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In IBD Patients, No Increased Risk for MACE Seen for JAK Inhibitors vs Anti-TNF
PHILADELPHIA — according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.
In particular, 1.76% of patients taking JAKi and 1.94% of patients taking anti-TNF developed MACE. There also weren’t significant differences when comparing ulcerative colitis with Crohn’s disease, upadacitinib with tofacitinib, or JAKi with infliximab.
“IBD is associated with an increased risk of cardiovascular diseases, and with the emergence of JAK inhibitors and anti-TNF therapies, there is a concern about the increased risk of MACE,” said lead author Saqr Alsakarneh, MD, an internal medicine resident at the University of Missouri–Kansas City School of Medicine.
Previous randomized controlled trials have indicated increased risks of MACE with JAKi and anti-TNF agents, compared with placebo, but researchers haven’t conducted a head-to-head comparison, he said.
“A potential explanation for previous associations could be linked to immune modulation and inflammation that can increase coagulation risk, as well as fluctuation in disease severity while patients are on the medications, which can impact cardiovascular risk factors,” he added.
Alsakarneh and colleagues conducted a retrospective cohort study using the TriNetX database to identify adult patients with IBD who were treated with JAKi or anti-TNF therapy after diagnosis. After matching patients in the JAKi cohort with patients in the anti-TNF cohort, the research team looked for MACE and VTE within a year of medication initiation, as well as associations by age, sex, and IBD type.
Overall, 3740 patients in the JAKi cohort had a mean age of 43.1 and were 48.9% women and 75.3% White individuals, while 3,740 patients in the anti-TNF cohort had a mean age of 43 and were 48.9% women and 75.3% White individuals.
After excluding those with a history of a prior cardiovascular event, 57 patients (1.76%) in the JAKi cohort developed MACE, compared with 63 patients (1.94%) in the anti-TNF cohort. There weren’t significant differences between the groups in MACE (adjusted hazard ratio [aHR], 0.99) or VTE (aHR, 0.9).
Among patients aged ≥ 65, 25 patients (5.3%) in the JAKi cohort developed MACE, as compared with 30 patients (6.4%) in the anti-TNF cohort. There weren’t significant differences between the groups in MACE (aHR, 0.83) or VTE (aHR, 0.77).
In addition, there were no differences when comparing Crohn’s disease with ulcerative colitis for MACE (aHR, 1.69) or VTE (aHR, 0.85); upadacitinib with tofacitinib for MACE (aHR, 1.1) or VTE (aHR, 1.13); or JAKi medications with infliximab for MACE (aHR, 0.85) or VTE (aHR, 0.8).
Patients in the JAKi group were more likely to undergo intestinal resection surgery (aHR, 1.32), but there wasn’t a statistically significant difference in systematic corticosteroid use (aHR, 0.99).
The study limitations included the inability to assess for disease severity, dose-dependent risk for MACE or VTE, or long-term outcomes among the two cohorts, Alsakarneh said. Prospective controlled trials are needed to confirm findings.
“This is a wonderful study and nice to see. We presented the same thing at Digestive Disease Week that’s being confirmed in this data,” said Miguel Regueiro, MD, AGAF, chief of Cleveland Clinic’s Digestive Disease Institute in Ohio. Regueiro, who wasn’t involved with the study, attended the conference session.
“Looking ahead, all of us are wondering if the regulatory guidance by the FDA [Food and Drug Administration] is going to change the label so we don’t need to step through a TNF,” he said. “I think we’re seeing study after study showing safety or at least not an increased risk with JAK.”
The study was awarded an ACG Noteworthy Abstract. Alsakarneh and Regueiro reported no relevant disclosures.
A version of this article appeared on Medscape.com.
PHILADELPHIA — according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.
In particular, 1.76% of patients taking JAKi and 1.94% of patients taking anti-TNF developed MACE. There also weren’t significant differences when comparing ulcerative colitis with Crohn’s disease, upadacitinib with tofacitinib, or JAKi with infliximab.
“IBD is associated with an increased risk of cardiovascular diseases, and with the emergence of JAK inhibitors and anti-TNF therapies, there is a concern about the increased risk of MACE,” said lead author Saqr Alsakarneh, MD, an internal medicine resident at the University of Missouri–Kansas City School of Medicine.
Previous randomized controlled trials have indicated increased risks of MACE with JAKi and anti-TNF agents, compared with placebo, but researchers haven’t conducted a head-to-head comparison, he said.
“A potential explanation for previous associations could be linked to immune modulation and inflammation that can increase coagulation risk, as well as fluctuation in disease severity while patients are on the medications, which can impact cardiovascular risk factors,” he added.
Alsakarneh and colleagues conducted a retrospective cohort study using the TriNetX database to identify adult patients with IBD who were treated with JAKi or anti-TNF therapy after diagnosis. After matching patients in the JAKi cohort with patients in the anti-TNF cohort, the research team looked for MACE and VTE within a year of medication initiation, as well as associations by age, sex, and IBD type.
Overall, 3740 patients in the JAKi cohort had a mean age of 43.1 and were 48.9% women and 75.3% White individuals, while 3,740 patients in the anti-TNF cohort had a mean age of 43 and were 48.9% women and 75.3% White individuals.
After excluding those with a history of a prior cardiovascular event, 57 patients (1.76%) in the JAKi cohort developed MACE, compared with 63 patients (1.94%) in the anti-TNF cohort. There weren’t significant differences between the groups in MACE (adjusted hazard ratio [aHR], 0.99) or VTE (aHR, 0.9).
Among patients aged ≥ 65, 25 patients (5.3%) in the JAKi cohort developed MACE, as compared with 30 patients (6.4%) in the anti-TNF cohort. There weren’t significant differences between the groups in MACE (aHR, 0.83) or VTE (aHR, 0.77).
In addition, there were no differences when comparing Crohn’s disease with ulcerative colitis for MACE (aHR, 1.69) or VTE (aHR, 0.85); upadacitinib with tofacitinib for MACE (aHR, 1.1) or VTE (aHR, 1.13); or JAKi medications with infliximab for MACE (aHR, 0.85) or VTE (aHR, 0.8).
Patients in the JAKi group were more likely to undergo intestinal resection surgery (aHR, 1.32), but there wasn’t a statistically significant difference in systematic corticosteroid use (aHR, 0.99).
The study limitations included the inability to assess for disease severity, dose-dependent risk for MACE or VTE, or long-term outcomes among the two cohorts, Alsakarneh said. Prospective controlled trials are needed to confirm findings.
“This is a wonderful study and nice to see. We presented the same thing at Digestive Disease Week that’s being confirmed in this data,” said Miguel Regueiro, MD, AGAF, chief of Cleveland Clinic’s Digestive Disease Institute in Ohio. Regueiro, who wasn’t involved with the study, attended the conference session.
“Looking ahead, all of us are wondering if the regulatory guidance by the FDA [Food and Drug Administration] is going to change the label so we don’t need to step through a TNF,” he said. “I think we’re seeing study after study showing safety or at least not an increased risk with JAK.”
The study was awarded an ACG Noteworthy Abstract. Alsakarneh and Regueiro reported no relevant disclosures.
A version of this article appeared on Medscape.com.
PHILADELPHIA — according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.
In particular, 1.76% of patients taking JAKi and 1.94% of patients taking anti-TNF developed MACE. There also weren’t significant differences when comparing ulcerative colitis with Crohn’s disease, upadacitinib with tofacitinib, or JAKi with infliximab.
“IBD is associated with an increased risk of cardiovascular diseases, and with the emergence of JAK inhibitors and anti-TNF therapies, there is a concern about the increased risk of MACE,” said lead author Saqr Alsakarneh, MD, an internal medicine resident at the University of Missouri–Kansas City School of Medicine.
Previous randomized controlled trials have indicated increased risks of MACE with JAKi and anti-TNF agents, compared with placebo, but researchers haven’t conducted a head-to-head comparison, he said.
“A potential explanation for previous associations could be linked to immune modulation and inflammation that can increase coagulation risk, as well as fluctuation in disease severity while patients are on the medications, which can impact cardiovascular risk factors,” he added.
Alsakarneh and colleagues conducted a retrospective cohort study using the TriNetX database to identify adult patients with IBD who were treated with JAKi or anti-TNF therapy after diagnosis. After matching patients in the JAKi cohort with patients in the anti-TNF cohort, the research team looked for MACE and VTE within a year of medication initiation, as well as associations by age, sex, and IBD type.
Overall, 3740 patients in the JAKi cohort had a mean age of 43.1 and were 48.9% women and 75.3% White individuals, while 3,740 patients in the anti-TNF cohort had a mean age of 43 and were 48.9% women and 75.3% White individuals.
After excluding those with a history of a prior cardiovascular event, 57 patients (1.76%) in the JAKi cohort developed MACE, compared with 63 patients (1.94%) in the anti-TNF cohort. There weren’t significant differences between the groups in MACE (adjusted hazard ratio [aHR], 0.99) or VTE (aHR, 0.9).
Among patients aged ≥ 65, 25 patients (5.3%) in the JAKi cohort developed MACE, as compared with 30 patients (6.4%) in the anti-TNF cohort. There weren’t significant differences between the groups in MACE (aHR, 0.83) or VTE (aHR, 0.77).
In addition, there were no differences when comparing Crohn’s disease with ulcerative colitis for MACE (aHR, 1.69) or VTE (aHR, 0.85); upadacitinib with tofacitinib for MACE (aHR, 1.1) or VTE (aHR, 1.13); or JAKi medications with infliximab for MACE (aHR, 0.85) or VTE (aHR, 0.8).
Patients in the JAKi group were more likely to undergo intestinal resection surgery (aHR, 1.32), but there wasn’t a statistically significant difference in systematic corticosteroid use (aHR, 0.99).
The study limitations included the inability to assess for disease severity, dose-dependent risk for MACE or VTE, or long-term outcomes among the two cohorts, Alsakarneh said. Prospective controlled trials are needed to confirm findings.
“This is a wonderful study and nice to see. We presented the same thing at Digestive Disease Week that’s being confirmed in this data,” said Miguel Regueiro, MD, AGAF, chief of Cleveland Clinic’s Digestive Disease Institute in Ohio. Regueiro, who wasn’t involved with the study, attended the conference session.
“Looking ahead, all of us are wondering if the regulatory guidance by the FDA [Food and Drug Administration] is going to change the label so we don’t need to step through a TNF,” he said. “I think we’re seeing study after study showing safety or at least not an increased risk with JAK.”
The study was awarded an ACG Noteworthy Abstract. Alsakarneh and Regueiro reported no relevant disclosures.
A version of this article appeared on Medscape.com.
FROM ACG 2024
Alcohol Use Disorder Therapy Remains Underutilized in Alcohol-Associated Liver Disease
PHILADELPHIA — according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.
In an analysis of commercially insured Americans, AUD medications were prescribed to only 1 in 50 patients with ALD and about 1 in 10 patients with acute alcohol-associated hepatitis (AAH).
“Providers caring for these patients should consider early initiation of this therapy in select cases,” said lead author Alex R. Jones, MD, chief resident of internal medicine at the University of Texas Southwestern Medical Center in Dallas.
“Based on additional analyses looking at the prescriber subspecialty, we didn’t identify any gastroenterologists or hepatologists who prescribed pharmacotherapy,” he said. “This could be a great opportunity for hepatologists to engage in the pharmacologic treatment of AUD.”
Jones and colleagues analyzed 2006-2021 data from IQVIA PharMetrics Plus for Academics, a nationally representative database of commercially insured patients in the United States. They looked for AUD pharmacologic treatment at any time after AUD diagnosis, including prescriptions for gabapentin, naltrexone, topiramate, acamprosate, baclofen, and disulfiram.
Among 28,625 patients with AUD (defined as at least two outpatient codes or at least one inpatient code), 1201 had ALD with cirrhosis and 439 had AAH.
Pharmacologic therapy was prescribed in 3924 (14.5%) patients without ALD, 28 (2.3%) with ALD, and 42 (9.8%) with AAH.
In addition, one-time prescriptions were observed in 1113 (28.4%) patients without ALD, three patients (10.7%) with ALD, and eight patients (18.6%) with AAH.
Overall, 64.5% of the general population consisted of men. About 46% had a psychiatric diagnosis other than substance use disorder (SUD), and 35.7% had a non-AUD SUD.
Patients who received AUD pharmacotherapy tended to be older, at a median age of 45 years, than those aged 42 years without a prescription.
The median time to prescription was 302 days, with no significant differences based on the presence of liver disease.
By medication, gabapentin was prescribed most often (9.4%), followed by oral naltrexone (2.6%) and topiramate (2%). Oral naltrexone was prescribed at a lower rate in patients with ALD and at a higher rate in patients with AAH than in patients without ALD. Baclofen was also prescribed at lower rates in patients with ALD and AAH.
In a multivariable logistic regression analysis, several characteristics were more significantly associated with pharmacologic therapy, such as age ≥ 50 years (adjusted odds ratio [aOR], 1.33), female sex (aOR, 1.31), a non-liver Charlson Comorbidity Index ≥ 3 (aOR, 2.21), and psychiatric comorbidities (aOR, 2.76).
On the other hand, the presence of hepatic decompensation — defined as ascites, hepatic encephalopathy, or bleeding varices — was associated with lower odds of receiving pharmacotherapy (aOR, 0.08). ALD cirrhosis (non-AAH) also had lower odds (aOR, 0.24).
The study was limited by only incorporating patients with commercial insurance, lacking demographic details related to race or ethnicity, and potentially misclassifying patients despite validated definitions of ALD and AUD, Jones said.
As the study couldn’t determine the indications for prescriptions, such as gabapentin use for migraines or diabetes-associated neuropathy, for instance, future studies could look at these precise details, he added.
“It’s important to know we’re underutilizing therapies that we have a lot of information about, such as gabapentin, which is an old medication that we should feel fairly comfortable using,” said Patricia Jones, MD, a hepatologist and associate professor of clinical medicine at the University of Miami Miller School of Medicine, in Florida. Patricia Jones comoderated the plenary session on small intestine, functional, and liver research.
“I also expect that, if a future study reviewed this data and excluded people with valid indications, such as migraines or diabetic neuropathy, we’d see even lower rates of prescription,” she said.
From a clinical perspective, patient communication and clinical decision-making are key, Patricia Jones added, particularly when clinical gastroenterologists and hepatologists may not offer this type of therapy or patients refuse this type of therapy.
“We need to think about our practice patterns and how we can offer therapy,” she said. “In general, we know these medications are very safe. Even though they’re not widely used in people with cirrhosis, there’s not enough evidence to suggest we shouldn’t use them.”
Alex Jones and Patricia Jones reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
PHILADELPHIA — according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.
In an analysis of commercially insured Americans, AUD medications were prescribed to only 1 in 50 patients with ALD and about 1 in 10 patients with acute alcohol-associated hepatitis (AAH).
“Providers caring for these patients should consider early initiation of this therapy in select cases,” said lead author Alex R. Jones, MD, chief resident of internal medicine at the University of Texas Southwestern Medical Center in Dallas.
“Based on additional analyses looking at the prescriber subspecialty, we didn’t identify any gastroenterologists or hepatologists who prescribed pharmacotherapy,” he said. “This could be a great opportunity for hepatologists to engage in the pharmacologic treatment of AUD.”
Jones and colleagues analyzed 2006-2021 data from IQVIA PharMetrics Plus for Academics, a nationally representative database of commercially insured patients in the United States. They looked for AUD pharmacologic treatment at any time after AUD diagnosis, including prescriptions for gabapentin, naltrexone, topiramate, acamprosate, baclofen, and disulfiram.
Among 28,625 patients with AUD (defined as at least two outpatient codes or at least one inpatient code), 1201 had ALD with cirrhosis and 439 had AAH.
Pharmacologic therapy was prescribed in 3924 (14.5%) patients without ALD, 28 (2.3%) with ALD, and 42 (9.8%) with AAH.
In addition, one-time prescriptions were observed in 1113 (28.4%) patients without ALD, three patients (10.7%) with ALD, and eight patients (18.6%) with AAH.
Overall, 64.5% of the general population consisted of men. About 46% had a psychiatric diagnosis other than substance use disorder (SUD), and 35.7% had a non-AUD SUD.
Patients who received AUD pharmacotherapy tended to be older, at a median age of 45 years, than those aged 42 years without a prescription.
The median time to prescription was 302 days, with no significant differences based on the presence of liver disease.
By medication, gabapentin was prescribed most often (9.4%), followed by oral naltrexone (2.6%) and topiramate (2%). Oral naltrexone was prescribed at a lower rate in patients with ALD and at a higher rate in patients with AAH than in patients without ALD. Baclofen was also prescribed at lower rates in patients with ALD and AAH.
In a multivariable logistic regression analysis, several characteristics were more significantly associated with pharmacologic therapy, such as age ≥ 50 years (adjusted odds ratio [aOR], 1.33), female sex (aOR, 1.31), a non-liver Charlson Comorbidity Index ≥ 3 (aOR, 2.21), and psychiatric comorbidities (aOR, 2.76).
On the other hand, the presence of hepatic decompensation — defined as ascites, hepatic encephalopathy, or bleeding varices — was associated with lower odds of receiving pharmacotherapy (aOR, 0.08). ALD cirrhosis (non-AAH) also had lower odds (aOR, 0.24).
The study was limited by only incorporating patients with commercial insurance, lacking demographic details related to race or ethnicity, and potentially misclassifying patients despite validated definitions of ALD and AUD, Jones said.
As the study couldn’t determine the indications for prescriptions, such as gabapentin use for migraines or diabetes-associated neuropathy, for instance, future studies could look at these precise details, he added.
“It’s important to know we’re underutilizing therapies that we have a lot of information about, such as gabapentin, which is an old medication that we should feel fairly comfortable using,” said Patricia Jones, MD, a hepatologist and associate professor of clinical medicine at the University of Miami Miller School of Medicine, in Florida. Patricia Jones comoderated the plenary session on small intestine, functional, and liver research.
“I also expect that, if a future study reviewed this data and excluded people with valid indications, such as migraines or diabetic neuropathy, we’d see even lower rates of prescription,” she said.
From a clinical perspective, patient communication and clinical decision-making are key, Patricia Jones added, particularly when clinical gastroenterologists and hepatologists may not offer this type of therapy or patients refuse this type of therapy.
“We need to think about our practice patterns and how we can offer therapy,” she said. “In general, we know these medications are very safe. Even though they’re not widely used in people with cirrhosis, there’s not enough evidence to suggest we shouldn’t use them.”
Alex Jones and Patricia Jones reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
PHILADELPHIA — according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.
In an analysis of commercially insured Americans, AUD medications were prescribed to only 1 in 50 patients with ALD and about 1 in 10 patients with acute alcohol-associated hepatitis (AAH).
“Providers caring for these patients should consider early initiation of this therapy in select cases,” said lead author Alex R. Jones, MD, chief resident of internal medicine at the University of Texas Southwestern Medical Center in Dallas.
“Based on additional analyses looking at the prescriber subspecialty, we didn’t identify any gastroenterologists or hepatologists who prescribed pharmacotherapy,” he said. “This could be a great opportunity for hepatologists to engage in the pharmacologic treatment of AUD.”
Jones and colleagues analyzed 2006-2021 data from IQVIA PharMetrics Plus for Academics, a nationally representative database of commercially insured patients in the United States. They looked for AUD pharmacologic treatment at any time after AUD diagnosis, including prescriptions for gabapentin, naltrexone, topiramate, acamprosate, baclofen, and disulfiram.
Among 28,625 patients with AUD (defined as at least two outpatient codes or at least one inpatient code), 1201 had ALD with cirrhosis and 439 had AAH.
Pharmacologic therapy was prescribed in 3924 (14.5%) patients without ALD, 28 (2.3%) with ALD, and 42 (9.8%) with AAH.
In addition, one-time prescriptions were observed in 1113 (28.4%) patients without ALD, three patients (10.7%) with ALD, and eight patients (18.6%) with AAH.
Overall, 64.5% of the general population consisted of men. About 46% had a psychiatric diagnosis other than substance use disorder (SUD), and 35.7% had a non-AUD SUD.
Patients who received AUD pharmacotherapy tended to be older, at a median age of 45 years, than those aged 42 years without a prescription.
The median time to prescription was 302 days, with no significant differences based on the presence of liver disease.
By medication, gabapentin was prescribed most often (9.4%), followed by oral naltrexone (2.6%) and topiramate (2%). Oral naltrexone was prescribed at a lower rate in patients with ALD and at a higher rate in patients with AAH than in patients without ALD. Baclofen was also prescribed at lower rates in patients with ALD and AAH.
In a multivariable logistic regression analysis, several characteristics were more significantly associated with pharmacologic therapy, such as age ≥ 50 years (adjusted odds ratio [aOR], 1.33), female sex (aOR, 1.31), a non-liver Charlson Comorbidity Index ≥ 3 (aOR, 2.21), and psychiatric comorbidities (aOR, 2.76).
On the other hand, the presence of hepatic decompensation — defined as ascites, hepatic encephalopathy, or bleeding varices — was associated with lower odds of receiving pharmacotherapy (aOR, 0.08). ALD cirrhosis (non-AAH) also had lower odds (aOR, 0.24).
The study was limited by only incorporating patients with commercial insurance, lacking demographic details related to race or ethnicity, and potentially misclassifying patients despite validated definitions of ALD and AUD, Jones said.
As the study couldn’t determine the indications for prescriptions, such as gabapentin use for migraines or diabetes-associated neuropathy, for instance, future studies could look at these precise details, he added.
“It’s important to know we’re underutilizing therapies that we have a lot of information about, such as gabapentin, which is an old medication that we should feel fairly comfortable using,” said Patricia Jones, MD, a hepatologist and associate professor of clinical medicine at the University of Miami Miller School of Medicine, in Florida. Patricia Jones comoderated the plenary session on small intestine, functional, and liver research.
“I also expect that, if a future study reviewed this data and excluded people with valid indications, such as migraines or diabetic neuropathy, we’d see even lower rates of prescription,” she said.
From a clinical perspective, patient communication and clinical decision-making are key, Patricia Jones added, particularly when clinical gastroenterologists and hepatologists may not offer this type of therapy or patients refuse this type of therapy.
“We need to think about our practice patterns and how we can offer therapy,” she said. “In general, we know these medications are very safe. Even though they’re not widely used in people with cirrhosis, there’s not enough evidence to suggest we shouldn’t use them.”
Alex Jones and Patricia Jones reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM ACG 2024
Endoscopic Sleeve Gastroplasty Yields Durable Weight Loss at 10 Years
PHILADELPHIA —
“The procedure is dependable and safe and should be considered among individuals who have not attained their desired results through lifestyle medications and those who are not eligible for or choose not to undergo bariatric procedures,” said Ali Lahooti, with the Department of Gastroenterology and Hepatology, Weill Cornell Medical College, New York City. He presented his research at the annual meeting of the American College of Gastroenterology (ACG).
Obesity is a growing global health challenge. Lifestyle modification as a standalone therapy has limited effectiveness achieving weight loss. Pharmacotherapies are more efficacious, but they’re also associated with higher costs of and risk for side effects, leading to lower rates of compliance, Lahooti explained.
Bariatric surgery remains the most effective therapy for management of obesity and improvement of comorbid conditions, yet < 1% of candidates undergo a surgical intervention either because of access, cost, or fear of the procedure.
“Endoscopic treatments for obesity, such as ESG, can potentially fill this gap by combining durable weight loss with lower risk and costs,” Lahooti said.
He and his colleagues assessed outcomes out to 10 years in 404 patients (mean age, 45 years; 76% women; mean body mass index, 37.3) who underwent ESG between 2013 and 2024 at a single large tertiary hospital.
Out of the 404 patients, 397, 335, 249, and 110 patients were eligible for 1-, 3-, 5-, and 10-year follow-up, with complete follow-up rates of 85%, 66%, 79%, and 62%, respectively.
The primary outcome was weight loss at 10 years after ESG reported at percent total body weight loss (%TBWL).
At 10 years, mean %TBWL (the primary outcome) was 10.5% — with 53% of patients maintaining at least 5% TBWL and 42% maintaining at least 10% weight loss, Lahooti reported.
ESG had a favorable safety profile; 20% of patients experienced mild abdominal pain, constipation, heartburn, and nausea after the procedure that typically resolved within 2 weeks of the procedure.
“There were a total of three moderate adverse events — two perigastric leaks, one repaired endoscopically, and another that only required antibiotics,” Lahooti reported. There were no severe or fatal adverse events.
About 11% of patients had endoscopic revision via retightening or resuturing at 10 years, the study team noted in their conference abstract.
Bariatric Surgery Remains Gold Standard
Lahooti shared that in his experience, some patients will need a revision at “about 40 months,” but at the same time, he’s seen some patients at 10 years “and their sutures are still in place.”
Session comoderator Shivangi Kothari, MD, with the Center for Advanced Therapeutic Endoscopy, University of Rochester Medical Center in New York, congratulated Lahooti for providing “robust” long-term data on ESG and said, “there is a need for more studies like this.”
In an interview, Ann M. Rogers, MD, president of the American Society for Metabolic and Bariatric Surgery, noted that bariatric surgery remains the “gold standard for weight loss and metabolic improvements,” with studies showing “around 30%” TWBL at 10 years, compared with about 10% at 10 years in this study.
Another key caveat, said Rogers, is that there are practical barriers to ESG; insurance typically does not cover the procedure because they view it as “cosmetic.”
The study had no commercial funding. Lahooti and Rogers had no relevant disclosures.
A version of this article first appeared on Medscape.com.
PHILADELPHIA —
“The procedure is dependable and safe and should be considered among individuals who have not attained their desired results through lifestyle medications and those who are not eligible for or choose not to undergo bariatric procedures,” said Ali Lahooti, with the Department of Gastroenterology and Hepatology, Weill Cornell Medical College, New York City. He presented his research at the annual meeting of the American College of Gastroenterology (ACG).
Obesity is a growing global health challenge. Lifestyle modification as a standalone therapy has limited effectiveness achieving weight loss. Pharmacotherapies are more efficacious, but they’re also associated with higher costs of and risk for side effects, leading to lower rates of compliance, Lahooti explained.
Bariatric surgery remains the most effective therapy for management of obesity and improvement of comorbid conditions, yet < 1% of candidates undergo a surgical intervention either because of access, cost, or fear of the procedure.
“Endoscopic treatments for obesity, such as ESG, can potentially fill this gap by combining durable weight loss with lower risk and costs,” Lahooti said.
He and his colleagues assessed outcomes out to 10 years in 404 patients (mean age, 45 years; 76% women; mean body mass index, 37.3) who underwent ESG between 2013 and 2024 at a single large tertiary hospital.
Out of the 404 patients, 397, 335, 249, and 110 patients were eligible for 1-, 3-, 5-, and 10-year follow-up, with complete follow-up rates of 85%, 66%, 79%, and 62%, respectively.
The primary outcome was weight loss at 10 years after ESG reported at percent total body weight loss (%TBWL).
At 10 years, mean %TBWL (the primary outcome) was 10.5% — with 53% of patients maintaining at least 5% TBWL and 42% maintaining at least 10% weight loss, Lahooti reported.
ESG had a favorable safety profile; 20% of patients experienced mild abdominal pain, constipation, heartburn, and nausea after the procedure that typically resolved within 2 weeks of the procedure.
“There were a total of three moderate adverse events — two perigastric leaks, one repaired endoscopically, and another that only required antibiotics,” Lahooti reported. There were no severe or fatal adverse events.
About 11% of patients had endoscopic revision via retightening or resuturing at 10 years, the study team noted in their conference abstract.
Bariatric Surgery Remains Gold Standard
Lahooti shared that in his experience, some patients will need a revision at “about 40 months,” but at the same time, he’s seen some patients at 10 years “and their sutures are still in place.”
Session comoderator Shivangi Kothari, MD, with the Center for Advanced Therapeutic Endoscopy, University of Rochester Medical Center in New York, congratulated Lahooti for providing “robust” long-term data on ESG and said, “there is a need for more studies like this.”
In an interview, Ann M. Rogers, MD, president of the American Society for Metabolic and Bariatric Surgery, noted that bariatric surgery remains the “gold standard for weight loss and metabolic improvements,” with studies showing “around 30%” TWBL at 10 years, compared with about 10% at 10 years in this study.
Another key caveat, said Rogers, is that there are practical barriers to ESG; insurance typically does not cover the procedure because they view it as “cosmetic.”
The study had no commercial funding. Lahooti and Rogers had no relevant disclosures.
A version of this article first appeared on Medscape.com.
PHILADELPHIA —
“The procedure is dependable and safe and should be considered among individuals who have not attained their desired results through lifestyle medications and those who are not eligible for or choose not to undergo bariatric procedures,” said Ali Lahooti, with the Department of Gastroenterology and Hepatology, Weill Cornell Medical College, New York City. He presented his research at the annual meeting of the American College of Gastroenterology (ACG).
Obesity is a growing global health challenge. Lifestyle modification as a standalone therapy has limited effectiveness achieving weight loss. Pharmacotherapies are more efficacious, but they’re also associated with higher costs of and risk for side effects, leading to lower rates of compliance, Lahooti explained.
Bariatric surgery remains the most effective therapy for management of obesity and improvement of comorbid conditions, yet < 1% of candidates undergo a surgical intervention either because of access, cost, or fear of the procedure.
“Endoscopic treatments for obesity, such as ESG, can potentially fill this gap by combining durable weight loss with lower risk and costs,” Lahooti said.
He and his colleagues assessed outcomes out to 10 years in 404 patients (mean age, 45 years; 76% women; mean body mass index, 37.3) who underwent ESG between 2013 and 2024 at a single large tertiary hospital.
Out of the 404 patients, 397, 335, 249, and 110 patients were eligible for 1-, 3-, 5-, and 10-year follow-up, with complete follow-up rates of 85%, 66%, 79%, and 62%, respectively.
The primary outcome was weight loss at 10 years after ESG reported at percent total body weight loss (%TBWL).
At 10 years, mean %TBWL (the primary outcome) was 10.5% — with 53% of patients maintaining at least 5% TBWL and 42% maintaining at least 10% weight loss, Lahooti reported.
ESG had a favorable safety profile; 20% of patients experienced mild abdominal pain, constipation, heartburn, and nausea after the procedure that typically resolved within 2 weeks of the procedure.
“There were a total of three moderate adverse events — two perigastric leaks, one repaired endoscopically, and another that only required antibiotics,” Lahooti reported. There were no severe or fatal adverse events.
About 11% of patients had endoscopic revision via retightening or resuturing at 10 years, the study team noted in their conference abstract.
Bariatric Surgery Remains Gold Standard
Lahooti shared that in his experience, some patients will need a revision at “about 40 months,” but at the same time, he’s seen some patients at 10 years “and their sutures are still in place.”
Session comoderator Shivangi Kothari, MD, with the Center for Advanced Therapeutic Endoscopy, University of Rochester Medical Center in New York, congratulated Lahooti for providing “robust” long-term data on ESG and said, “there is a need for more studies like this.”
In an interview, Ann M. Rogers, MD, president of the American Society for Metabolic and Bariatric Surgery, noted that bariatric surgery remains the “gold standard for weight loss and metabolic improvements,” with studies showing “around 30%” TWBL at 10 years, compared with about 10% at 10 years in this study.
Another key caveat, said Rogers, is that there are practical barriers to ESG; insurance typically does not cover the procedure because they view it as “cosmetic.”
The study had no commercial funding. Lahooti and Rogers had no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM ACG 2024
PRECISE-DAPT Score Predicts GI Bleeding Risk Among Post-PCI Patients
PHILADELPHIA — Gastrointestinal (GI) bleeding after percutaneous coronary intervention (PCI) among patients on dual antiplatelet therapy (DAPT) remains risky in terms of morbidity and mortality, but the Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) score could help predict that risk, according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.
In a predominantly Hispanic population in Texas, 2.5% of post-PCI patients on DAPT had GI bleeding in the first year.
“Our study established that the PRECISE-DAPT score possesses a moderate predictive accuracy not only for overall bleeding risk but also specifically for gastrointestinal bleeding,” said lead author Jesus Guzman, MD, a gastroenterology fellow at the Texas Tech University Health Sciences Center El Paso.
Current guidelines from the American College of Cardiology and American Heart Association recommend DAPT for 6-12 months post-PCI, with consideration for shorter durations in patients with lower ischemic risks but higher bleeding risks.
“Interestingly, some of these patients were on DAPT for more than 2 years, which goes beyond the guidelines,” he said. “In this patient population, this has to do with them being lost to follow-up and getting reestablished, and they kept refilling their prescriptions.”
Guzman and colleagues conducted a retrospective cohort study of patients receiving DAPT after PCI from 2014 to 2021. They looked for GI bleeding rates at 1 year and across the duration of the study period, as well as endoscopic indications, findings, concurrent antiplatelet therapy, and the primary cause of bleeding.
In addition, the research team evaluated the predictive value of the PRECISE-DAPT score, which categorizes patients based on low risk (≤ 17), moderate risk (18-24), and high risk (≥ 25) for bleeding. The score aims to optimize the balance between bleeding and ischemic risks, Guzman said, by incorporating five factors: Age, creatinine clearance, hemoglobin, white blood cell count, and history of spontaneous bleeding.
Among 1067 patients, 563 (57.9%) received clopidogrel and 409 (42%) received ticagrelor. The overall cohort was 66.6% men, 77.1% Hispanic, and had a mean age of 62 years.
The GI bleeding rate was 2.5% at 1-year post-PCI among 27 patients and 3.7% for the study duration among 39 patients, with a median follow-up of 2.2 years.
Among the 39 GI bleeds, 41% were lower GI bleeds, 28% were upper GI bleeds, 15% were small bowel bleeds, and 15% were undetermined. The most frequent etiology was colon cancer, accounting for 18% of bleeds, followed by 15% for gastric ulcers, 10% for diverticular bleeds, and 10% for hemorrhoidal bleeds.
In general, analyses indicated no significant differences in GI bleeding between patients on clopidogrel (21.2%) and those on ticagrelor (19.2%).
However, the odds of GI bleeding were significantly higher in patients with high-risk PRECISE-DAPT scores (odds ratio [OR], 2.5) and moderate-risk scores (OR, 2.8) than in those with low-risk scores. The majority of patients without GI bleeding had scores < 17, whereas the majority of patients with GI bleeding had scores > 24. An optimal threshold for the PRECISE-DAPT score was identified as ≥ 19.
“When patients on DAPT present with GI bleeding, it can be a clinical conundrum for gastroenterologists and cardiologists, especially when it can be a life-or-death event, and stopping DAPT can increase risk of thrombosis,” said Jeff Taclob, MD, a hepatology fellow at The University of Tennessee Health Science Center in Memphis. Taclob, who wasn’t involved with the study, attended the conference session.
“In this population in El Paso, in particular, many patients don’t have adequate healthcare, may be lost to follow-up, and get their prescriptions filled elsewhere, such as Juárez, Mexico,” he said. “Then they come in with this life-threatening bleed, so we need to focus more on their risks.”
Paying attention to specific patient populations, cultures, and values remains important for patient communication and clinical decision-making, Taclob noted.
“In this population of older men, there’s often a macho persona where they don’t want to seek help,” he said. “DAPT criteria could differ in other populations, but here, the PRECISE-DAPT score appeared to help.”
The study was awarded the ACG Outstanding Research Award in the GI Bleeding Category (Trainee). Guzman and Taclob reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
PHILADELPHIA — Gastrointestinal (GI) bleeding after percutaneous coronary intervention (PCI) among patients on dual antiplatelet therapy (DAPT) remains risky in terms of morbidity and mortality, but the Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) score could help predict that risk, according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.
In a predominantly Hispanic population in Texas, 2.5% of post-PCI patients on DAPT had GI bleeding in the first year.
“Our study established that the PRECISE-DAPT score possesses a moderate predictive accuracy not only for overall bleeding risk but also specifically for gastrointestinal bleeding,” said lead author Jesus Guzman, MD, a gastroenterology fellow at the Texas Tech University Health Sciences Center El Paso.
Current guidelines from the American College of Cardiology and American Heart Association recommend DAPT for 6-12 months post-PCI, with consideration for shorter durations in patients with lower ischemic risks but higher bleeding risks.
“Interestingly, some of these patients were on DAPT for more than 2 years, which goes beyond the guidelines,” he said. “In this patient population, this has to do with them being lost to follow-up and getting reestablished, and they kept refilling their prescriptions.”
Guzman and colleagues conducted a retrospective cohort study of patients receiving DAPT after PCI from 2014 to 2021. They looked for GI bleeding rates at 1 year and across the duration of the study period, as well as endoscopic indications, findings, concurrent antiplatelet therapy, and the primary cause of bleeding.
In addition, the research team evaluated the predictive value of the PRECISE-DAPT score, which categorizes patients based on low risk (≤ 17), moderate risk (18-24), and high risk (≥ 25) for bleeding. The score aims to optimize the balance between bleeding and ischemic risks, Guzman said, by incorporating five factors: Age, creatinine clearance, hemoglobin, white blood cell count, and history of spontaneous bleeding.
Among 1067 patients, 563 (57.9%) received clopidogrel and 409 (42%) received ticagrelor. The overall cohort was 66.6% men, 77.1% Hispanic, and had a mean age of 62 years.
The GI bleeding rate was 2.5% at 1-year post-PCI among 27 patients and 3.7% for the study duration among 39 patients, with a median follow-up of 2.2 years.
Among the 39 GI bleeds, 41% were lower GI bleeds, 28% were upper GI bleeds, 15% were small bowel bleeds, and 15% were undetermined. The most frequent etiology was colon cancer, accounting for 18% of bleeds, followed by 15% for gastric ulcers, 10% for diverticular bleeds, and 10% for hemorrhoidal bleeds.
In general, analyses indicated no significant differences in GI bleeding between patients on clopidogrel (21.2%) and those on ticagrelor (19.2%).
However, the odds of GI bleeding were significantly higher in patients with high-risk PRECISE-DAPT scores (odds ratio [OR], 2.5) and moderate-risk scores (OR, 2.8) than in those with low-risk scores. The majority of patients without GI bleeding had scores < 17, whereas the majority of patients with GI bleeding had scores > 24. An optimal threshold for the PRECISE-DAPT score was identified as ≥ 19.
“When patients on DAPT present with GI bleeding, it can be a clinical conundrum for gastroenterologists and cardiologists, especially when it can be a life-or-death event, and stopping DAPT can increase risk of thrombosis,” said Jeff Taclob, MD, a hepatology fellow at The University of Tennessee Health Science Center in Memphis. Taclob, who wasn’t involved with the study, attended the conference session.
“In this population in El Paso, in particular, many patients don’t have adequate healthcare, may be lost to follow-up, and get their prescriptions filled elsewhere, such as Juárez, Mexico,” he said. “Then they come in with this life-threatening bleed, so we need to focus more on their risks.”
Paying attention to specific patient populations, cultures, and values remains important for patient communication and clinical decision-making, Taclob noted.
“In this population of older men, there’s often a macho persona where they don’t want to seek help,” he said. “DAPT criteria could differ in other populations, but here, the PRECISE-DAPT score appeared to help.”
The study was awarded the ACG Outstanding Research Award in the GI Bleeding Category (Trainee). Guzman and Taclob reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
PHILADELPHIA — Gastrointestinal (GI) bleeding after percutaneous coronary intervention (PCI) among patients on dual antiplatelet therapy (DAPT) remains risky in terms of morbidity and mortality, but the Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) score could help predict that risk, according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.
In a predominantly Hispanic population in Texas, 2.5% of post-PCI patients on DAPT had GI bleeding in the first year.
“Our study established that the PRECISE-DAPT score possesses a moderate predictive accuracy not only for overall bleeding risk but also specifically for gastrointestinal bleeding,” said lead author Jesus Guzman, MD, a gastroenterology fellow at the Texas Tech University Health Sciences Center El Paso.
Current guidelines from the American College of Cardiology and American Heart Association recommend DAPT for 6-12 months post-PCI, with consideration for shorter durations in patients with lower ischemic risks but higher bleeding risks.
“Interestingly, some of these patients were on DAPT for more than 2 years, which goes beyond the guidelines,” he said. “In this patient population, this has to do with them being lost to follow-up and getting reestablished, and they kept refilling their prescriptions.”
Guzman and colleagues conducted a retrospective cohort study of patients receiving DAPT after PCI from 2014 to 2021. They looked for GI bleeding rates at 1 year and across the duration of the study period, as well as endoscopic indications, findings, concurrent antiplatelet therapy, and the primary cause of bleeding.
In addition, the research team evaluated the predictive value of the PRECISE-DAPT score, which categorizes patients based on low risk (≤ 17), moderate risk (18-24), and high risk (≥ 25) for bleeding. The score aims to optimize the balance between bleeding and ischemic risks, Guzman said, by incorporating five factors: Age, creatinine clearance, hemoglobin, white blood cell count, and history of spontaneous bleeding.
Among 1067 patients, 563 (57.9%) received clopidogrel and 409 (42%) received ticagrelor. The overall cohort was 66.6% men, 77.1% Hispanic, and had a mean age of 62 years.
The GI bleeding rate was 2.5% at 1-year post-PCI among 27 patients and 3.7% for the study duration among 39 patients, with a median follow-up of 2.2 years.
Among the 39 GI bleeds, 41% were lower GI bleeds, 28% were upper GI bleeds, 15% were small bowel bleeds, and 15% were undetermined. The most frequent etiology was colon cancer, accounting for 18% of bleeds, followed by 15% for gastric ulcers, 10% for diverticular bleeds, and 10% for hemorrhoidal bleeds.
In general, analyses indicated no significant differences in GI bleeding between patients on clopidogrel (21.2%) and those on ticagrelor (19.2%).
However, the odds of GI bleeding were significantly higher in patients with high-risk PRECISE-DAPT scores (odds ratio [OR], 2.5) and moderate-risk scores (OR, 2.8) than in those with low-risk scores. The majority of patients without GI bleeding had scores < 17, whereas the majority of patients with GI bleeding had scores > 24. An optimal threshold for the PRECISE-DAPT score was identified as ≥ 19.
“When patients on DAPT present with GI bleeding, it can be a clinical conundrum for gastroenterologists and cardiologists, especially when it can be a life-or-death event, and stopping DAPT can increase risk of thrombosis,” said Jeff Taclob, MD, a hepatology fellow at The University of Tennessee Health Science Center in Memphis. Taclob, who wasn’t involved with the study, attended the conference session.
“In this population in El Paso, in particular, many patients don’t have adequate healthcare, may be lost to follow-up, and get their prescriptions filled elsewhere, such as Juárez, Mexico,” he said. “Then they come in with this life-threatening bleed, so we need to focus more on their risks.”
Paying attention to specific patient populations, cultures, and values remains important for patient communication and clinical decision-making, Taclob noted.
“In this population of older men, there’s often a macho persona where they don’t want to seek help,” he said. “DAPT criteria could differ in other populations, but here, the PRECISE-DAPT score appeared to help.”
The study was awarded the ACG Outstanding Research Award in the GI Bleeding Category (Trainee). Guzman and Taclob reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM ACG 2024