoids are used to treat a variety of inflammatory conditions, from multiple sclerosis to lupus, and often are prescribed to transplant patients to prevent their immune systems from rejecting new organs. When taken over time these medications can cause osteoporosis, which in turn raises the risk of fracture.

More than 10% of patients who receive long-term glucocorticoid treatment are diagnosed with clinical fractures. In addition, even low-dose glucocorticoid therapy is associated with a bone loss rate of 10% per year for a patient.

Osteoporosis prevention

After stopping some prevention therapies for GIOP, a high risk of bone loss or fracture still persists, according to Linda A. Russell, MD, director of the Osteoporosis and Metabolic Bone Health Center for the Hospital for Special Surgery, New York, and co-principal investigator of the new guideline.

“We wanted to be sure the need for sequential treatment is adequately communicated, including to patients who might not know they need to start a second medication,” Dr. Russell said.

Physicians and patients must be aware that when completing a course of one GIOP treatment, another drug for the condition should be started, as specified in the guideline.

“Early intervention can prevent glucocorticoid-induced fractures that can lead to substantial morbidity and increased mortality,” said Mary Beth Humphrey, MD, PhD, interim vice president for research at the University of Oklahoma Health Sciences Center in Oklahoma City and co-principal investigator of the ACR guideline.

Anyone can fracture

While age and other risk factors, including menopause, increase the risk of developing GIOP, bone loss can occur rapidly for a patient of any age.

Even a glucocorticoid dose as low as 2.5 mg will increase the risk of vertebral fractures, with some occurring as soon as 3 months after treatment starts, Dr. Humphrey said. For patients taking up to 7.5 mg daily, the risk of vertebral fracture doubles. Doses greater than 10 mg daily for more than 3 months raise the likelihood of a vertebral fracture by a factor of 14, and result in a 300% increase in the likelihood of hip fractures, according to Dr. Humphrey.

“When on steroids, even patients with high bone density scores can fracture,” Dr. Tanner said. “The 2017 guideline was almost too elaborate in its effort to calculate risk. The updated guideline acknowledges moderate risk and suggests that this is a group of patients who need treatment.”
 

Rank ordering adds flexibility

The updated ACR guideline no longer ranks medications based on patient fracture data, side effects, cost care, and whether the drug is provided through injection, pill, or IV.

All of the preventive treatments the panel recommends reduce the risk of steroid-induced bone loss, Dr. Humphrey said.

“We thought the 2017 guideline was too restrictive,” Dr. Russell said. “We’re giving physicians and patients more leeway to choose a medication based on their preferences.”

Patient preference of delivery mechanism – such as a desire for pills only – can now be weighed more heavily into drug treatment decisions.

“In the exam room, there are three dynamics going on: What the patient wants, what the doctor knows is most effective, and what the insurer will pay,” Dr. Tanner said. “Doing away with rank ordering opens up the conversation beyond cost to consider all those factors.”

The guideline team conducted a systematic literature review for clinical questions on nonpharmacologic and pharmacologic treatment addressed in the 2017 guideline, and for questions on new pharmacologic treatments, discontinuation of medications, and sequential and combination therapy. The voting panel consisted of two patient representatives and 13 experts representing adult and pediatric rheumatology and endocrinology, nephrology, and gastroenterology.

A full manuscript has been submitted for publication in Arthritis & Rheumatology and Arthritis Care and Research for peer review, and is expected to publish in early 2023.

Dr. Humphrey and Dr. Russell, the co-principal investigators for the guideline, and Dr. Rubin have disclosed no relevant financial relationships. Dr. Tanner reported a current research grant funded by Amgen through the University of Alabama at Birmingham and being a paid course instructor for the International Society for Clinical Densitometry bone density course, Osteoporosis Essentials.

A version of this article first appeared on Medscape.com.

Doctors caring for patients taking steroids now have broader flexibility for which drugs to use to prevent osteoporosis associated with the medications.

The American College of Rheumatology (ACR) has released an updated guideline that advises treatment providers on when and how long to prescribe therapies that prevent or treat glucocorticoid-induced osteoporosis (GIOP). Since the ACR last updated the guideline in 2017, the Food and Drug Administration has approved new treatments for osteoporosis, which are now included in the recommendations.

The new guideline also advises physicians that they may need to transition patients to a second treatment after concluding a first course – so-called sequential therapy – to better protect them against bone loss and fracture. It also offers detailed instructions for which drugs to use, when, and how long these medications should be administered for patients taking glucocorticoids over a long period of time.

The guideline’s inclusion of sequential therapy is significant and will be helpful to practicing clinicians, according to S.B. Tanner IV, MD, director of the Osteoporosis Clinic at Vanderbilt Health, Nashville, Tenn.

“For the first time, the ACR has offered guidance for starting and stopping treatments,” Dr. Tanner said. “This guideline supports awareness that osteoporosis is lifelong – something that will consistently need monitoring.”

An estimated 2.5 million Americans use glucocorticoids, according to a 2013 study in Arthritis Care & Research. Meanwhile, a 2019 study of residents in Denmark found 3% of people in the country were prescribed glucocorticoids annually. That study estimated 54% of glucocorticoid users were female and found the percentage of people taking glucocorticoids increased with age.

Glucocorticoids are used to treat a variety of inflammatory conditions, from multiple sclerosis to lupus, and often are prescribed to transplant patients to prevent their immune systems from rejecting new organs. When taken over time these medications can cause osteoporosis, which in turn raises the risk of fracture.

More than 10% of patients who receive long-term glucocorticoid treatment are diagnosed with clinical fractures. In addition, even low-dose glucocorticoid therapy is associated with a bone loss rate of 10% per year for a patient.

Osteoporosis prevention

After stopping some prevention therapies for GIOP, a high risk of bone loss or fracture still persists, according to Linda A. Russell, MD, director of the Osteoporosis and Metabolic Bone Health Center for the Hospital for Special Surgery, New York, and co-principal investigator of the new guideline.

“We wanted to be sure the need for sequential treatment is adequately communicated, including to patients who might not know they need to start a second medication,” Dr. Russell said.

Physicians and patients must be aware that when completing a course of one GIOP treatment, another drug for the condition should be started, as specified in the guideline.

“Early intervention can prevent glucocorticoid-induced fractures that can lead to substantial morbidity and increased mortality,” said Mary Beth Humphrey, MD, PhD, interim vice president for research at the University of Oklahoma Health Sciences Center in Oklahoma City and co-principal investigator of the ACR guideline.

Anyone can fracture

While age and other risk factors, including menopause, increase the risk of developing GIOP, bone loss can occur rapidly for a patient of any age.

Even a glucocorticoid dose as low as 2.5 mg will increase the risk of vertebral fractures, with some occurring as soon as 3 months after treatment starts, Dr. Humphrey said. For patients taking up to 7.5 mg daily, the risk of vertebral fracture doubles. Doses greater than 10 mg daily for more than 3 months raise the likelihood of a vertebral fracture by a factor of 14, and result in a 300% increase in the likelihood of hip fractures, according to Dr. Humphrey.

“When on steroids, even patients with high bone density scores can fracture,” Dr. Tanner said. “The 2017 guideline was almost too elaborate in its effort to calculate risk. The updated guideline acknowledges moderate risk and suggests that this is a group of patients who need treatment.”
 

Rank ordering adds flexibility

The updated ACR guideline no longer ranks medications based on patient fracture data, side effects, cost care, and whether the drug is provided through injection, pill, or IV.

All of the preventive treatments the panel recommends reduce the risk of steroid-induced bone loss, Dr. Humphrey said.

“We thought the 2017 guideline was too restrictive,” Dr. Russell said. “We’re giving physicians and patients more leeway to choose a medication based on their preferences.”

Patient preference of delivery mechanism – such as a desire for pills only – can now be weighed more heavily into drug treatment decisions.

“In the exam room, there are three dynamics going on: What the patient wants, what the doctor knows is most effective, and what the insurer will pay,” Dr. Tanner said. “Doing away with rank ordering opens up the conversation beyond cost to consider all those factors.”

The guideline team conducted a systematic literature review for clinical questions on nonpharmacologic and pharmacologic treatment addressed in the 2017 guideline, and for questions on new pharmacologic treatments, discontinuation of medications, and sequential and combination therapy. The voting panel consisted of two patient representatives and 13 experts representing adult and pediatric rheumatology and endocrinology, nephrology, and gastroenterology.

A full manuscript has been submitted for publication in Arthritis & Rheumatology and Arthritis Care and Research for peer review, and is expected to publish in early 2023.

Dr. Humphrey and Dr. Russell, the co-principal investigators for the guideline, and Dr. Rubin have disclosed no relevant financial relationships. Dr. Tanner reported a current research grant funded by Amgen through the University of Alabama at Birmingham and being a paid course instructor for the International Society for Clinical Densitometry bone density course, Osteoporosis Essentials.

A version of this article first appeared on Medscape.com.

Doctors caring for patients taking steroids now have broader flexibility for which drugs to use to prevent osteoporosis associated with the medications.

The American College of Rheumatology (ACR) has released an updated guideline that advises treatment providers on when and how long to prescribe therapies that prevent or treat glucocorticoid-induced osteoporosis (GIOP). Since the ACR last updated the guideline in 2017, the Food and Drug Administration has approved new treatments for osteoporosis, which are now included in the recommendations.

The new guideline also advises physicians that they may need to transition patients to a second treatment after concluding a first course – so-called sequential therapy – to better protect them against bone loss and fracture. It also offers detailed instructions for which drugs to use, when, and how long these medications should be administered for patients taking glucocorticoids over a long period of time.

The guideline’s inclusion of sequential therapy is significant and will be helpful to practicing clinicians, according to S.B. Tanner IV, MD, director of the Osteoporosis Clinic at Vanderbilt Health, Nashville, Tenn.

“For the first time, the ACR has offered guidance for starting and stopping treatments,” Dr. Tanner said. “This guideline supports awareness that osteoporosis is lifelong – something that will consistently need monitoring.”

An estimated 2.5 million Americans use glucocorticoids, according to a 2013 study in Arthritis Care & Research. Meanwhile, a 2019 study of residents in Denmark found 3% of people in the country were prescribed glucocorticoids annually. That study estimated 54% of glucocorticoid users were female and found the percentage of people taking glucocorticoids increased with age.

Glucocorticoids are used to treat a variety of inflammatory conditions, from multiple sclerosis to lupus, and often are prescribed to transplant patients to prevent their immune systems from rejecting new organs. When taken over time these medications can cause osteoporosis, which in turn raises the risk of fracture.

More than 10% of patients who receive long-term glucocorticoid treatment are diagnosed with clinical fractures. In addition, even low-dose glucocorticoid therapy is associated with a bone loss rate of 10% per year for a patient.

Osteoporosis prevention

After stopping some prevention therapies for GIOP, a high risk of bone loss or fracture still persists, according to Linda A. Russell, MD, director of the Osteoporosis and Metabolic Bone Health Center for the Hospital for Special Surgery, New York, and co-principal investigator of the new guideline.

“We wanted to be sure the need for sequential treatment is adequately communicated, including to patients who might not know they need to start a second medication,” Dr. Russell said.

Physicians and patients must be aware that when completing a course of one GIOP treatment, another drug for the condition should be started, as specified in the guideline.

“Early intervention can prevent glucocorticoid-induced fractures that can lead to substantial morbidity and increased mortality,” said Mary Beth Humphrey, MD, PhD, interim vice president for research at the University of Oklahoma Health Sciences Center in Oklahoma City and co-principal investigator of the ACR guideline.

Anyone can fracture

While age and other risk factors, including menopause, increase the risk of developing GIOP, bone loss can occur rapidly for a patient of any age.

Even a glucocorticoid dose as low as 2.5 mg will increase the risk of vertebral fractures, with some occurring as soon as 3 months after treatment starts, Dr. Humphrey said. For patients taking up to 7.5 mg daily, the risk of vertebral fracture doubles. Doses greater than 10 mg daily for more than 3 months raise the likelihood of a vertebral fracture by a factor of 14, and result in a 300% increase in the likelihood of hip fractures, according to Dr. Humphrey.

“When on steroids, even patients with high bone density scores can fracture,” Dr. Tanner said. “The 2017 guideline was almost too elaborate in its effort to calculate risk. The updated guideline acknowledges moderate risk and suggests that this is a group of patients who need treatment.”
 

Rank ordering adds flexibility

The updated ACR guideline no longer ranks medications based on patient fracture data, side effects, cost care, and whether the drug is provided through injection, pill, or IV.

All of the preventive treatments the panel recommends reduce the risk of steroid-induced bone loss, Dr. Humphrey said.

“We thought the 2017 guideline was too restrictive,” Dr. Russell said. “We’re giving physicians and patients more leeway to choose a medication based on their preferences.”

Patient preference of delivery mechanism – such as a desire for pills only – can now be weighed more heavily into drug treatment decisions.

“In the exam room, there are three dynamics going on: What the patient wants, what the doctor knows is most effective, and what the insurer will pay,” Dr. Tanner said. “Doing away with rank ordering opens up the conversation beyond cost to consider all those factors.”

The guideline team conducted a systematic literature review for clinical questions on nonpharmacologic and pharmacologic treatment addressed in the 2017 guideline, and for questions on new pharmacologic treatments, discontinuation of medications, and sequential and combination therapy. The voting panel consisted of two patient representatives and 13 experts representing adult and pediatric rheumatology and endocrinology, nephrology, and gastroenterology.

A full manuscript has been submitted for publication in Arthritis & Rheumatology and Arthritis Care and Research for peer review, and is expected to publish in early 2023.

Dr. Humphrey and Dr. Russell, the co-principal investigators for the guideline, and Dr. Rubin have disclosed no relevant financial relationships. Dr. Tanner reported a current research grant funded by Amgen through the University of Alabama at Birmingham and being a paid course instructor for the International Society for Clinical Densitometry bone density course, Osteoporosis Essentials.

A version of this article first appeared on Medscape.com.

An athletic coach stands in front of a packed gym full of high school students.
 

“Don’t have sex,” he instructs, “because you will get pregnant and die. Don’t have sex in the missionary position. Don’t have sex standing up. Just don’t do it, promise? Okay, everybody take some rubbers.”

Sad to say, this scene from the 2004 movie “Mean Girls” bears a striking resemblance to the actual sex education courses taught in schools across the United States today. In fact, things may have gotten measurably worse.

National data recently published by the Guttmacher Institute showed that adolescents were less likely to receive adequate sex education from 2015 to 2019 than they were in 1995. Only half of kids aged 15-19 received sex education that met minimum standards recommended by the Department of Health & Human Services, and fewer than half were given this information before having sex for the first time. With such a vast learning gap, it is no surprise that the United States has some of the highest rates of teenage pregnancy and sexually transmitted infections in the developed world.

Concerned and motivated by this need for sex education, physicians and other medical professionals are stepping in to fill the void, offering sexual health information through a range of methods to students of all ages (some a lot older than one may think). It is a calling that takes them outside their hospitals and exam rooms into workshops and through educational materials, video, and social media content created from scratch.

“The fact that we’re able to go in and provide factual, scientific, important information that can affect the trajectory of someone’s life is powerful,” said Julia Rossen, part of a contingent of med students at Brown University, Providence, R.I., who now teach sex ed as an elective.

Their goals are not just about protecting health. Many are also teaching about other topics commonly ignored in sex education classes, such as consent, pleasure, LGBTQ+ identities, and cultural competence. There is a mutually beneficial relationship, they say, between their sex education work and their medical practice.
 

Changing the status quo

A jumble of state laws govern how and when schools should offer sex education courses. Individual school districts often make the final decisions about their content, creating even more inconsistent standards. Only 29 states and the District of Columbia mandate sex education, and 13 of those do not require that it be medically accurate. Abstinence-only education, which has been shown to be ineffective, is exclusively taught in 16 states.

Without formal instruction, many young people must learn about sex from family members, who may be unwilling, or they may share knowledge between themselves, which is often incorrect, or navigate the limitless information and misinformation available on the internet.

The consequences of this were apparent to several medical students at Brown University in 2013. At the time, the rate of teenage pregnancy across Rhode Island was 1 in 100, but in the small city of Central Falls, it was 1 in 25. Aiming to improve this, the group created a comprehensive sex education program for a Central Falls middle school that was taught by medical student volunteers.

The Sex Ed by Brown Med program continues today. It consists of eight in-person sessions. Topics include anatomy, contraception, STIs, sexual decision-making, consent, sexual violence, and sexual and gender identity. Through this program, as well as other factors, the Central Falls teenage pregnancy rate declined to 1.6 in 100 from 2016 to 2020, according to the Rhode Island Department of Health.

“Historically, sexual education has been politicized,” said Ms. Rossen, one of the current program leaders. “It’s been at the discretion of a lot of different factors that aren’t under the control of the communities that are actually receiving the education.”

Among seventh graders, the teachers say they encounter different levels of maturity. But they feel that the kids are more receptive and open with younger adults who, like them, are still students. Some volunteers recall the flaws in their own sex education, particularly regarding topics such as consent and gender and sexual identity, and they believe middle school is the time to begin the sexual health conversation. “By the time you’re talking to college-age students, it’s pretty much too late,” said another group leader, Benjamin Stone.

Mr. Stone feels that practicing having these often-awkward discussions enhances their clinical skills as physicians. “Sex and sexual history are part of the comprehensive medical interview. People want to have these conversations, and they’re looking for someone to open the door. The kids are excited that we’re opening that door for them. And I think patients feel the same way.”
 

Conquering social media

Opening the door has been more like releasing a floodgate for Danielle Jones, MD, an ob.gyn. physician who is originally from Texas but who moved to New Zealand in 2021. Known on social media as “Mama Doctor Jones,” she has garnered more than 3 million followers across YouTube, TikTok, Twitter, Instagram, and Facebook. Dr. Jones produces short, friendly, entertaining videos on a range of reproductive health and sex education topics. They appeal to an adolescent audience hungry for a trustworthy voice on issues such as,: “5 ‘Strange’ Things Your Vagina Does That Are NORMAL” and “Condom Broke ... Now What?”

Dr. Jones uses her platform to debunk some of the misleading and inaccurate sexual health information being taught in classrooms, by other social media influencers, and that is found on the internet in general. Her no-nonsense-style videos call out such myths as being unable to pee with a tampon in, Plan B emergency contraception causing abortions, and COVID-19 vaccines damaging fertility.

“The way sex ed is done in the U.S. in most places is continuing the taboo by making it a one-time discussion or health class,” said Dr. Jones, “particularly if boys and girls are separated. That doesn’t further communication between people or foster an environment where it’s okay to discuss your body and puberty and changes in sexual health in general. And if you can’t talk about it in educational spaces, you’re certainly not going to be comfortable talking about that in a one-on-one situation with another 16-year-old.”

Taking on other taboos, Dr. Jones has been outspoken about abortion and the consequences of the recent Supreme Court decision, both as an ethical issue and a medical one that endangers lives. Raised in a deeply religious family, Dr. Jones said she was indoctrinated with antiabortion views, and it took time for her thinking to evolve “from a scientific and humanistic standpoint.” While working in a Texas private practice, Dr. Jones described being unable to mention abortion online because of fear of losing her patients and for her own safety.

Now free of those constraints, Dr. Jones feels that her videos can be important resources for teachers who may have little health training. And she is enthusiastic about the complementary relationship between her social media work and her clinical practice. “There are conversations I have all the time in the clinic where patients tell me: ‘Nobody’s ever really had this conversation in this way with me. Thank you for explaining that,’ ” said Dr. Jones. “And then I think: ‘Well, now I’ll have it with a hundred thousand other people too.’ ”
 

Promoting pleasure

While not an ob.gyn., discussing sexuality with patients has become a focus for Evelin Dacker, MD, a family physician in Salem, Ore. Dr. Dacker is certified in functional medicine, which takes a holistic and integrative approach. During her training she had a sudden realization: Sexuality had not been discussed at any point during her medical education.

“I recognized that this was a huge gap in how we deal with a person as a human,” Dr. Dacker explained. “Since sexuality plays a role in so many aspects of our humanness, not just having sex.”

Dr. Dacker believes in rethinking sexuality as a fundamental part of overall health, as vital as nutrition or blood pressure. Outside her medical practice, she teaches classes and workshops on sexual health and sex positivity for young adults and other physicians. She has also developed an educational framework for sexual health topics. Dr. Dacker said she frequently confronts the idea that sexuality is only about engaging with another person. She disagrees. Using food as a metaphor, she argues that just as the pleasure of eating something is purely for oneself, sexuality belongs to the individual.

Sexuality can also be a tool for pleasure, which Dr. Dacker believes plays an essential role in physical health. “Pleasure is a medicine,” Dr. Dacker said. “I actually prescribe self-pleasure practices to my patients, so they can start owning it within themselves. Make sure you get 7-8 hours of sleep, do some breathing exercises to help bring down your stress, and do self-pleasure so that you can integrate into your body better.”

She added that the impact of prioritizing one’s own desires, needs, and boundaries can transform how people view their sexuality. Her adult students frequently ask: “Why wasn’t I taught this as a teenager?”
 

Speaking of adult students – An older generation learns new tricks

While the teen cohort is usually the focus, the lack of sex education in previous decades – and the way sexual culture has evolved in that time – have an impact on older groups. Among U.S. adults aged 55 and older, the rate of STIs has more than doubled in the past 10 years, according to the Centers for Disease Control and Prevention. While the majority of STI cases still occur among teenagers and young adults, the consistent increase in STIs among older persons is cause for concern among physicians and researchers.

The issue worries Shannon Dowler, MD, a family physician in western North Carolina and chief medical officer for North Carolina Medicaid. Dr. Dowler, who has practiced in an STI clinic throughout her career, began seeing more and more older adults with chlamydia, herpes, and other STIs. Dowler cites several factors behind the rise, including the growing retirement community population, the availability of pharmaceuticals for sexual dysfunction, and the “hook-up culture” that is active on dating apps, which research shows are regularly used by more than a third of adults older than 55.

Dr. Dowler also sees a lack of communication about sexual health between physicians and their older patients. “Older adults are more likely to be in relationship with their physician outside the exam room, especially if they’re in a small community,” Dr. Dowler said. “Sometimes they aren’t as comfortable sharing what their risks are. But we are guilty in medicine all the time of not asking. We assume someone’s older so they’re not having sex anymore. But, in fact, they are, and we’re not taking the time to say: ‘Let’s talk about your sex life. Are you at risk for anything? Are you having any difficulties with sex?’ We tend to avoid it as a health care culture.”

In contrast, Dr. Dowler said she talks about sexual health with anyone who will listen. She teaches classes in private schools and universities and for church youth groups and other physicians. She often finds that public schools are not interested, which she attributes to fear of her discussing things “outside the rule book.”

Dr. Dowler takes creative approaches. In 2017, she released a hip-hop video, “STD’s Never Get Old,” in which she raps about safe sex for older adults. Her video went viral, was mentioned by several news outlets, and received over 50,000 views on YouTube. Dr. Dowler’s latest project is a book, “Never Too Late: Your Guide to Safer Sex after 60,” which is scheduled for publication on Valentine’s Day, 2023.

“It’s sex ed for seniors,” she explained. “It’s that gym class that some people got – I won’t say everyone got – in high school. This is the version for older adults who didn’t get that. There are new infections now that didn’t exist when they had sex education, if they had sex education.”
 

A big subject requires a big mission

For others in the sex education field, physicians are allies in their fight against agendas designed to obstruct or erode sex education. Alison Macklin, director of policy and advocacy at SIECUS: Sex Ed for Social Change, formerly the Sexuality Information and Education Council of the United States, sees this struggle playing out in school boards and state legislatures across the country. For every comprehensive sex education bill passed or school district victory, there is yet another blocked proposal or restrictive law somewhere else.

Ms. Macklin urged doctors to get more involved locally and to expand their knowledge of sexual health issues by reaching out to organizations such as Planned Parenthood and to be “hyper vigilant” in their own communities.

“Doctors are trusted. People really respect what they have to say,” Ms. Macklin said. “And this is an important time for them to speak up.”

A version of this article first appeared on Medscape.com.

An athletic coach stands in front of a packed gym full of high school students.
 

“Don’t have sex,” he instructs, “because you will get pregnant and die. Don’t have sex in the missionary position. Don’t have sex standing up. Just don’t do it, promise? Okay, everybody take some rubbers.”

Sad to say, this scene from the 2004 movie “Mean Girls” bears a striking resemblance to the actual sex education courses taught in schools across the United States today. In fact, things may have gotten measurably worse.

National data recently published by the Guttmacher Institute showed that adolescents were less likely to receive adequate sex education from 2015 to 2019 than they were in 1995. Only half of kids aged 15-19 received sex education that met minimum standards recommended by the Department of Health & Human Services, and fewer than half were given this information before having sex for the first time. With such a vast learning gap, it is no surprise that the United States has some of the highest rates of teenage pregnancy and sexually transmitted infections in the developed world.

Concerned and motivated by this need for sex education, physicians and other medical professionals are stepping in to fill the void, offering sexual health information through a range of methods to students of all ages (some a lot older than one may think). It is a calling that takes them outside their hospitals and exam rooms into workshops and through educational materials, video, and social media content created from scratch.

“The fact that we’re able to go in and provide factual, scientific, important information that can affect the trajectory of someone’s life is powerful,” said Julia Rossen, part of a contingent of med students at Brown University, Providence, R.I., who now teach sex ed as an elective.

Their goals are not just about protecting health. Many are also teaching about other topics commonly ignored in sex education classes, such as consent, pleasure, LGBTQ+ identities, and cultural competence. There is a mutually beneficial relationship, they say, between their sex education work and their medical practice.
 

Changing the status quo

A jumble of state laws govern how and when schools should offer sex education courses. Individual school districts often make the final decisions about their content, creating even more inconsistent standards. Only 29 states and the District of Columbia mandate sex education, and 13 of those do not require that it be medically accurate. Abstinence-only education, which has been shown to be ineffective, is exclusively taught in 16 states.

Without formal instruction, many young people must learn about sex from family members, who may be unwilling, or they may share knowledge between themselves, which is often incorrect, or navigate the limitless information and misinformation available on the internet.

The consequences of this were apparent to several medical students at Brown University in 2013. At the time, the rate of teenage pregnancy across Rhode Island was 1 in 100, but in the small city of Central Falls, it was 1 in 25. Aiming to improve this, the group created a comprehensive sex education program for a Central Falls middle school that was taught by medical student volunteers.

The Sex Ed by Brown Med program continues today. It consists of eight in-person sessions. Topics include anatomy, contraception, STIs, sexual decision-making, consent, sexual violence, and sexual and gender identity. Through this program, as well as other factors, the Central Falls teenage pregnancy rate declined to 1.6 in 100 from 2016 to 2020, according to the Rhode Island Department of Health.

“Historically, sexual education has been politicized,” said Ms. Rossen, one of the current program leaders. “It’s been at the discretion of a lot of different factors that aren’t under the control of the communities that are actually receiving the education.”

Among seventh graders, the teachers say they encounter different levels of maturity. But they feel that the kids are more receptive and open with younger adults who, like them, are still students. Some volunteers recall the flaws in their own sex education, particularly regarding topics such as consent and gender and sexual identity, and they believe middle school is the time to begin the sexual health conversation. “By the time you’re talking to college-age students, it’s pretty much too late,” said another group leader, Benjamin Stone.

Mr. Stone feels that practicing having these often-awkward discussions enhances their clinical skills as physicians. “Sex and sexual history are part of the comprehensive medical interview. People want to have these conversations, and they’re looking for someone to open the door. The kids are excited that we’re opening that door for them. And I think patients feel the same way.”
 

Conquering social media

Opening the door has been more like releasing a floodgate for Danielle Jones, MD, an ob.gyn. physician who is originally from Texas but who moved to New Zealand in 2021. Known on social media as “Mama Doctor Jones,” she has garnered more than 3 million followers across YouTube, TikTok, Twitter, Instagram, and Facebook. Dr. Jones produces short, friendly, entertaining videos on a range of reproductive health and sex education topics. They appeal to an adolescent audience hungry for a trustworthy voice on issues such as,: “5 ‘Strange’ Things Your Vagina Does That Are NORMAL” and “Condom Broke ... Now What?”

Dr. Jones uses her platform to debunk some of the misleading and inaccurate sexual health information being taught in classrooms, by other social media influencers, and that is found on the internet in general. Her no-nonsense-style videos call out such myths as being unable to pee with a tampon in, Plan B emergency contraception causing abortions, and COVID-19 vaccines damaging fertility.

“The way sex ed is done in the U.S. in most places is continuing the taboo by making it a one-time discussion or health class,” said Dr. Jones, “particularly if boys and girls are separated. That doesn’t further communication between people or foster an environment where it’s okay to discuss your body and puberty and changes in sexual health in general. And if you can’t talk about it in educational spaces, you’re certainly not going to be comfortable talking about that in a one-on-one situation with another 16-year-old.”

Taking on other taboos, Dr. Jones has been outspoken about abortion and the consequences of the recent Supreme Court decision, both as an ethical issue and a medical one that endangers lives. Raised in a deeply religious family, Dr. Jones said she was indoctrinated with antiabortion views, and it took time for her thinking to evolve “from a scientific and humanistic standpoint.” While working in a Texas private practice, Dr. Jones described being unable to mention abortion online because of fear of losing her patients and for her own safety.

Now free of those constraints, Dr. Jones feels that her videos can be important resources for teachers who may have little health training. And she is enthusiastic about the complementary relationship between her social media work and her clinical practice. “There are conversations I have all the time in the clinic where patients tell me: ‘Nobody’s ever really had this conversation in this way with me. Thank you for explaining that,’ ” said Dr. Jones. “And then I think: ‘Well, now I’ll have it with a hundred thousand other people too.’ ”
 

Promoting pleasure

While not an ob.gyn., discussing sexuality with patients has become a focus for Evelin Dacker, MD, a family physician in Salem, Ore. Dr. Dacker is certified in functional medicine, which takes a holistic and integrative approach. During her training she had a sudden realization: Sexuality had not been discussed at any point during her medical education.

“I recognized that this was a huge gap in how we deal with a person as a human,” Dr. Dacker explained. “Since sexuality plays a role in so many aspects of our humanness, not just having sex.”

Dr. Dacker believes in rethinking sexuality as a fundamental part of overall health, as vital as nutrition or blood pressure. Outside her medical practice, she teaches classes and workshops on sexual health and sex positivity for young adults and other physicians. She has also developed an educational framework for sexual health topics. Dr. Dacker said she frequently confronts the idea that sexuality is only about engaging with another person. She disagrees. Using food as a metaphor, she argues that just as the pleasure of eating something is purely for oneself, sexuality belongs to the individual.

Sexuality can also be a tool for pleasure, which Dr. Dacker believes plays an essential role in physical health. “Pleasure is a medicine,” Dr. Dacker said. “I actually prescribe self-pleasure practices to my patients, so they can start owning it within themselves. Make sure you get 7-8 hours of sleep, do some breathing exercises to help bring down your stress, and do self-pleasure so that you can integrate into your body better.”

She added that the impact of prioritizing one’s own desires, needs, and boundaries can transform how people view their sexuality. Her adult students frequently ask: “Why wasn’t I taught this as a teenager?”
 

Speaking of adult students – An older generation learns new tricks

While the teen cohort is usually the focus, the lack of sex education in previous decades – and the way sexual culture has evolved in that time – have an impact on older groups. Among U.S. adults aged 55 and older, the rate of STIs has more than doubled in the past 10 years, according to the Centers for Disease Control and Prevention. While the majority of STI cases still occur among teenagers and young adults, the consistent increase in STIs among older persons is cause for concern among physicians and researchers.

The issue worries Shannon Dowler, MD, a family physician in western North Carolina and chief medical officer for North Carolina Medicaid. Dr. Dowler, who has practiced in an STI clinic throughout her career, began seeing more and more older adults with chlamydia, herpes, and other STIs. Dowler cites several factors behind the rise, including the growing retirement community population, the availability of pharmaceuticals for sexual dysfunction, and the “hook-up culture” that is active on dating apps, which research shows are regularly used by more than a third of adults older than 55.

Dr. Dowler also sees a lack of communication about sexual health between physicians and their older patients. “Older adults are more likely to be in relationship with their physician outside the exam room, especially if they’re in a small community,” Dr. Dowler said. “Sometimes they aren’t as comfortable sharing what their risks are. But we are guilty in medicine all the time of not asking. We assume someone’s older so they’re not having sex anymore. But, in fact, they are, and we’re not taking the time to say: ‘Let’s talk about your sex life. Are you at risk for anything? Are you having any difficulties with sex?’ We tend to avoid it as a health care culture.”

In contrast, Dr. Dowler said she talks about sexual health with anyone who will listen. She teaches classes in private schools and universities and for church youth groups and other physicians. She often finds that public schools are not interested, which she attributes to fear of her discussing things “outside the rule book.”

Dr. Dowler takes creative approaches. In 2017, she released a hip-hop video, “STD’s Never Get Old,” in which she raps about safe sex for older adults. Her video went viral, was mentioned by several news outlets, and received over 50,000 views on YouTube. Dr. Dowler’s latest project is a book, “Never Too Late: Your Guide to Safer Sex after 60,” which is scheduled for publication on Valentine’s Day, 2023.

“It’s sex ed for seniors,” she explained. “It’s that gym class that some people got – I won’t say everyone got – in high school. This is the version for older adults who didn’t get that. There are new infections now that didn’t exist when they had sex education, if they had sex education.”
 

A big subject requires a big mission

For others in the sex education field, physicians are allies in their fight against agendas designed to obstruct or erode sex education. Alison Macklin, director of policy and advocacy at SIECUS: Sex Ed for Social Change, formerly the Sexuality Information and Education Council of the United States, sees this struggle playing out in school boards and state legislatures across the country. For every comprehensive sex education bill passed or school district victory, there is yet another blocked proposal or restrictive law somewhere else.

Ms. Macklin urged doctors to get more involved locally and to expand their knowledge of sexual health issues by reaching out to organizations such as Planned Parenthood and to be “hyper vigilant” in their own communities.

“Doctors are trusted. People really respect what they have to say,” Ms. Macklin said. “And this is an important time for them to speak up.”

A version of this article first appeared on Medscape.com.

An athletic coach stands in front of a packed gym full of high school students.
 

“Don’t have sex,” he instructs, “because you will get pregnant and die. Don’t have sex in the missionary position. Don’t have sex standing up. Just don’t do it, promise? Okay, everybody take some rubbers.”

Sad to say, this scene from the 2004 movie “Mean Girls” bears a striking resemblance to the actual sex education courses taught in schools across the United States today. In fact, things may have gotten measurably worse.

National data recently published by the Guttmacher Institute showed that adolescents were less likely to receive adequate sex education from 2015 to 2019 than they were in 1995. Only half of kids aged 15-19 received sex education that met minimum standards recommended by the Department of Health & Human Services, and fewer than half were given this information before having sex for the first time. With such a vast learning gap, it is no surprise that the United States has some of the highest rates of teenage pregnancy and sexually transmitted infections in the developed world.

Concerned and motivated by this need for sex education, physicians and other medical professionals are stepping in to fill the void, offering sexual health information through a range of methods to students of all ages (some a lot older than one may think). It is a calling that takes them outside their hospitals and exam rooms into workshops and through educational materials, video, and social media content created from scratch.

“The fact that we’re able to go in and provide factual, scientific, important information that can affect the trajectory of someone’s life is powerful,” said Julia Rossen, part of a contingent of med students at Brown University, Providence, R.I., who now teach sex ed as an elective.

Their goals are not just about protecting health. Many are also teaching about other topics commonly ignored in sex education classes, such as consent, pleasure, LGBTQ+ identities, and cultural competence. There is a mutually beneficial relationship, they say, between their sex education work and their medical practice.
 

Changing the status quo

A jumble of state laws govern how and when schools should offer sex education courses. Individual school districts often make the final decisions about their content, creating even more inconsistent standards. Only 29 states and the District of Columbia mandate sex education, and 13 of those do not require that it be medically accurate. Abstinence-only education, which has been shown to be ineffective, is exclusively taught in 16 states.

Without formal instruction, many young people must learn about sex from family members, who may be unwilling, or they may share knowledge between themselves, which is often incorrect, or navigate the limitless information and misinformation available on the internet.

The consequences of this were apparent to several medical students at Brown University in 2013. At the time, the rate of teenage pregnancy across Rhode Island was 1 in 100, but in the small city of Central Falls, it was 1 in 25. Aiming to improve this, the group created a comprehensive sex education program for a Central Falls middle school that was taught by medical student volunteers.

The Sex Ed by Brown Med program continues today. It consists of eight in-person sessions. Topics include anatomy, contraception, STIs, sexual decision-making, consent, sexual violence, and sexual and gender identity. Through this program, as well as other factors, the Central Falls teenage pregnancy rate declined to 1.6 in 100 from 2016 to 2020, according to the Rhode Island Department of Health.

“Historically, sexual education has been politicized,” said Ms. Rossen, one of the current program leaders. “It’s been at the discretion of a lot of different factors that aren’t under the control of the communities that are actually receiving the education.”

Among seventh graders, the teachers say they encounter different levels of maturity. But they feel that the kids are more receptive and open with younger adults who, like them, are still students. Some volunteers recall the flaws in their own sex education, particularly regarding topics such as consent and gender and sexual identity, and they believe middle school is the time to begin the sexual health conversation. “By the time you’re talking to college-age students, it’s pretty much too late,” said another group leader, Benjamin Stone.

Mr. Stone feels that practicing having these often-awkward discussions enhances their clinical skills as physicians. “Sex and sexual history are part of the comprehensive medical interview. People want to have these conversations, and they’re looking for someone to open the door. The kids are excited that we’re opening that door for them. And I think patients feel the same way.”
 

Conquering social media

Opening the door has been more like releasing a floodgate for Danielle Jones, MD, an ob.gyn. physician who is originally from Texas but who moved to New Zealand in 2021. Known on social media as “Mama Doctor Jones,” she has garnered more than 3 million followers across YouTube, TikTok, Twitter, Instagram, and Facebook. Dr. Jones produces short, friendly, entertaining videos on a range of reproductive health and sex education topics. They appeal to an adolescent audience hungry for a trustworthy voice on issues such as,: “5 ‘Strange’ Things Your Vagina Does That Are NORMAL” and “Condom Broke ... Now What?”

Dr. Jones uses her platform to debunk some of the misleading and inaccurate sexual health information being taught in classrooms, by other social media influencers, and that is found on the internet in general. Her no-nonsense-style videos call out such myths as being unable to pee with a tampon in, Plan B emergency contraception causing abortions, and COVID-19 vaccines damaging fertility.

“The way sex ed is done in the U.S. in most places is continuing the taboo by making it a one-time discussion or health class,” said Dr. Jones, “particularly if boys and girls are separated. That doesn’t further communication between people or foster an environment where it’s okay to discuss your body and puberty and changes in sexual health in general. And if you can’t talk about it in educational spaces, you’re certainly not going to be comfortable talking about that in a one-on-one situation with another 16-year-old.”

Taking on other taboos, Dr. Jones has been outspoken about abortion and the consequences of the recent Supreme Court decision, both as an ethical issue and a medical one that endangers lives. Raised in a deeply religious family, Dr. Jones said she was indoctrinated with antiabortion views, and it took time for her thinking to evolve “from a scientific and humanistic standpoint.” While working in a Texas private practice, Dr. Jones described being unable to mention abortion online because of fear of losing her patients and for her own safety.

Now free of those constraints, Dr. Jones feels that her videos can be important resources for teachers who may have little health training. And she is enthusiastic about the complementary relationship between her social media work and her clinical practice. “There are conversations I have all the time in the clinic where patients tell me: ‘Nobody’s ever really had this conversation in this way with me. Thank you for explaining that,’ ” said Dr. Jones. “And then I think: ‘Well, now I’ll have it with a hundred thousand other people too.’ ”
 

Promoting pleasure

While not an ob.gyn., discussing sexuality with patients has become a focus for Evelin Dacker, MD, a family physician in Salem, Ore. Dr. Dacker is certified in functional medicine, which takes a holistic and integrative approach. During her training she had a sudden realization: Sexuality had not been discussed at any point during her medical education.

“I recognized that this was a huge gap in how we deal with a person as a human,” Dr. Dacker explained. “Since sexuality plays a role in so many aspects of our humanness, not just having sex.”

Dr. Dacker believes in rethinking sexuality as a fundamental part of overall health, as vital as nutrition or blood pressure. Outside her medical practice, she teaches classes and workshops on sexual health and sex positivity for young adults and other physicians. She has also developed an educational framework for sexual health topics. Dr. Dacker said she frequently confronts the idea that sexuality is only about engaging with another person. She disagrees. Using food as a metaphor, she argues that just as the pleasure of eating something is purely for oneself, sexuality belongs to the individual.

Sexuality can also be a tool for pleasure, which Dr. Dacker believes plays an essential role in physical health. “Pleasure is a medicine,” Dr. Dacker said. “I actually prescribe self-pleasure practices to my patients, so they can start owning it within themselves. Make sure you get 7-8 hours of sleep, do some breathing exercises to help bring down your stress, and do self-pleasure so that you can integrate into your body better.”

She added that the impact of prioritizing one’s own desires, needs, and boundaries can transform how people view their sexuality. Her adult students frequently ask: “Why wasn’t I taught this as a teenager?”
 

Speaking of adult students – An older generation learns new tricks

While the teen cohort is usually the focus, the lack of sex education in previous decades – and the way sexual culture has evolved in that time – have an impact on older groups. Among U.S. adults aged 55 and older, the rate of STIs has more than doubled in the past 10 years, according to the Centers for Disease Control and Prevention. While the majority of STI cases still occur among teenagers and young adults, the consistent increase in STIs among older persons is cause for concern among physicians and researchers.

The issue worries Shannon Dowler, MD, a family physician in western North Carolina and chief medical officer for North Carolina Medicaid. Dr. Dowler, who has practiced in an STI clinic throughout her career, began seeing more and more older adults with chlamydia, herpes, and other STIs. Dowler cites several factors behind the rise, including the growing retirement community population, the availability of pharmaceuticals for sexual dysfunction, and the “hook-up culture” that is active on dating apps, which research shows are regularly used by more than a third of adults older than 55.

Dr. Dowler also sees a lack of communication about sexual health between physicians and their older patients. “Older adults are more likely to be in relationship with their physician outside the exam room, especially if they’re in a small community,” Dr. Dowler said. “Sometimes they aren’t as comfortable sharing what their risks are. But we are guilty in medicine all the time of not asking. We assume someone’s older so they’re not having sex anymore. But, in fact, they are, and we’re not taking the time to say: ‘Let’s talk about your sex life. Are you at risk for anything? Are you having any difficulties with sex?’ We tend to avoid it as a health care culture.”

In contrast, Dr. Dowler said she talks about sexual health with anyone who will listen. She teaches classes in private schools and universities and for church youth groups and other physicians. She often finds that public schools are not interested, which she attributes to fear of her discussing things “outside the rule book.”

Dr. Dowler takes creative approaches. In 2017, she released a hip-hop video, “STD’s Never Get Old,” in which she raps about safe sex for older adults. Her video went viral, was mentioned by several news outlets, and received over 50,000 views on YouTube. Dr. Dowler’s latest project is a book, “Never Too Late: Your Guide to Safer Sex after 60,” which is scheduled for publication on Valentine’s Day, 2023.

“It’s sex ed for seniors,” she explained. “It’s that gym class that some people got – I won’t say everyone got – in high school. This is the version for older adults who didn’t get that. There are new infections now that didn’t exist when they had sex education, if they had sex education.”
 

A big subject requires a big mission

For others in the sex education field, physicians are allies in their fight against agendas designed to obstruct or erode sex education. Alison Macklin, director of policy and advocacy at SIECUS: Sex Ed for Social Change, formerly the Sexuality Information and Education Council of the United States, sees this struggle playing out in school boards and state legislatures across the country. For every comprehensive sex education bill passed or school district victory, there is yet another blocked proposal or restrictive law somewhere else.

Ms. Macklin urged doctors to get more involved locally and to expand their knowledge of sexual health issues by reaching out to organizations such as Planned Parenthood and to be “hyper vigilant” in their own communities.

“Doctors are trusted. People really respect what they have to say,” Ms. Macklin said. “And this is an important time for them to speak up.”

A version of this article first appeared on Medscape.com.

In May 2022, the Digestive Disease Week (DDW) conference was held in person again for the first time in 3 years. Two years prior in July 2020 AGA launched the Equity Project, a six-point strategic plan to achieve equity and eradicate health disparities in digestive diseases.

President John Inadomi elected to focus his AGA Presidential Plenary session on updates in gastrointestinal and hepatic health disparities, and opened with a powerful testimony on his personal experiences encountering racism, and recognizing the need to translate spoken intentions into action.

This served as the perfect segue to the second plenary presentation in which an update was given on the progress of the Equity Project by co-chairs Byron Cryer, MD, and Sandra Quezada, MD, MS. Dr. Cryer described the vision of the Equity Project, including: a just world, free of inequities in access and health care delivery; state-of-the-art and well-funded research of multicultural populations; a diverse physician and scientist workforce and leadership; recognition of achievements of people of color; membership and staff committed to self-awareness and eliminating unconscious bias; and an engaged, large, diverse, vocal, and culturally- and socially aware early career membership.

Concrete action items were identified by a coalition of AGA members with diverse representation across specialties, practice settings, and identities. AGA staff and constituency programs have been critical in the execution of each action item. Key performance indicators were selected to gauge progress and hold the organization accountable in implementation of project tactics. These metrics demonstrate that the first 2 years of the Equity Project have been very productive. Salient accomplishments include three congressional briefings on health disparities topics, increased education and dialogue on diversity, equity, and inclusion (DEI) through podcasts, career development workshops and DDW sessions, fundraising of over $300,000 to support health disparities research, dedicated DEI sections and section editors for Gastroenterology and Clinical Gastroenterology and Hepatology, and the creation of a guide for GI fellowship program directors to promote equity and mitigate bias in the fellowship selection process.

Although the Equity Project is entering its third and final implementation year, the spirit and values of the Equity Project will live on. Excellence in equity requires ongoing, focused dedication – AGA is committed to ensuring that equity, diversity, and inclusion are inherently embedded through the fabric of the organization, and continuously integrated and assessed in all of the organization’s future strategic initiatives.

Dr. Quezada is an associate professor of medicine in the division of gastroenterology and hepatology at the University of Maryland, Baltimore. She reports being on the People of Color Advisory Board for Janssen. Dr. Cryer is chief of internal medicine and the Ralph Tompsett Endowed Chair in Medicine at Baylor University Medical Center, Dallas, and a professor of internal medicine at Texas A&M School of Medicine. He has no relevant conflicts of interest. These remarks were made during the AGA Presidential Plenary at DDW 2022.

In May 2022, the Digestive Disease Week (DDW) conference was held in person again for the first time in 3 years. Two years prior in July 2020 AGA launched the Equity Project, a six-point strategic plan to achieve equity and eradicate health disparities in digestive diseases.

President John Inadomi elected to focus his AGA Presidential Plenary session on updates in gastrointestinal and hepatic health disparities, and opened with a powerful testimony on his personal experiences encountering racism, and recognizing the need to translate spoken intentions into action.

This served as the perfect segue to the second plenary presentation in which an update was given on the progress of the Equity Project by co-chairs Byron Cryer, MD, and Sandra Quezada, MD, MS. Dr. Cryer described the vision of the Equity Project, including: a just world, free of inequities in access and health care delivery; state-of-the-art and well-funded research of multicultural populations; a diverse physician and scientist workforce and leadership; recognition of achievements of people of color; membership and staff committed to self-awareness and eliminating unconscious bias; and an engaged, large, diverse, vocal, and culturally- and socially aware early career membership.

Concrete action items were identified by a coalition of AGA members with diverse representation across specialties, practice settings, and identities. AGA staff and constituency programs have been critical in the execution of each action item. Key performance indicators were selected to gauge progress and hold the organization accountable in implementation of project tactics. These metrics demonstrate that the first 2 years of the Equity Project have been very productive. Salient accomplishments include three congressional briefings on health disparities topics, increased education and dialogue on diversity, equity, and inclusion (DEI) through podcasts, career development workshops and DDW sessions, fundraising of over $300,000 to support health disparities research, dedicated DEI sections and section editors for Gastroenterology and Clinical Gastroenterology and Hepatology, and the creation of a guide for GI fellowship program directors to promote equity and mitigate bias in the fellowship selection process.

Although the Equity Project is entering its third and final implementation year, the spirit and values of the Equity Project will live on. Excellence in equity requires ongoing, focused dedication – AGA is committed to ensuring that equity, diversity, and inclusion are inherently embedded through the fabric of the organization, and continuously integrated and assessed in all of the organization’s future strategic initiatives.

Dr. Quezada is an associate professor of medicine in the division of gastroenterology and hepatology at the University of Maryland, Baltimore. She reports being on the People of Color Advisory Board for Janssen. Dr. Cryer is chief of internal medicine and the Ralph Tompsett Endowed Chair in Medicine at Baylor University Medical Center, Dallas, and a professor of internal medicine at Texas A&M School of Medicine. He has no relevant conflicts of interest. These remarks were made during the AGA Presidential Plenary at DDW 2022.

In May 2022, the Digestive Disease Week (DDW) conference was held in person again for the first time in 3 years. Two years prior in July 2020 AGA launched the Equity Project, a six-point strategic plan to achieve equity and eradicate health disparities in digestive diseases.

President John Inadomi elected to focus his AGA Presidential Plenary session on updates in gastrointestinal and hepatic health disparities, and opened with a powerful testimony on his personal experiences encountering racism, and recognizing the need to translate spoken intentions into action.

This served as the perfect segue to the second plenary presentation in which an update was given on the progress of the Equity Project by co-chairs Byron Cryer, MD, and Sandra Quezada, MD, MS. Dr. Cryer described the vision of the Equity Project, including: a just world, free of inequities in access and health care delivery; state-of-the-art and well-funded research of multicultural populations; a diverse physician and scientist workforce and leadership; recognition of achievements of people of color; membership and staff committed to self-awareness and eliminating unconscious bias; and an engaged, large, diverse, vocal, and culturally- and socially aware early career membership.

Concrete action items were identified by a coalition of AGA members with diverse representation across specialties, practice settings, and identities. AGA staff and constituency programs have been critical in the execution of each action item. Key performance indicators were selected to gauge progress and hold the organization accountable in implementation of project tactics. These metrics demonstrate that the first 2 years of the Equity Project have been very productive. Salient accomplishments include three congressional briefings on health disparities topics, increased education and dialogue on diversity, equity, and inclusion (DEI) through podcasts, career development workshops and DDW sessions, fundraising of over $300,000 to support health disparities research, dedicated DEI sections and section editors for Gastroenterology and Clinical Gastroenterology and Hepatology, and the creation of a guide for GI fellowship program directors to promote equity and mitigate bias in the fellowship selection process.

Although the Equity Project is entering its third and final implementation year, the spirit and values of the Equity Project will live on. Excellence in equity requires ongoing, focused dedication – AGA is committed to ensuring that equity, diversity, and inclusion are inherently embedded through the fabric of the organization, and continuously integrated and assessed in all of the organization’s future strategic initiatives.

Dr. Quezada is an associate professor of medicine in the division of gastroenterology and hepatology at the University of Maryland, Baltimore. She reports being on the People of Color Advisory Board for Janssen. Dr. Cryer is chief of internal medicine and the Ralph Tompsett Endowed Chair in Medicine at Baylor University Medical Center, Dallas, and a professor of internal medicine at Texas A&M School of Medicine. He has no relevant conflicts of interest. These remarks were made during the AGA Presidential Plenary at DDW 2022.

Eosinophilic gastrointestinal diseases (EGIDs) are characterized by GI signs or symptoms occurring along with tissue eosinophilia. Eosinophilic esophagitis (EoE) is the more commonly recognized EGID as endoscopic and histopathologic diagnostic criteria have long been established. Because of a lack of consensus on biopsy protocols, poorly understood histopathologic diagnostic criteria, and vague, nonspecific gastrointestinal complaints, patients with non-EoE EGIDs go unrecognized for years. Because of this, there is increasing emphasis on better defining rare, distal eosinophilic gastrointestinal diseases (i.e., eosinophilic gastritis, enteritis, and colitis).

EGID nomenclature was standardized in 2022 in part to minimize vague terminology (i.e., eosinophilic gastroenteritis) and to provide more specific information about the location of eosinophilic disease. The 2022 nomenclature suggest that EGID be used as the umbrella term for all GI luminal eosinophilia (without a known cause) but with emphasis on the site of specific eosinophilic involvement (i.e., eosinophilic gastritis or eosinophilic gastritis and colitis). Importantly, there is much work to be done to adequately identify patients suffering from EGIDs. Symptoms are variable, ranging from abdominal pain, bloating, and nausea seen in proximal disease to loose stools and hematochezia in more distal involvement. Signs of disease, such as iron or other nutrient deficiencies and protein loss, may also occur. Endoscopic findings can vary from erythema, granularity, erosions, ulcerations, and blunting to even normal-appearing tissue. In eosinophilic gastritis, Ikuo Hirano, MD, and colleagues demonstrated that increasing endoscopic inflammatory findings in the stomach correlate with assessment of disease severity. Regardless of endoscopic findings, numerous biopsies are needed for the diagnosis of EGIDs because, as already established in EoE, eosinophil involvement is patchy. Nirmala Gonsalves, MD, and Evan Dellon, MD, found that a minimum of four biopsies each in the gastric antrum, gastric body, and small bowel are needed to detect disease. Optimal biopsy patterns have not yet been determined for eosinophilic ileitis or colitis.

Despite these advances, there is more work to be performed. Although these disease states are termed “eosinophilic,” the immunopathology driving these diseases is multifactorial, involving lymphocytes and mast cells and creating different phenotypes of disease in a similar fashion to inflammatory bowel disease. Current therapies being studied include eosinophil-depleting medications along with others targeting T2 immune pathways. Patients may need multiple therapeutic options, and personalized medicine will soon play a larger role in defining treatments. For now, researchers are fervently working on improved methods to identify, phenotype, and treat these morbid disorders.
 

Dr. Peterson is associate professor of gastroenterology at University of Utah Health, Salt Lake City. She has no relevant conflicts of interest. These remarks were made during one of the AGA Postgraduate Course sessions held at DDW 2022.

Eosinophilic gastrointestinal diseases (EGIDs) are characterized by GI signs or symptoms occurring along with tissue eosinophilia. Eosinophilic esophagitis (EoE) is the more commonly recognized EGID as endoscopic and histopathologic diagnostic criteria have long been established. Because of a lack of consensus on biopsy protocols, poorly understood histopathologic diagnostic criteria, and vague, nonspecific gastrointestinal complaints, patients with non-EoE EGIDs go unrecognized for years. Because of this, there is increasing emphasis on better defining rare, distal eosinophilic gastrointestinal diseases (i.e., eosinophilic gastritis, enteritis, and colitis).

EGID nomenclature was standardized in 2022 in part to minimize vague terminology (i.e., eosinophilic gastroenteritis) and to provide more specific information about the location of eosinophilic disease. The 2022 nomenclature suggest that EGID be used as the umbrella term for all GI luminal eosinophilia (without a known cause) but with emphasis on the site of specific eosinophilic involvement (i.e., eosinophilic gastritis or eosinophilic gastritis and colitis). Importantly, there is much work to be done to adequately identify patients suffering from EGIDs. Symptoms are variable, ranging from abdominal pain, bloating, and nausea seen in proximal disease to loose stools and hematochezia in more distal involvement. Signs of disease, such as iron or other nutrient deficiencies and protein loss, may also occur. Endoscopic findings can vary from erythema, granularity, erosions, ulcerations, and blunting to even normal-appearing tissue. In eosinophilic gastritis, Ikuo Hirano, MD, and colleagues demonstrated that increasing endoscopic inflammatory findings in the stomach correlate with assessment of disease severity. Regardless of endoscopic findings, numerous biopsies are needed for the diagnosis of EGIDs because, as already established in EoE, eosinophil involvement is patchy. Nirmala Gonsalves, MD, and Evan Dellon, MD, found that a minimum of four biopsies each in the gastric antrum, gastric body, and small bowel are needed to detect disease. Optimal biopsy patterns have not yet been determined for eosinophilic ileitis or colitis.

Despite these advances, there is more work to be performed. Although these disease states are termed “eosinophilic,” the immunopathology driving these diseases is multifactorial, involving lymphocytes and mast cells and creating different phenotypes of disease in a similar fashion to inflammatory bowel disease. Current therapies being studied include eosinophil-depleting medications along with others targeting T2 immune pathways. Patients may need multiple therapeutic options, and personalized medicine will soon play a larger role in defining treatments. For now, researchers are fervently working on improved methods to identify, phenotype, and treat these morbid disorders.
 

Dr. Peterson is associate professor of gastroenterology at University of Utah Health, Salt Lake City. She has no relevant conflicts of interest. These remarks were made during one of the AGA Postgraduate Course sessions held at DDW 2022.

Eosinophilic gastrointestinal diseases (EGIDs) are characterized by GI signs or symptoms occurring along with tissue eosinophilia. Eosinophilic esophagitis (EoE) is the more commonly recognized EGID as endoscopic and histopathologic diagnostic criteria have long been established. Because of a lack of consensus on biopsy protocols, poorly understood histopathologic diagnostic criteria, and vague, nonspecific gastrointestinal complaints, patients with non-EoE EGIDs go unrecognized for years. Because of this, there is increasing emphasis on better defining rare, distal eosinophilic gastrointestinal diseases (i.e., eosinophilic gastritis, enteritis, and colitis).

EGID nomenclature was standardized in 2022 in part to minimize vague terminology (i.e., eosinophilic gastroenteritis) and to provide more specific information about the location of eosinophilic disease. The 2022 nomenclature suggest that EGID be used as the umbrella term for all GI luminal eosinophilia (without a known cause) but with emphasis on the site of specific eosinophilic involvement (i.e., eosinophilic gastritis or eosinophilic gastritis and colitis). Importantly, there is much work to be done to adequately identify patients suffering from EGIDs. Symptoms are variable, ranging from abdominal pain, bloating, and nausea seen in proximal disease to loose stools and hematochezia in more distal involvement. Signs of disease, such as iron or other nutrient deficiencies and protein loss, may also occur. Endoscopic findings can vary from erythema, granularity, erosions, ulcerations, and blunting to even normal-appearing tissue. In eosinophilic gastritis, Ikuo Hirano, MD, and colleagues demonstrated that increasing endoscopic inflammatory findings in the stomach correlate with assessment of disease severity. Regardless of endoscopic findings, numerous biopsies are needed for the diagnosis of EGIDs because, as already established in EoE, eosinophil involvement is patchy. Nirmala Gonsalves, MD, and Evan Dellon, MD, found that a minimum of four biopsies each in the gastric antrum, gastric body, and small bowel are needed to detect disease. Optimal biopsy patterns have not yet been determined for eosinophilic ileitis or colitis.

Despite these advances, there is more work to be performed. Although these disease states are termed “eosinophilic,” the immunopathology driving these diseases is multifactorial, involving lymphocytes and mast cells and creating different phenotypes of disease in a similar fashion to inflammatory bowel disease. Current therapies being studied include eosinophil-depleting medications along with others targeting T2 immune pathways. Patients may need multiple therapeutic options, and personalized medicine will soon play a larger role in defining treatments. For now, researchers are fervently working on improved methods to identify, phenotype, and treat these morbid disorders.
 

Dr. Peterson is associate professor of gastroenterology at University of Utah Health, Salt Lake City. She has no relevant conflicts of interest. These remarks were made during one of the AGA Postgraduate Course sessions held at DDW 2022.

Adults hospitalized with community-acquired pneumonia were less likely to need mechanical ventilation after treatment with corticosteroids, but mortality was unaffected, based on data from a meta-analysis of nearly 4,000 patients.

Community-acquired pneumonia (CAP) remains a leading cause of morbidity and mortality in adults, but no routinely used strategies are associated with improvements in mortality, disease severity, or length of hospital stay, wrote Naveed Saleem, MSc, of University College, London, and colleagues.

Corticosteroids are recommended for various infectious diseases including bacterial meningitis, septic shock, and tuberculosis, as well as for COVID-19 pneumonia, because of their ability to reduce systemic inflammation, but have not been well studied in CAP, they noted.

In a study published in Chest, the researchers identified 16 randomized, controlled trials that compared the use of corticosteroids to standard care in CAP management. Of these, 9 were sponsored by pharmaceutical companies, 4 were open-label, and 11 were double-blind. The primary outcome was all-cause mortality; secondary outcomes were ICU admission, mechanical ventilation, treatment failure, readmission, and adverse events.

Although corticosteroids had no significant impact on the primary outcome of all-cause mortality, their use was associated with a significant reduction in the need for mechanical ventilation (relative risk 0.51, P = .001). The relative risk for the primary outcome of all-cause mortality was 0.85 (P = .17). Corticosteroids had no significant impact on the other secondary outcomes of ICU admission (RR 0.66), treatment failure (RR 0.78), and the incidence of adverse events (RR 1.10). However, data from five studies showed an increase in hospital admission rates for patients who received corticosteroids (RR 1.20, P = .008).

Overall, the risk of total adverse events was similar in patients who received corticosteroids vs. standard of care (55.8% vs. 48.5%). However, 27.2% of patients reported at least one adverse event related to corticosteroids. Incidence of most adverse events including gastrointestinal bleeding and secondary infections were similar between the groups, but patients who received corticosteroids had a significantly higher incidence of new-onset hyperglycemia compared to standard care patients (17.6% vs. 9.5%, P = .0001).

“Despite an increased risk of hyperglycemia associated with steroid use, we found no association between corticosteroid use and infectious complications,” the researchers wrote in their discussion. The optimal type, dose, and duration of corticosteroids for hospitalized CAP patients has yet to be determined, and the type of corticosteroid may affect outcomes, they added.

The study findings were limited by several factors, including the consideration of hospitalized patients only, not those in the community, and by the inability to adjust for differing diagnostic criteria, illness severity at baseline, or other therapeutic interventions, the researchers noted. Larger studies are needed to assess mortality benefit, and longer follow-up is needed to identify causes of readmission, they said. However, the results suggest that corticosteroids may be useful for preventing the need for mechanical ventilation in hospitalized patients with bacterial pneumonia, they concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Adults hospitalized with community-acquired pneumonia were less likely to need mechanical ventilation after treatment with corticosteroids, but mortality was unaffected, based on data from a meta-analysis of nearly 4,000 patients.

Community-acquired pneumonia (CAP) remains a leading cause of morbidity and mortality in adults, but no routinely used strategies are associated with improvements in mortality, disease severity, or length of hospital stay, wrote Naveed Saleem, MSc, of University College, London, and colleagues.

Corticosteroids are recommended for various infectious diseases including bacterial meningitis, septic shock, and tuberculosis, as well as for COVID-19 pneumonia, because of their ability to reduce systemic inflammation, but have not been well studied in CAP, they noted.

In a study published in Chest, the researchers identified 16 randomized, controlled trials that compared the use of corticosteroids to standard care in CAP management. Of these, 9 were sponsored by pharmaceutical companies, 4 were open-label, and 11 were double-blind. The primary outcome was all-cause mortality; secondary outcomes were ICU admission, mechanical ventilation, treatment failure, readmission, and adverse events.

Although corticosteroids had no significant impact on the primary outcome of all-cause mortality, their use was associated with a significant reduction in the need for mechanical ventilation (relative risk 0.51, P = .001). The relative risk for the primary outcome of all-cause mortality was 0.85 (P = .17). Corticosteroids had no significant impact on the other secondary outcomes of ICU admission (RR 0.66), treatment failure (RR 0.78), and the incidence of adverse events (RR 1.10). However, data from five studies showed an increase in hospital admission rates for patients who received corticosteroids (RR 1.20, P = .008).

Overall, the risk of total adverse events was similar in patients who received corticosteroids vs. standard of care (55.8% vs. 48.5%). However, 27.2% of patients reported at least one adverse event related to corticosteroids. Incidence of most adverse events including gastrointestinal bleeding and secondary infections were similar between the groups, but patients who received corticosteroids had a significantly higher incidence of new-onset hyperglycemia compared to standard care patients (17.6% vs. 9.5%, P = .0001).

“Despite an increased risk of hyperglycemia associated with steroid use, we found no association between corticosteroid use and infectious complications,” the researchers wrote in their discussion. The optimal type, dose, and duration of corticosteroids for hospitalized CAP patients has yet to be determined, and the type of corticosteroid may affect outcomes, they added.

The study findings were limited by several factors, including the consideration of hospitalized patients only, not those in the community, and by the inability to adjust for differing diagnostic criteria, illness severity at baseline, or other therapeutic interventions, the researchers noted. Larger studies are needed to assess mortality benefit, and longer follow-up is needed to identify causes of readmission, they said. However, the results suggest that corticosteroids may be useful for preventing the need for mechanical ventilation in hospitalized patients with bacterial pneumonia, they concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Adults hospitalized with community-acquired pneumonia were less likely to need mechanical ventilation after treatment with corticosteroids, but mortality was unaffected, based on data from a meta-analysis of nearly 4,000 patients.

Community-acquired pneumonia (CAP) remains a leading cause of morbidity and mortality in adults, but no routinely used strategies are associated with improvements in mortality, disease severity, or length of hospital stay, wrote Naveed Saleem, MSc, of University College, London, and colleagues.

Corticosteroids are recommended for various infectious diseases including bacterial meningitis, septic shock, and tuberculosis, as well as for COVID-19 pneumonia, because of their ability to reduce systemic inflammation, but have not been well studied in CAP, they noted.

In a study published in Chest, the researchers identified 16 randomized, controlled trials that compared the use of corticosteroids to standard care in CAP management. Of these, 9 were sponsored by pharmaceutical companies, 4 were open-label, and 11 were double-blind. The primary outcome was all-cause mortality; secondary outcomes were ICU admission, mechanical ventilation, treatment failure, readmission, and adverse events.

Although corticosteroids had no significant impact on the primary outcome of all-cause mortality, their use was associated with a significant reduction in the need for mechanical ventilation (relative risk 0.51, P = .001). The relative risk for the primary outcome of all-cause mortality was 0.85 (P = .17). Corticosteroids had no significant impact on the other secondary outcomes of ICU admission (RR 0.66), treatment failure (RR 0.78), and the incidence of adverse events (RR 1.10). However, data from five studies showed an increase in hospital admission rates for patients who received corticosteroids (RR 1.20, P = .008).

Overall, the risk of total adverse events was similar in patients who received corticosteroids vs. standard of care (55.8% vs. 48.5%). However, 27.2% of patients reported at least one adverse event related to corticosteroids. Incidence of most adverse events including gastrointestinal bleeding and secondary infections were similar between the groups, but patients who received corticosteroids had a significantly higher incidence of new-onset hyperglycemia compared to standard care patients (17.6% vs. 9.5%, P = .0001).

“Despite an increased risk of hyperglycemia associated with steroid use, we found no association between corticosteroid use and infectious complications,” the researchers wrote in their discussion. The optimal type, dose, and duration of corticosteroids for hospitalized CAP patients has yet to be determined, and the type of corticosteroid may affect outcomes, they added.

The study findings were limited by several factors, including the consideration of hospitalized patients only, not those in the community, and by the inability to adjust for differing diagnostic criteria, illness severity at baseline, or other therapeutic interventions, the researchers noted. Larger studies are needed to assess mortality benefit, and longer follow-up is needed to identify causes of readmission, they said. However, the results suggest that corticosteroids may be useful for preventing the need for mechanical ventilation in hospitalized patients with bacterial pneumonia, they concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

In a new analysis of the previously published FAME 3 trial, which compared fractional flow reserve–guided percutaneous coronary interventions to coronary artery bypass surgery (CABG) in patients with three-vessel disease, post-PCI FFR was shown to predict both target vessel failure (TVF) and risk of cardiac events.

“We found that the post-PCI FFR had prognostic value both for the vessel and for the patient,” reported Zsolt Piroth, MD, PhD, deputy head, adult cardiology, György Gottsegen Institute of Cardiology, Budapest.

In this post hoc analysis, which was not a prespecified FAME 3 substudy, the goal was to look at the prognostic value of both post-PCI FFR and intravascular ultrasound, which were recommended in the study protocol. Several studies have addressed the value of these measures previously, according to Dr. Piroth, but he said the clinical value “has remained poorly defined” despite the currently available data.

The FAME 3 trial, published in the New England Journal of Medicine, was negative. It failed to confirm the study hypothesis that FFR-guided PCI is noninferior to CABG for the outcome of major adverse cardiac events (MACE) at 12 months.

However, this multinational trial has generated a large body of data with which to explore other issues relevant to revascularization. In this analysis, the goal was to evaluate whether post-PCI FFR predicted outcomes in complex multivessel revascularizations as it has been shown previously to do in single-vessel disease.

Presented at the Transcatheter Cardiovascular Therapeutics annual meeting, the focus of this analysis was on the 461 (61%) of patients in the 757-patient PCI arm of FAME 3 who underwent post-PCI FFR. The authors also looked at the predictive value of intravascular ultrasound, even though this was performed in just 11% of this group of trial participants.

As a continuous value, each 0.1-unit change in the post-PCI FFR was found to be prognostically significant for the outcome of TVF, defined as a composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization (only postprocedural events were counted in this analysis). Specifically, for each 0.1-unit increase on a univariate analysis, the risk of TVF was reduced by about one-third (hazard ratio, 0.67; P = .0165).

On a patient level, a 0.1-unit increase in lowest post-PCI FFR of any assessed vessel was also associated with the same relative risk reduction (HR, 0.65; P = .0074) in the outcomes of cardiac death, target vessel MI, or target vessel revascularization, according to Dr. Piroth. On a receiver operating characteristic curve analysis, a value of 0.88 or below was predictive of TVF.

Although several other patient characteristics were also risk predictors of TVF on univariate analysis, only renal disease and the single lowest post-PCI FFR (as a continuous variable) emerged as predictors of TVF on multivariable analysis after adjustment for key clinical parameters, Dr. Piroth reported.

The reason why post-PCI FFR was not performed in almost 40% of patients randomized to PCI is unclear, but Dr. Piroth reported that the baseline characteristics of those who were or were not assessed with FFR after their procedure did not differ to any major degree.

Despite “a trend for improved outcomes in those who underwent post-PCI FFR,” Dr. Piroth, whose substudy was published in Circulation: Cardiovascular Interventions simultaneously with his TCT presentation, acknowledged that the reasons for a potential benefit cannot be derived from this post hoc analysis.

As for the prognostic value of IVUS, any conclusions are limited by the small proportion of patients who underwent this form of imaging. Overall, IVUS imaging was associated with longer procedures and more stents and “if anything, a signal for harm” in this analysis, but Dr. Piroth cautioned against any conclusions because of the small data pool.

The prognostic value of post-PCI FFR in complex multivessel disease is supported by these data, but the analysis was not designed to determine whether post-PCI FFR has relevance to intervention.

According to J. Dawn Abbott, MD, an FFR analysis conducted to identify lesions that are candidates for treatment should not be confused with FFR for physiologically guided PCI to optimize outcomes.

Noting that post-PCI FFR was encouraged in this study but not mandated and that these FFR values did not typically or necessarily lead to a change in management, take home messages about the value of post-PCI FFR in multivessel disease remain limited, said Dr. Abbott, director of interventional cardiology fellowship training, Brown University, Providence, R.I.

“There was a trend toward improved outcomes in patients who had this measurement done, but, unfortunately, we do not have data regarding whether these patients had further interventions performed,” Dr. Piroth acknowledged.

The post-PCI FFR values were made available to the treating physicians, but Dr. Piroth reiterated that it is unknown whether the physicians considered this information actionable. Moreover, “the vast majority had a nonsignificant post-PCI FFR” result, and “all of the patients had an angiographically successful PCI,” Dr. Piroth added.

Dr. Piroth has financial relationships with Abbott Vascular and Boston Scientific. Dr. Abbott reports financial relationships with Abbott Vascular, Boston Scientific, Medtronic, Microport, Philips, Penumbra, Recor, and Shockwave.


 

In a new analysis of the previously published FAME 3 trial, which compared fractional flow reserve–guided percutaneous coronary interventions to coronary artery bypass surgery (CABG) in patients with three-vessel disease, post-PCI FFR was shown to predict both target vessel failure (TVF) and risk of cardiac events.

“We found that the post-PCI FFR had prognostic value both for the vessel and for the patient,” reported Zsolt Piroth, MD, PhD, deputy head, adult cardiology, György Gottsegen Institute of Cardiology, Budapest.

In this post hoc analysis, which was not a prespecified FAME 3 substudy, the goal was to look at the prognostic value of both post-PCI FFR and intravascular ultrasound, which were recommended in the study protocol. Several studies have addressed the value of these measures previously, according to Dr. Piroth, but he said the clinical value “has remained poorly defined” despite the currently available data.

The FAME 3 trial, published in the New England Journal of Medicine, was negative. It failed to confirm the study hypothesis that FFR-guided PCI is noninferior to CABG for the outcome of major adverse cardiac events (MACE) at 12 months.

However, this multinational trial has generated a large body of data with which to explore other issues relevant to revascularization. In this analysis, the goal was to evaluate whether post-PCI FFR predicted outcomes in complex multivessel revascularizations as it has been shown previously to do in single-vessel disease.

Presented at the Transcatheter Cardiovascular Therapeutics annual meeting, the focus of this analysis was on the 461 (61%) of patients in the 757-patient PCI arm of FAME 3 who underwent post-PCI FFR. The authors also looked at the predictive value of intravascular ultrasound, even though this was performed in just 11% of this group of trial participants.

As a continuous value, each 0.1-unit change in the post-PCI FFR was found to be prognostically significant for the outcome of TVF, defined as a composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization (only postprocedural events were counted in this analysis). Specifically, for each 0.1-unit increase on a univariate analysis, the risk of TVF was reduced by about one-third (hazard ratio, 0.67; P = .0165).

On a patient level, a 0.1-unit increase in lowest post-PCI FFR of any assessed vessel was also associated with the same relative risk reduction (HR, 0.65; P = .0074) in the outcomes of cardiac death, target vessel MI, or target vessel revascularization, according to Dr. Piroth. On a receiver operating characteristic curve analysis, a value of 0.88 or below was predictive of TVF.

Although several other patient characteristics were also risk predictors of TVF on univariate analysis, only renal disease and the single lowest post-PCI FFR (as a continuous variable) emerged as predictors of TVF on multivariable analysis after adjustment for key clinical parameters, Dr. Piroth reported.

The reason why post-PCI FFR was not performed in almost 40% of patients randomized to PCI is unclear, but Dr. Piroth reported that the baseline characteristics of those who were or were not assessed with FFR after their procedure did not differ to any major degree.

Despite “a trend for improved outcomes in those who underwent post-PCI FFR,” Dr. Piroth, whose substudy was published in Circulation: Cardiovascular Interventions simultaneously with his TCT presentation, acknowledged that the reasons for a potential benefit cannot be derived from this post hoc analysis.

As for the prognostic value of IVUS, any conclusions are limited by the small proportion of patients who underwent this form of imaging. Overall, IVUS imaging was associated with longer procedures and more stents and “if anything, a signal for harm” in this analysis, but Dr. Piroth cautioned against any conclusions because of the small data pool.

The prognostic value of post-PCI FFR in complex multivessel disease is supported by these data, but the analysis was not designed to determine whether post-PCI FFR has relevance to intervention.

According to J. Dawn Abbott, MD, an FFR analysis conducted to identify lesions that are candidates for treatment should not be confused with FFR for physiologically guided PCI to optimize outcomes.

Noting that post-PCI FFR was encouraged in this study but not mandated and that these FFR values did not typically or necessarily lead to a change in management, take home messages about the value of post-PCI FFR in multivessel disease remain limited, said Dr. Abbott, director of interventional cardiology fellowship training, Brown University, Providence, R.I.

“There was a trend toward improved outcomes in patients who had this measurement done, but, unfortunately, we do not have data regarding whether these patients had further interventions performed,” Dr. Piroth acknowledged.

The post-PCI FFR values were made available to the treating physicians, but Dr. Piroth reiterated that it is unknown whether the physicians considered this information actionable. Moreover, “the vast majority had a nonsignificant post-PCI FFR” result, and “all of the patients had an angiographically successful PCI,” Dr. Piroth added.

Dr. Piroth has financial relationships with Abbott Vascular and Boston Scientific. Dr. Abbott reports financial relationships with Abbott Vascular, Boston Scientific, Medtronic, Microport, Philips, Penumbra, Recor, and Shockwave.


 

In a new analysis of the previously published FAME 3 trial, which compared fractional flow reserve–guided percutaneous coronary interventions to coronary artery bypass surgery (CABG) in patients with three-vessel disease, post-PCI FFR was shown to predict both target vessel failure (TVF) and risk of cardiac events.

“We found that the post-PCI FFR had prognostic value both for the vessel and for the patient,” reported Zsolt Piroth, MD, PhD, deputy head, adult cardiology, György Gottsegen Institute of Cardiology, Budapest.

In this post hoc analysis, which was not a prespecified FAME 3 substudy, the goal was to look at the prognostic value of both post-PCI FFR and intravascular ultrasound, which were recommended in the study protocol. Several studies have addressed the value of these measures previously, according to Dr. Piroth, but he said the clinical value “has remained poorly defined” despite the currently available data.

The FAME 3 trial, published in the New England Journal of Medicine, was negative. It failed to confirm the study hypothesis that FFR-guided PCI is noninferior to CABG for the outcome of major adverse cardiac events (MACE) at 12 months.

However, this multinational trial has generated a large body of data with which to explore other issues relevant to revascularization. In this analysis, the goal was to evaluate whether post-PCI FFR predicted outcomes in complex multivessel revascularizations as it has been shown previously to do in single-vessel disease.

Presented at the Transcatheter Cardiovascular Therapeutics annual meeting, the focus of this analysis was on the 461 (61%) of patients in the 757-patient PCI arm of FAME 3 who underwent post-PCI FFR. The authors also looked at the predictive value of intravascular ultrasound, even though this was performed in just 11% of this group of trial participants.

As a continuous value, each 0.1-unit change in the post-PCI FFR was found to be prognostically significant for the outcome of TVF, defined as a composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization (only postprocedural events were counted in this analysis). Specifically, for each 0.1-unit increase on a univariate analysis, the risk of TVF was reduced by about one-third (hazard ratio, 0.67; P = .0165).

On a patient level, a 0.1-unit increase in lowest post-PCI FFR of any assessed vessel was also associated with the same relative risk reduction (HR, 0.65; P = .0074) in the outcomes of cardiac death, target vessel MI, or target vessel revascularization, according to Dr. Piroth. On a receiver operating characteristic curve analysis, a value of 0.88 or below was predictive of TVF.

Although several other patient characteristics were also risk predictors of TVF on univariate analysis, only renal disease and the single lowest post-PCI FFR (as a continuous variable) emerged as predictors of TVF on multivariable analysis after adjustment for key clinical parameters, Dr. Piroth reported.

The reason why post-PCI FFR was not performed in almost 40% of patients randomized to PCI is unclear, but Dr. Piroth reported that the baseline characteristics of those who were or were not assessed with FFR after their procedure did not differ to any major degree.

Despite “a trend for improved outcomes in those who underwent post-PCI FFR,” Dr. Piroth, whose substudy was published in Circulation: Cardiovascular Interventions simultaneously with his TCT presentation, acknowledged that the reasons for a potential benefit cannot be derived from this post hoc analysis.

As for the prognostic value of IVUS, any conclusions are limited by the small proportion of patients who underwent this form of imaging. Overall, IVUS imaging was associated with longer procedures and more stents and “if anything, a signal for harm” in this analysis, but Dr. Piroth cautioned against any conclusions because of the small data pool.

The prognostic value of post-PCI FFR in complex multivessel disease is supported by these data, but the analysis was not designed to determine whether post-PCI FFR has relevance to intervention.

According to J. Dawn Abbott, MD, an FFR analysis conducted to identify lesions that are candidates for treatment should not be confused with FFR for physiologically guided PCI to optimize outcomes.

Noting that post-PCI FFR was encouraged in this study but not mandated and that these FFR values did not typically or necessarily lead to a change in management, take home messages about the value of post-PCI FFR in multivessel disease remain limited, said Dr. Abbott, director of interventional cardiology fellowship training, Brown University, Providence, R.I.

“There was a trend toward improved outcomes in patients who had this measurement done, but, unfortunately, we do not have data regarding whether these patients had further interventions performed,” Dr. Piroth acknowledged.

The post-PCI FFR values were made available to the treating physicians, but Dr. Piroth reiterated that it is unknown whether the physicians considered this information actionable. Moreover, “the vast majority had a nonsignificant post-PCI FFR” result, and “all of the patients had an angiographically successful PCI,” Dr. Piroth added.

Dr. Piroth has financial relationships with Abbott Vascular and Boston Scientific. Dr. Abbott reports financial relationships with Abbott Vascular, Boston Scientific, Medtronic, Microport, Philips, Penumbra, Recor, and Shockwave.


 

If isolated, patients with mental disorders may end up having higher levels of social impairment. This has led several hospitals in Spain to set up open-door departments that are more accessible.

The purpose of the open-door model is to help remove the stigma from individuals who need to be admitted to a psychiatric ward because they have a mental disorder.
 

Traditional locked wards

According to the World Health Organization (WHO), in 2019, one in every eight people were living with a mental disorder. Having the least restrictive type of mental health care is one of the 10 basic principles listed in a 1996 reference document from the WHO.

Among people suffering from severe psychiatric disorders, there is a high probability of being involuntarily admitted to a psychiatry ward with locked doors (PWLD). Admission to a PWLD involves the application of a set of measures that restrict the individual’s freedom.

The main argument for keeping the doors locked is that it prevents suicides and self-harm behavior, as well as abscondment. But in recent years, efforts have been made to apply a model called open-door policy psychiatry wards (ODPWs).
 

Open wards model

Experiments were undertaken in various countries, including the United Kingdom, Australia, Switzerland, and Germany. Investigators found that the new forms of hospitalization led to a reduction in conflictive events; self-harm behavior; restrictive measures, such as seclusion, mechanical restraints, and chemical restraints; as well as forced medication. On the basis of these findings, ODPWs were launched.

According to Ignacio García Cabeza, MD, psychiatrist and coordinator of the department of psychiatry at Gregorio Marañón General University Hospital in Madrid, “The open wards model is founded on the idea of respecting the patient and their autonomy. In addition, it advocates a reduction in coercive measures.

“We wanted our department to be the same as the other departments in the hospital, with patients going in and out, receiving treatment, and being able to have family visits,” he explained. “A patient’s diagnosis should not factor into these things. People with schizophrenia, people with any type of mental disorder, should be able to enjoy this minimally restrictive environment.”

Use of open wards constitutes a paradigm shift in hospitalization toward a person-centered psychiatry. The goal of this new paradigm is to prepare the individual so that he or she can live in harmony with the usual environment and participate in it to the same extent as everyone else in the community.

This model also implies fundamental changes in the interaction between health care professionals and patients. The implementation of new nursing care models, among which the Safewards model stands out, is a key element for the success of the project.

Based on a set of tools for preventing and managing conflict, the Safewards model seeks to modify the factors that regulate the relationship between staff and patients. Use of this model brought about a 15% reduction in the rate of conflictive events and a 23% reduction in the rate of coercive interventions, in comparison with a control group.

One of the major debates is about whether every patient should be able to choose this open-door system. For Dr. García Cabeza, the answer is yes, but with one caveat. “There’s a certain group of patients who perhaps need to be in locked wards, who perhaps require greater means of control – patients whose conditions put them at a high risk of suicide or of self-harm behavior or of absconding.”

He had no hesitation in saying that an open-door ward increases the patient’s self-esteem. It helps promote autonomy and a sense of control and of normalcy with respect to a community. “The idea is to get to the point where we’ve got an atmosphere, a climate, that serves to benefit the therapeutic actions that are going to continue to influence the patient’s future progress and their treatment.”

That’s why it’s important to bring about the kind of health care activities that can prevent the patient from experiencing some of the negative psychological effects, such as distrust and feeling removed from normalcy. “In traditional locked wards, the patient feels incapable of making decisions. They feel that they have very little to do with [and have] no say in the decisions made, and a lot of times, this leads to a situation where, after discharge, the patient ends up giving up on the treatments. If we can manage to break this perception held by the patient,” Dr. García Cabeza suggested, “it’s quite likely that we’ll manage to improve the course of their disorder in general.”
 

What the literature says

The effect of ODPW has been investigated through comparative studies with PWLD and research of the transition from PWLD to ODPW, both from a therapeutic and safety a point of view.

A 15-year observational study published in The Lancet Psychiatry found that, with respect to abscondment, suicide attempts, and suicide, there were no significant differences between hospitals with open-door policies and those without.

A subsequent study that was published in 2017 found that on open wards, any aggressive behavior and restraint or seclusion were less likely than on closed wards.
 

The Spanish situation

This system is already at work in some Spanish hospitals, among them Inca Comarcal Hospital (Palma de Mallorca), Elda General University Hospital (Alicante), Germans Trias i Pujol Hospital in Badalona, and Gregorio Marañón General University Hospital in Madrid.

“At Gregorio Marañón, we started the experiment just before the pandemic hit. We’re up and running now, but still with some limitations; the patient can go in and out, but not with the flexibility we’d like,” explained Dr. García Cabeza. “An open ward plays a clinical, patient-care role and a symbolic one as well. Locking the doors has a lot to do with the fear felt toward these patients. It’s a stigma that they’ve had to deal with and that they continue to have to deal with. In terms of the symbolic role, there’s also the fear that comes with giving these patients some rights.”

While the experiment at Gregorio Marañón’s psychiatric ward “is still very much in the early stages,” there have been no recorded incidents related to its open-door policy. Dr. García Cabeza is aware of the challenges of such a policy, “starting with assistance when conflictive events arise. Challenges faced by the staff – especially the nursing staff, as they’re the ones who are with the patients 24 hours day – and challenges faced by those in charge of providing care. In all of this, there are new things to learn and be aware of, new ways of understanding and looking at the patient-physician relationship. The fears are still there – they haven’t been done away with. But the way we conduct ourselves should be adjusted, matching how we act toward other patients. Although the differences have to be taken into account, we have to try to normalize, as much as possible, the environment where patients with mental disorders receive treatment.”

Dr. García Cabeza has no doubts. “The most sensible and reasonable decisions need to be made at these sites so as to allow the broadest applicability to cases. Anyone who needs psychiatric hospitalization and who is competent to consent to admission and who voluntarily agrees to be admitted – they can and must be placed in an open ward.”

The hope is that in the future, the number of open wards will increase and the number of locked wards – which have more stigma attached to them – will go down. The involvement of the staff and appropriate institutional support are essential to making this a reality.

This article was translated from Univadis Spain.

If isolated, patients with mental disorders may end up having higher levels of social impairment. This has led several hospitals in Spain to set up open-door departments that are more accessible.

The purpose of the open-door model is to help remove the stigma from individuals who need to be admitted to a psychiatric ward because they have a mental disorder.
 

Traditional locked wards

According to the World Health Organization (WHO), in 2019, one in every eight people were living with a mental disorder. Having the least restrictive type of mental health care is one of the 10 basic principles listed in a 1996 reference document from the WHO.

Among people suffering from severe psychiatric disorders, there is a high probability of being involuntarily admitted to a psychiatry ward with locked doors (PWLD). Admission to a PWLD involves the application of a set of measures that restrict the individual’s freedom.

The main argument for keeping the doors locked is that it prevents suicides and self-harm behavior, as well as abscondment. But in recent years, efforts have been made to apply a model called open-door policy psychiatry wards (ODPWs).
 

Open wards model

Experiments were undertaken in various countries, including the United Kingdom, Australia, Switzerland, and Germany. Investigators found that the new forms of hospitalization led to a reduction in conflictive events; self-harm behavior; restrictive measures, such as seclusion, mechanical restraints, and chemical restraints; as well as forced medication. On the basis of these findings, ODPWs were launched.

According to Ignacio García Cabeza, MD, psychiatrist and coordinator of the department of psychiatry at Gregorio Marañón General University Hospital in Madrid, “The open wards model is founded on the idea of respecting the patient and their autonomy. In addition, it advocates a reduction in coercive measures.

“We wanted our department to be the same as the other departments in the hospital, with patients going in and out, receiving treatment, and being able to have family visits,” he explained. “A patient’s diagnosis should not factor into these things. People with schizophrenia, people with any type of mental disorder, should be able to enjoy this minimally restrictive environment.”

Use of open wards constitutes a paradigm shift in hospitalization toward a person-centered psychiatry. The goal of this new paradigm is to prepare the individual so that he or she can live in harmony with the usual environment and participate in it to the same extent as everyone else in the community.

This model also implies fundamental changes in the interaction between health care professionals and patients. The implementation of new nursing care models, among which the Safewards model stands out, is a key element for the success of the project.

Based on a set of tools for preventing and managing conflict, the Safewards model seeks to modify the factors that regulate the relationship between staff and patients. Use of this model brought about a 15% reduction in the rate of conflictive events and a 23% reduction in the rate of coercive interventions, in comparison with a control group.

One of the major debates is about whether every patient should be able to choose this open-door system. For Dr. García Cabeza, the answer is yes, but with one caveat. “There’s a certain group of patients who perhaps need to be in locked wards, who perhaps require greater means of control – patients whose conditions put them at a high risk of suicide or of self-harm behavior or of absconding.”

He had no hesitation in saying that an open-door ward increases the patient’s self-esteem. It helps promote autonomy and a sense of control and of normalcy with respect to a community. “The idea is to get to the point where we’ve got an atmosphere, a climate, that serves to benefit the therapeutic actions that are going to continue to influence the patient’s future progress and their treatment.”

That’s why it’s important to bring about the kind of health care activities that can prevent the patient from experiencing some of the negative psychological effects, such as distrust and feeling removed from normalcy. “In traditional locked wards, the patient feels incapable of making decisions. They feel that they have very little to do with [and have] no say in the decisions made, and a lot of times, this leads to a situation where, after discharge, the patient ends up giving up on the treatments. If we can manage to break this perception held by the patient,” Dr. García Cabeza suggested, “it’s quite likely that we’ll manage to improve the course of their disorder in general.”
 

What the literature says

The effect of ODPW has been investigated through comparative studies with PWLD and research of the transition from PWLD to ODPW, both from a therapeutic and safety a point of view.

A 15-year observational study published in The Lancet Psychiatry found that, with respect to abscondment, suicide attempts, and suicide, there were no significant differences between hospitals with open-door policies and those without.

A subsequent study that was published in 2017 found that on open wards, any aggressive behavior and restraint or seclusion were less likely than on closed wards.
 

The Spanish situation

This system is already at work in some Spanish hospitals, among them Inca Comarcal Hospital (Palma de Mallorca), Elda General University Hospital (Alicante), Germans Trias i Pujol Hospital in Badalona, and Gregorio Marañón General University Hospital in Madrid.

“At Gregorio Marañón, we started the experiment just before the pandemic hit. We’re up and running now, but still with some limitations; the patient can go in and out, but not with the flexibility we’d like,” explained Dr. García Cabeza. “An open ward plays a clinical, patient-care role and a symbolic one as well. Locking the doors has a lot to do with the fear felt toward these patients. It’s a stigma that they’ve had to deal with and that they continue to have to deal with. In terms of the symbolic role, there’s also the fear that comes with giving these patients some rights.”

While the experiment at Gregorio Marañón’s psychiatric ward “is still very much in the early stages,” there have been no recorded incidents related to its open-door policy. Dr. García Cabeza is aware of the challenges of such a policy, “starting with assistance when conflictive events arise. Challenges faced by the staff – especially the nursing staff, as they’re the ones who are with the patients 24 hours day – and challenges faced by those in charge of providing care. In all of this, there are new things to learn and be aware of, new ways of understanding and looking at the patient-physician relationship. The fears are still there – they haven’t been done away with. But the way we conduct ourselves should be adjusted, matching how we act toward other patients. Although the differences have to be taken into account, we have to try to normalize, as much as possible, the environment where patients with mental disorders receive treatment.”

Dr. García Cabeza has no doubts. “The most sensible and reasonable decisions need to be made at these sites so as to allow the broadest applicability to cases. Anyone who needs psychiatric hospitalization and who is competent to consent to admission and who voluntarily agrees to be admitted – they can and must be placed in an open ward.”

The hope is that in the future, the number of open wards will increase and the number of locked wards – which have more stigma attached to them – will go down. The involvement of the staff and appropriate institutional support are essential to making this a reality.

This article was translated from Univadis Spain.

If isolated, patients with mental disorders may end up having higher levels of social impairment. This has led several hospitals in Spain to set up open-door departments that are more accessible.

The purpose of the open-door model is to help remove the stigma from individuals who need to be admitted to a psychiatric ward because they have a mental disorder.
 

Traditional locked wards

According to the World Health Organization (WHO), in 2019, one in every eight people were living with a mental disorder. Having the least restrictive type of mental health care is one of the 10 basic principles listed in a 1996 reference document from the WHO.

Among people suffering from severe psychiatric disorders, there is a high probability of being involuntarily admitted to a psychiatry ward with locked doors (PWLD). Admission to a PWLD involves the application of a set of measures that restrict the individual’s freedom.

The main argument for keeping the doors locked is that it prevents suicides and self-harm behavior, as well as abscondment. But in recent years, efforts have been made to apply a model called open-door policy psychiatry wards (ODPWs).
 

Open wards model

Experiments were undertaken in various countries, including the United Kingdom, Australia, Switzerland, and Germany. Investigators found that the new forms of hospitalization led to a reduction in conflictive events; self-harm behavior; restrictive measures, such as seclusion, mechanical restraints, and chemical restraints; as well as forced medication. On the basis of these findings, ODPWs were launched.

According to Ignacio García Cabeza, MD, psychiatrist and coordinator of the department of psychiatry at Gregorio Marañón General University Hospital in Madrid, “The open wards model is founded on the idea of respecting the patient and their autonomy. In addition, it advocates a reduction in coercive measures.

“We wanted our department to be the same as the other departments in the hospital, with patients going in and out, receiving treatment, and being able to have family visits,” he explained. “A patient’s diagnosis should not factor into these things. People with schizophrenia, people with any type of mental disorder, should be able to enjoy this minimally restrictive environment.”

Use of open wards constitutes a paradigm shift in hospitalization toward a person-centered psychiatry. The goal of this new paradigm is to prepare the individual so that he or she can live in harmony with the usual environment and participate in it to the same extent as everyone else in the community.

This model also implies fundamental changes in the interaction between health care professionals and patients. The implementation of new nursing care models, among which the Safewards model stands out, is a key element for the success of the project.

Based on a set of tools for preventing and managing conflict, the Safewards model seeks to modify the factors that regulate the relationship between staff and patients. Use of this model brought about a 15% reduction in the rate of conflictive events and a 23% reduction in the rate of coercive interventions, in comparison with a control group.

One of the major debates is about whether every patient should be able to choose this open-door system. For Dr. García Cabeza, the answer is yes, but with one caveat. “There’s a certain group of patients who perhaps need to be in locked wards, who perhaps require greater means of control – patients whose conditions put them at a high risk of suicide or of self-harm behavior or of absconding.”

He had no hesitation in saying that an open-door ward increases the patient’s self-esteem. It helps promote autonomy and a sense of control and of normalcy with respect to a community. “The idea is to get to the point where we’ve got an atmosphere, a climate, that serves to benefit the therapeutic actions that are going to continue to influence the patient’s future progress and their treatment.”

That’s why it’s important to bring about the kind of health care activities that can prevent the patient from experiencing some of the negative psychological effects, such as distrust and feeling removed from normalcy. “In traditional locked wards, the patient feels incapable of making decisions. They feel that they have very little to do with [and have] no say in the decisions made, and a lot of times, this leads to a situation where, after discharge, the patient ends up giving up on the treatments. If we can manage to break this perception held by the patient,” Dr. García Cabeza suggested, “it’s quite likely that we’ll manage to improve the course of their disorder in general.”
 

What the literature says

The effect of ODPW has been investigated through comparative studies with PWLD and research of the transition from PWLD to ODPW, both from a therapeutic and safety a point of view.

A 15-year observational study published in The Lancet Psychiatry found that, with respect to abscondment, suicide attempts, and suicide, there were no significant differences between hospitals with open-door policies and those without.

A subsequent study that was published in 2017 found that on open wards, any aggressive behavior and restraint or seclusion were less likely than on closed wards.
 

The Spanish situation

This system is already at work in some Spanish hospitals, among them Inca Comarcal Hospital (Palma de Mallorca), Elda General University Hospital (Alicante), Germans Trias i Pujol Hospital in Badalona, and Gregorio Marañón General University Hospital in Madrid.

“At Gregorio Marañón, we started the experiment just before the pandemic hit. We’re up and running now, but still with some limitations; the patient can go in and out, but not with the flexibility we’d like,” explained Dr. García Cabeza. “An open ward plays a clinical, patient-care role and a symbolic one as well. Locking the doors has a lot to do with the fear felt toward these patients. It’s a stigma that they’ve had to deal with and that they continue to have to deal with. In terms of the symbolic role, there’s also the fear that comes with giving these patients some rights.”

While the experiment at Gregorio Marañón’s psychiatric ward “is still very much in the early stages,” there have been no recorded incidents related to its open-door policy. Dr. García Cabeza is aware of the challenges of such a policy, “starting with assistance when conflictive events arise. Challenges faced by the staff – especially the nursing staff, as they’re the ones who are with the patients 24 hours day – and challenges faced by those in charge of providing care. In all of this, there are new things to learn and be aware of, new ways of understanding and looking at the patient-physician relationship. The fears are still there – they haven’t been done away with. But the way we conduct ourselves should be adjusted, matching how we act toward other patients. Although the differences have to be taken into account, we have to try to normalize, as much as possible, the environment where patients with mental disorders receive treatment.”

Dr. García Cabeza has no doubts. “The most sensible and reasonable decisions need to be made at these sites so as to allow the broadest applicability to cases. Anyone who needs psychiatric hospitalization and who is competent to consent to admission and who voluntarily agrees to be admitted – they can and must be placed in an open ward.”

The hope is that in the future, the number of open wards will increase and the number of locked wards – which have more stigma attached to them – will go down. The involvement of the staff and appropriate institutional support are essential to making this a reality.

This article was translated from Univadis Spain.

The level of remission in patients with remitting inflammatory bowel disease (IBD) appears to play a major role in whether they will relapse after treatment when biologic therapies are discontinued, according to a new prospective study.

Patients with complete endoscopic healing have half the rate of relapse after withdrawal of anti-tumor necrosis factor alpha (anti-TNF) treatment than those with only partial healing, according to a study published online in Clinical Gastroenterology and Hepatology.

“Applying strict criteria for endoscopic healing and mesalamine treatment ... may lower the risk of relapse after withdrawal of anti-TNF treatment,” write Bas Oldenburg, MD, PhD, a professor at University Medical Center Utrecht, the Netherlands, and colleagues in their analysis of 81 patients.

De-escalation of anti-TNF treatment in IBD patients in remission has the potential to “reduce side effects, including risks of serious infections and malignancies, decrease health care expenditures, and meet patients’ preferences,” they note.

However, withdrawal of the drugs increases the risk of relapse by 30%-45% at 12 months. When patients relapse, reintroduction of anti-TNF therapy returns over 80% to remission.

Although no consensus exists on how to select patients for therapy de-escalation, evidence suggests that persistent inflammation affects outcomes and that the “depth” of endoscopic healing is a key indicator, the authors note.
 

Study details

To further the knowledge base, they conducted a prospective study of patients in remission to determine the relapse rate following de-escalation of anti-TNF therapy; evaluate relapse factors, including degree of endoscopic healing; and assess outcomes after reintroduction of anti-TNF therapy.

The study was limited to adult patients with IBD with at least 6 months of corticosteroid-free clinical remission, confirmed baseline clinical remission and endoscopic healing, no current hospitalization, and no pregnancy.

The patients underwent elective discontinuation of anti-TNF therapy between 2018 and 2020. The recommended protocol was to measure C-reactive protein (CRP) and fecal calprotectin at 3, 6, 12, and 24 months and to perform endoscopy at 12 months.

Patients also completed questionnaires at baseline and at 3, 6, 12, and 24 months. The authors selected the patient–Harvey-Bradshaw Index for patients with Crohn’s disease and the patient–Simple Clinical Colitis Activity Index for patients with ulcerative colitis and unclassified IBD, as well as the short IBD Quality of Life measure.

Of the 81 patients from 13 centers who took part, 51% had Crohn’s disease. The median duration of remission at baseline was 3.5 years, and the median disease duration was 9.1 years.

All patients had evidence of endoscopic healing, and 88% met the strict criteria for complete endoscopic healing. In 34%, trough levels of anti-TNF treatments were judged to be subtherapeutic.

After withdrawal of the drugs, 25.9% of patients continued on immunomodulators.

Over a median follow-up of 2 years, 49% of patients relapsed, which was confirmed via endoscopy, fecal calprotectin, or CRP in 83% of cases and inferred from treatment escalation for clinical flare in 17%. Rates of relapse were comparable between patients with Crohn’s disease and ulcerative colitis or unclassified IBD and between those discontinuing adalimumab and those stopping infliximab.
 

Better healing, better outcomes

However, analysis showed that partial endoscopic healing was independently associated with a higher risk of relapse, at an adjusted hazard ratio versus complete endoscopic healing of 3.28.

At 12 months, 70% of patients with partial endoscopic healing had relapsed versus 35% of those with complete endoscopic healing.

Treatment with the anti-inflammatory agent mesalamine (multiple brands) was independently associated with a reduced risk of relapse, at an adjusted hazard ratio of 0.08. No other potential predictors of relapse were identified.

Of the patients who relapsed, 75% restarted anti-TNF treatment, and the majority (87%) were restarted on the same agent at a median of 0.9 years since its withdrawal and a median of 24 days since the onset of relapse.

Clinical remission was achieved at 3 months in 73% of patients who restarted anti-TNF therapy, which was found to restore quality of life and well-being in relapsed patients, the authors report.
 

Reluctance remains

Stephen B. Hanauer, MD, professor of medicine (gastroenterology and hepatology) at Northwestern University Feinberg School of Medicine, Chicago, said the findings “reinforce the benefits of the maintenance versus the withdrawal of therapy” and “the deeper the remission” the more likely it is to be sustained.

The 35% relapse rate at 12 months, even in patients with compete endoscopic healing, indicates that treatment should be maintained, Dr. Hanauer said.

“What is also relevant, but was not evaluated, is the additional endpoint of histologic healing, which is likely to sustain remissions even longer,” he added.

Nevertheless, Dr. Hanauer said, the “observed relapse rate is important to discuss in shared decision-making with patients.”

The findings are interesting, but the study didn’t follow the patients for long enough to understand why 35% of those with complete endoscopic healing relapsed, Miguel Regueiro, MD, chair of the Cleveland Clinic’s Digestive Disease & Surgery Institute, told this news organization.

“Are there predictors, factors, or other treatments that could be used to reduce that 35% risk of relapse further?” he questioned.

Although the study didn’t clear up that question for Dr. Regueiro, he found it compelling that mesalamine continuation resulted in higher rates of sustained remission after anti-TNF withdrawal among patients with ulcerative colitis.

Dr. Regueiro said that he will not begin recommending withdrawal of advanced therapies, including anti-TNF drugs, in patients who have achieved a stable remission.

“We have not yet found the cure for IBD, and my concern is that patients may relapse with more severe disease than previously and that recurrence of inflammation could have potential risks for complications,” he said.

“Nonetheless, this study is intriguing and important, and at least prompts the discussion of withdrawing therapy in those who have achieved a deep endoscopic remission for a sustained period of time,” Dr. Regueiro added.

The study received support from the Dutch Health Insurance Innovation Fund.

Dr. Oldenburg declares relationships with AbbVie, Celltrion, Ferring, Takeda, Galapagos, Pfizer, Cablon, PBMS, Janssen, and MSD. Other authors also declare numerous relationships. The full list can be found with the original article. Dr. Hanauer declares relationships with AbbVie, Janssen, Pfizer, and Boehringer Ingelheim. Dr. Regueiro declares relationships with AbbVie, Janssen, UCB, Takeda, Pfizer, Miraca Labs, Amgen, Celgene, Seres, Allergan, Genentech, Gilead, Salix, Prometheus, Lilly, TARGET Pharma Solutions, ALFASIGMA, S.p.A., BMS, CME Outfitters, Imedex, GI Health Foundation, Cornerstones, Remedy, MJH Life Sciences, Medscape, MDEducation, WebMD, and HMPGlobal.

A version of this article first appeared on Medscape.com.

The level of remission in patients with remitting inflammatory bowel disease (IBD) appears to play a major role in whether they will relapse after treatment when biologic therapies are discontinued, according to a new prospective study.

Patients with complete endoscopic healing have half the rate of relapse after withdrawal of anti-tumor necrosis factor alpha (anti-TNF) treatment than those with only partial healing, according to a study published online in Clinical Gastroenterology and Hepatology.

“Applying strict criteria for endoscopic healing and mesalamine treatment ... may lower the risk of relapse after withdrawal of anti-TNF treatment,” write Bas Oldenburg, MD, PhD, a professor at University Medical Center Utrecht, the Netherlands, and colleagues in their analysis of 81 patients.

De-escalation of anti-TNF treatment in IBD patients in remission has the potential to “reduce side effects, including risks of serious infections and malignancies, decrease health care expenditures, and meet patients’ preferences,” they note.

However, withdrawal of the drugs increases the risk of relapse by 30%-45% at 12 months. When patients relapse, reintroduction of anti-TNF therapy returns over 80% to remission.

Although no consensus exists on how to select patients for therapy de-escalation, evidence suggests that persistent inflammation affects outcomes and that the “depth” of endoscopic healing is a key indicator, the authors note.
 

Study details

To further the knowledge base, they conducted a prospective study of patients in remission to determine the relapse rate following de-escalation of anti-TNF therapy; evaluate relapse factors, including degree of endoscopic healing; and assess outcomes after reintroduction of anti-TNF therapy.

The study was limited to adult patients with IBD with at least 6 months of corticosteroid-free clinical remission, confirmed baseline clinical remission and endoscopic healing, no current hospitalization, and no pregnancy.

The patients underwent elective discontinuation of anti-TNF therapy between 2018 and 2020. The recommended protocol was to measure C-reactive protein (CRP) and fecal calprotectin at 3, 6, 12, and 24 months and to perform endoscopy at 12 months.

Patients also completed questionnaires at baseline and at 3, 6, 12, and 24 months. The authors selected the patient–Harvey-Bradshaw Index for patients with Crohn’s disease and the patient–Simple Clinical Colitis Activity Index for patients with ulcerative colitis and unclassified IBD, as well as the short IBD Quality of Life measure.

Of the 81 patients from 13 centers who took part, 51% had Crohn’s disease. The median duration of remission at baseline was 3.5 years, and the median disease duration was 9.1 years.

All patients had evidence of endoscopic healing, and 88% met the strict criteria for complete endoscopic healing. In 34%, trough levels of anti-TNF treatments were judged to be subtherapeutic.

After withdrawal of the drugs, 25.9% of patients continued on immunomodulators.

Over a median follow-up of 2 years, 49% of patients relapsed, which was confirmed via endoscopy, fecal calprotectin, or CRP in 83% of cases and inferred from treatment escalation for clinical flare in 17%. Rates of relapse were comparable between patients with Crohn’s disease and ulcerative colitis or unclassified IBD and between those discontinuing adalimumab and those stopping infliximab.
 

Better healing, better outcomes

However, analysis showed that partial endoscopic healing was independently associated with a higher risk of relapse, at an adjusted hazard ratio versus complete endoscopic healing of 3.28.

At 12 months, 70% of patients with partial endoscopic healing had relapsed versus 35% of those with complete endoscopic healing.

Treatment with the anti-inflammatory agent mesalamine (multiple brands) was independently associated with a reduced risk of relapse, at an adjusted hazard ratio of 0.08. No other potential predictors of relapse were identified.

Of the patients who relapsed, 75% restarted anti-TNF treatment, and the majority (87%) were restarted on the same agent at a median of 0.9 years since its withdrawal and a median of 24 days since the onset of relapse.

Clinical remission was achieved at 3 months in 73% of patients who restarted anti-TNF therapy, which was found to restore quality of life and well-being in relapsed patients, the authors report.
 

Reluctance remains

Stephen B. Hanauer, MD, professor of medicine (gastroenterology and hepatology) at Northwestern University Feinberg School of Medicine, Chicago, said the findings “reinforce the benefits of the maintenance versus the withdrawal of therapy” and “the deeper the remission” the more likely it is to be sustained.

The 35% relapse rate at 12 months, even in patients with compete endoscopic healing, indicates that treatment should be maintained, Dr. Hanauer said.

“What is also relevant, but was not evaluated, is the additional endpoint of histologic healing, which is likely to sustain remissions even longer,” he added.

Nevertheless, Dr. Hanauer said, the “observed relapse rate is important to discuss in shared decision-making with patients.”

The findings are interesting, but the study didn’t follow the patients for long enough to understand why 35% of those with complete endoscopic healing relapsed, Miguel Regueiro, MD, chair of the Cleveland Clinic’s Digestive Disease & Surgery Institute, told this news organization.

“Are there predictors, factors, or other treatments that could be used to reduce that 35% risk of relapse further?” he questioned.

Although the study didn’t clear up that question for Dr. Regueiro, he found it compelling that mesalamine continuation resulted in higher rates of sustained remission after anti-TNF withdrawal among patients with ulcerative colitis.

Dr. Regueiro said that he will not begin recommending withdrawal of advanced therapies, including anti-TNF drugs, in patients who have achieved a stable remission.

“We have not yet found the cure for IBD, and my concern is that patients may relapse with more severe disease than previously and that recurrence of inflammation could have potential risks for complications,” he said.

“Nonetheless, this study is intriguing and important, and at least prompts the discussion of withdrawing therapy in those who have achieved a deep endoscopic remission for a sustained period of time,” Dr. Regueiro added.

The study received support from the Dutch Health Insurance Innovation Fund.

Dr. Oldenburg declares relationships with AbbVie, Celltrion, Ferring, Takeda, Galapagos, Pfizer, Cablon, PBMS, Janssen, and MSD. Other authors also declare numerous relationships. The full list can be found with the original article. Dr. Hanauer declares relationships with AbbVie, Janssen, Pfizer, and Boehringer Ingelheim. Dr. Regueiro declares relationships with AbbVie, Janssen, UCB, Takeda, Pfizer, Miraca Labs, Amgen, Celgene, Seres, Allergan, Genentech, Gilead, Salix, Prometheus, Lilly, TARGET Pharma Solutions, ALFASIGMA, S.p.A., BMS, CME Outfitters, Imedex, GI Health Foundation, Cornerstones, Remedy, MJH Life Sciences, Medscape, MDEducation, WebMD, and HMPGlobal.

A version of this article first appeared on Medscape.com.

The level of remission in patients with remitting inflammatory bowel disease (IBD) appears to play a major role in whether they will relapse after treatment when biologic therapies are discontinued, according to a new prospective study.

Patients with complete endoscopic healing have half the rate of relapse after withdrawal of anti-tumor necrosis factor alpha (anti-TNF) treatment than those with only partial healing, according to a study published online in Clinical Gastroenterology and Hepatology.

“Applying strict criteria for endoscopic healing and mesalamine treatment ... may lower the risk of relapse after withdrawal of anti-TNF treatment,” write Bas Oldenburg, MD, PhD, a professor at University Medical Center Utrecht, the Netherlands, and colleagues in their analysis of 81 patients.

De-escalation of anti-TNF treatment in IBD patients in remission has the potential to “reduce side effects, including risks of serious infections and malignancies, decrease health care expenditures, and meet patients’ preferences,” they note.

However, withdrawal of the drugs increases the risk of relapse by 30%-45% at 12 months. When patients relapse, reintroduction of anti-TNF therapy returns over 80% to remission.

Although no consensus exists on how to select patients for therapy de-escalation, evidence suggests that persistent inflammation affects outcomes and that the “depth” of endoscopic healing is a key indicator, the authors note.
 

Study details

To further the knowledge base, they conducted a prospective study of patients in remission to determine the relapse rate following de-escalation of anti-TNF therapy; evaluate relapse factors, including degree of endoscopic healing; and assess outcomes after reintroduction of anti-TNF therapy.

The study was limited to adult patients with IBD with at least 6 months of corticosteroid-free clinical remission, confirmed baseline clinical remission and endoscopic healing, no current hospitalization, and no pregnancy.

The patients underwent elective discontinuation of anti-TNF therapy between 2018 and 2020. The recommended protocol was to measure C-reactive protein (CRP) and fecal calprotectin at 3, 6, 12, and 24 months and to perform endoscopy at 12 months.

Patients also completed questionnaires at baseline and at 3, 6, 12, and 24 months. The authors selected the patient–Harvey-Bradshaw Index for patients with Crohn’s disease and the patient–Simple Clinical Colitis Activity Index for patients with ulcerative colitis and unclassified IBD, as well as the short IBD Quality of Life measure.

Of the 81 patients from 13 centers who took part, 51% had Crohn’s disease. The median duration of remission at baseline was 3.5 years, and the median disease duration was 9.1 years.

All patients had evidence of endoscopic healing, and 88% met the strict criteria for complete endoscopic healing. In 34%, trough levels of anti-TNF treatments were judged to be subtherapeutic.

After withdrawal of the drugs, 25.9% of patients continued on immunomodulators.

Over a median follow-up of 2 years, 49% of patients relapsed, which was confirmed via endoscopy, fecal calprotectin, or CRP in 83% of cases and inferred from treatment escalation for clinical flare in 17%. Rates of relapse were comparable between patients with Crohn’s disease and ulcerative colitis or unclassified IBD and between those discontinuing adalimumab and those stopping infliximab.
 

Better healing, better outcomes

However, analysis showed that partial endoscopic healing was independently associated with a higher risk of relapse, at an adjusted hazard ratio versus complete endoscopic healing of 3.28.

At 12 months, 70% of patients with partial endoscopic healing had relapsed versus 35% of those with complete endoscopic healing.

Treatment with the anti-inflammatory agent mesalamine (multiple brands) was independently associated with a reduced risk of relapse, at an adjusted hazard ratio of 0.08. No other potential predictors of relapse were identified.

Of the patients who relapsed, 75% restarted anti-TNF treatment, and the majority (87%) were restarted on the same agent at a median of 0.9 years since its withdrawal and a median of 24 days since the onset of relapse.

Clinical remission was achieved at 3 months in 73% of patients who restarted anti-TNF therapy, which was found to restore quality of life and well-being in relapsed patients, the authors report.
 

Reluctance remains

Stephen B. Hanauer, MD, professor of medicine (gastroenterology and hepatology) at Northwestern University Feinberg School of Medicine, Chicago, said the findings “reinforce the benefits of the maintenance versus the withdrawal of therapy” and “the deeper the remission” the more likely it is to be sustained.

The 35% relapse rate at 12 months, even in patients with compete endoscopic healing, indicates that treatment should be maintained, Dr. Hanauer said.

“What is also relevant, but was not evaluated, is the additional endpoint of histologic healing, which is likely to sustain remissions even longer,” he added.

Nevertheless, Dr. Hanauer said, the “observed relapse rate is important to discuss in shared decision-making with patients.”

The findings are interesting, but the study didn’t follow the patients for long enough to understand why 35% of those with complete endoscopic healing relapsed, Miguel Regueiro, MD, chair of the Cleveland Clinic’s Digestive Disease & Surgery Institute, told this news organization.

“Are there predictors, factors, or other treatments that could be used to reduce that 35% risk of relapse further?” he questioned.

Although the study didn’t clear up that question for Dr. Regueiro, he found it compelling that mesalamine continuation resulted in higher rates of sustained remission after anti-TNF withdrawal among patients with ulcerative colitis.

Dr. Regueiro said that he will not begin recommending withdrawal of advanced therapies, including anti-TNF drugs, in patients who have achieved a stable remission.

“We have not yet found the cure for IBD, and my concern is that patients may relapse with more severe disease than previously and that recurrence of inflammation could have potential risks for complications,” he said.

“Nonetheless, this study is intriguing and important, and at least prompts the discussion of withdrawing therapy in those who have achieved a deep endoscopic remission for a sustained period of time,” Dr. Regueiro added.

The study received support from the Dutch Health Insurance Innovation Fund.

Dr. Oldenburg declares relationships with AbbVie, Celltrion, Ferring, Takeda, Galapagos, Pfizer, Cablon, PBMS, Janssen, and MSD. Other authors also declare numerous relationships. The full list can be found with the original article. Dr. Hanauer declares relationships with AbbVie, Janssen, Pfizer, and Boehringer Ingelheim. Dr. Regueiro declares relationships with AbbVie, Janssen, UCB, Takeda, Pfizer, Miraca Labs, Amgen, Celgene, Seres, Allergan, Genentech, Gilead, Salix, Prometheus, Lilly, TARGET Pharma Solutions, ALFASIGMA, S.p.A., BMS, CME Outfitters, Imedex, GI Health Foundation, Cornerstones, Remedy, MJH Life Sciences, Medscape, MDEducation, WebMD, and HMPGlobal.

A version of this article first appeared on Medscape.com.