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Bone degradation measure can sway osteoporosis diagnosis
Assessing a key aspect of bone architecture, for which clinicians can now be reimbursed under Medicare, can significantly improve the ability to predict a patient’s risk for bone fracture.
Although bone mineral density (BMD) is traditionally used to identify patients with osteoporosis or low bone mass, some physicians have begun incorporating the trabecular bone score (TBS) into their exams.
At the Cleveland Clinic Center for Specialized Women’s Health, factoring in the TBS changed the diagnosis for 16% of 432 patients, according to Holly Thacker, MD, the center’s director.
“Importantly, 11% got worse diagnoses, and I use that in terms of prioritizing treatment,” Dr. Thacker said in an interview. The ability to determine how degraded the bone microarchitecture is through a software system “is a huge advance.”
Dr. Thacker described her center’s experience with the technology at the annual meeting of the Menopause Society (formerly The North American Menopause Society).
While BMD captures the amount of minerals like calcium in the skeleton, TBS assesses the underlying microarchitecture by looking at the distribution of shades of gray on dual-energy x-ray absorptiometry (DXA) scans.
Based on the TBS, patients’ bones are classified as normal, partially degraded, or degraded. Among the 432 patients who received a TBS analysis in 2022, 3% shifted from a normal diagnosis to osteopenia, 8% worsened from osteopenia to osteoporosis, 4% went from osteopenia to normal, and 1.6% downgraded from osteoporosis to osteopenia, Dr. Thacker reported.
The new test may also provide some reassurance for female patients who have thinner bones, which may raise alarms based on BMD. TBS, however, may show that the structure of the bone looks normal.
“When you know that the microarchitecture is normal, you’re a lot less concerned that they actually have a bone disease of osteoporosis,” Dr. Thacker said.
Conversely, unexpectedly degraded bone raises questions.
“That makes you go back and say [to the patient]: ‘Have you been on steroids? Were you malnourished? Is there some other metabolic problem? Have you had some calcium disorder?’ ” Dr. Thacker said.
Dr. Thacker leverages the TBS to help patients obtain effective therapy, typically an anabolic agent followed by antiresorptive medication.
“When I see a patient who not only has osteoporosis on bone density but has completely degraded bone architecture, it’s a lot easier for me to make the argument to the insurance company that this patient is at grave risk for a low trauma fracture and bad outcome without the best treatment,” Dr. Thacker said.
10-year-old tech, recently covered
The Food and Drug Administration approved TBS software in 2012, but Medicare only recently started paying for it.
Medimaps Group, a company that markets imaging software to calculate TBS, announced in 2022 that reimbursement from the Centers for Medicare & Medicaid Services was available, at $41.53 on the Physician Fee Schedule and $82.61 on the Hospital Outpatient Prospective Payment Schedule.
“Reimbursement through CMS is an important endorsement of the clinical value of TBS for clinicians and their patients,” Didier Hans, PhD, MBA, the CEO of Medimaps, said in a statement at the time. He noted that more than 600,000 TBS procedures were being performed in the United States each year.
Nevertheless, the initial investment in purchasing the software may be a barrier for health systems.
“We are the first and only site in our health system to offer TBS, as this is an extra expense and not uniformly reimbursed by insurers,” Dr. Thacker reported at the meeting.
Potential drawbacks
The TBS software used in Dr. Thacker’s study has been validated only in Asian and White patients between certain ages and weights, meaning the system is not designed to be used for other populations. Other researchers have highlighted a need for trabecular bone scoring to be validated more broadly. The authors of a recent analysis, however, suggest that TBS can be used the same way no matter a patient’s race.
TBS “is going to be most helpful in those with osteopenia who are right near the threshold for treatment,” said Marcella Donovan Walker, MD, MS, in a presentation on bone quality at the meeting.
Many studies have shown that TBS “provides additive information to bone density,” said Dr. Walker, a professor of medicine in the division of endocrinology at Columbia University, New York. For example, a large study of women in Manitoba found that, regardless of whether their bone density was normal, osteopenic, or osteoporotic, those with a low TBS had a much higher risk for fracture.
‘Opportunistic screening’ with CT?
TBS relies on the same DXA scans that are used to calculate bone mineral density, so obtaining the score does not add time or radiation to the scanning process, Dr. Thacker said.
But many patients who should receive DXA scans do not, which adds to the promise of “opportunistic screening” for osteoporosis, Dr. Walker said. With this approach, physicians would analyze a CT scan that a patient received for another purpose, such as to investigate abdominal pain or chest pain.
“In these images is information about the bone,” Dr. Walker said.
Researchers have used high-resolution peripheral quantitative CT to perform finite element analysis, where a computer program simulates compression of the bone to create a measure of bone stiffness and determine the load required for a break.
One study found that including those elements predicted fractures better than bone mineral density or the Fracture Risk Assessment Tool alone, Dr. Walker noted.
Other aspects of bone quality include how many cracks are in the bone, the amount of adipose in the marrow space, and the rate at which bone is broken down and rebuilt. But Dr. Walker suggested that the longstanding focus on bone mineral density in clinical practice makes sense.
“By far, bone mass is the most important bone quality,” Dr. Walker said.
Dr. Thacker is the executive director of the nonprofit Speaking of Women’s Health. Dr. Walker reported receiving funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and Amgen.
A version of this article first appeared on Medscape.com.
Assessing a key aspect of bone architecture, for which clinicians can now be reimbursed under Medicare, can significantly improve the ability to predict a patient’s risk for bone fracture.
Although bone mineral density (BMD) is traditionally used to identify patients with osteoporosis or low bone mass, some physicians have begun incorporating the trabecular bone score (TBS) into their exams.
At the Cleveland Clinic Center for Specialized Women’s Health, factoring in the TBS changed the diagnosis for 16% of 432 patients, according to Holly Thacker, MD, the center’s director.
“Importantly, 11% got worse diagnoses, and I use that in terms of prioritizing treatment,” Dr. Thacker said in an interview. The ability to determine how degraded the bone microarchitecture is through a software system “is a huge advance.”
Dr. Thacker described her center’s experience with the technology at the annual meeting of the Menopause Society (formerly The North American Menopause Society).
While BMD captures the amount of minerals like calcium in the skeleton, TBS assesses the underlying microarchitecture by looking at the distribution of shades of gray on dual-energy x-ray absorptiometry (DXA) scans.
Based on the TBS, patients’ bones are classified as normal, partially degraded, or degraded. Among the 432 patients who received a TBS analysis in 2022, 3% shifted from a normal diagnosis to osteopenia, 8% worsened from osteopenia to osteoporosis, 4% went from osteopenia to normal, and 1.6% downgraded from osteoporosis to osteopenia, Dr. Thacker reported.
The new test may also provide some reassurance for female patients who have thinner bones, which may raise alarms based on BMD. TBS, however, may show that the structure of the bone looks normal.
“When you know that the microarchitecture is normal, you’re a lot less concerned that they actually have a bone disease of osteoporosis,” Dr. Thacker said.
Conversely, unexpectedly degraded bone raises questions.
“That makes you go back and say [to the patient]: ‘Have you been on steroids? Were you malnourished? Is there some other metabolic problem? Have you had some calcium disorder?’ ” Dr. Thacker said.
Dr. Thacker leverages the TBS to help patients obtain effective therapy, typically an anabolic agent followed by antiresorptive medication.
“When I see a patient who not only has osteoporosis on bone density but has completely degraded bone architecture, it’s a lot easier for me to make the argument to the insurance company that this patient is at grave risk for a low trauma fracture and bad outcome without the best treatment,” Dr. Thacker said.
10-year-old tech, recently covered
The Food and Drug Administration approved TBS software in 2012, but Medicare only recently started paying for it.
Medimaps Group, a company that markets imaging software to calculate TBS, announced in 2022 that reimbursement from the Centers for Medicare & Medicaid Services was available, at $41.53 on the Physician Fee Schedule and $82.61 on the Hospital Outpatient Prospective Payment Schedule.
“Reimbursement through CMS is an important endorsement of the clinical value of TBS for clinicians and their patients,” Didier Hans, PhD, MBA, the CEO of Medimaps, said in a statement at the time. He noted that more than 600,000 TBS procedures were being performed in the United States each year.
Nevertheless, the initial investment in purchasing the software may be a barrier for health systems.
“We are the first and only site in our health system to offer TBS, as this is an extra expense and not uniformly reimbursed by insurers,” Dr. Thacker reported at the meeting.
Potential drawbacks
The TBS software used in Dr. Thacker’s study has been validated only in Asian and White patients between certain ages and weights, meaning the system is not designed to be used for other populations. Other researchers have highlighted a need for trabecular bone scoring to be validated more broadly. The authors of a recent analysis, however, suggest that TBS can be used the same way no matter a patient’s race.
TBS “is going to be most helpful in those with osteopenia who are right near the threshold for treatment,” said Marcella Donovan Walker, MD, MS, in a presentation on bone quality at the meeting.
Many studies have shown that TBS “provides additive information to bone density,” said Dr. Walker, a professor of medicine in the division of endocrinology at Columbia University, New York. For example, a large study of women in Manitoba found that, regardless of whether their bone density was normal, osteopenic, or osteoporotic, those with a low TBS had a much higher risk for fracture.
‘Opportunistic screening’ with CT?
TBS relies on the same DXA scans that are used to calculate bone mineral density, so obtaining the score does not add time or radiation to the scanning process, Dr. Thacker said.
But many patients who should receive DXA scans do not, which adds to the promise of “opportunistic screening” for osteoporosis, Dr. Walker said. With this approach, physicians would analyze a CT scan that a patient received for another purpose, such as to investigate abdominal pain or chest pain.
“In these images is information about the bone,” Dr. Walker said.
Researchers have used high-resolution peripheral quantitative CT to perform finite element analysis, where a computer program simulates compression of the bone to create a measure of bone stiffness and determine the load required for a break.
One study found that including those elements predicted fractures better than bone mineral density or the Fracture Risk Assessment Tool alone, Dr. Walker noted.
Other aspects of bone quality include how many cracks are in the bone, the amount of adipose in the marrow space, and the rate at which bone is broken down and rebuilt. But Dr. Walker suggested that the longstanding focus on bone mineral density in clinical practice makes sense.
“By far, bone mass is the most important bone quality,” Dr. Walker said.
Dr. Thacker is the executive director of the nonprofit Speaking of Women’s Health. Dr. Walker reported receiving funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and Amgen.
A version of this article first appeared on Medscape.com.
Assessing a key aspect of bone architecture, for which clinicians can now be reimbursed under Medicare, can significantly improve the ability to predict a patient’s risk for bone fracture.
Although bone mineral density (BMD) is traditionally used to identify patients with osteoporosis or low bone mass, some physicians have begun incorporating the trabecular bone score (TBS) into their exams.
At the Cleveland Clinic Center for Specialized Women’s Health, factoring in the TBS changed the diagnosis for 16% of 432 patients, according to Holly Thacker, MD, the center’s director.
“Importantly, 11% got worse diagnoses, and I use that in terms of prioritizing treatment,” Dr. Thacker said in an interview. The ability to determine how degraded the bone microarchitecture is through a software system “is a huge advance.”
Dr. Thacker described her center’s experience with the technology at the annual meeting of the Menopause Society (formerly The North American Menopause Society).
While BMD captures the amount of minerals like calcium in the skeleton, TBS assesses the underlying microarchitecture by looking at the distribution of shades of gray on dual-energy x-ray absorptiometry (DXA) scans.
Based on the TBS, patients’ bones are classified as normal, partially degraded, or degraded. Among the 432 patients who received a TBS analysis in 2022, 3% shifted from a normal diagnosis to osteopenia, 8% worsened from osteopenia to osteoporosis, 4% went from osteopenia to normal, and 1.6% downgraded from osteoporosis to osteopenia, Dr. Thacker reported.
The new test may also provide some reassurance for female patients who have thinner bones, which may raise alarms based on BMD. TBS, however, may show that the structure of the bone looks normal.
“When you know that the microarchitecture is normal, you’re a lot less concerned that they actually have a bone disease of osteoporosis,” Dr. Thacker said.
Conversely, unexpectedly degraded bone raises questions.
“That makes you go back and say [to the patient]: ‘Have you been on steroids? Were you malnourished? Is there some other metabolic problem? Have you had some calcium disorder?’ ” Dr. Thacker said.
Dr. Thacker leverages the TBS to help patients obtain effective therapy, typically an anabolic agent followed by antiresorptive medication.
“When I see a patient who not only has osteoporosis on bone density but has completely degraded bone architecture, it’s a lot easier for me to make the argument to the insurance company that this patient is at grave risk for a low trauma fracture and bad outcome without the best treatment,” Dr. Thacker said.
10-year-old tech, recently covered
The Food and Drug Administration approved TBS software in 2012, but Medicare only recently started paying for it.
Medimaps Group, a company that markets imaging software to calculate TBS, announced in 2022 that reimbursement from the Centers for Medicare & Medicaid Services was available, at $41.53 on the Physician Fee Schedule and $82.61 on the Hospital Outpatient Prospective Payment Schedule.
“Reimbursement through CMS is an important endorsement of the clinical value of TBS for clinicians and their patients,” Didier Hans, PhD, MBA, the CEO of Medimaps, said in a statement at the time. He noted that more than 600,000 TBS procedures were being performed in the United States each year.
Nevertheless, the initial investment in purchasing the software may be a barrier for health systems.
“We are the first and only site in our health system to offer TBS, as this is an extra expense and not uniformly reimbursed by insurers,” Dr. Thacker reported at the meeting.
Potential drawbacks
The TBS software used in Dr. Thacker’s study has been validated only in Asian and White patients between certain ages and weights, meaning the system is not designed to be used for other populations. Other researchers have highlighted a need for trabecular bone scoring to be validated more broadly. The authors of a recent analysis, however, suggest that TBS can be used the same way no matter a patient’s race.
TBS “is going to be most helpful in those with osteopenia who are right near the threshold for treatment,” said Marcella Donovan Walker, MD, MS, in a presentation on bone quality at the meeting.
Many studies have shown that TBS “provides additive information to bone density,” said Dr. Walker, a professor of medicine in the division of endocrinology at Columbia University, New York. For example, a large study of women in Manitoba found that, regardless of whether their bone density was normal, osteopenic, or osteoporotic, those with a low TBS had a much higher risk for fracture.
‘Opportunistic screening’ with CT?
TBS relies on the same DXA scans that are used to calculate bone mineral density, so obtaining the score does not add time or radiation to the scanning process, Dr. Thacker said.
But many patients who should receive DXA scans do not, which adds to the promise of “opportunistic screening” for osteoporosis, Dr. Walker said. With this approach, physicians would analyze a CT scan that a patient received for another purpose, such as to investigate abdominal pain or chest pain.
“In these images is information about the bone,” Dr. Walker said.
Researchers have used high-resolution peripheral quantitative CT to perform finite element analysis, where a computer program simulates compression of the bone to create a measure of bone stiffness and determine the load required for a break.
One study found that including those elements predicted fractures better than bone mineral density or the Fracture Risk Assessment Tool alone, Dr. Walker noted.
Other aspects of bone quality include how many cracks are in the bone, the amount of adipose in the marrow space, and the rate at which bone is broken down and rebuilt. But Dr. Walker suggested that the longstanding focus on bone mineral density in clinical practice makes sense.
“By far, bone mass is the most important bone quality,” Dr. Walker said.
Dr. Thacker is the executive director of the nonprofit Speaking of Women’s Health. Dr. Walker reported receiving funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and Amgen.
A version of this article first appeared on Medscape.com.
FROM NAMS 2023
Hyaluronic acid suppository improves menopause symptoms
TOPLINE:
Among women with genitourinary syndrome of menopause, 12 weeks of treatment with vaginal suppositories containing hyaluronic acid (HLA) reduces vulvovaginal symptoms, according to trial results presented at the annual Menopause Meeting. HLA may be a promising nonhormonal therapy for this condition, the researchers said.
METHODOLOGY:
- Investigators randomly assigned 49 women to receive treatment with a vaginal suppository containing 5 mg of HLA or standard-of-care treatment with vaginal estrogen cream (0.01%).
- The trial was conducted between September 2021 and August 2022.
TAKEAWAY:
- Patients in both treatment arms experienced improvements on the Vulvovaginal Symptom Questionnaire (VSQ), the study’s primary outcome.
- The VSQ assesses vulvovaginal symptoms associated with menopause such as itching, burning, and dryness, as well as the emotional toll of symptoms and their effect on sexual activity.
- Change in VSQ score did not significantly differ between the treatment groups. The measure improved from 5.2 to 1.7 in the group that received estrogen, and from 5.8 to 2.5 in those who received HLA (P = .81).
- No treatment-related severe adverse events were reported.
IN PRACTICE:
“Women often need to decide between different therapies for genitourinary syndrome of menopause,” study author Benjamin Brucker, MD, of New York University said in an interview. “Now we can help counsel them about this formulation of HLA.”
SOURCE:
Poster P-1 was presented at the 2023 meeting of the Menopause Society, held Sept. 27-30 in Philadelphia.
DISCLOSURES:
The study was funded by Bonafide Health, a company that sells supplements to treat menopause symptoms, including vaginal suppositories containing HLA.
A version of this article appeared on Medscape.com.
TOPLINE:
Among women with genitourinary syndrome of menopause, 12 weeks of treatment with vaginal suppositories containing hyaluronic acid (HLA) reduces vulvovaginal symptoms, according to trial results presented at the annual Menopause Meeting. HLA may be a promising nonhormonal therapy for this condition, the researchers said.
METHODOLOGY:
- Investigators randomly assigned 49 women to receive treatment with a vaginal suppository containing 5 mg of HLA or standard-of-care treatment with vaginal estrogen cream (0.01%).
- The trial was conducted between September 2021 and August 2022.
TAKEAWAY:
- Patients in both treatment arms experienced improvements on the Vulvovaginal Symptom Questionnaire (VSQ), the study’s primary outcome.
- The VSQ assesses vulvovaginal symptoms associated with menopause such as itching, burning, and dryness, as well as the emotional toll of symptoms and their effect on sexual activity.
- Change in VSQ score did not significantly differ between the treatment groups. The measure improved from 5.2 to 1.7 in the group that received estrogen, and from 5.8 to 2.5 in those who received HLA (P = .81).
- No treatment-related severe adverse events were reported.
IN PRACTICE:
“Women often need to decide between different therapies for genitourinary syndrome of menopause,” study author Benjamin Brucker, MD, of New York University said in an interview. “Now we can help counsel them about this formulation of HLA.”
SOURCE:
Poster P-1 was presented at the 2023 meeting of the Menopause Society, held Sept. 27-30 in Philadelphia.
DISCLOSURES:
The study was funded by Bonafide Health, a company that sells supplements to treat menopause symptoms, including vaginal suppositories containing HLA.
A version of this article appeared on Medscape.com.
TOPLINE:
Among women with genitourinary syndrome of menopause, 12 weeks of treatment with vaginal suppositories containing hyaluronic acid (HLA) reduces vulvovaginal symptoms, according to trial results presented at the annual Menopause Meeting. HLA may be a promising nonhormonal therapy for this condition, the researchers said.
METHODOLOGY:
- Investigators randomly assigned 49 women to receive treatment with a vaginal suppository containing 5 mg of HLA or standard-of-care treatment with vaginal estrogen cream (0.01%).
- The trial was conducted between September 2021 and August 2022.
TAKEAWAY:
- Patients in both treatment arms experienced improvements on the Vulvovaginal Symptom Questionnaire (VSQ), the study’s primary outcome.
- The VSQ assesses vulvovaginal symptoms associated with menopause such as itching, burning, and dryness, as well as the emotional toll of symptoms and their effect on sexual activity.
- Change in VSQ score did not significantly differ between the treatment groups. The measure improved from 5.2 to 1.7 in the group that received estrogen, and from 5.8 to 2.5 in those who received HLA (P = .81).
- No treatment-related severe adverse events were reported.
IN PRACTICE:
“Women often need to decide between different therapies for genitourinary syndrome of menopause,” study author Benjamin Brucker, MD, of New York University said in an interview. “Now we can help counsel them about this formulation of HLA.”
SOURCE:
Poster P-1 was presented at the 2023 meeting of the Menopause Society, held Sept. 27-30 in Philadelphia.
DISCLOSURES:
The study was funded by Bonafide Health, a company that sells supplements to treat menopause symptoms, including vaginal suppositories containing HLA.
A version of this article appeared on Medscape.com.
Can this device take on enlarged prostates?
Inflating a drug-coated balloon in the prostate is the latest approach to treating a common cause of frequent or difficult urination in older men.
As the prostate naturally grows with age, the gland can obstruct the flow of urine – leading to frequent trips to the bathroom and disrupted nights. An estimated 50% of men aged 60 years and older have benign prostatic hyperplasia (BPH). That figure rises to more than 80% by age 70 and to 90% by age 80.
Transurethral resection of the prostate was the main surgical treatment for symptomatic BPH for much of the 20th century.
More recently, researchers have developed various minimally invasive surgical therapy (MIST) devices to treat the obstruction while limiting effects on sexual function. Some newer devices use lasers or water vapor to remove prostate tissue. Another approach uses implants to move and hold prostate tissue out of the way.
Now drug-coated balloons have entered the picture.
, paclitaxel – best known as a chemotherapy medication – to limit further growth and keep the lobes apart.
The Food and Drug Administration approved Optilume BPH in June. The results from a randomized controlled trial of the device were published in The Journal of Urology.
Uptake of MIST devices for BPH “has been variable due to a host of factors including mixed results, complexity of equipment, and costs,” the journal’s editor, D. Robert Siemens, MD, noted in the issue.
The developer of the device, Urotronic, said it expects that the newest treatment will be commercially available in the near future. Discussions about cost, insurance coverage, and how to train urologists to use it are ongoing, said Ian Schorn, the company’s vice president of clinical affairs.
Raevti Bole, MD, a urologic surgeon at Cleveland Clinic’s Glickman Urological and Kidney Institute, said BPH treatments ideally benefit patients for years, so she is eager to see how patients are doing 5 and 10 years after the Optilume BPH procedure. Studies should also examine its effects on fertility.
But given the safety and efficacy results reported 1 year after treatment, “I think this is something that a lot of people are going to be able to use in their practice and that their patients are going to benefit from,” Dr. Bole told this news organization.
She said she expects most urologists will be able to master the technology. The procedure’s minimal effect on sexual issues and the relatively short time needed to perform it are other advantages.
“All of those things are very positive in terms of whether patients are going to want to consider it and also whether surgeons are going to be able to realistically learn it and offer it at their centers,” Dr. Bole said.
In choosing a particular treatment, Dr. Bole discusses options with patients and takes into account factors such as trial data, the nature and severity of symptoms, treatment goals, comorbidities, and the size of the prostate.
Available MIST devices can vary by institution, and urologists can have different levels of experience with each device. If a patient is interested in an approach a surgeon does not offer, the surgeon can refer the patient to a colleague who does.
Active vs. sham treatment
Urologists may be familiar with another Optilume device, the Optilume urethral drug-coated balloon, that is used for urethral strictures.
The devices have similar names, and the underlying technology is similar, but there are major differences, Mr. Schorn said.
The BPH device expands between the lobes of the prostate, creating an anterior commissurotomy. A double-lobe balloon locks the device in place during inflation.
For the PINNACLE trial of the BPH device, which was conducted at 18 sites in the United States and Canada, Steven A. Kaplan, MD, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues enrolled 148 men with symptomatic BPH who were experiencing urinary flow obstruction.
The average age of the patients was 65 years; 100 of them were assigned to undergo active treatment with Optilume BPH. The rest received a sham procedure that mimicked active treatment.
At 3 months, men who received active treatment had an average improvement in the International Prostate Symptom Score of about 11 points. This improvement was maintained at 1 year. Those who received sham treatment experienced an 8-point improvement at 3 months that dissipated over time.
The rate of urine flow increased dramatically with Optilume BPH, the researchers reported.
Five serious adverse events were considered to be possibly related to the device. There were four cases of postprocedural hematuria that required cystoscopic management or extended observation, and one case of urethral false passage that required extended catheterization.
Nonserious adverse events in the men who underwent the Optilume procedure typically resolved in about a month and included hematuria (40%), urinary tract infection (14%), dysuria (9.2%), urge or mixed incontinence (8.2%), mild stress incontinence (7.1%), bladder spasms (6.1%), elevated prostate-specific antigen levels (6.1%), and urinary urgency (6.1%), according to the researchers.
In a subset of participants for whom pharmacokinetic data were available, systemic exposure to paclitaxel was minimal.
Four participants in the Optilume BPH arm (4.1%) reported ejaculatory dysfunction, compared with one man in the sham treatment arm (2.1%). There were no cases of treatment-related erectile dysfunction.
Most patients were treated under deep sedation or general anesthesia, and the average procedure time was 26 minutes.
After the procedure, patients received a Foley catheter, which remained in place for about 2 days, “which is not significantly different from water vapor thermal therapy, holmium laser enucleation of the prostate, or laser photovaporization in similar gland sizes,” Dr. Bole and Petar Bajic, MD, also with Cleveland Clinic, noted in a commentary accompanying the article in The Journal of Urology.
MIST devices can be ideal for patients who prioritize sexual function, but the need for a temporary catheter after the procedure can be a “major postoperative source of patient dissatisfaction,” they acknowledged.
“Consistent with other minimally invasive technologies, the Optilume BPH procedure is a straightforward procedure that can be conducted in an ambulatory or office outpatient setting with pain management at physician and patient discretion,” Dr. Kaplan and his coauthors wrote.
The study was featured on the cover of the journal, which the research team saw as an unusual but welcome spotlight for a treatment for BPH.
“We were thrilled that we got on the cover of The Journal of Urology, which is not a common thing for BPH technology,” Mr. Schorn said.
Urotronic funded the PINNACLE study. Dr. Bole has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Inflating a drug-coated balloon in the prostate is the latest approach to treating a common cause of frequent or difficult urination in older men.
As the prostate naturally grows with age, the gland can obstruct the flow of urine – leading to frequent trips to the bathroom and disrupted nights. An estimated 50% of men aged 60 years and older have benign prostatic hyperplasia (BPH). That figure rises to more than 80% by age 70 and to 90% by age 80.
Transurethral resection of the prostate was the main surgical treatment for symptomatic BPH for much of the 20th century.
More recently, researchers have developed various minimally invasive surgical therapy (MIST) devices to treat the obstruction while limiting effects on sexual function. Some newer devices use lasers or water vapor to remove prostate tissue. Another approach uses implants to move and hold prostate tissue out of the way.
Now drug-coated balloons have entered the picture.
, paclitaxel – best known as a chemotherapy medication – to limit further growth and keep the lobes apart.
The Food and Drug Administration approved Optilume BPH in June. The results from a randomized controlled trial of the device were published in The Journal of Urology.
Uptake of MIST devices for BPH “has been variable due to a host of factors including mixed results, complexity of equipment, and costs,” the journal’s editor, D. Robert Siemens, MD, noted in the issue.
The developer of the device, Urotronic, said it expects that the newest treatment will be commercially available in the near future. Discussions about cost, insurance coverage, and how to train urologists to use it are ongoing, said Ian Schorn, the company’s vice president of clinical affairs.
Raevti Bole, MD, a urologic surgeon at Cleveland Clinic’s Glickman Urological and Kidney Institute, said BPH treatments ideally benefit patients for years, so she is eager to see how patients are doing 5 and 10 years after the Optilume BPH procedure. Studies should also examine its effects on fertility.
But given the safety and efficacy results reported 1 year after treatment, “I think this is something that a lot of people are going to be able to use in their practice and that their patients are going to benefit from,” Dr. Bole told this news organization.
She said she expects most urologists will be able to master the technology. The procedure’s minimal effect on sexual issues and the relatively short time needed to perform it are other advantages.
“All of those things are very positive in terms of whether patients are going to want to consider it and also whether surgeons are going to be able to realistically learn it and offer it at their centers,” Dr. Bole said.
In choosing a particular treatment, Dr. Bole discusses options with patients and takes into account factors such as trial data, the nature and severity of symptoms, treatment goals, comorbidities, and the size of the prostate.
Available MIST devices can vary by institution, and urologists can have different levels of experience with each device. If a patient is interested in an approach a surgeon does not offer, the surgeon can refer the patient to a colleague who does.
Active vs. sham treatment
Urologists may be familiar with another Optilume device, the Optilume urethral drug-coated balloon, that is used for urethral strictures.
The devices have similar names, and the underlying technology is similar, but there are major differences, Mr. Schorn said.
The BPH device expands between the lobes of the prostate, creating an anterior commissurotomy. A double-lobe balloon locks the device in place during inflation.
For the PINNACLE trial of the BPH device, which was conducted at 18 sites in the United States and Canada, Steven A. Kaplan, MD, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues enrolled 148 men with symptomatic BPH who were experiencing urinary flow obstruction.
The average age of the patients was 65 years; 100 of them were assigned to undergo active treatment with Optilume BPH. The rest received a sham procedure that mimicked active treatment.
At 3 months, men who received active treatment had an average improvement in the International Prostate Symptom Score of about 11 points. This improvement was maintained at 1 year. Those who received sham treatment experienced an 8-point improvement at 3 months that dissipated over time.
The rate of urine flow increased dramatically with Optilume BPH, the researchers reported.
Five serious adverse events were considered to be possibly related to the device. There were four cases of postprocedural hematuria that required cystoscopic management or extended observation, and one case of urethral false passage that required extended catheterization.
Nonserious adverse events in the men who underwent the Optilume procedure typically resolved in about a month and included hematuria (40%), urinary tract infection (14%), dysuria (9.2%), urge or mixed incontinence (8.2%), mild stress incontinence (7.1%), bladder spasms (6.1%), elevated prostate-specific antigen levels (6.1%), and urinary urgency (6.1%), according to the researchers.
In a subset of participants for whom pharmacokinetic data were available, systemic exposure to paclitaxel was minimal.
Four participants in the Optilume BPH arm (4.1%) reported ejaculatory dysfunction, compared with one man in the sham treatment arm (2.1%). There were no cases of treatment-related erectile dysfunction.
Most patients were treated under deep sedation or general anesthesia, and the average procedure time was 26 minutes.
After the procedure, patients received a Foley catheter, which remained in place for about 2 days, “which is not significantly different from water vapor thermal therapy, holmium laser enucleation of the prostate, or laser photovaporization in similar gland sizes,” Dr. Bole and Petar Bajic, MD, also with Cleveland Clinic, noted in a commentary accompanying the article in The Journal of Urology.
MIST devices can be ideal for patients who prioritize sexual function, but the need for a temporary catheter after the procedure can be a “major postoperative source of patient dissatisfaction,” they acknowledged.
“Consistent with other minimally invasive technologies, the Optilume BPH procedure is a straightforward procedure that can be conducted in an ambulatory or office outpatient setting with pain management at physician and patient discretion,” Dr. Kaplan and his coauthors wrote.
The study was featured on the cover of the journal, which the research team saw as an unusual but welcome spotlight for a treatment for BPH.
“We were thrilled that we got on the cover of The Journal of Urology, which is not a common thing for BPH technology,” Mr. Schorn said.
Urotronic funded the PINNACLE study. Dr. Bole has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Inflating a drug-coated balloon in the prostate is the latest approach to treating a common cause of frequent or difficult urination in older men.
As the prostate naturally grows with age, the gland can obstruct the flow of urine – leading to frequent trips to the bathroom and disrupted nights. An estimated 50% of men aged 60 years and older have benign prostatic hyperplasia (BPH). That figure rises to more than 80% by age 70 and to 90% by age 80.
Transurethral resection of the prostate was the main surgical treatment for symptomatic BPH for much of the 20th century.
More recently, researchers have developed various minimally invasive surgical therapy (MIST) devices to treat the obstruction while limiting effects on sexual function. Some newer devices use lasers or water vapor to remove prostate tissue. Another approach uses implants to move and hold prostate tissue out of the way.
Now drug-coated balloons have entered the picture.
, paclitaxel – best known as a chemotherapy medication – to limit further growth and keep the lobes apart.
The Food and Drug Administration approved Optilume BPH in June. The results from a randomized controlled trial of the device were published in The Journal of Urology.
Uptake of MIST devices for BPH “has been variable due to a host of factors including mixed results, complexity of equipment, and costs,” the journal’s editor, D. Robert Siemens, MD, noted in the issue.
The developer of the device, Urotronic, said it expects that the newest treatment will be commercially available in the near future. Discussions about cost, insurance coverage, and how to train urologists to use it are ongoing, said Ian Schorn, the company’s vice president of clinical affairs.
Raevti Bole, MD, a urologic surgeon at Cleveland Clinic’s Glickman Urological and Kidney Institute, said BPH treatments ideally benefit patients for years, so she is eager to see how patients are doing 5 and 10 years after the Optilume BPH procedure. Studies should also examine its effects on fertility.
But given the safety and efficacy results reported 1 year after treatment, “I think this is something that a lot of people are going to be able to use in their practice and that their patients are going to benefit from,” Dr. Bole told this news organization.
She said she expects most urologists will be able to master the technology. The procedure’s minimal effect on sexual issues and the relatively short time needed to perform it are other advantages.
“All of those things are very positive in terms of whether patients are going to want to consider it and also whether surgeons are going to be able to realistically learn it and offer it at their centers,” Dr. Bole said.
In choosing a particular treatment, Dr. Bole discusses options with patients and takes into account factors such as trial data, the nature and severity of symptoms, treatment goals, comorbidities, and the size of the prostate.
Available MIST devices can vary by institution, and urologists can have different levels of experience with each device. If a patient is interested in an approach a surgeon does not offer, the surgeon can refer the patient to a colleague who does.
Active vs. sham treatment
Urologists may be familiar with another Optilume device, the Optilume urethral drug-coated balloon, that is used for urethral strictures.
The devices have similar names, and the underlying technology is similar, but there are major differences, Mr. Schorn said.
The BPH device expands between the lobes of the prostate, creating an anterior commissurotomy. A double-lobe balloon locks the device in place during inflation.
For the PINNACLE trial of the BPH device, which was conducted at 18 sites in the United States and Canada, Steven A. Kaplan, MD, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues enrolled 148 men with symptomatic BPH who were experiencing urinary flow obstruction.
The average age of the patients was 65 years; 100 of them were assigned to undergo active treatment with Optilume BPH. The rest received a sham procedure that mimicked active treatment.
At 3 months, men who received active treatment had an average improvement in the International Prostate Symptom Score of about 11 points. This improvement was maintained at 1 year. Those who received sham treatment experienced an 8-point improvement at 3 months that dissipated over time.
The rate of urine flow increased dramatically with Optilume BPH, the researchers reported.
Five serious adverse events were considered to be possibly related to the device. There were four cases of postprocedural hematuria that required cystoscopic management or extended observation, and one case of urethral false passage that required extended catheterization.
Nonserious adverse events in the men who underwent the Optilume procedure typically resolved in about a month and included hematuria (40%), urinary tract infection (14%), dysuria (9.2%), urge or mixed incontinence (8.2%), mild stress incontinence (7.1%), bladder spasms (6.1%), elevated prostate-specific antigen levels (6.1%), and urinary urgency (6.1%), according to the researchers.
In a subset of participants for whom pharmacokinetic data were available, systemic exposure to paclitaxel was minimal.
Four participants in the Optilume BPH arm (4.1%) reported ejaculatory dysfunction, compared with one man in the sham treatment arm (2.1%). There were no cases of treatment-related erectile dysfunction.
Most patients were treated under deep sedation or general anesthesia, and the average procedure time was 26 minutes.
After the procedure, patients received a Foley catheter, which remained in place for about 2 days, “which is not significantly different from water vapor thermal therapy, holmium laser enucleation of the prostate, or laser photovaporization in similar gland sizes,” Dr. Bole and Petar Bajic, MD, also with Cleveland Clinic, noted in a commentary accompanying the article in The Journal of Urology.
MIST devices can be ideal for patients who prioritize sexual function, but the need for a temporary catheter after the procedure can be a “major postoperative source of patient dissatisfaction,” they acknowledged.
“Consistent with other minimally invasive technologies, the Optilume BPH procedure is a straightforward procedure that can be conducted in an ambulatory or office outpatient setting with pain management at physician and patient discretion,” Dr. Kaplan and his coauthors wrote.
The study was featured on the cover of the journal, which the research team saw as an unusual but welcome spotlight for a treatment for BPH.
“We were thrilled that we got on the cover of The Journal of Urology, which is not a common thing for BPH technology,” Mr. Schorn said.
Urotronic funded the PINNACLE study. Dr. Bole has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
New guideline for managing toothache in children
Nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, or both medications together can effectively manage a child’s toothache as a stopgap until definitive treatment is available, according to a new guideline.
The guideline, published in the September issue of the Journal of the American Dental Association, does not recommend opioids for a toothache or after tooth extraction in this population.
Opioid prescriptions for children entail risk for hospitalization and death. Yet, some dentists continued to prescribe contraindicated opioids to young children after a Food and Drug Administration warning in 2017 about the use of tramadol and codeine in this population, the guideline notes.
Opioid prescribing to children also continued after the American Academy of Pediatric Dentistry in 2018 recommended acetaminophen and NSAIDs as first-line medications for pain management and said that the use of opioids should be “rare.”
Although the new guidance, which also covers pain management after tooth extraction, is geared toward general dentists, it could help emergency clinicians and primary care providers manage children’s pain when definitive treatment is not immediately available, the authors noted.
Definitive treatment could include pulpectomy, nonsurgical root canal, incision for drainage of an abscess, or tooth extraction.
If definitive care in 2-3 days is not possible, parents should let the health care team know, the guideline says.
“These pharmacologic strategies will alleviate dental pain temporarily until a referral for definitive dental treatment is in place,” the authors wrote.
The American Dental Association (ADA) endorsed the new guideline, which was developed by researchers with the ADA Science & Research Institute, the University of Pittsburgh School of Dental Medicine, and the Center for Integrative Global Oral Health at the University of Pennsylvania School of Dental Medicine in Philadelphia.
The guideline recommends ibuprofen and, for children older than 2 years, naproxen as NSAID options. The use of naproxen in children younger than 12 years for this purpose is off label, they noted.
The guideline suggests doses of acetaminophen and NSAIDs on the basis of age and weight that may differ from those on medication packaging.
“When acetaminophen or NSAIDs are administered as directed, the risk of harm to children from either medication is low,” the guideline states.
“While prescribing opioids to children has become less frequent overall, this guideline ensures that both dentists and parents have evidence-based recommendations to determine the most appropriate treatment for dental pain,” senior guideline author Paul Moore, DMD, PhD, MPH, professor emeritus at the University of Pittsburgh’s School of Dental Medicine, said in a news release from the ADA. “Parents and caregivers can take comfort that widely available medications that have no abuse potential, such as acetaminophen or ibuprofen, are safe and effective for helping their children find relief from short-term dental pain.”
A 2018 review by Dr. Moore and coauthors found that NSAIDs, with or without acetaminophen, were effective and minimized adverse events, relative to opioids, for acute dental pain across ages.
The new recommendations for children will “allow for better treatment of this kind of pain” and “will help prevent unnecessary prescribing of medications with abuse potential, including opioids,” Patrizia Cavazzoni, MD, director of the FDA Center for Drug Evaluation and Research, said in the news release.
The report stems from a 3-year, $1.5 million grant awarded by the FDA in 2020 to the University of Pittsburgh and the ADA Science & Research Institute to develop a clinical practice guideline for the management of acute pain in dentistry in children, adolescents, and adults. The recommendations for adolescents and adults are still in development.
The report was supported by an FDA grant, and the guideline authors received technical and methodologic support from the agency. Some authors disclosed ties to pharmaceutical companies.
A version of this article appeared on Medscape.com.
Nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, or both medications together can effectively manage a child’s toothache as a stopgap until definitive treatment is available, according to a new guideline.
The guideline, published in the September issue of the Journal of the American Dental Association, does not recommend opioids for a toothache or after tooth extraction in this population.
Opioid prescriptions for children entail risk for hospitalization and death. Yet, some dentists continued to prescribe contraindicated opioids to young children after a Food and Drug Administration warning in 2017 about the use of tramadol and codeine in this population, the guideline notes.
Opioid prescribing to children also continued after the American Academy of Pediatric Dentistry in 2018 recommended acetaminophen and NSAIDs as first-line medications for pain management and said that the use of opioids should be “rare.”
Although the new guidance, which also covers pain management after tooth extraction, is geared toward general dentists, it could help emergency clinicians and primary care providers manage children’s pain when definitive treatment is not immediately available, the authors noted.
Definitive treatment could include pulpectomy, nonsurgical root canal, incision for drainage of an abscess, or tooth extraction.
If definitive care in 2-3 days is not possible, parents should let the health care team know, the guideline says.
“These pharmacologic strategies will alleviate dental pain temporarily until a referral for definitive dental treatment is in place,” the authors wrote.
The American Dental Association (ADA) endorsed the new guideline, which was developed by researchers with the ADA Science & Research Institute, the University of Pittsburgh School of Dental Medicine, and the Center for Integrative Global Oral Health at the University of Pennsylvania School of Dental Medicine in Philadelphia.
The guideline recommends ibuprofen and, for children older than 2 years, naproxen as NSAID options. The use of naproxen in children younger than 12 years for this purpose is off label, they noted.
The guideline suggests doses of acetaminophen and NSAIDs on the basis of age and weight that may differ from those on medication packaging.
“When acetaminophen or NSAIDs are administered as directed, the risk of harm to children from either medication is low,” the guideline states.
“While prescribing opioids to children has become less frequent overall, this guideline ensures that both dentists and parents have evidence-based recommendations to determine the most appropriate treatment for dental pain,” senior guideline author Paul Moore, DMD, PhD, MPH, professor emeritus at the University of Pittsburgh’s School of Dental Medicine, said in a news release from the ADA. “Parents and caregivers can take comfort that widely available medications that have no abuse potential, such as acetaminophen or ibuprofen, are safe and effective for helping their children find relief from short-term dental pain.”
A 2018 review by Dr. Moore and coauthors found that NSAIDs, with or without acetaminophen, were effective and minimized adverse events, relative to opioids, for acute dental pain across ages.
The new recommendations for children will “allow for better treatment of this kind of pain” and “will help prevent unnecessary prescribing of medications with abuse potential, including opioids,” Patrizia Cavazzoni, MD, director of the FDA Center for Drug Evaluation and Research, said in the news release.
The report stems from a 3-year, $1.5 million grant awarded by the FDA in 2020 to the University of Pittsburgh and the ADA Science & Research Institute to develop a clinical practice guideline for the management of acute pain in dentistry in children, adolescents, and adults. The recommendations for adolescents and adults are still in development.
The report was supported by an FDA grant, and the guideline authors received technical and methodologic support from the agency. Some authors disclosed ties to pharmaceutical companies.
A version of this article appeared on Medscape.com.
Nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, or both medications together can effectively manage a child’s toothache as a stopgap until definitive treatment is available, according to a new guideline.
The guideline, published in the September issue of the Journal of the American Dental Association, does not recommend opioids for a toothache or after tooth extraction in this population.
Opioid prescriptions for children entail risk for hospitalization and death. Yet, some dentists continued to prescribe contraindicated opioids to young children after a Food and Drug Administration warning in 2017 about the use of tramadol and codeine in this population, the guideline notes.
Opioid prescribing to children also continued after the American Academy of Pediatric Dentistry in 2018 recommended acetaminophen and NSAIDs as first-line medications for pain management and said that the use of opioids should be “rare.”
Although the new guidance, which also covers pain management after tooth extraction, is geared toward general dentists, it could help emergency clinicians and primary care providers manage children’s pain when definitive treatment is not immediately available, the authors noted.
Definitive treatment could include pulpectomy, nonsurgical root canal, incision for drainage of an abscess, or tooth extraction.
If definitive care in 2-3 days is not possible, parents should let the health care team know, the guideline says.
“These pharmacologic strategies will alleviate dental pain temporarily until a referral for definitive dental treatment is in place,” the authors wrote.
The American Dental Association (ADA) endorsed the new guideline, which was developed by researchers with the ADA Science & Research Institute, the University of Pittsburgh School of Dental Medicine, and the Center for Integrative Global Oral Health at the University of Pennsylvania School of Dental Medicine in Philadelphia.
The guideline recommends ibuprofen and, for children older than 2 years, naproxen as NSAID options. The use of naproxen in children younger than 12 years for this purpose is off label, they noted.
The guideline suggests doses of acetaminophen and NSAIDs on the basis of age and weight that may differ from those on medication packaging.
“When acetaminophen or NSAIDs are administered as directed, the risk of harm to children from either medication is low,” the guideline states.
“While prescribing opioids to children has become less frequent overall, this guideline ensures that both dentists and parents have evidence-based recommendations to determine the most appropriate treatment for dental pain,” senior guideline author Paul Moore, DMD, PhD, MPH, professor emeritus at the University of Pittsburgh’s School of Dental Medicine, said in a news release from the ADA. “Parents and caregivers can take comfort that widely available medications that have no abuse potential, such as acetaminophen or ibuprofen, are safe and effective for helping their children find relief from short-term dental pain.”
A 2018 review by Dr. Moore and coauthors found that NSAIDs, with or without acetaminophen, were effective and minimized adverse events, relative to opioids, for acute dental pain across ages.
The new recommendations for children will “allow for better treatment of this kind of pain” and “will help prevent unnecessary prescribing of medications with abuse potential, including opioids,” Patrizia Cavazzoni, MD, director of the FDA Center for Drug Evaluation and Research, said in the news release.
The report stems from a 3-year, $1.5 million grant awarded by the FDA in 2020 to the University of Pittsburgh and the ADA Science & Research Institute to develop a clinical practice guideline for the management of acute pain in dentistry in children, adolescents, and adults. The recommendations for adolescents and adults are still in development.
The report was supported by an FDA grant, and the guideline authors received technical and methodologic support from the agency. Some authors disclosed ties to pharmaceutical companies.
A version of this article appeared on Medscape.com.
Poor sleep and chronic pain prove pesky bedfellows
Early in his career as a pain researcher, Daniel Whibley, PhD, was struck by an article that drew parallels between methods of torture and the experiences of patients with insomnia and chronic pain.
The author of that article, Nicole Tang, DPhil, observed that two methods used by torturers – pain infliction and sleep deprivation – harm people in ways that also are experienced by many patients with pain and sleep conditions.
Patients are “essentially living in this perpetually undesirable, at best, situation where both of these features are playing out in their lives,” said Dr. Whibley, a research assistant professor of physical medicine and rehabilitation at the University of Michigan, Ann Arbor.
The problems create a “kind of vicious circle,” he said. Pain disrupts sleep. Insufficient sleep worsens pain.
Studies have established important relationships between the conditions, but investigators are still trying to clarify the mechanisms that connect them and the best ways to intervene to improve patient outcomes.
To that end, Dr. Whibley has developed an intervention known as Move & Snooze to benefit patients with pain associated with osteoarthritis.
The program includes remote exercise coaching and an automated 6-week course of digital cognitive-behavioral therapy for insomnia (CBT-I).
He and his colleagues have tested the intervention in a feasibility study and are in the process of securing grant funding to test it in a large, nationwide trial.
Losing sleep for science
Michael Smith, PhD, is examining the sleep-pain connection from a different angle.
Dr. Smith, the director of the Behavioral Medicine Research Laboratory at Johns Hopkins University, Baltimore, is recruiting healthy adults to endure restless nights and painful stimuli.
His team is conducting a study known as Sleep-MOR that aims to reveal how different types of sleep disturbances influence pain and a person’s response to opioids.
Nearly three dozen participants have completed the study so far, Dr. Smith said, out of what he hopes will be 200 in all.
Participants are randomly assigned to sleep normally or to undergo an experimental condition that is designed to mimic the sleep disturbances of insomnia or obstructive sleep apnea (OSA).
In a “forced awakening” group, participants are awakened for 20-minute intervals every hour and for a full hour-long window during the night. In this condition, they could sleep for about four hours in all. Forced awakening is intended to represent insomnia
A “sleep fragmentation” group is meant to represent patients with OSA. About 30 times per hour, tones and tactile buzzers rouse sleeping participants without fully waking them up. Although the experiment involves brief arousals such as those experienced by patients with OSA, it does not capture another important feature of sleep apnea – the cessation of breathing, Dr. Smith noted.
The next day, researchers perform pain testing and brain imaging and see how opioid receptors respond to pain medication.
“Some of the forms of sleep loss that we are studying may actually alter the efficacy of the binding of those receptors, and that might then require you to have higher doses of an opioid to get the same effect,” Dr. Smith said. “That’s our hypothesis.”
If that bears out, disturbed sleep may play a role in the development of opioid use disorder and have implications for patients who receive opioids after surgery, he said.
In the lab, researchers examine pain thresholds using techniques such as thermal pain testing, in which a thermode attached to a participant’s arm heats up. The temperature “slowly goes up and the patient just says: ‘Ouch,’ when it first hurts. Then we have their pain threshold,” Dr. Smith said.
A bidirectional relationship
Epidemiologic studies have found that, if you follow women who do not have pain, those with complaints about sleep are more than twice as likely to develop fibromyalgia.
Dr. Smith’s group and others have shown that if you deprive a healthy person of sleep, they become more sensitive to pain.
Inflammation could be one possible reason for this effect. In one study, participants who experienced forced awakening experienced less slow-wave sleep, which was tied to more inflammation in the morning. Increased inflammation was linked to greater pain sensitivity.
“We are starting to piece together some of the pathways. That’s just one,” Dr. Smith said.
A recent study by researchers at Harvard University and elsewhere investigated how sleep disturbances affected three pain pathways. In that study, the results varied by sex. The data indicate that optimal treatment approaches might differ for men and women, the researchers said.
Waking up to the problem
Sleep problems can be neglected in medical school and in the clinic. “People just have other things to focus on that they clearly know what they can do about it,” Dr. Smith said.
But clinicians should not hesitate to screen for conditions such as insomnia or OSA and refer patients to a specialist. If a patient has had pain for 6 months and treatments are not working, the chance that they have a treatable sleep disorder “is very high, above 50%,” Dr. Smith said. Many could have more than one sleep disorder, he added.
Continuous positive airway pressure for OSA and CBT for insomnia can improve sleep. Dr. Smith said he expects these measures will improve overall pain management as well.
If treating a sleep disorder fails to help with pain, however, it may still help prevent other sleep-related problems, such as depression, poor glucose control, and heart disease. It also could improve patients’ ability to function day to day, he said.
Evidence on whether treating sleep problems reduces pain has so far been mixed.
“We’ve done some studies showing that if you have CBT-I and you have knee arthritis, improvements in the amount of time you spend awake at night translate into improvements in pain at 6 months. There is a signal there, but it’s not as strong as we would like,” he said. “It may be that it takes longer than anyone would like” to have an effect.
A structured intervention such as CBT-I is likely more beneficial than education about sleep hygiene alone in resolving sleep disturbances, Dr. Whibley said. CBT-I includes active components such as sleep restriction therapy and stimulus control therapy and is recommended by the American Academy of Sleep Medicine as the first-line treatment for chronic insomnia (J Clin Sleep Med. 2008 Oct 15;4[5]:487-504).
Patients should consider the role that sleep may play in their chronic pain condition, he said.
“An increasing number of researchers and clinicians are becoming more interested in this as a foundational pillar of health, alongside activity and diet,” Dr. Whibley said. “Sleep is recognized as just as important but doesn’t seem to get the airtime.”
Clinicians, he added, should regularly assess their patients’ sleep and know where to refer those whom they feel would benefit from more advanced management: “They [should] know that they have at least got it on their radar to check as one of the important pillars of health that you should be able to control.”
Sleep trials seeking pain patients
Researchers around the United States are conducting dozens of studies related to sleep and pain. The following trials are recruiting participants, according to ClinicalTrials.gov.
Sleep and Pain Interventions in Women With Fibromyalgia (SPIN-II). Investigators at the University of Missouri–Columbia are examining two cognitive-behavioral treatments for women with fibromyalgia and insomnia. “This trial will yield important information about the roles of sleep, arousal, and brain structure and function in the development and maintenance of chronic pain in women with fibromyalgia,” the researchers say.
Prospective Randomized Trial of CPAP for SDB in Patients Who Use Opioids (PRESTO). At the University of California, San Diego, researchers are investigating whether patients with chronic pain who use opioids and have sleep-disordered breathing may benefit from treatment with continuous positive airway pressure. They plan to assess the intervention’s effects on sleep quality, pain, and quality of life. They also will see which patients are least likely to benefit from this treatment approach.
Latent Aging Mechanisms in Pain and Sleep (LAMPS). Researchers at the University of Florida are studying the effects of oral gamma-aminobutyric acid in older adults with chronic pain and sleep difficulties.
Sleep and Pain in Sickle Cell Disease. At Johns Hopkins University, investigators are evaluating how behavioral sleep interventions influence pain and brain function in patients with sickle cell disease.
Pain in Long COVID-19: The Role of Sleep. Researchers at Beth Israel Deaconess Medical Center are conducting an observational study of patients with long COVID who have pain and sleep disturbances. The study aims “to understand the role of sleep in the development and persistence of pain symptoms in long COVID.”
Intervention for Sleep and Pain in Youth: A Randomized Controlled Trial (I-SPY-RCT). Adolescents with migraine are being recruited by a team at Seattle Children’s Hospital for a randomized controlled trial. The study will examine the effects of CBT-I as well as the combined effect of CBT-I and pain interventions on reducing insomnia symptoms and headache-related disability in this population.
A version of this article appeared on Medscape.com.
Early in his career as a pain researcher, Daniel Whibley, PhD, was struck by an article that drew parallels between methods of torture and the experiences of patients with insomnia and chronic pain.
The author of that article, Nicole Tang, DPhil, observed that two methods used by torturers – pain infliction and sleep deprivation – harm people in ways that also are experienced by many patients with pain and sleep conditions.
Patients are “essentially living in this perpetually undesirable, at best, situation where both of these features are playing out in their lives,” said Dr. Whibley, a research assistant professor of physical medicine and rehabilitation at the University of Michigan, Ann Arbor.
The problems create a “kind of vicious circle,” he said. Pain disrupts sleep. Insufficient sleep worsens pain.
Studies have established important relationships between the conditions, but investigators are still trying to clarify the mechanisms that connect them and the best ways to intervene to improve patient outcomes.
To that end, Dr. Whibley has developed an intervention known as Move & Snooze to benefit patients with pain associated with osteoarthritis.
The program includes remote exercise coaching and an automated 6-week course of digital cognitive-behavioral therapy for insomnia (CBT-I).
He and his colleagues have tested the intervention in a feasibility study and are in the process of securing grant funding to test it in a large, nationwide trial.
Losing sleep for science
Michael Smith, PhD, is examining the sleep-pain connection from a different angle.
Dr. Smith, the director of the Behavioral Medicine Research Laboratory at Johns Hopkins University, Baltimore, is recruiting healthy adults to endure restless nights and painful stimuli.
His team is conducting a study known as Sleep-MOR that aims to reveal how different types of sleep disturbances influence pain and a person’s response to opioids.
Nearly three dozen participants have completed the study so far, Dr. Smith said, out of what he hopes will be 200 in all.
Participants are randomly assigned to sleep normally or to undergo an experimental condition that is designed to mimic the sleep disturbances of insomnia or obstructive sleep apnea (OSA).
In a “forced awakening” group, participants are awakened for 20-minute intervals every hour and for a full hour-long window during the night. In this condition, they could sleep for about four hours in all. Forced awakening is intended to represent insomnia
A “sleep fragmentation” group is meant to represent patients with OSA. About 30 times per hour, tones and tactile buzzers rouse sleeping participants without fully waking them up. Although the experiment involves brief arousals such as those experienced by patients with OSA, it does not capture another important feature of sleep apnea – the cessation of breathing, Dr. Smith noted.
The next day, researchers perform pain testing and brain imaging and see how opioid receptors respond to pain medication.
“Some of the forms of sleep loss that we are studying may actually alter the efficacy of the binding of those receptors, and that might then require you to have higher doses of an opioid to get the same effect,” Dr. Smith said. “That’s our hypothesis.”
If that bears out, disturbed sleep may play a role in the development of opioid use disorder and have implications for patients who receive opioids after surgery, he said.
In the lab, researchers examine pain thresholds using techniques such as thermal pain testing, in which a thermode attached to a participant’s arm heats up. The temperature “slowly goes up and the patient just says: ‘Ouch,’ when it first hurts. Then we have their pain threshold,” Dr. Smith said.
A bidirectional relationship
Epidemiologic studies have found that, if you follow women who do not have pain, those with complaints about sleep are more than twice as likely to develop fibromyalgia.
Dr. Smith’s group and others have shown that if you deprive a healthy person of sleep, they become more sensitive to pain.
Inflammation could be one possible reason for this effect. In one study, participants who experienced forced awakening experienced less slow-wave sleep, which was tied to more inflammation in the morning. Increased inflammation was linked to greater pain sensitivity.
“We are starting to piece together some of the pathways. That’s just one,” Dr. Smith said.
A recent study by researchers at Harvard University and elsewhere investigated how sleep disturbances affected three pain pathways. In that study, the results varied by sex. The data indicate that optimal treatment approaches might differ for men and women, the researchers said.
Waking up to the problem
Sleep problems can be neglected in medical school and in the clinic. “People just have other things to focus on that they clearly know what they can do about it,” Dr. Smith said.
But clinicians should not hesitate to screen for conditions such as insomnia or OSA and refer patients to a specialist. If a patient has had pain for 6 months and treatments are not working, the chance that they have a treatable sleep disorder “is very high, above 50%,” Dr. Smith said. Many could have more than one sleep disorder, he added.
Continuous positive airway pressure for OSA and CBT for insomnia can improve sleep. Dr. Smith said he expects these measures will improve overall pain management as well.
If treating a sleep disorder fails to help with pain, however, it may still help prevent other sleep-related problems, such as depression, poor glucose control, and heart disease. It also could improve patients’ ability to function day to day, he said.
Evidence on whether treating sleep problems reduces pain has so far been mixed.
“We’ve done some studies showing that if you have CBT-I and you have knee arthritis, improvements in the amount of time you spend awake at night translate into improvements in pain at 6 months. There is a signal there, but it’s not as strong as we would like,” he said. “It may be that it takes longer than anyone would like” to have an effect.
A structured intervention such as CBT-I is likely more beneficial than education about sleep hygiene alone in resolving sleep disturbances, Dr. Whibley said. CBT-I includes active components such as sleep restriction therapy and stimulus control therapy and is recommended by the American Academy of Sleep Medicine as the first-line treatment for chronic insomnia (J Clin Sleep Med. 2008 Oct 15;4[5]:487-504).
Patients should consider the role that sleep may play in their chronic pain condition, he said.
“An increasing number of researchers and clinicians are becoming more interested in this as a foundational pillar of health, alongside activity and diet,” Dr. Whibley said. “Sleep is recognized as just as important but doesn’t seem to get the airtime.”
Clinicians, he added, should regularly assess their patients’ sleep and know where to refer those whom they feel would benefit from more advanced management: “They [should] know that they have at least got it on their radar to check as one of the important pillars of health that you should be able to control.”
Sleep trials seeking pain patients
Researchers around the United States are conducting dozens of studies related to sleep and pain. The following trials are recruiting participants, according to ClinicalTrials.gov.
Sleep and Pain Interventions in Women With Fibromyalgia (SPIN-II). Investigators at the University of Missouri–Columbia are examining two cognitive-behavioral treatments for women with fibromyalgia and insomnia. “This trial will yield important information about the roles of sleep, arousal, and brain structure and function in the development and maintenance of chronic pain in women with fibromyalgia,” the researchers say.
Prospective Randomized Trial of CPAP for SDB in Patients Who Use Opioids (PRESTO). At the University of California, San Diego, researchers are investigating whether patients with chronic pain who use opioids and have sleep-disordered breathing may benefit from treatment with continuous positive airway pressure. They plan to assess the intervention’s effects on sleep quality, pain, and quality of life. They also will see which patients are least likely to benefit from this treatment approach.
Latent Aging Mechanisms in Pain and Sleep (LAMPS). Researchers at the University of Florida are studying the effects of oral gamma-aminobutyric acid in older adults with chronic pain and sleep difficulties.
Sleep and Pain in Sickle Cell Disease. At Johns Hopkins University, investigators are evaluating how behavioral sleep interventions influence pain and brain function in patients with sickle cell disease.
Pain in Long COVID-19: The Role of Sleep. Researchers at Beth Israel Deaconess Medical Center are conducting an observational study of patients with long COVID who have pain and sleep disturbances. The study aims “to understand the role of sleep in the development and persistence of pain symptoms in long COVID.”
Intervention for Sleep and Pain in Youth: A Randomized Controlled Trial (I-SPY-RCT). Adolescents with migraine are being recruited by a team at Seattle Children’s Hospital for a randomized controlled trial. The study will examine the effects of CBT-I as well as the combined effect of CBT-I and pain interventions on reducing insomnia symptoms and headache-related disability in this population.
A version of this article appeared on Medscape.com.
Early in his career as a pain researcher, Daniel Whibley, PhD, was struck by an article that drew parallels between methods of torture and the experiences of patients with insomnia and chronic pain.
The author of that article, Nicole Tang, DPhil, observed that two methods used by torturers – pain infliction and sleep deprivation – harm people in ways that also are experienced by many patients with pain and sleep conditions.
Patients are “essentially living in this perpetually undesirable, at best, situation where both of these features are playing out in their lives,” said Dr. Whibley, a research assistant professor of physical medicine and rehabilitation at the University of Michigan, Ann Arbor.
The problems create a “kind of vicious circle,” he said. Pain disrupts sleep. Insufficient sleep worsens pain.
Studies have established important relationships between the conditions, but investigators are still trying to clarify the mechanisms that connect them and the best ways to intervene to improve patient outcomes.
To that end, Dr. Whibley has developed an intervention known as Move & Snooze to benefit patients with pain associated with osteoarthritis.
The program includes remote exercise coaching and an automated 6-week course of digital cognitive-behavioral therapy for insomnia (CBT-I).
He and his colleagues have tested the intervention in a feasibility study and are in the process of securing grant funding to test it in a large, nationwide trial.
Losing sleep for science
Michael Smith, PhD, is examining the sleep-pain connection from a different angle.
Dr. Smith, the director of the Behavioral Medicine Research Laboratory at Johns Hopkins University, Baltimore, is recruiting healthy adults to endure restless nights and painful stimuli.
His team is conducting a study known as Sleep-MOR that aims to reveal how different types of sleep disturbances influence pain and a person’s response to opioids.
Nearly three dozen participants have completed the study so far, Dr. Smith said, out of what he hopes will be 200 in all.
Participants are randomly assigned to sleep normally or to undergo an experimental condition that is designed to mimic the sleep disturbances of insomnia or obstructive sleep apnea (OSA).
In a “forced awakening” group, participants are awakened for 20-minute intervals every hour and for a full hour-long window during the night. In this condition, they could sleep for about four hours in all. Forced awakening is intended to represent insomnia
A “sleep fragmentation” group is meant to represent patients with OSA. About 30 times per hour, tones and tactile buzzers rouse sleeping participants without fully waking them up. Although the experiment involves brief arousals such as those experienced by patients with OSA, it does not capture another important feature of sleep apnea – the cessation of breathing, Dr. Smith noted.
The next day, researchers perform pain testing and brain imaging and see how opioid receptors respond to pain medication.
“Some of the forms of sleep loss that we are studying may actually alter the efficacy of the binding of those receptors, and that might then require you to have higher doses of an opioid to get the same effect,” Dr. Smith said. “That’s our hypothesis.”
If that bears out, disturbed sleep may play a role in the development of opioid use disorder and have implications for patients who receive opioids after surgery, he said.
In the lab, researchers examine pain thresholds using techniques such as thermal pain testing, in which a thermode attached to a participant’s arm heats up. The temperature “slowly goes up and the patient just says: ‘Ouch,’ when it first hurts. Then we have their pain threshold,” Dr. Smith said.
A bidirectional relationship
Epidemiologic studies have found that, if you follow women who do not have pain, those with complaints about sleep are more than twice as likely to develop fibromyalgia.
Dr. Smith’s group and others have shown that if you deprive a healthy person of sleep, they become more sensitive to pain.
Inflammation could be one possible reason for this effect. In one study, participants who experienced forced awakening experienced less slow-wave sleep, which was tied to more inflammation in the morning. Increased inflammation was linked to greater pain sensitivity.
“We are starting to piece together some of the pathways. That’s just one,” Dr. Smith said.
A recent study by researchers at Harvard University and elsewhere investigated how sleep disturbances affected three pain pathways. In that study, the results varied by sex. The data indicate that optimal treatment approaches might differ for men and women, the researchers said.
Waking up to the problem
Sleep problems can be neglected in medical school and in the clinic. “People just have other things to focus on that they clearly know what they can do about it,” Dr. Smith said.
But clinicians should not hesitate to screen for conditions such as insomnia or OSA and refer patients to a specialist. If a patient has had pain for 6 months and treatments are not working, the chance that they have a treatable sleep disorder “is very high, above 50%,” Dr. Smith said. Many could have more than one sleep disorder, he added.
Continuous positive airway pressure for OSA and CBT for insomnia can improve sleep. Dr. Smith said he expects these measures will improve overall pain management as well.
If treating a sleep disorder fails to help with pain, however, it may still help prevent other sleep-related problems, such as depression, poor glucose control, and heart disease. It also could improve patients’ ability to function day to day, he said.
Evidence on whether treating sleep problems reduces pain has so far been mixed.
“We’ve done some studies showing that if you have CBT-I and you have knee arthritis, improvements in the amount of time you spend awake at night translate into improvements in pain at 6 months. There is a signal there, but it’s not as strong as we would like,” he said. “It may be that it takes longer than anyone would like” to have an effect.
A structured intervention such as CBT-I is likely more beneficial than education about sleep hygiene alone in resolving sleep disturbances, Dr. Whibley said. CBT-I includes active components such as sleep restriction therapy and stimulus control therapy and is recommended by the American Academy of Sleep Medicine as the first-line treatment for chronic insomnia (J Clin Sleep Med. 2008 Oct 15;4[5]:487-504).
Patients should consider the role that sleep may play in their chronic pain condition, he said.
“An increasing number of researchers and clinicians are becoming more interested in this as a foundational pillar of health, alongside activity and diet,” Dr. Whibley said. “Sleep is recognized as just as important but doesn’t seem to get the airtime.”
Clinicians, he added, should regularly assess their patients’ sleep and know where to refer those whom they feel would benefit from more advanced management: “They [should] know that they have at least got it on their radar to check as one of the important pillars of health that you should be able to control.”
Sleep trials seeking pain patients
Researchers around the United States are conducting dozens of studies related to sleep and pain. The following trials are recruiting participants, according to ClinicalTrials.gov.
Sleep and Pain Interventions in Women With Fibromyalgia (SPIN-II). Investigators at the University of Missouri–Columbia are examining two cognitive-behavioral treatments for women with fibromyalgia and insomnia. “This trial will yield important information about the roles of sleep, arousal, and brain structure and function in the development and maintenance of chronic pain in women with fibromyalgia,” the researchers say.
Prospective Randomized Trial of CPAP for SDB in Patients Who Use Opioids (PRESTO). At the University of California, San Diego, researchers are investigating whether patients with chronic pain who use opioids and have sleep-disordered breathing may benefit from treatment with continuous positive airway pressure. They plan to assess the intervention’s effects on sleep quality, pain, and quality of life. They also will see which patients are least likely to benefit from this treatment approach.
Latent Aging Mechanisms in Pain and Sleep (LAMPS). Researchers at the University of Florida are studying the effects of oral gamma-aminobutyric acid in older adults with chronic pain and sleep difficulties.
Sleep and Pain in Sickle Cell Disease. At Johns Hopkins University, investigators are evaluating how behavioral sleep interventions influence pain and brain function in patients with sickle cell disease.
Pain in Long COVID-19: The Role of Sleep. Researchers at Beth Israel Deaconess Medical Center are conducting an observational study of patients with long COVID who have pain and sleep disturbances. The study aims “to understand the role of sleep in the development and persistence of pain symptoms in long COVID.”
Intervention for Sleep and Pain in Youth: A Randomized Controlled Trial (I-SPY-RCT). Adolescents with migraine are being recruited by a team at Seattle Children’s Hospital for a randomized controlled trial. The study will examine the effects of CBT-I as well as the combined effect of CBT-I and pain interventions on reducing insomnia symptoms and headache-related disability in this population.
A version of this article appeared on Medscape.com.
ACP sticks with 50 as age to start CRC screening
Not so fast with earlier screening for colorectal cancer (CRC), at least according to one professional group.
The American College of Physicians published updated clinical guidance maintaining 50 as the age when clinicians should start screening for CRC in patients who are asymptomatic and at average risk.
The recommendation conflicts with guidelines from the American Cancer Society and the U.S. Preventive Services Task Force, which lowered the recommended age to start screening to age 45.
Although the rate of CRC has increased among adults aged 45-49, the incidence is 35.1 cases per 100,000 people, much lower than among persons aged 50-64 (71.9 per 100,000) and those aged 65-74 (128.9 per 100,000), the guidance notes.
“The net benefit of screening is much less favorable in average-risk adults between ages 45 and 49 years than in those aged 50-75 years,” the authors wrote. “Clinicians should discuss the uncertainty around benefits and harms of screening in this population.”
The ACP’s updated guidance is provocative and should be considered in the context of other groups’ recommendations, not as superseding them just because it is the most recently published document, according to Jeffrey A. Meyerhardt, MD, MPH, codirector of the Colon and Rectal Cancer Center at Dana-Farber Cancer Institute, Boston.
“As with a lot of the things we do in medicine, it is balancing risk and potential benefit,” Dr. Meyerhardt said in an interview. “If a patient is informed that at a younger age doing screening is very likely not to find anything and there are some risks to screening, that patient could then weigh the risks and benefit with their provider.”
Three screening approaches
The new guidance statement is based on a critical review of existing clinical guidelines, evidence reviews, and modeling studies. The guidance does not apply to patients who have long-standing inflammatory bowel disease and those with a family history of CRC.
The guideline also addresses when clinicians should stop screening – at age 75 – and what types of tests patients should choose from.
After discussing the benefits, harms, cost, availability, and patient preferences, clinicians and patients should select one of three screening approaches, according to the ACP: a fecal immunochemical or high-sensitivity guaiac fecal occult blood test every 2 years; colonoscopy every 10 years; or flexible sigmoidoscopy every 10 years plus a fecal immunochemical test every 2 years.
They should avoid CRC screening tests that use stool DNA, CT colonography, capsule endoscopy, urine, or serum, according to the guidance.
A balancing act
Some physicians view starting screenings at age 45 as a settled argument.
“The entire nation is now focused on increasing screening capacity and getting everyone screened,” said Richard C. Wender, MD, professor and chair of family medicine and community health at the University of Pennsylvania, Philadelphia, who was not involved in the new guidelines. “There is not a controversy about age to start, and I anticipate that this paper won’t create a new one.”
The epidemiology of CRC is changing rapidly, Dr. Wender said.
“While CRC mortality is going down in older age groups, mortality is now rising in younger people,” he said. “While cancer incidence is lower in the 45- to 49-years-old group, the precursors to cancer are present and can be found in a substantial percentage of patients – the same percentage as 50- to 55-year-olds.”
Dr. Meyerhardt said in an interview that the recommendation to start screening at age 45 was reasonable but that more people need to be screened to detect CRC than the older population.
“Ultimately, one’s going to have to consider the various recommendations from these different societies when having a patient in front of you as a primary care or other physician to discuss screening in someone who’s what we call average risk,” he said.
Younger patients who notice any possible symptoms of CRC such as blood in stool or changes in bowel habits should discuss them with a physician, he said.
The ACP also differs from other groups in not recommending stool DNA tests such as Cologuard (Exact Sciences). Dr. Wender said this test is the least cost effective based on comparing adherence for other options. “If Cologuard can lead to higher adherence and there are data suggesting it can, then relative cost-effectiveness looks better.”
Why 50
In weighing the risks and benefits of screening, the ACP noted that CRC screening can entail risk for serious bleeding and perforation in the case of colonoscopy.
Overdiagnosis and associated overtreatment, as well as costly follow-ups for findings that are clinically unimportant, are additional factors to consider with various cancer screening tests, said Amir Qaseem, MD, PhD, MHA, the ACP’s chief science officer and the corresponding author of the updated guidance.
Despite some differences between various groups’ recommendations, Dr. Qaseem saw important similarities.
“We need to get everyone between 50 and 75 screened,” Dr. Qaseem said. On that point, “there is no disagreement.”
One guideline author reported receiving salary from the ACP. Dr. Qaseem reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
Not so fast with earlier screening for colorectal cancer (CRC), at least according to one professional group.
The American College of Physicians published updated clinical guidance maintaining 50 as the age when clinicians should start screening for CRC in patients who are asymptomatic and at average risk.
The recommendation conflicts with guidelines from the American Cancer Society and the U.S. Preventive Services Task Force, which lowered the recommended age to start screening to age 45.
Although the rate of CRC has increased among adults aged 45-49, the incidence is 35.1 cases per 100,000 people, much lower than among persons aged 50-64 (71.9 per 100,000) and those aged 65-74 (128.9 per 100,000), the guidance notes.
“The net benefit of screening is much less favorable in average-risk adults between ages 45 and 49 years than in those aged 50-75 years,” the authors wrote. “Clinicians should discuss the uncertainty around benefits and harms of screening in this population.”
The ACP’s updated guidance is provocative and should be considered in the context of other groups’ recommendations, not as superseding them just because it is the most recently published document, according to Jeffrey A. Meyerhardt, MD, MPH, codirector of the Colon and Rectal Cancer Center at Dana-Farber Cancer Institute, Boston.
“As with a lot of the things we do in medicine, it is balancing risk and potential benefit,” Dr. Meyerhardt said in an interview. “If a patient is informed that at a younger age doing screening is very likely not to find anything and there are some risks to screening, that patient could then weigh the risks and benefit with their provider.”
Three screening approaches
The new guidance statement is based on a critical review of existing clinical guidelines, evidence reviews, and modeling studies. The guidance does not apply to patients who have long-standing inflammatory bowel disease and those with a family history of CRC.
The guideline also addresses when clinicians should stop screening – at age 75 – and what types of tests patients should choose from.
After discussing the benefits, harms, cost, availability, and patient preferences, clinicians and patients should select one of three screening approaches, according to the ACP: a fecal immunochemical or high-sensitivity guaiac fecal occult blood test every 2 years; colonoscopy every 10 years; or flexible sigmoidoscopy every 10 years plus a fecal immunochemical test every 2 years.
They should avoid CRC screening tests that use stool DNA, CT colonography, capsule endoscopy, urine, or serum, according to the guidance.
A balancing act
Some physicians view starting screenings at age 45 as a settled argument.
“The entire nation is now focused on increasing screening capacity and getting everyone screened,” said Richard C. Wender, MD, professor and chair of family medicine and community health at the University of Pennsylvania, Philadelphia, who was not involved in the new guidelines. “There is not a controversy about age to start, and I anticipate that this paper won’t create a new one.”
The epidemiology of CRC is changing rapidly, Dr. Wender said.
“While CRC mortality is going down in older age groups, mortality is now rising in younger people,” he said. “While cancer incidence is lower in the 45- to 49-years-old group, the precursors to cancer are present and can be found in a substantial percentage of patients – the same percentage as 50- to 55-year-olds.”
Dr. Meyerhardt said in an interview that the recommendation to start screening at age 45 was reasonable but that more people need to be screened to detect CRC than the older population.
“Ultimately, one’s going to have to consider the various recommendations from these different societies when having a patient in front of you as a primary care or other physician to discuss screening in someone who’s what we call average risk,” he said.
Younger patients who notice any possible symptoms of CRC such as blood in stool or changes in bowel habits should discuss them with a physician, he said.
The ACP also differs from other groups in not recommending stool DNA tests such as Cologuard (Exact Sciences). Dr. Wender said this test is the least cost effective based on comparing adherence for other options. “If Cologuard can lead to higher adherence and there are data suggesting it can, then relative cost-effectiveness looks better.”
Why 50
In weighing the risks and benefits of screening, the ACP noted that CRC screening can entail risk for serious bleeding and perforation in the case of colonoscopy.
Overdiagnosis and associated overtreatment, as well as costly follow-ups for findings that are clinically unimportant, are additional factors to consider with various cancer screening tests, said Amir Qaseem, MD, PhD, MHA, the ACP’s chief science officer and the corresponding author of the updated guidance.
Despite some differences between various groups’ recommendations, Dr. Qaseem saw important similarities.
“We need to get everyone between 50 and 75 screened,” Dr. Qaseem said. On that point, “there is no disagreement.”
One guideline author reported receiving salary from the ACP. Dr. Qaseem reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
Not so fast with earlier screening for colorectal cancer (CRC), at least according to one professional group.
The American College of Physicians published updated clinical guidance maintaining 50 as the age when clinicians should start screening for CRC in patients who are asymptomatic and at average risk.
The recommendation conflicts with guidelines from the American Cancer Society and the U.S. Preventive Services Task Force, which lowered the recommended age to start screening to age 45.
Although the rate of CRC has increased among adults aged 45-49, the incidence is 35.1 cases per 100,000 people, much lower than among persons aged 50-64 (71.9 per 100,000) and those aged 65-74 (128.9 per 100,000), the guidance notes.
“The net benefit of screening is much less favorable in average-risk adults between ages 45 and 49 years than in those aged 50-75 years,” the authors wrote. “Clinicians should discuss the uncertainty around benefits and harms of screening in this population.”
The ACP’s updated guidance is provocative and should be considered in the context of other groups’ recommendations, not as superseding them just because it is the most recently published document, according to Jeffrey A. Meyerhardt, MD, MPH, codirector of the Colon and Rectal Cancer Center at Dana-Farber Cancer Institute, Boston.
“As with a lot of the things we do in medicine, it is balancing risk and potential benefit,” Dr. Meyerhardt said in an interview. “If a patient is informed that at a younger age doing screening is very likely not to find anything and there are some risks to screening, that patient could then weigh the risks and benefit with their provider.”
Three screening approaches
The new guidance statement is based on a critical review of existing clinical guidelines, evidence reviews, and modeling studies. The guidance does not apply to patients who have long-standing inflammatory bowel disease and those with a family history of CRC.
The guideline also addresses when clinicians should stop screening – at age 75 – and what types of tests patients should choose from.
After discussing the benefits, harms, cost, availability, and patient preferences, clinicians and patients should select one of three screening approaches, according to the ACP: a fecal immunochemical or high-sensitivity guaiac fecal occult blood test every 2 years; colonoscopy every 10 years; or flexible sigmoidoscopy every 10 years plus a fecal immunochemical test every 2 years.
They should avoid CRC screening tests that use stool DNA, CT colonography, capsule endoscopy, urine, or serum, according to the guidance.
A balancing act
Some physicians view starting screenings at age 45 as a settled argument.
“The entire nation is now focused on increasing screening capacity and getting everyone screened,” said Richard C. Wender, MD, professor and chair of family medicine and community health at the University of Pennsylvania, Philadelphia, who was not involved in the new guidelines. “There is not a controversy about age to start, and I anticipate that this paper won’t create a new one.”
The epidemiology of CRC is changing rapidly, Dr. Wender said.
“While CRC mortality is going down in older age groups, mortality is now rising in younger people,” he said. “While cancer incidence is lower in the 45- to 49-years-old group, the precursors to cancer are present and can be found in a substantial percentage of patients – the same percentage as 50- to 55-year-olds.”
Dr. Meyerhardt said in an interview that the recommendation to start screening at age 45 was reasonable but that more people need to be screened to detect CRC than the older population.
“Ultimately, one’s going to have to consider the various recommendations from these different societies when having a patient in front of you as a primary care or other physician to discuss screening in someone who’s what we call average risk,” he said.
Younger patients who notice any possible symptoms of CRC such as blood in stool or changes in bowel habits should discuss them with a physician, he said.
The ACP also differs from other groups in not recommending stool DNA tests such as Cologuard (Exact Sciences). Dr. Wender said this test is the least cost effective based on comparing adherence for other options. “If Cologuard can lead to higher adherence and there are data suggesting it can, then relative cost-effectiveness looks better.”
Why 50
In weighing the risks and benefits of screening, the ACP noted that CRC screening can entail risk for serious bleeding and perforation in the case of colonoscopy.
Overdiagnosis and associated overtreatment, as well as costly follow-ups for findings that are clinically unimportant, are additional factors to consider with various cancer screening tests, said Amir Qaseem, MD, PhD, MHA, the ACP’s chief science officer and the corresponding author of the updated guidance.
Despite some differences between various groups’ recommendations, Dr. Qaseem saw important similarities.
“We need to get everyone between 50 and 75 screened,” Dr. Qaseem said. On that point, “there is no disagreement.”
One guideline author reported receiving salary from the ACP. Dr. Qaseem reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM ANNALS OF INTERNAL MEDICINE
How a heat wave affects glycemic control
TOPLINE:
, according to research published online May 17 in Science of The Total Environment.
METHODOLOGY:
Researchers in Spain analyzed data from 2,701 adults with type 1 diabetes who had been using intermittently scanned continuous glucose monitoring (CGM) devices during a 2022 heat wave (July 9-26) and 14 days after. Extreme heat claimed nearly 62,000 lives across Europe in the summer of 2022.
TAKEAWAY:
Time in range (between 70 mg/dL and 180 mg/dL of interstitial glucose) decreased by 4%, from 60.8% during the heat wave to 54.8% after (P < .001).
Patients who scanned their CGM results the most during the heat wave (more than 13 scans per day) scanned less often after the weather broke (1.8 fewer scans per day) and experienced the biggest drop in time in range (−5.4%).
More patients met all time-in-range recommendations during the heat wave (10.6% vs. 8.4%, P < .001).
IN PRACTICE:
“We hypothesized that people with diabetes, who are highly vulnerable, have more time for self-management as they spend more time indoors,” study author Jesús Moreno Fernández, MD, PhD, said in an interview. “During the COVID-19 pandemic, something similar was observed among people with diabetes.”
SOURCE:
Moreno Fernández, with the department of endocrinology and nutrition at Ciudad Real General University Hospital in Spain, is the study’s lead author.
LIMITATIONS:
The CGM data were anonymized, so researchers could not examine how individual patient factors like sex, education, or treatment type may have influenced outcomes. Temperatures remained higher than usual even after the heat wave. Worsening glycemic control could be interpreted as a lag effect of prolonged heat exposure, the researchers note.
DISCLOSURES:
The authors reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
, according to research published online May 17 in Science of The Total Environment.
METHODOLOGY:
Researchers in Spain analyzed data from 2,701 adults with type 1 diabetes who had been using intermittently scanned continuous glucose monitoring (CGM) devices during a 2022 heat wave (July 9-26) and 14 days after. Extreme heat claimed nearly 62,000 lives across Europe in the summer of 2022.
TAKEAWAY:
Time in range (between 70 mg/dL and 180 mg/dL of interstitial glucose) decreased by 4%, from 60.8% during the heat wave to 54.8% after (P < .001).
Patients who scanned their CGM results the most during the heat wave (more than 13 scans per day) scanned less often after the weather broke (1.8 fewer scans per day) and experienced the biggest drop in time in range (−5.4%).
More patients met all time-in-range recommendations during the heat wave (10.6% vs. 8.4%, P < .001).
IN PRACTICE:
“We hypothesized that people with diabetes, who are highly vulnerable, have more time for self-management as they spend more time indoors,” study author Jesús Moreno Fernández, MD, PhD, said in an interview. “During the COVID-19 pandemic, something similar was observed among people with diabetes.”
SOURCE:
Moreno Fernández, with the department of endocrinology and nutrition at Ciudad Real General University Hospital in Spain, is the study’s lead author.
LIMITATIONS:
The CGM data were anonymized, so researchers could not examine how individual patient factors like sex, education, or treatment type may have influenced outcomes. Temperatures remained higher than usual even after the heat wave. Worsening glycemic control could be interpreted as a lag effect of prolonged heat exposure, the researchers note.
DISCLOSURES:
The authors reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
, according to research published online May 17 in Science of The Total Environment.
METHODOLOGY:
Researchers in Spain analyzed data from 2,701 adults with type 1 diabetes who had been using intermittently scanned continuous glucose monitoring (CGM) devices during a 2022 heat wave (July 9-26) and 14 days after. Extreme heat claimed nearly 62,000 lives across Europe in the summer of 2022.
TAKEAWAY:
Time in range (between 70 mg/dL and 180 mg/dL of interstitial glucose) decreased by 4%, from 60.8% during the heat wave to 54.8% after (P < .001).
Patients who scanned their CGM results the most during the heat wave (more than 13 scans per day) scanned less often after the weather broke (1.8 fewer scans per day) and experienced the biggest drop in time in range (−5.4%).
More patients met all time-in-range recommendations during the heat wave (10.6% vs. 8.4%, P < .001).
IN PRACTICE:
“We hypothesized that people with diabetes, who are highly vulnerable, have more time for self-management as they spend more time indoors,” study author Jesús Moreno Fernández, MD, PhD, said in an interview. “During the COVID-19 pandemic, something similar was observed among people with diabetes.”
SOURCE:
Moreno Fernández, with the department of endocrinology and nutrition at Ciudad Real General University Hospital in Spain, is the study’s lead author.
LIMITATIONS:
The CGM data were anonymized, so researchers could not examine how individual patient factors like sex, education, or treatment type may have influenced outcomes. Temperatures remained higher than usual even after the heat wave. Worsening glycemic control could be interpreted as a lag effect of prolonged heat exposure, the researchers note.
DISCLOSURES:
The authors reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM SCIENCE OF THE TOTAL ENVIRONMENT
Foot ulcers red flag for eye disease in diabetes
Sores on the feet can signal problems with the eyes in patients with diabetes.
Prior research and anecdotal experience show that diabetic foot ulcers and diabetic retinopathy frequently co-occur.
David J. Ramsey, MD, PhD, MPH, director of ophthalmic research at Lahey Hospital & Medical Center, Burlington, Mass., said when clinicians detect either condition, they should involve a team that can intervene to help protect a patient’s vision and mobility.
For example, they should ensure patients receive comprehensive eye and foot evaluations and help them optimize diabetes management.
The new study, presented at the annual meeting of the Association for Research in Vision and Ophthalmology, “adds an important dimension” to understanding the association between the conditions, said Dr. Ramsey, who recently reviewed correlations between diabetic foot ulcers and diabetic retinopathy and their underlying causes.
“Patients with diabetic foot ulcers appear to receive less attention to their diabetic retinopathy and may receive fewer treatments with eye injections targeting vascular endothelial growth factor (VEGF), an important driver of progression of diabetic retinopathy,” said Dr. Ramsey, who is also an associate professor of ophthalmology at Tufts University School of Medicine, Boston. He was not involved in the study presented at ARVO 2023.
In the new study, Christopher T. Zhu, a medical student at UT Health San Antonio, and colleagues analyzed data from 426 eyes of 213 patients with type 2 diabetes who had had at least two eye exams between 2012 and 2022; 72 of the patients had diabetic foot ulcers. Patients were followed for about 4 years on average.
Patients with diabetic foot ulcers had a higher percentage of eyes with macular edema on their initial exam (32.6% vs. 28%). By the final exam, the percentage of eyes with macular edema was significantly greater in the group with diabetic foot ulcers (64.6% vs. 37.6%; P < .0001), Mr. Zhu’s group reported.
Eyes with nonproliferative diabetic retinopathy progressed to proliferative diabetic retinopathy, the worst grade, at a higher rate in the group with foot ulcers (50.6% vs. 35.6%; P = .03). In addition, patients with foot ulcers were more likely to experience vitreous hemorrhage (55.6% vs. 38.7%), the researchers found.
Despite patients with foot ulcers tending to have worse disease, they received fewer treatments for retinopathy. Those without ulcers received an average of 6.9 anti-VEGF injections per eye, while those with ulcers averaged 4.3.
Foot ulcers may hinder the ability of patients to get to appointments to receive the injections, Mr. Zhu and colleagues wrote. “For many patients in our part of the country [South Texas], a lack of transportation is a particular barrier to health care access,” Mr. Zhu told this news organization.
Mr. Zhu’s team conducted their study after noticing that patients with diabetes and foot ulcers who presented to their eye clinics “appeared to progress faster to worse grades of retinopathy” than patients with diabetes who did not have ulcers.
“Similar to how foot ulcers develop due to a severe disruption in blood flow [vascular] and a loss of sensation [neurologic], diabetic retinopathy may have a relation to microvascular disease, neurologic degeneration, and inflammation,” he said.
The findings confirm “that poor perfusion of the eye and foot are linked and can cause ischemic retinopathy leading to the development of proliferative diabetic retinopathy and vitreous hemorrhages, both serious, vision-threatening conditions,” Dr. Ramsey said.
To some extent, fewer treatments with anti-VEGF agents may account for why patients with foot ulcers have more eye complications, Dr. Ramsey added. “Additional research needs to be done to further dissect the cause and the effect, but it’s a very important finding that we need to increase awareness about,” he said.
Dr. Ramsey and Mr. Zhu reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Sores on the feet can signal problems with the eyes in patients with diabetes.
Prior research and anecdotal experience show that diabetic foot ulcers and diabetic retinopathy frequently co-occur.
David J. Ramsey, MD, PhD, MPH, director of ophthalmic research at Lahey Hospital & Medical Center, Burlington, Mass., said when clinicians detect either condition, they should involve a team that can intervene to help protect a patient’s vision and mobility.
For example, they should ensure patients receive comprehensive eye and foot evaluations and help them optimize diabetes management.
The new study, presented at the annual meeting of the Association for Research in Vision and Ophthalmology, “adds an important dimension” to understanding the association between the conditions, said Dr. Ramsey, who recently reviewed correlations between diabetic foot ulcers and diabetic retinopathy and their underlying causes.
“Patients with diabetic foot ulcers appear to receive less attention to their diabetic retinopathy and may receive fewer treatments with eye injections targeting vascular endothelial growth factor (VEGF), an important driver of progression of diabetic retinopathy,” said Dr. Ramsey, who is also an associate professor of ophthalmology at Tufts University School of Medicine, Boston. He was not involved in the study presented at ARVO 2023.
In the new study, Christopher T. Zhu, a medical student at UT Health San Antonio, and colleagues analyzed data from 426 eyes of 213 patients with type 2 diabetes who had had at least two eye exams between 2012 and 2022; 72 of the patients had diabetic foot ulcers. Patients were followed for about 4 years on average.
Patients with diabetic foot ulcers had a higher percentage of eyes with macular edema on their initial exam (32.6% vs. 28%). By the final exam, the percentage of eyes with macular edema was significantly greater in the group with diabetic foot ulcers (64.6% vs. 37.6%; P < .0001), Mr. Zhu’s group reported.
Eyes with nonproliferative diabetic retinopathy progressed to proliferative diabetic retinopathy, the worst grade, at a higher rate in the group with foot ulcers (50.6% vs. 35.6%; P = .03). In addition, patients with foot ulcers were more likely to experience vitreous hemorrhage (55.6% vs. 38.7%), the researchers found.
Despite patients with foot ulcers tending to have worse disease, they received fewer treatments for retinopathy. Those without ulcers received an average of 6.9 anti-VEGF injections per eye, while those with ulcers averaged 4.3.
Foot ulcers may hinder the ability of patients to get to appointments to receive the injections, Mr. Zhu and colleagues wrote. “For many patients in our part of the country [South Texas], a lack of transportation is a particular barrier to health care access,” Mr. Zhu told this news organization.
Mr. Zhu’s team conducted their study after noticing that patients with diabetes and foot ulcers who presented to their eye clinics “appeared to progress faster to worse grades of retinopathy” than patients with diabetes who did not have ulcers.
“Similar to how foot ulcers develop due to a severe disruption in blood flow [vascular] and a loss of sensation [neurologic], diabetic retinopathy may have a relation to microvascular disease, neurologic degeneration, and inflammation,” he said.
The findings confirm “that poor perfusion of the eye and foot are linked and can cause ischemic retinopathy leading to the development of proliferative diabetic retinopathy and vitreous hemorrhages, both serious, vision-threatening conditions,” Dr. Ramsey said.
To some extent, fewer treatments with anti-VEGF agents may account for why patients with foot ulcers have more eye complications, Dr. Ramsey added. “Additional research needs to be done to further dissect the cause and the effect, but it’s a very important finding that we need to increase awareness about,” he said.
Dr. Ramsey and Mr. Zhu reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Sores on the feet can signal problems with the eyes in patients with diabetes.
Prior research and anecdotal experience show that diabetic foot ulcers and diabetic retinopathy frequently co-occur.
David J. Ramsey, MD, PhD, MPH, director of ophthalmic research at Lahey Hospital & Medical Center, Burlington, Mass., said when clinicians detect either condition, they should involve a team that can intervene to help protect a patient’s vision and mobility.
For example, they should ensure patients receive comprehensive eye and foot evaluations and help them optimize diabetes management.
The new study, presented at the annual meeting of the Association for Research in Vision and Ophthalmology, “adds an important dimension” to understanding the association between the conditions, said Dr. Ramsey, who recently reviewed correlations between diabetic foot ulcers and diabetic retinopathy and their underlying causes.
“Patients with diabetic foot ulcers appear to receive less attention to their diabetic retinopathy and may receive fewer treatments with eye injections targeting vascular endothelial growth factor (VEGF), an important driver of progression of diabetic retinopathy,” said Dr. Ramsey, who is also an associate professor of ophthalmology at Tufts University School of Medicine, Boston. He was not involved in the study presented at ARVO 2023.
In the new study, Christopher T. Zhu, a medical student at UT Health San Antonio, and colleagues analyzed data from 426 eyes of 213 patients with type 2 diabetes who had had at least two eye exams between 2012 and 2022; 72 of the patients had diabetic foot ulcers. Patients were followed for about 4 years on average.
Patients with diabetic foot ulcers had a higher percentage of eyes with macular edema on their initial exam (32.6% vs. 28%). By the final exam, the percentage of eyes with macular edema was significantly greater in the group with diabetic foot ulcers (64.6% vs. 37.6%; P < .0001), Mr. Zhu’s group reported.
Eyes with nonproliferative diabetic retinopathy progressed to proliferative diabetic retinopathy, the worst grade, at a higher rate in the group with foot ulcers (50.6% vs. 35.6%; P = .03). In addition, patients with foot ulcers were more likely to experience vitreous hemorrhage (55.6% vs. 38.7%), the researchers found.
Despite patients with foot ulcers tending to have worse disease, they received fewer treatments for retinopathy. Those without ulcers received an average of 6.9 anti-VEGF injections per eye, while those with ulcers averaged 4.3.
Foot ulcers may hinder the ability of patients to get to appointments to receive the injections, Mr. Zhu and colleagues wrote. “For many patients in our part of the country [South Texas], a lack of transportation is a particular barrier to health care access,” Mr. Zhu told this news organization.
Mr. Zhu’s team conducted their study after noticing that patients with diabetes and foot ulcers who presented to their eye clinics “appeared to progress faster to worse grades of retinopathy” than patients with diabetes who did not have ulcers.
“Similar to how foot ulcers develop due to a severe disruption in blood flow [vascular] and a loss of sensation [neurologic], diabetic retinopathy may have a relation to microvascular disease, neurologic degeneration, and inflammation,” he said.
The findings confirm “that poor perfusion of the eye and foot are linked and can cause ischemic retinopathy leading to the development of proliferative diabetic retinopathy and vitreous hemorrhages, both serious, vision-threatening conditions,” Dr. Ramsey said.
To some extent, fewer treatments with anti-VEGF agents may account for why patients with foot ulcers have more eye complications, Dr. Ramsey added. “Additional research needs to be done to further dissect the cause and the effect, but it’s a very important finding that we need to increase awareness about,” he said.
Dr. Ramsey and Mr. Zhu reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ARVO 2023
FDA withdraws approval of Makena
The Food and Drug Administration has decided to withdraw approval of Makena and generic versions of the drug, the agency announced April 6.
The medication was approved in 2011 to reduce the risk for preterm birth in women who had previously experienced spontaneous preterm birth. The treatment had been approved under an accelerated pathway that required another trial to confirm clinical benefit.
A postmarketing study did not show clinical benefit, however, and the agency proposed withdrawing the drug, hydroxyprogesterone caproate injection, in 2020. The drug’s sponsor requested a hearing on the decision, and that meeting was held in October 2022.
The FDA commissioner and chief scientist subsequently reviewed submitted reports, comments, and transcripts, and made the decision to withdraw the drug.
“Effective today, Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce,” the agency said.
“It is tragic that the scientific research and medical communities have not yet found a treatment shown to be effective in preventing preterm birth and improving neonatal outcomes – particularly in light of the fact that this serious condition has a disparate impact on communities of color, especially Black women,” FDA Commissioner Robert M. Califf, MD, said in a statement.
Risks associated with the drug include thromboembolic disorders, allergic reactions, decreased glucose tolerance, and fluid retention, regulators have noted. The agency acknowledged that some supplies of the product have already been distributed. Patients with questions should talk to their health care provider, the FDA advised.
The Food and Drug Administration has decided to withdraw approval of Makena and generic versions of the drug, the agency announced April 6.
The medication was approved in 2011 to reduce the risk for preterm birth in women who had previously experienced spontaneous preterm birth. The treatment had been approved under an accelerated pathway that required another trial to confirm clinical benefit.
A postmarketing study did not show clinical benefit, however, and the agency proposed withdrawing the drug, hydroxyprogesterone caproate injection, in 2020. The drug’s sponsor requested a hearing on the decision, and that meeting was held in October 2022.
The FDA commissioner and chief scientist subsequently reviewed submitted reports, comments, and transcripts, and made the decision to withdraw the drug.
“Effective today, Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce,” the agency said.
“It is tragic that the scientific research and medical communities have not yet found a treatment shown to be effective in preventing preterm birth and improving neonatal outcomes – particularly in light of the fact that this serious condition has a disparate impact on communities of color, especially Black women,” FDA Commissioner Robert M. Califf, MD, said in a statement.
Risks associated with the drug include thromboembolic disorders, allergic reactions, decreased glucose tolerance, and fluid retention, regulators have noted. The agency acknowledged that some supplies of the product have already been distributed. Patients with questions should talk to their health care provider, the FDA advised.
The Food and Drug Administration has decided to withdraw approval of Makena and generic versions of the drug, the agency announced April 6.
The medication was approved in 2011 to reduce the risk for preterm birth in women who had previously experienced spontaneous preterm birth. The treatment had been approved under an accelerated pathway that required another trial to confirm clinical benefit.
A postmarketing study did not show clinical benefit, however, and the agency proposed withdrawing the drug, hydroxyprogesterone caproate injection, in 2020. The drug’s sponsor requested a hearing on the decision, and that meeting was held in October 2022.
The FDA commissioner and chief scientist subsequently reviewed submitted reports, comments, and transcripts, and made the decision to withdraw the drug.
“Effective today, Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce,” the agency said.
“It is tragic that the scientific research and medical communities have not yet found a treatment shown to be effective in preventing preterm birth and improving neonatal outcomes – particularly in light of the fact that this serious condition has a disparate impact on communities of color, especially Black women,” FDA Commissioner Robert M. Califf, MD, said in a statement.
Risks associated with the drug include thromboembolic disorders, allergic reactions, decreased glucose tolerance, and fluid retention, regulators have noted. The agency acknowledged that some supplies of the product have already been distributed. Patients with questions should talk to their health care provider, the FDA advised.
Forceps may help moms with obesity avoid cesareans
Among patients who undergo forceps-assisted vaginal delivery, obesity does not appear to be associated with increased risk for complications such as injuries to the anal sphincter or the need for their babies to be admitted to the neonatal intensive care unit, researchers have found.
But obesity does appear to increase the chances that when physicians attempt operative vaginal delivery with either forceps or a vacuum, patients will wind up undergoing cesarean delivery, another study found.
Taken together, the new data may help inform physicians’ decisions about when to consider operative vaginal delivery as an alternative to emergency cesarean births.
A prospective study showed that failed operative vaginal delivery – that is, a cesarean delivery after an attempted operative vaginal delivery – occurred for 10.1% of patients with obesity and 4.2% of those without obesity.
Researchers presented the findings at the meeting sponsored by the Society for Maternal-Fetal Medicine.
“We want to really try to reduce the rate of C-sections and primary cesarean deliveries. One of the ways to do that is to attempt operative vaginal delivery,” said Marissa Platner, MD, assistant professor of maternal-fetal medicine at Emory University School of Medicine, Atlanta, who was not involved in the new research.
Data on how obesity influences risks with operative vaginal delivery have been limited and mixed, the researchers said.
To examine how often attempted operative vaginal delivery fails in patients with obesity, Jennifer Grasch, MD, a maternal-fetal medicine fellow at the Ohio State University Wexner Medical Center, Columbus, and her colleagues conducted a secondary analysis of data from the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be, which included more than 10,000 participants.
“We know that cesarean sections among people with obesity are associated with increased complications, such as higher rates of infection and wound complications, than for people with lower BMI,” Dr. Grasch said. “Operative vaginal delivery can be an alternative to cesarean delivery in some situations, so we were interested in whether attempted operative vaginal delivery was also associated with higher rates of complications in individuals with obesity than those without obesity.”
The researchers focused on 791 patients with an attempted operative vaginal delivery. About 40% had a BMI of 30 or greater. Clinicians used a vacuum in approximately 60% of the attempts.
After an attempted vacuum-assisted delivery, neonatal morbidity was more common for infants whose mothers had obesity than for those whose mothers did not (32.7% vs. 22.3%; adjusted odds ratio, 1.61 [1.07-2.43]). Neonatal morbidity did not differ by obesity status following forceps-attempted delivery. Other adverse outcomes, including measures of maternal morbidity, did not significantly differ by obesity status, according to the researchers.
Choice may come down to experience
Several factors influence whether a clinician chooses forceps- or vacuum-assisted delivery or cesarean delivery, “but one of the most important is experience,” Dr. Grasch said. “Complication rates with both forms of operative vaginal delivery are low, yet there has been a trend toward lower rates of both in the last few decades.”
Elizabeth Cochrane, MD, a maternal-fetal medicine fellow at Mount Sinai Hospital, New York, and her colleagues investigated the relationship between obesity and adverse outcomes among patients with forceps-assisted vaginal deliveries.
The researchers analyzed data from 897 patients who underwent a forceps-assisted vaginal delivery between 2017 and 2021; 29% had a BMI of 30 or greater.
Injuries to the anal sphincter – which can lead to fecal incontinence – occurred in 18.7% of patients without obesity and in 17.7% of those with obesity. Admission to the neonatal intensive care unit occurred in 11.5% of patients without obesity and in 12.3% of patients with obesity. The differences were not statistically significant.
The bottom line: For forceps-assisted vaginal delivery, “obesity does not appear to be associated with increased rates” of adverse outcomes for mothers or newborns, the researchers concluded.
Reassuring data
The study by Dr. Cochrane’s group “provides helpful information for providers to be reassured when they are performing forceps deliveries” for patients with obesity, Dr. Platner said.
Rates of obesity have risen in the United States, and physicians often wonder whether a patient with obesity could be a candidate for forceps-assisted delivery, Dr. Cochrane said. In 2019, 29% of women had obesity before becoming pregnant.
“It all really comes down to how comfortable the provider is in that skill set and also the overall clinical scenario,” she said. “Sometimes an operative delivery with forceps or a vacuum can be the fastest way to deliver a baby when there is acute concern for maternal decompensation or fetal decompensation.”
The alternative is an emergency cesarean delivery. Given that those operations can be riskier and more difficult for patients with higher BMIs, a forceps-assisted delivery may be “an interesting alternative to emergency caesarean sections, as long as it is in an appropriate clinical setting with providers who feel very confident and comfortable using those devices,” Dr. Cochrane said.
A version of this article first appeared on Medscape.com.
Among patients who undergo forceps-assisted vaginal delivery, obesity does not appear to be associated with increased risk for complications such as injuries to the anal sphincter or the need for their babies to be admitted to the neonatal intensive care unit, researchers have found.
But obesity does appear to increase the chances that when physicians attempt operative vaginal delivery with either forceps or a vacuum, patients will wind up undergoing cesarean delivery, another study found.
Taken together, the new data may help inform physicians’ decisions about when to consider operative vaginal delivery as an alternative to emergency cesarean births.
A prospective study showed that failed operative vaginal delivery – that is, a cesarean delivery after an attempted operative vaginal delivery – occurred for 10.1% of patients with obesity and 4.2% of those without obesity.
Researchers presented the findings at the meeting sponsored by the Society for Maternal-Fetal Medicine.
“We want to really try to reduce the rate of C-sections and primary cesarean deliveries. One of the ways to do that is to attempt operative vaginal delivery,” said Marissa Platner, MD, assistant professor of maternal-fetal medicine at Emory University School of Medicine, Atlanta, who was not involved in the new research.
Data on how obesity influences risks with operative vaginal delivery have been limited and mixed, the researchers said.
To examine how often attempted operative vaginal delivery fails in patients with obesity, Jennifer Grasch, MD, a maternal-fetal medicine fellow at the Ohio State University Wexner Medical Center, Columbus, and her colleagues conducted a secondary analysis of data from the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be, which included more than 10,000 participants.
“We know that cesarean sections among people with obesity are associated with increased complications, such as higher rates of infection and wound complications, than for people with lower BMI,” Dr. Grasch said. “Operative vaginal delivery can be an alternative to cesarean delivery in some situations, so we were interested in whether attempted operative vaginal delivery was also associated with higher rates of complications in individuals with obesity than those without obesity.”
The researchers focused on 791 patients with an attempted operative vaginal delivery. About 40% had a BMI of 30 or greater. Clinicians used a vacuum in approximately 60% of the attempts.
After an attempted vacuum-assisted delivery, neonatal morbidity was more common for infants whose mothers had obesity than for those whose mothers did not (32.7% vs. 22.3%; adjusted odds ratio, 1.61 [1.07-2.43]). Neonatal morbidity did not differ by obesity status following forceps-attempted delivery. Other adverse outcomes, including measures of maternal morbidity, did not significantly differ by obesity status, according to the researchers.
Choice may come down to experience
Several factors influence whether a clinician chooses forceps- or vacuum-assisted delivery or cesarean delivery, “but one of the most important is experience,” Dr. Grasch said. “Complication rates with both forms of operative vaginal delivery are low, yet there has been a trend toward lower rates of both in the last few decades.”
Elizabeth Cochrane, MD, a maternal-fetal medicine fellow at Mount Sinai Hospital, New York, and her colleagues investigated the relationship between obesity and adverse outcomes among patients with forceps-assisted vaginal deliveries.
The researchers analyzed data from 897 patients who underwent a forceps-assisted vaginal delivery between 2017 and 2021; 29% had a BMI of 30 or greater.
Injuries to the anal sphincter – which can lead to fecal incontinence – occurred in 18.7% of patients without obesity and in 17.7% of those with obesity. Admission to the neonatal intensive care unit occurred in 11.5% of patients without obesity and in 12.3% of patients with obesity. The differences were not statistically significant.
The bottom line: For forceps-assisted vaginal delivery, “obesity does not appear to be associated with increased rates” of adverse outcomes for mothers or newborns, the researchers concluded.
Reassuring data
The study by Dr. Cochrane’s group “provides helpful information for providers to be reassured when they are performing forceps deliveries” for patients with obesity, Dr. Platner said.
Rates of obesity have risen in the United States, and physicians often wonder whether a patient with obesity could be a candidate for forceps-assisted delivery, Dr. Cochrane said. In 2019, 29% of women had obesity before becoming pregnant.
“It all really comes down to how comfortable the provider is in that skill set and also the overall clinical scenario,” she said. “Sometimes an operative delivery with forceps or a vacuum can be the fastest way to deliver a baby when there is acute concern for maternal decompensation or fetal decompensation.”
The alternative is an emergency cesarean delivery. Given that those operations can be riskier and more difficult for patients with higher BMIs, a forceps-assisted delivery may be “an interesting alternative to emergency caesarean sections, as long as it is in an appropriate clinical setting with providers who feel very confident and comfortable using those devices,” Dr. Cochrane said.
A version of this article first appeared on Medscape.com.
Among patients who undergo forceps-assisted vaginal delivery, obesity does not appear to be associated with increased risk for complications such as injuries to the anal sphincter or the need for their babies to be admitted to the neonatal intensive care unit, researchers have found.
But obesity does appear to increase the chances that when physicians attempt operative vaginal delivery with either forceps or a vacuum, patients will wind up undergoing cesarean delivery, another study found.
Taken together, the new data may help inform physicians’ decisions about when to consider operative vaginal delivery as an alternative to emergency cesarean births.
A prospective study showed that failed operative vaginal delivery – that is, a cesarean delivery after an attempted operative vaginal delivery – occurred for 10.1% of patients with obesity and 4.2% of those without obesity.
Researchers presented the findings at the meeting sponsored by the Society for Maternal-Fetal Medicine.
“We want to really try to reduce the rate of C-sections and primary cesarean deliveries. One of the ways to do that is to attempt operative vaginal delivery,” said Marissa Platner, MD, assistant professor of maternal-fetal medicine at Emory University School of Medicine, Atlanta, who was not involved in the new research.
Data on how obesity influences risks with operative vaginal delivery have been limited and mixed, the researchers said.
To examine how often attempted operative vaginal delivery fails in patients with obesity, Jennifer Grasch, MD, a maternal-fetal medicine fellow at the Ohio State University Wexner Medical Center, Columbus, and her colleagues conducted a secondary analysis of data from the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be, which included more than 10,000 participants.
“We know that cesarean sections among people with obesity are associated with increased complications, such as higher rates of infection and wound complications, than for people with lower BMI,” Dr. Grasch said. “Operative vaginal delivery can be an alternative to cesarean delivery in some situations, so we were interested in whether attempted operative vaginal delivery was also associated with higher rates of complications in individuals with obesity than those without obesity.”
The researchers focused on 791 patients with an attempted operative vaginal delivery. About 40% had a BMI of 30 or greater. Clinicians used a vacuum in approximately 60% of the attempts.
After an attempted vacuum-assisted delivery, neonatal morbidity was more common for infants whose mothers had obesity than for those whose mothers did not (32.7% vs. 22.3%; adjusted odds ratio, 1.61 [1.07-2.43]). Neonatal morbidity did not differ by obesity status following forceps-attempted delivery. Other adverse outcomes, including measures of maternal morbidity, did not significantly differ by obesity status, according to the researchers.
Choice may come down to experience
Several factors influence whether a clinician chooses forceps- or vacuum-assisted delivery or cesarean delivery, “but one of the most important is experience,” Dr. Grasch said. “Complication rates with both forms of operative vaginal delivery are low, yet there has been a trend toward lower rates of both in the last few decades.”
Elizabeth Cochrane, MD, a maternal-fetal medicine fellow at Mount Sinai Hospital, New York, and her colleagues investigated the relationship between obesity and adverse outcomes among patients with forceps-assisted vaginal deliveries.
The researchers analyzed data from 897 patients who underwent a forceps-assisted vaginal delivery between 2017 and 2021; 29% had a BMI of 30 or greater.
Injuries to the anal sphincter – which can lead to fecal incontinence – occurred in 18.7% of patients without obesity and in 17.7% of those with obesity. Admission to the neonatal intensive care unit occurred in 11.5% of patients without obesity and in 12.3% of patients with obesity. The differences were not statistically significant.
The bottom line: For forceps-assisted vaginal delivery, “obesity does not appear to be associated with increased rates” of adverse outcomes for mothers or newborns, the researchers concluded.
Reassuring data
The study by Dr. Cochrane’s group “provides helpful information for providers to be reassured when they are performing forceps deliveries” for patients with obesity, Dr. Platner said.
Rates of obesity have risen in the United States, and physicians often wonder whether a patient with obesity could be a candidate for forceps-assisted delivery, Dr. Cochrane said. In 2019, 29% of women had obesity before becoming pregnant.
“It all really comes down to how comfortable the provider is in that skill set and also the overall clinical scenario,” she said. “Sometimes an operative delivery with forceps or a vacuum can be the fastest way to deliver a baby when there is acute concern for maternal decompensation or fetal decompensation.”
The alternative is an emergency cesarean delivery. Given that those operations can be riskier and more difficult for patients with higher BMIs, a forceps-assisted delivery may be “an interesting alternative to emergency caesarean sections, as long as it is in an appropriate clinical setting with providers who feel very confident and comfortable using those devices,” Dr. Cochrane said.
A version of this article first appeared on Medscape.com.
FROM SMFM 2023