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Hip T scores can guide duration of osteoporosis therapy
according to Serge Ferrari, MD, and his colleagues.
Using 10 years of follow-up data from 1,343 women who took denosumab in the FREEDOM trial, Dr. Ferrari and his colleagues determined that a T score of at least –2.5 would be an appropriate target for this decision.
“A T-score unit increase of 1.0 was associated with a significant reduction in fracture risk for T scores up to, but no greater than, –2.0, suggesting that a T-score threshold of at least –2.0 would be an appropriate target for therapy to maximize treatment,” said Dr. Ferrari of the University of Geneva and his colleagues. “Further improvements in bone mineral density were not associated with major additional changes in 1-year nonvertebral fracture incidence.”
The findings “highlight the importance of the relationship between hip T score and fracture risk, which is maintained during long-term therapy with denosumab. Regular monitoring of bone mineral density during therapy may be useful to determine when fracture risk has reached a minimal threshold; treatment could therefore be suspended and/or consolidated, as in the case of a reversible therapy such as denosumab.”
SOURCE: Ferrari S et al. J Bone Miner Res. 2019 Mar 28. doi: 10.1002/jbmr.3722.
according to Serge Ferrari, MD, and his colleagues.
Using 10 years of follow-up data from 1,343 women who took denosumab in the FREEDOM trial, Dr. Ferrari and his colleagues determined that a T score of at least –2.5 would be an appropriate target for this decision.
“A T-score unit increase of 1.0 was associated with a significant reduction in fracture risk for T scores up to, but no greater than, –2.0, suggesting that a T-score threshold of at least –2.0 would be an appropriate target for therapy to maximize treatment,” said Dr. Ferrari of the University of Geneva and his colleagues. “Further improvements in bone mineral density were not associated with major additional changes in 1-year nonvertebral fracture incidence.”
The findings “highlight the importance of the relationship between hip T score and fracture risk, which is maintained during long-term therapy with denosumab. Regular monitoring of bone mineral density during therapy may be useful to determine when fracture risk has reached a minimal threshold; treatment could therefore be suspended and/or consolidated, as in the case of a reversible therapy such as denosumab.”
SOURCE: Ferrari S et al. J Bone Miner Res. 2019 Mar 28. doi: 10.1002/jbmr.3722.
according to Serge Ferrari, MD, and his colleagues.
Using 10 years of follow-up data from 1,343 women who took denosumab in the FREEDOM trial, Dr. Ferrari and his colleagues determined that a T score of at least –2.5 would be an appropriate target for this decision.
“A T-score unit increase of 1.0 was associated with a significant reduction in fracture risk for T scores up to, but no greater than, –2.0, suggesting that a T-score threshold of at least –2.0 would be an appropriate target for therapy to maximize treatment,” said Dr. Ferrari of the University of Geneva and his colleagues. “Further improvements in bone mineral density were not associated with major additional changes in 1-year nonvertebral fracture incidence.”
The findings “highlight the importance of the relationship between hip T score and fracture risk, which is maintained during long-term therapy with denosumab. Regular monitoring of bone mineral density during therapy may be useful to determine when fracture risk has reached a minimal threshold; treatment could therefore be suspended and/or consolidated, as in the case of a reversible therapy such as denosumab.”
SOURCE: Ferrari S et al. J Bone Miner Res. 2019 Mar 28. doi: 10.1002/jbmr.3722.
FROM THE JOURNAL OF BONE AND MINERAL RESEARCH
Decline in CIN2+ in younger women after HPV vaccine introduced
The introduction of human papillomavirus vaccination in the United States in 2006 was associated with a significant decrease in the rates of cervical intraepithelial neoplasia grades 2 and above (CIN2+) in younger women.
The overall rate of CIN2+ declined from an estimated 216,000 cases in 2008 – 55% of which were in women aged 18-29 years – to 196,000 cases in 2016, of which 36% were in women aged 18-29 years, according to analysis of data from the Human Papillomavirus Vaccine Impact Monitoring Program (MMWR. 2019 Apr 19;68:337-43.
In 2008, the highest rates of CIN2+ were seen in women aged 20-24 years and decreased with age, but in 2016, the highest rates were in women aged 25-29 years. The rates of CIN2+ declined significantly in women aged 18-19 years from 2008-2016, but increased in women aged 40-64 years.
In 2008 and 2016, around three-quarters of all CIN2+ cases were attributable to HPV types that are targeted by the HPV vaccine. However the rates of vaccine-preventable CIN2+ declined among women aged 18-24 years, from 52% in 2008 to 30% in 2016.
“Both the estimated number and rates of U.S. CIN2+ cases in this report must be interpreted in the context of cervical cancer prevention strategies, including HPV vaccination and cervical cancer screening,” wrote Nancy M. McClung, PhD, of the Epidemic Intelligence Service at the Centers for Disease Control and Prevention and coauthors.
Notably, the screening interval for cervical cancer was increased from yearly in 2008 to once in 3 years with cytology alone or once in 5 years with cytology plus HPV testing for women aged 30 or above in 2016.
“Older age at screening initiation, longer screening intervals, and more conservative management in young women might be expected to reduce the number of CIN2+ cases detected in younger age groups in whom lesions are most likely to regress and shift detection of some CIN2+ to older age groups, resulting in a transient increase in rates,” Dr. McClung and colleagues wrote.
However they noted that the decrease in HPV 16/18–attributable CIN2+ rates among younger age groups was likely a reflection of the impact of the introduction of the quadrivalent vaccine immunization program.
One author declared personal fees from Merck during the course of the study. No other conflicts of interest were declared.
SOURCE: McClung N et al. MMWR. 2019 Apr 19;68:337-43.
The introduction of human papillomavirus vaccination in the United States in 2006 was associated with a significant decrease in the rates of cervical intraepithelial neoplasia grades 2 and above (CIN2+) in younger women.
The overall rate of CIN2+ declined from an estimated 216,000 cases in 2008 – 55% of which were in women aged 18-29 years – to 196,000 cases in 2016, of which 36% were in women aged 18-29 years, according to analysis of data from the Human Papillomavirus Vaccine Impact Monitoring Program (MMWR. 2019 Apr 19;68:337-43.
In 2008, the highest rates of CIN2+ were seen in women aged 20-24 years and decreased with age, but in 2016, the highest rates were in women aged 25-29 years. The rates of CIN2+ declined significantly in women aged 18-19 years from 2008-2016, but increased in women aged 40-64 years.
In 2008 and 2016, around three-quarters of all CIN2+ cases were attributable to HPV types that are targeted by the HPV vaccine. However the rates of vaccine-preventable CIN2+ declined among women aged 18-24 years, from 52% in 2008 to 30% in 2016.
“Both the estimated number and rates of U.S. CIN2+ cases in this report must be interpreted in the context of cervical cancer prevention strategies, including HPV vaccination and cervical cancer screening,” wrote Nancy M. McClung, PhD, of the Epidemic Intelligence Service at the Centers for Disease Control and Prevention and coauthors.
Notably, the screening interval for cervical cancer was increased from yearly in 2008 to once in 3 years with cytology alone or once in 5 years with cytology plus HPV testing for women aged 30 or above in 2016.
“Older age at screening initiation, longer screening intervals, and more conservative management in young women might be expected to reduce the number of CIN2+ cases detected in younger age groups in whom lesions are most likely to regress and shift detection of some CIN2+ to older age groups, resulting in a transient increase in rates,” Dr. McClung and colleagues wrote.
However they noted that the decrease in HPV 16/18–attributable CIN2+ rates among younger age groups was likely a reflection of the impact of the introduction of the quadrivalent vaccine immunization program.
One author declared personal fees from Merck during the course of the study. No other conflicts of interest were declared.
SOURCE: McClung N et al. MMWR. 2019 Apr 19;68:337-43.
The introduction of human papillomavirus vaccination in the United States in 2006 was associated with a significant decrease in the rates of cervical intraepithelial neoplasia grades 2 and above (CIN2+) in younger women.
The overall rate of CIN2+ declined from an estimated 216,000 cases in 2008 – 55% of which were in women aged 18-29 years – to 196,000 cases in 2016, of which 36% were in women aged 18-29 years, according to analysis of data from the Human Papillomavirus Vaccine Impact Monitoring Program (MMWR. 2019 Apr 19;68:337-43.
In 2008, the highest rates of CIN2+ were seen in women aged 20-24 years and decreased with age, but in 2016, the highest rates were in women aged 25-29 years. The rates of CIN2+ declined significantly in women aged 18-19 years from 2008-2016, but increased in women aged 40-64 years.
In 2008 and 2016, around three-quarters of all CIN2+ cases were attributable to HPV types that are targeted by the HPV vaccine. However the rates of vaccine-preventable CIN2+ declined among women aged 18-24 years, from 52% in 2008 to 30% in 2016.
“Both the estimated number and rates of U.S. CIN2+ cases in this report must be interpreted in the context of cervical cancer prevention strategies, including HPV vaccination and cervical cancer screening,” wrote Nancy M. McClung, PhD, of the Epidemic Intelligence Service at the Centers for Disease Control and Prevention and coauthors.
Notably, the screening interval for cervical cancer was increased from yearly in 2008 to once in 3 years with cytology alone or once in 5 years with cytology plus HPV testing for women aged 30 or above in 2016.
“Older age at screening initiation, longer screening intervals, and more conservative management in young women might be expected to reduce the number of CIN2+ cases detected in younger age groups in whom lesions are most likely to regress and shift detection of some CIN2+ to older age groups, resulting in a transient increase in rates,” Dr. McClung and colleagues wrote.
However they noted that the decrease in HPV 16/18–attributable CIN2+ rates among younger age groups was likely a reflection of the impact of the introduction of the quadrivalent vaccine immunization program.
One author declared personal fees from Merck during the course of the study. No other conflicts of interest were declared.
SOURCE: McClung N et al. MMWR. 2019 Apr 19;68:337-43.
FROM MMWR
Anticipating a Problem Pregnancy
FDA orders companies to cease all sales of transvaginal mesh for POP repair
The mandate came after Boston Scientific and Coloplast failed to provide adequate safety and efficacy information to the federal regulatory body in the wake of a 2016 reclassification to Class III (high-risk) devices, according to an FDA press statement. Both companies were required to submit a premarket approval application to continue marketing the mesh in the United States. Boston Scientific did file two PMAs, one for each of its transvaginal mesh products, but the FDA said the applications did not contain the required efficacy and safety data.
Both companies will have 10 days to submit their plan to withdraw these products from the market.
“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” said Jeffrey Shuren, MD, director of FDA’s Center for Devices and Radiological Health. “Patient safety is our highest priority, and women must have access to safe medical devices that provide relief from symptoms and better management of their medical conditions. The FDA has committed to taking forceful new actions to enhance device safety and encourage innovations that lead to safer medical devices, so that patients have access to safe and effective medical devices and the information they need to make informed decisions about their care.”
The deadline for submitting premarket approval applications for POP repair with transvaginal mesh was July 5, 2018. Manufacturers that did not file PMAs were required to pull their devices from the market. Those that did could keep selling the mesh while FDA reviewed their PMAs.
Boston Scientific submitted PMAs for its two devices, the Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair System. Coloplast filed a PMA for its device, Restorelle DirectFix Anterior. But in February, the FDA convened an advisory panel to discuss just how to evaluate the safety and efficacy of the products.
To prove efficacy, the panel concluded, transvaginal POP repair with mesh should be better than repair with native tissue at 36 months, and the safety should be superior to repair with native tissue repair. The FDA agreed. However, the submitted premarket approval application did not include these kinds of data. Therefore, the agency declined to approve the devices.
In addition to stopping U.S. sales, FDA has required Boston Scientific and Coloplast to continue safety and efficacy follow-up of all women included in their 522 studies.
Coloplast did not have a press or public statement on its website as of April 16. Boston Scientific did have one.
“Up to 50% of women in the U.S. will suffer from POP during their lives, and we believe these women should have access to safe and effective treatment options,” according to the statement. “As a global leader in the pelvic floor space, we remain steadfast in our commitment to helping women live better and healthier lives. We also remain confident in the benefits and safety of our treatments for POP, and we look forward to continuing to work with the FDA on our PMAs for the Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair Matrix, which are currently under review.”
The FDA statement also included advice to women who have had the mesh procedure for POP, and for their physicians
“Women who have had transvaginal mesh placed for the surgical repair of POP should continue with their annual and other routine check-ups and follow-up care. There is no need to take additional action if they are satisfied with their surgery and are not having complications or symptoms. Patients should notify their health care professionals if they have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain, or pain with sex. They should also let their health care professional know if they have surgical mesh, especially if they plan to have another surgery or other medical procedures. Women who were planning to have mesh placed transvaginally for the repair of POP should discuss other treatment options with their doctors.”
The Food and Drug Administration’s decision ordering manufacturers to remove mesh for transvaginal repair of prolapse from the market was based on the products’ effectiveness and safety profile, compared with vaginal native tissue repairs. Previous studies have shown that polypropylene mesh for anterior repair had similar or slightly higher success, compared with native tissue repairs. This was not a sufficient benefit considering the potential adverse events that include mesh exposure, and the pelvic pain and dyspareunia associated with using these products. There is no additional benefit of using polypropylene mesh in the posterior compartment.
It would be interesting to review the information provided by manufacturers as part of the premarket approval. What were the primary endpoints for efficacy that were used? What were the rates of complications for mesh exposure, pelvic pain, and dyspareunia? How did the rates of pelvic pain and dyspareunia compare with native tissue repair.
Gynecologic surgeons still have a number of options for treating vaginal prolapse, which include vaginal native tissue repairs, and laparoscopic and abdominal surgeries that involve native tissue or polypropylene mesh. It will be interesting to see how the FDA’s Medical Device Safety action plan will affect future innovations for treating vaginal prolapse, while at the same time providing women and their physicians with products that are safe and effective.
Jose S. Maceda, MD, is a urogynecologist at Axia Women’s Health in King of Prussia, Penn. Dr. Maceda, who was asked to comment on the FDA decision, has no relevant financial disclosures.
The Food and Drug Administration’s decision ordering manufacturers to remove mesh for transvaginal repair of prolapse from the market was based on the products’ effectiveness and safety profile, compared with vaginal native tissue repairs. Previous studies have shown that polypropylene mesh for anterior repair had similar or slightly higher success, compared with native tissue repairs. This was not a sufficient benefit considering the potential adverse events that include mesh exposure, and the pelvic pain and dyspareunia associated with using these products. There is no additional benefit of using polypropylene mesh in the posterior compartment.
It would be interesting to review the information provided by manufacturers as part of the premarket approval. What were the primary endpoints for efficacy that were used? What were the rates of complications for mesh exposure, pelvic pain, and dyspareunia? How did the rates of pelvic pain and dyspareunia compare with native tissue repair.
Gynecologic surgeons still have a number of options for treating vaginal prolapse, which include vaginal native tissue repairs, and laparoscopic and abdominal surgeries that involve native tissue or polypropylene mesh. It will be interesting to see how the FDA’s Medical Device Safety action plan will affect future innovations for treating vaginal prolapse, while at the same time providing women and their physicians with products that are safe and effective.
Jose S. Maceda, MD, is a urogynecologist at Axia Women’s Health in King of Prussia, Penn. Dr. Maceda, who was asked to comment on the FDA decision, has no relevant financial disclosures.
The Food and Drug Administration’s decision ordering manufacturers to remove mesh for transvaginal repair of prolapse from the market was based on the products’ effectiveness and safety profile, compared with vaginal native tissue repairs. Previous studies have shown that polypropylene mesh for anterior repair had similar or slightly higher success, compared with native tissue repairs. This was not a sufficient benefit considering the potential adverse events that include mesh exposure, and the pelvic pain and dyspareunia associated with using these products. There is no additional benefit of using polypropylene mesh in the posterior compartment.
It would be interesting to review the information provided by manufacturers as part of the premarket approval. What were the primary endpoints for efficacy that were used? What were the rates of complications for mesh exposure, pelvic pain, and dyspareunia? How did the rates of pelvic pain and dyspareunia compare with native tissue repair.
Gynecologic surgeons still have a number of options for treating vaginal prolapse, which include vaginal native tissue repairs, and laparoscopic and abdominal surgeries that involve native tissue or polypropylene mesh. It will be interesting to see how the FDA’s Medical Device Safety action plan will affect future innovations for treating vaginal prolapse, while at the same time providing women and their physicians with products that are safe and effective.
Jose S. Maceda, MD, is a urogynecologist at Axia Women’s Health in King of Prussia, Penn. Dr. Maceda, who was asked to comment on the FDA decision, has no relevant financial disclosures.
The mandate came after Boston Scientific and Coloplast failed to provide adequate safety and efficacy information to the federal regulatory body in the wake of a 2016 reclassification to Class III (high-risk) devices, according to an FDA press statement. Both companies were required to submit a premarket approval application to continue marketing the mesh in the United States. Boston Scientific did file two PMAs, one for each of its transvaginal mesh products, but the FDA said the applications did not contain the required efficacy and safety data.
Both companies will have 10 days to submit their plan to withdraw these products from the market.
“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” said Jeffrey Shuren, MD, director of FDA’s Center for Devices and Radiological Health. “Patient safety is our highest priority, and women must have access to safe medical devices that provide relief from symptoms and better management of their medical conditions. The FDA has committed to taking forceful new actions to enhance device safety and encourage innovations that lead to safer medical devices, so that patients have access to safe and effective medical devices and the information they need to make informed decisions about their care.”
The deadline for submitting premarket approval applications for POP repair with transvaginal mesh was July 5, 2018. Manufacturers that did not file PMAs were required to pull their devices from the market. Those that did could keep selling the mesh while FDA reviewed their PMAs.
Boston Scientific submitted PMAs for its two devices, the Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair System. Coloplast filed a PMA for its device, Restorelle DirectFix Anterior. But in February, the FDA convened an advisory panel to discuss just how to evaluate the safety and efficacy of the products.
To prove efficacy, the panel concluded, transvaginal POP repair with mesh should be better than repair with native tissue at 36 months, and the safety should be superior to repair with native tissue repair. The FDA agreed. However, the submitted premarket approval application did not include these kinds of data. Therefore, the agency declined to approve the devices.
In addition to stopping U.S. sales, FDA has required Boston Scientific and Coloplast to continue safety and efficacy follow-up of all women included in their 522 studies.
Coloplast did not have a press or public statement on its website as of April 16. Boston Scientific did have one.
“Up to 50% of women in the U.S. will suffer from POP during their lives, and we believe these women should have access to safe and effective treatment options,” according to the statement. “As a global leader in the pelvic floor space, we remain steadfast in our commitment to helping women live better and healthier lives. We also remain confident in the benefits and safety of our treatments for POP, and we look forward to continuing to work with the FDA on our PMAs for the Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair Matrix, which are currently under review.”
The FDA statement also included advice to women who have had the mesh procedure for POP, and for their physicians
“Women who have had transvaginal mesh placed for the surgical repair of POP should continue with their annual and other routine check-ups and follow-up care. There is no need to take additional action if they are satisfied with their surgery and are not having complications or symptoms. Patients should notify their health care professionals if they have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain, or pain with sex. They should also let their health care professional know if they have surgical mesh, especially if they plan to have another surgery or other medical procedures. Women who were planning to have mesh placed transvaginally for the repair of POP should discuss other treatment options with their doctors.”
The mandate came after Boston Scientific and Coloplast failed to provide adequate safety and efficacy information to the federal regulatory body in the wake of a 2016 reclassification to Class III (high-risk) devices, according to an FDA press statement. Both companies were required to submit a premarket approval application to continue marketing the mesh in the United States. Boston Scientific did file two PMAs, one for each of its transvaginal mesh products, but the FDA said the applications did not contain the required efficacy and safety data.
Both companies will have 10 days to submit their plan to withdraw these products from the market.
“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” said Jeffrey Shuren, MD, director of FDA’s Center for Devices and Radiological Health. “Patient safety is our highest priority, and women must have access to safe medical devices that provide relief from symptoms and better management of their medical conditions. The FDA has committed to taking forceful new actions to enhance device safety and encourage innovations that lead to safer medical devices, so that patients have access to safe and effective medical devices and the information they need to make informed decisions about their care.”
The deadline for submitting premarket approval applications for POP repair with transvaginal mesh was July 5, 2018. Manufacturers that did not file PMAs were required to pull their devices from the market. Those that did could keep selling the mesh while FDA reviewed their PMAs.
Boston Scientific submitted PMAs for its two devices, the Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair System. Coloplast filed a PMA for its device, Restorelle DirectFix Anterior. But in February, the FDA convened an advisory panel to discuss just how to evaluate the safety and efficacy of the products.
To prove efficacy, the panel concluded, transvaginal POP repair with mesh should be better than repair with native tissue at 36 months, and the safety should be superior to repair with native tissue repair. The FDA agreed. However, the submitted premarket approval application did not include these kinds of data. Therefore, the agency declined to approve the devices.
In addition to stopping U.S. sales, FDA has required Boston Scientific and Coloplast to continue safety and efficacy follow-up of all women included in their 522 studies.
Coloplast did not have a press or public statement on its website as of April 16. Boston Scientific did have one.
“Up to 50% of women in the U.S. will suffer from POP during their lives, and we believe these women should have access to safe and effective treatment options,” according to the statement. “As a global leader in the pelvic floor space, we remain steadfast in our commitment to helping women live better and healthier lives. We also remain confident in the benefits and safety of our treatments for POP, and we look forward to continuing to work with the FDA on our PMAs for the Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair Matrix, which are currently under review.”
The FDA statement also included advice to women who have had the mesh procedure for POP, and for their physicians
“Women who have had transvaginal mesh placed for the surgical repair of POP should continue with their annual and other routine check-ups and follow-up care. There is no need to take additional action if they are satisfied with their surgery and are not having complications or symptoms. Patients should notify their health care professionals if they have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain, or pain with sex. They should also let their health care professional know if they have surgical mesh, especially if they plan to have another surgery or other medical procedures. Women who were planning to have mesh placed transvaginally for the repair of POP should discuss other treatment options with their doctors.”
Low LDL cholesterol may increase women’s risk of hemorrhagic stroke
, according to research published in Neurology.
“Women with very low LDL cholesterol or low triglycerides should be monitored by their doctors for other stroke risk factors that can be modified, like high blood pressure and smoking, in order to reduce their risk of hemorrhagic stroke,” said Pamela M. Rist, ScD, instructor in epidemiology at Harvard Medical School, Boston. “Additional research is needed to determine how to lower the risk of hemorrhagic stroke in women with very low LDL and low triglycerides.”
Several meta-analyses have indicated that LDL cholesterol levels are inversely associated with the risk of hemorrhagic stroke. Because lipid-lowering treatments are used to prevent cardiovascular disease, this potential association has implications for clinical practice. Most of the studies included in these meta-analyses had low numbers of events among women, which prevented researchers from stratifying their results by sex. Because women are at greater risk of stroke than men, Dr. Rist and her colleagues sought to evaluate the association between lipid levels and risk of hemorrhagic stroke.
An analysis of the Women’s Health Study
The investigators examined data from the Women’s Health Study, a randomized, double-blind, placebo-controlled trial of low-dose aspirin and vitamin E for the primary prevention of cardiovascular disease and cancer among female American health professionals aged 45 years or older. The study ended in March 2004, but follow-up is ongoing. At regular intervals, the women complete a questionnaire about disease outcomes, including stroke. Some participants agreed to provide a fasting venous blood sample before randomization. With the subjects’ permission, a committee of physicians examined medical records for women who reported a stroke on a follow-up questionnaire.
Dr. Rist and her colleagues analyzed 27,937 samples for levels of LDL cholesterol, HDL cholesterol, total cholesterol, and triglycerides. They assigned each sample to one of five cholesterol level categories that were based on Adult Treatment Panel III guidelines. Cox proportional hazards models enabled the researchers to calculate the hazard ratio of incident hemorrhagic stroke events. They adjusted their results for covariates such as age, smoking status, menopausal status, body mass index, and alcohol consumption.
A U-shaped association
Women in the lowest category of LDL cholesterol level (less than 70 mg/dL) were younger, less likely to have a history of hypertension, and less likely to use cholesterol-lowering drugs than women in the reference group (100.0-129.9 mg/dL). Women with the lowest LDL cholesterol level were more likely to consume alcohol, have a normal weight, engage in physical activity, and be premenopausal than women in the reference group. The investigators confirmed 137 incident hemorrhagic stroke events during a mean 19.3 years of follow-up.
After data adjustment, the researchers found that women with the lowest level of LDL cholesterol had 2.17 times the risk of hemorrhagic stroke, compared with participants in the reference group. They found a trend toward increased risk among women with an LDL cholesterol level of 160 mg/dL or higher, but the result was not statistically significant. The highest risk for intracerebral hemorrhage (ICH) was among women with an LDL cholesterol level of less than 70 mg/dL (relative risk, 2.32), followed by women with a level of 160 mg/dL or higher (RR, 1.71).
In addition, after multivariable adjustment, women in the lowest quartile of triglycerides (less than or equal to 74 mg/dL for fasting and less than or equal to 85 mg/dL for nonfasting) had a significantly increased risk of hemorrhagic stroke, compared with women in the highest quartile (RR, 2.00). Low triglyceride levels were associated with an increased risk of subarachnoid hemorrhage, but not with an increased risk of ICH. Neither HDL cholesterol nor total cholesterol was associated with risk of hemorrhagic stroke, the researchers wrote.
Mechanism of increased risk unclear
The researchers do not yet know how low triglyceride and LDL cholesterol levels increase the risk of hemorrhagic stroke. One hypothesis is that low cholesterol promotes necrosis of the arterial medial layer’s smooth muscle cells. This impaired endothelium might be more susceptible to microaneurysms, which are common in patients with ICH, said the researchers.
The prospective design and the large sample size were two of the study’s strengths, but the study had important weaknesses as well, the researchers wrote. For example, few women were premenopausal at baseline, so the investigators could not evaluate whether menopausal status modifies the association between lipid levels and risk of hemorrhagic stroke. In addition, lipid levels were measured only at baseline, which prevented an analysis of whether change in lipid levels over time modifies the risk of hemorrhagic stroke.
Dr. Rist reported receiving a grant from the National Institutes of Health.
SOURCE: Rist PM et al. Neurology. 2019 April 10. doi: 10.1212/WNL.0000000000007454.
, according to research published in Neurology.
“Women with very low LDL cholesterol or low triglycerides should be monitored by their doctors for other stroke risk factors that can be modified, like high blood pressure and smoking, in order to reduce their risk of hemorrhagic stroke,” said Pamela M. Rist, ScD, instructor in epidemiology at Harvard Medical School, Boston. “Additional research is needed to determine how to lower the risk of hemorrhagic stroke in women with very low LDL and low triglycerides.”
Several meta-analyses have indicated that LDL cholesterol levels are inversely associated with the risk of hemorrhagic stroke. Because lipid-lowering treatments are used to prevent cardiovascular disease, this potential association has implications for clinical practice. Most of the studies included in these meta-analyses had low numbers of events among women, which prevented researchers from stratifying their results by sex. Because women are at greater risk of stroke than men, Dr. Rist and her colleagues sought to evaluate the association between lipid levels and risk of hemorrhagic stroke.
An analysis of the Women’s Health Study
The investigators examined data from the Women’s Health Study, a randomized, double-blind, placebo-controlled trial of low-dose aspirin and vitamin E for the primary prevention of cardiovascular disease and cancer among female American health professionals aged 45 years or older. The study ended in March 2004, but follow-up is ongoing. At regular intervals, the women complete a questionnaire about disease outcomes, including stroke. Some participants agreed to provide a fasting venous blood sample before randomization. With the subjects’ permission, a committee of physicians examined medical records for women who reported a stroke on a follow-up questionnaire.
Dr. Rist and her colleagues analyzed 27,937 samples for levels of LDL cholesterol, HDL cholesterol, total cholesterol, and triglycerides. They assigned each sample to one of five cholesterol level categories that were based on Adult Treatment Panel III guidelines. Cox proportional hazards models enabled the researchers to calculate the hazard ratio of incident hemorrhagic stroke events. They adjusted their results for covariates such as age, smoking status, menopausal status, body mass index, and alcohol consumption.
A U-shaped association
Women in the lowest category of LDL cholesterol level (less than 70 mg/dL) were younger, less likely to have a history of hypertension, and less likely to use cholesterol-lowering drugs than women in the reference group (100.0-129.9 mg/dL). Women with the lowest LDL cholesterol level were more likely to consume alcohol, have a normal weight, engage in physical activity, and be premenopausal than women in the reference group. The investigators confirmed 137 incident hemorrhagic stroke events during a mean 19.3 years of follow-up.
After data adjustment, the researchers found that women with the lowest level of LDL cholesterol had 2.17 times the risk of hemorrhagic stroke, compared with participants in the reference group. They found a trend toward increased risk among women with an LDL cholesterol level of 160 mg/dL or higher, but the result was not statistically significant. The highest risk for intracerebral hemorrhage (ICH) was among women with an LDL cholesterol level of less than 70 mg/dL (relative risk, 2.32), followed by women with a level of 160 mg/dL or higher (RR, 1.71).
In addition, after multivariable adjustment, women in the lowest quartile of triglycerides (less than or equal to 74 mg/dL for fasting and less than or equal to 85 mg/dL for nonfasting) had a significantly increased risk of hemorrhagic stroke, compared with women in the highest quartile (RR, 2.00). Low triglyceride levels were associated with an increased risk of subarachnoid hemorrhage, but not with an increased risk of ICH. Neither HDL cholesterol nor total cholesterol was associated with risk of hemorrhagic stroke, the researchers wrote.
Mechanism of increased risk unclear
The researchers do not yet know how low triglyceride and LDL cholesterol levels increase the risk of hemorrhagic stroke. One hypothesis is that low cholesterol promotes necrosis of the arterial medial layer’s smooth muscle cells. This impaired endothelium might be more susceptible to microaneurysms, which are common in patients with ICH, said the researchers.
The prospective design and the large sample size were two of the study’s strengths, but the study had important weaknesses as well, the researchers wrote. For example, few women were premenopausal at baseline, so the investigators could not evaluate whether menopausal status modifies the association between lipid levels and risk of hemorrhagic stroke. In addition, lipid levels were measured only at baseline, which prevented an analysis of whether change in lipid levels over time modifies the risk of hemorrhagic stroke.
Dr. Rist reported receiving a grant from the National Institutes of Health.
SOURCE: Rist PM et al. Neurology. 2019 April 10. doi: 10.1212/WNL.0000000000007454.
, according to research published in Neurology.
“Women with very low LDL cholesterol or low triglycerides should be monitored by their doctors for other stroke risk factors that can be modified, like high blood pressure and smoking, in order to reduce their risk of hemorrhagic stroke,” said Pamela M. Rist, ScD, instructor in epidemiology at Harvard Medical School, Boston. “Additional research is needed to determine how to lower the risk of hemorrhagic stroke in women with very low LDL and low triglycerides.”
Several meta-analyses have indicated that LDL cholesterol levels are inversely associated with the risk of hemorrhagic stroke. Because lipid-lowering treatments are used to prevent cardiovascular disease, this potential association has implications for clinical practice. Most of the studies included in these meta-analyses had low numbers of events among women, which prevented researchers from stratifying their results by sex. Because women are at greater risk of stroke than men, Dr. Rist and her colleagues sought to evaluate the association between lipid levels and risk of hemorrhagic stroke.
An analysis of the Women’s Health Study
The investigators examined data from the Women’s Health Study, a randomized, double-blind, placebo-controlled trial of low-dose aspirin and vitamin E for the primary prevention of cardiovascular disease and cancer among female American health professionals aged 45 years or older. The study ended in March 2004, but follow-up is ongoing. At regular intervals, the women complete a questionnaire about disease outcomes, including stroke. Some participants agreed to provide a fasting venous blood sample before randomization. With the subjects’ permission, a committee of physicians examined medical records for women who reported a stroke on a follow-up questionnaire.
Dr. Rist and her colleagues analyzed 27,937 samples for levels of LDL cholesterol, HDL cholesterol, total cholesterol, and triglycerides. They assigned each sample to one of five cholesterol level categories that were based on Adult Treatment Panel III guidelines. Cox proportional hazards models enabled the researchers to calculate the hazard ratio of incident hemorrhagic stroke events. They adjusted their results for covariates such as age, smoking status, menopausal status, body mass index, and alcohol consumption.
A U-shaped association
Women in the lowest category of LDL cholesterol level (less than 70 mg/dL) were younger, less likely to have a history of hypertension, and less likely to use cholesterol-lowering drugs than women in the reference group (100.0-129.9 mg/dL). Women with the lowest LDL cholesterol level were more likely to consume alcohol, have a normal weight, engage in physical activity, and be premenopausal than women in the reference group. The investigators confirmed 137 incident hemorrhagic stroke events during a mean 19.3 years of follow-up.
After data adjustment, the researchers found that women with the lowest level of LDL cholesterol had 2.17 times the risk of hemorrhagic stroke, compared with participants in the reference group. They found a trend toward increased risk among women with an LDL cholesterol level of 160 mg/dL or higher, but the result was not statistically significant. The highest risk for intracerebral hemorrhage (ICH) was among women with an LDL cholesterol level of less than 70 mg/dL (relative risk, 2.32), followed by women with a level of 160 mg/dL or higher (RR, 1.71).
In addition, after multivariable adjustment, women in the lowest quartile of triglycerides (less than or equal to 74 mg/dL for fasting and less than or equal to 85 mg/dL for nonfasting) had a significantly increased risk of hemorrhagic stroke, compared with women in the highest quartile (RR, 2.00). Low triglyceride levels were associated with an increased risk of subarachnoid hemorrhage, but not with an increased risk of ICH. Neither HDL cholesterol nor total cholesterol was associated with risk of hemorrhagic stroke, the researchers wrote.
Mechanism of increased risk unclear
The researchers do not yet know how low triglyceride and LDL cholesterol levels increase the risk of hemorrhagic stroke. One hypothesis is that low cholesterol promotes necrosis of the arterial medial layer’s smooth muscle cells. This impaired endothelium might be more susceptible to microaneurysms, which are common in patients with ICH, said the researchers.
The prospective design and the large sample size were two of the study’s strengths, but the study had important weaknesses as well, the researchers wrote. For example, few women were premenopausal at baseline, so the investigators could not evaluate whether menopausal status modifies the association between lipid levels and risk of hemorrhagic stroke. In addition, lipid levels were measured only at baseline, which prevented an analysis of whether change in lipid levels over time modifies the risk of hemorrhagic stroke.
Dr. Rist reported receiving a grant from the National Institutes of Health.
SOURCE: Rist PM et al. Neurology. 2019 April 10. doi: 10.1212/WNL.0000000000007454.
FROM NEUROLOGY
FDA modifies safety label for Addyi
The Food and Drug Administration has issued a safety labeling change for flibanserin (Addyi), a treatment for premenopausal women with acquired, generalized hypoactive sexual desire disorder, according to a press release issued April 11 by the agency. Previously, the warning said women should abstain from alcohol entirely.
According to the release, the manufacturer, Sprout, had hoped the FDA would remove the boxed warning and contraindication entirely. However, based on a review of two postmarket research studies, the agency chose to order these modifications to the warnings instead.
The first postmarket study was missing information related to participants’ blood pressure, which FDA officials thought was critical in determining risk; it appeared that this resulted from safety precautions built into the trial. The concern was that not only did this absent information provide further evidence of an interaction but that women at home would not have the benefit of these safety precautions and could suffer serious outcomes, including falls, accidents, and bodily harm. The other postmarketing trial showed that delaying administration of flibanserin until at least 2 hours after consuming alcohol reduced the risk of serious hypotension and syncope.
It is recommended that flibanserin be taken at bedtime because of risks associated with hypotension and syncope, as well as risks associated with central nervous system depression (such as sleepiness). Furthermore, patients are encouraged to discontinue treatment with flibanserin if their hypoactive sexual desire disorder does not improve after 8 weeks. The most common adverse reactions include dizziness, sleepiness, nausea, fatigue, insomnia, and dry mouth.
Full prescribing information is available on the FDA website, as is the full release regarding these safety label modifications.
The Food and Drug Administration has issued a safety labeling change for flibanserin (Addyi), a treatment for premenopausal women with acquired, generalized hypoactive sexual desire disorder, according to a press release issued April 11 by the agency. Previously, the warning said women should abstain from alcohol entirely.
According to the release, the manufacturer, Sprout, had hoped the FDA would remove the boxed warning and contraindication entirely. However, based on a review of two postmarket research studies, the agency chose to order these modifications to the warnings instead.
The first postmarket study was missing information related to participants’ blood pressure, which FDA officials thought was critical in determining risk; it appeared that this resulted from safety precautions built into the trial. The concern was that not only did this absent information provide further evidence of an interaction but that women at home would not have the benefit of these safety precautions and could suffer serious outcomes, including falls, accidents, and bodily harm. The other postmarketing trial showed that delaying administration of flibanserin until at least 2 hours after consuming alcohol reduced the risk of serious hypotension and syncope.
It is recommended that flibanserin be taken at bedtime because of risks associated with hypotension and syncope, as well as risks associated with central nervous system depression (such as sleepiness). Furthermore, patients are encouraged to discontinue treatment with flibanserin if their hypoactive sexual desire disorder does not improve after 8 weeks. The most common adverse reactions include dizziness, sleepiness, nausea, fatigue, insomnia, and dry mouth.
Full prescribing information is available on the FDA website, as is the full release regarding these safety label modifications.
The Food and Drug Administration has issued a safety labeling change for flibanserin (Addyi), a treatment for premenopausal women with acquired, generalized hypoactive sexual desire disorder, according to a press release issued April 11 by the agency. Previously, the warning said women should abstain from alcohol entirely.
According to the release, the manufacturer, Sprout, had hoped the FDA would remove the boxed warning and contraindication entirely. However, based on a review of two postmarket research studies, the agency chose to order these modifications to the warnings instead.
The first postmarket study was missing information related to participants’ blood pressure, which FDA officials thought was critical in determining risk; it appeared that this resulted from safety precautions built into the trial. The concern was that not only did this absent information provide further evidence of an interaction but that women at home would not have the benefit of these safety precautions and could suffer serious outcomes, including falls, accidents, and bodily harm. The other postmarketing trial showed that delaying administration of flibanserin until at least 2 hours after consuming alcohol reduced the risk of serious hypotension and syncope.
It is recommended that flibanserin be taken at bedtime because of risks associated with hypotension and syncope, as well as risks associated with central nervous system depression (such as sleepiness). Furthermore, patients are encouraged to discontinue treatment with flibanserin if their hypoactive sexual desire disorder does not improve after 8 weeks. The most common adverse reactions include dizziness, sleepiness, nausea, fatigue, insomnia, and dry mouth.
Full prescribing information is available on the FDA website, as is the full release regarding these safety label modifications.
First-of-its-kind study looks at pregnancies in prison
according to a systematic study believed to be the first of its kind.
That works out to 0.6% of the 56,262 women housed in the 23 prison systems on Dec. 31, 2016, Carolyn Sufrin, MD, PhD, of Johns Hopkins University, Baltimore, and her associates wrote in the American Journal of Public Health.
Nearly 1,400 pregnant women were admitted to the 26 federal prisons that house women and 22 state prison systems over a 1-year period in 2016-2017. The prisons involved in the study represent 57% of all women incarcerated in the United States, they noted.
Among the pregnancies completed while women were in prison, there were 753 live births: 685 at state facilities and 68 at federal sites. About 6% of those births were preterm, compared with almost 10% nationally in 2016, and 32% were cesarean deliveries, Dr. Sufrin and her associates reported.
All but six births occurred in a hospital; three “were attributable to precipitous labor with prison nurses or paramedics in attendance, and details were not available for the others,” they wrote. Of the 8% of non–live birth pregnancies, 6% were miscarriages, 1% were abortions, and the remainder were stillbirths or ectopic pregnancies. There were three newborn deaths and no maternal deaths.
“That prison pregnancy data have previously not been systematically collected or reported signals a glaring disregard for the health and well-being of incarcerated pregnant women. The Bureau of Justice Statistics collects data on deaths during custody but not births during custody. Despite this marginalization, it is important to recognize that incarcerated women are still members of broader society, that most of them will be released, and that some will give birth while in custody; therefore, their pregnancies must be counted,” the investigators wrote.
The study was supported by the Society of Family Planning Research Fund and the Eunice Kennedy Shriver National Institute of Child Health and Development. The investigators had no conflicts of interest to report.
SOURCE: Sufrin C et al. Am J Public Health. 2019 Mar 21:e1-7. doi: 10.2105/AJPH.2019.305006.
according to a systematic study believed to be the first of its kind.
That works out to 0.6% of the 56,262 women housed in the 23 prison systems on Dec. 31, 2016, Carolyn Sufrin, MD, PhD, of Johns Hopkins University, Baltimore, and her associates wrote in the American Journal of Public Health.
Nearly 1,400 pregnant women were admitted to the 26 federal prisons that house women and 22 state prison systems over a 1-year period in 2016-2017. The prisons involved in the study represent 57% of all women incarcerated in the United States, they noted.
Among the pregnancies completed while women were in prison, there were 753 live births: 685 at state facilities and 68 at federal sites. About 6% of those births were preterm, compared with almost 10% nationally in 2016, and 32% were cesarean deliveries, Dr. Sufrin and her associates reported.
All but six births occurred in a hospital; three “were attributable to precipitous labor with prison nurses or paramedics in attendance, and details were not available for the others,” they wrote. Of the 8% of non–live birth pregnancies, 6% were miscarriages, 1% were abortions, and the remainder were stillbirths or ectopic pregnancies. There were three newborn deaths and no maternal deaths.
“That prison pregnancy data have previously not been systematically collected or reported signals a glaring disregard for the health and well-being of incarcerated pregnant women. The Bureau of Justice Statistics collects data on deaths during custody but not births during custody. Despite this marginalization, it is important to recognize that incarcerated women are still members of broader society, that most of them will be released, and that some will give birth while in custody; therefore, their pregnancies must be counted,” the investigators wrote.
The study was supported by the Society of Family Planning Research Fund and the Eunice Kennedy Shriver National Institute of Child Health and Development. The investigators had no conflicts of interest to report.
SOURCE: Sufrin C et al. Am J Public Health. 2019 Mar 21:e1-7. doi: 10.2105/AJPH.2019.305006.
according to a systematic study believed to be the first of its kind.
That works out to 0.6% of the 56,262 women housed in the 23 prison systems on Dec. 31, 2016, Carolyn Sufrin, MD, PhD, of Johns Hopkins University, Baltimore, and her associates wrote in the American Journal of Public Health.
Nearly 1,400 pregnant women were admitted to the 26 federal prisons that house women and 22 state prison systems over a 1-year period in 2016-2017. The prisons involved in the study represent 57% of all women incarcerated in the United States, they noted.
Among the pregnancies completed while women were in prison, there were 753 live births: 685 at state facilities and 68 at federal sites. About 6% of those births were preterm, compared with almost 10% nationally in 2016, and 32% were cesarean deliveries, Dr. Sufrin and her associates reported.
All but six births occurred in a hospital; three “were attributable to precipitous labor with prison nurses or paramedics in attendance, and details were not available for the others,” they wrote. Of the 8% of non–live birth pregnancies, 6% were miscarriages, 1% were abortions, and the remainder were stillbirths or ectopic pregnancies. There were three newborn deaths and no maternal deaths.
“That prison pregnancy data have previously not been systematically collected or reported signals a glaring disregard for the health and well-being of incarcerated pregnant women. The Bureau of Justice Statistics collects data on deaths during custody but not births during custody. Despite this marginalization, it is important to recognize that incarcerated women are still members of broader society, that most of them will be released, and that some will give birth while in custody; therefore, their pregnancies must be counted,” the investigators wrote.
The study was supported by the Society of Family Planning Research Fund and the Eunice Kennedy Shriver National Institute of Child Health and Development. The investigators had no conflicts of interest to report.
SOURCE: Sufrin C et al. Am J Public Health. 2019 Mar 21:e1-7. doi: 10.2105/AJPH.2019.305006.
FROM THE AMERICAN JOURNAL OF PUBLIC HEALTH
Stress incontinence surgery improves sexual dysfunction
TUCSON, ARIZ. –
The finding comes from a secondary analysis of two randomized, controlled trials comparing Burch colposuspension, autologous fascial slings, retropubic midurethral polypropylene slings, and transobturator midurethral polypropylene slings. The analysis looked at outcomes at 24 months after surgery. Stephanie Glass Clark, MD, a resident at Virginia Commonwealth University, Richmond, presented the results at the annual scientific meeting of the Society of Gynecologic Surgeons.
In the secondary analysis of the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr) and the Trial of Midurethral Slings (TOMUS) trials, Dr. Clark and her fellow researchers looked at the effect of surgical failure on sexual dysfunction outcomes. Subjective failure was defined as self-reported SUI symptoms or self-reported leakage by 3-day voiding diary beyond 3 months after the surgery. Objective failure was defined as any treatment for SUI after the surgery or a positive stress test or pad test beyond 3 months after the surgery.
Participants were excluded from the two studies if they were sexually inactive in the previous 6 months at baseline, at 12 months post baseline, or at 24 months. The studies employed the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), which had 12 questions with scores ranging from 0 to 4. The secondary analysis sample included 488 women from SISTEr and 436 women from TOMUS.
There were some baseline differences among groups between the two trials, including vaginal deliveries, race/ethnicity, stage of prolapse, and concomitant surgeries performed at time of the anti-incontinence procedure.
All four surgeries were associated with improvements in sexual function, with no statistically significant between-group differences. Mean PISQ-12 scores improved from a range of 31-33 to a range of 36-38 at 24 months. Although there is no published minimum important difference for PISQ-12 scores, an improvement of at least one-half of a standard deviation is generally accepted as clinically meaningful. “In this case, the standard deviation at baseline was just under 3 and so the improvement of each treatment group by more than 1.5 is a clinically meaningful improvement in their sexual function,” Dr. Clark said.
“Sexual dysfunction is a much more common problem than we previously thought, so we’ve been trying to figure out if patients with pelvic floor disorders like stress incontinence are going to have any improvement in sexual dysfunction by surgically treating their stress incontinence. Previously published data had been pretty conflicting,” Dr. Clark added in an interview.
That previous research was mostly retrospective and could have been impacted by patient selection bias. By analyzing clinical trials, the researchers hoped to test their idea that the pelvic floor symptoms themselves may be key to sexual dysfunction and that treating it surgically would improve matters.
The positive result is encouraging, but it still leaves unanswered questions about the mechanism behind the relationship. Dr. Clark wondered whether leaking urine leakage during sex might be the culprit, or whether it is fear or shame associated with the condition.
The answer may come from further analysis of women who were sexually inactive at baseline, but became sexually active over the course of the studies. “I think looking at that patient population in particular is going to be an interesting area of research. Is it that it was completely related to their pelvic floor disorder, and then we fixed it [so] they could have a more fulfilling sexual life?” speculated Dr. Clark.
The study received some funding from the National Institutes of Health. Dr. Clark reported no relevant financial disclosures.
SOURCE: Clark SG et al. SGS 2019, Oral Presentation 11.
TUCSON, ARIZ. –
The finding comes from a secondary analysis of two randomized, controlled trials comparing Burch colposuspension, autologous fascial slings, retropubic midurethral polypropylene slings, and transobturator midurethral polypropylene slings. The analysis looked at outcomes at 24 months after surgery. Stephanie Glass Clark, MD, a resident at Virginia Commonwealth University, Richmond, presented the results at the annual scientific meeting of the Society of Gynecologic Surgeons.
In the secondary analysis of the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr) and the Trial of Midurethral Slings (TOMUS) trials, Dr. Clark and her fellow researchers looked at the effect of surgical failure on sexual dysfunction outcomes. Subjective failure was defined as self-reported SUI symptoms or self-reported leakage by 3-day voiding diary beyond 3 months after the surgery. Objective failure was defined as any treatment for SUI after the surgery or a positive stress test or pad test beyond 3 months after the surgery.
Participants were excluded from the two studies if they were sexually inactive in the previous 6 months at baseline, at 12 months post baseline, or at 24 months. The studies employed the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), which had 12 questions with scores ranging from 0 to 4. The secondary analysis sample included 488 women from SISTEr and 436 women from TOMUS.
There were some baseline differences among groups between the two trials, including vaginal deliveries, race/ethnicity, stage of prolapse, and concomitant surgeries performed at time of the anti-incontinence procedure.
All four surgeries were associated with improvements in sexual function, with no statistically significant between-group differences. Mean PISQ-12 scores improved from a range of 31-33 to a range of 36-38 at 24 months. Although there is no published minimum important difference for PISQ-12 scores, an improvement of at least one-half of a standard deviation is generally accepted as clinically meaningful. “In this case, the standard deviation at baseline was just under 3 and so the improvement of each treatment group by more than 1.5 is a clinically meaningful improvement in their sexual function,” Dr. Clark said.
“Sexual dysfunction is a much more common problem than we previously thought, so we’ve been trying to figure out if patients with pelvic floor disorders like stress incontinence are going to have any improvement in sexual dysfunction by surgically treating their stress incontinence. Previously published data had been pretty conflicting,” Dr. Clark added in an interview.
That previous research was mostly retrospective and could have been impacted by patient selection bias. By analyzing clinical trials, the researchers hoped to test their idea that the pelvic floor symptoms themselves may be key to sexual dysfunction and that treating it surgically would improve matters.
The positive result is encouraging, but it still leaves unanswered questions about the mechanism behind the relationship. Dr. Clark wondered whether leaking urine leakage during sex might be the culprit, or whether it is fear or shame associated with the condition.
The answer may come from further analysis of women who were sexually inactive at baseline, but became sexually active over the course of the studies. “I think looking at that patient population in particular is going to be an interesting area of research. Is it that it was completely related to their pelvic floor disorder, and then we fixed it [so] they could have a more fulfilling sexual life?” speculated Dr. Clark.
The study received some funding from the National Institutes of Health. Dr. Clark reported no relevant financial disclosures.
SOURCE: Clark SG et al. SGS 2019, Oral Presentation 11.
TUCSON, ARIZ. –
The finding comes from a secondary analysis of two randomized, controlled trials comparing Burch colposuspension, autologous fascial slings, retropubic midurethral polypropylene slings, and transobturator midurethral polypropylene slings. The analysis looked at outcomes at 24 months after surgery. Stephanie Glass Clark, MD, a resident at Virginia Commonwealth University, Richmond, presented the results at the annual scientific meeting of the Society of Gynecologic Surgeons.
In the secondary analysis of the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr) and the Trial of Midurethral Slings (TOMUS) trials, Dr. Clark and her fellow researchers looked at the effect of surgical failure on sexual dysfunction outcomes. Subjective failure was defined as self-reported SUI symptoms or self-reported leakage by 3-day voiding diary beyond 3 months after the surgery. Objective failure was defined as any treatment for SUI after the surgery or a positive stress test or pad test beyond 3 months after the surgery.
Participants were excluded from the two studies if they were sexually inactive in the previous 6 months at baseline, at 12 months post baseline, or at 24 months. The studies employed the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), which had 12 questions with scores ranging from 0 to 4. The secondary analysis sample included 488 women from SISTEr and 436 women from TOMUS.
There were some baseline differences among groups between the two trials, including vaginal deliveries, race/ethnicity, stage of prolapse, and concomitant surgeries performed at time of the anti-incontinence procedure.
All four surgeries were associated with improvements in sexual function, with no statistically significant between-group differences. Mean PISQ-12 scores improved from a range of 31-33 to a range of 36-38 at 24 months. Although there is no published minimum important difference for PISQ-12 scores, an improvement of at least one-half of a standard deviation is generally accepted as clinically meaningful. “In this case, the standard deviation at baseline was just under 3 and so the improvement of each treatment group by more than 1.5 is a clinically meaningful improvement in their sexual function,” Dr. Clark said.
“Sexual dysfunction is a much more common problem than we previously thought, so we’ve been trying to figure out if patients with pelvic floor disorders like stress incontinence are going to have any improvement in sexual dysfunction by surgically treating their stress incontinence. Previously published data had been pretty conflicting,” Dr. Clark added in an interview.
That previous research was mostly retrospective and could have been impacted by patient selection bias. By analyzing clinical trials, the researchers hoped to test their idea that the pelvic floor symptoms themselves may be key to sexual dysfunction and that treating it surgically would improve matters.
The positive result is encouraging, but it still leaves unanswered questions about the mechanism behind the relationship. Dr. Clark wondered whether leaking urine leakage during sex might be the culprit, or whether it is fear or shame associated with the condition.
The answer may come from further analysis of women who were sexually inactive at baseline, but became sexually active over the course of the studies. “I think looking at that patient population in particular is going to be an interesting area of research. Is it that it was completely related to their pelvic floor disorder, and then we fixed it [so] they could have a more fulfilling sexual life?” speculated Dr. Clark.
The study received some funding from the National Institutes of Health. Dr. Clark reported no relevant financial disclosures.
SOURCE: Clark SG et al. SGS 2019, Oral Presentation 11.
REPORTING FROM SGS 2019
Romosozumab gets FDA approval for treating osteoporosis
“These are women who have a history of osteoporotic fracture or multiple risk factors or have failed other treatments for osteoporosis,” according to a news release from the agency.
The monthly treatment of two injections (given one after the other at one visit) mainly works by increasing new bone formation, but these effects wane after 12 doses. If patients still need osteoporosis therapy after that maximum of 12 doses, it’s recommended they are put on treatments that reduce bone breakdown. Romosozumab-aqqg is “a monoclonal antibody that blocks the effects of the protein sclerostin,” according to the news release.
The treatment’s efficacy and safety was evaluated in two clinical trials of more than 11,000 women with postmenopausal osteoporosis. In one trial, women received 12 months of either romosozumab-aqqg or placebo. The treatment arm had a 73% lower risk of vertebral fracture than did the placebo arm, and this benefit was maintained over a second year when both groups were switched to denosumab, another osteoporosis therapy. In the second trial, one group received romosozumab-aqqg for 1 year and then a year of alendronate, and the other group received 2 years of alendronate, another osteoporosis therapy, according to the news release. In this trial, the romosozumab-aqqg arm had 50% less risk of vertebral fractures than did the alendronate-only arm, as well as reduced risk of nonvertebral fractures.
Romosozumab-aqqg was associated with higher risks of cardiovascular death, heart attack, and stroke in the alendronate trial, so the treatment comes with a boxed warning regarding those risks and recommends that the drug not be used in patients who have had a heart attack or stroke within the previous year, according to the news release. Common side effects include joint pain and headache, as well as injection-site reactions.
“These are women who have a history of osteoporotic fracture or multiple risk factors or have failed other treatments for osteoporosis,” according to a news release from the agency.
The monthly treatment of two injections (given one after the other at one visit) mainly works by increasing new bone formation, but these effects wane after 12 doses. If patients still need osteoporosis therapy after that maximum of 12 doses, it’s recommended they are put on treatments that reduce bone breakdown. Romosozumab-aqqg is “a monoclonal antibody that blocks the effects of the protein sclerostin,” according to the news release.
The treatment’s efficacy and safety was evaluated in two clinical trials of more than 11,000 women with postmenopausal osteoporosis. In one trial, women received 12 months of either romosozumab-aqqg or placebo. The treatment arm had a 73% lower risk of vertebral fracture than did the placebo arm, and this benefit was maintained over a second year when both groups were switched to denosumab, another osteoporosis therapy. In the second trial, one group received romosozumab-aqqg for 1 year and then a year of alendronate, and the other group received 2 years of alendronate, another osteoporosis therapy, according to the news release. In this trial, the romosozumab-aqqg arm had 50% less risk of vertebral fractures than did the alendronate-only arm, as well as reduced risk of nonvertebral fractures.
Romosozumab-aqqg was associated with higher risks of cardiovascular death, heart attack, and stroke in the alendronate trial, so the treatment comes with a boxed warning regarding those risks and recommends that the drug not be used in patients who have had a heart attack or stroke within the previous year, according to the news release. Common side effects include joint pain and headache, as well as injection-site reactions.
“These are women who have a history of osteoporotic fracture or multiple risk factors or have failed other treatments for osteoporosis,” according to a news release from the agency.
The monthly treatment of two injections (given one after the other at one visit) mainly works by increasing new bone formation, but these effects wane after 12 doses. If patients still need osteoporosis therapy after that maximum of 12 doses, it’s recommended they are put on treatments that reduce bone breakdown. Romosozumab-aqqg is “a monoclonal antibody that blocks the effects of the protein sclerostin,” according to the news release.
The treatment’s efficacy and safety was evaluated in two clinical trials of more than 11,000 women with postmenopausal osteoporosis. In one trial, women received 12 months of either romosozumab-aqqg or placebo. The treatment arm had a 73% lower risk of vertebral fracture than did the placebo arm, and this benefit was maintained over a second year when both groups were switched to denosumab, another osteoporosis therapy. In the second trial, one group received romosozumab-aqqg for 1 year and then a year of alendronate, and the other group received 2 years of alendronate, another osteoporosis therapy, according to the news release. In this trial, the romosozumab-aqqg arm had 50% less risk of vertebral fractures than did the alendronate-only arm, as well as reduced risk of nonvertebral fractures.
Romosozumab-aqqg was associated with higher risks of cardiovascular death, heart attack, and stroke in the alendronate trial, so the treatment comes with a boxed warning regarding those risks and recommends that the drug not be used in patients who have had a heart attack or stroke within the previous year, according to the news release. Common side effects include joint pain and headache, as well as injection-site reactions.
Expert gives tips on timing, managing lupus pregnancies
SAN FRANCISCO – Not that many years ago, women with systemic lupus erythematosus were told not to get pregnant. It was just one more lupus heartbreak.
Times have changed, according to Lisa Sammaritano, MD, a lupus specialist and associate professor of clinical medicine at Weill Cornell Medical College, New York.
While lupus certainly complicates pregnancy, it by no means rules it out these days. With careful management, the dream of motherhood can become a reality for many women. Dr. Sammaritano shared her insights about timing and treatment at an international congress on systemic lupus erythematosus.
It’s important that the disease is under control as much as possible; that means that timing – and contraception – are key. Antiphospholipid antibodies, common in lupus, complicate matters, but there are workarounds, she said.
SAN FRANCISCO – Not that many years ago, women with systemic lupus erythematosus were told not to get pregnant. It was just one more lupus heartbreak.
Times have changed, according to Lisa Sammaritano, MD, a lupus specialist and associate professor of clinical medicine at Weill Cornell Medical College, New York.
While lupus certainly complicates pregnancy, it by no means rules it out these days. With careful management, the dream of motherhood can become a reality for many women. Dr. Sammaritano shared her insights about timing and treatment at an international congress on systemic lupus erythematosus.
It’s important that the disease is under control as much as possible; that means that timing – and contraception – are key. Antiphospholipid antibodies, common in lupus, complicate matters, but there are workarounds, she said.
SAN FRANCISCO – Not that many years ago, women with systemic lupus erythematosus were told not to get pregnant. It was just one more lupus heartbreak.
Times have changed, according to Lisa Sammaritano, MD, a lupus specialist and associate professor of clinical medicine at Weill Cornell Medical College, New York.
While lupus certainly complicates pregnancy, it by no means rules it out these days. With careful management, the dream of motherhood can become a reality for many women. Dr. Sammaritano shared her insights about timing and treatment at an international congress on systemic lupus erythematosus.
It’s important that the disease is under control as much as possible; that means that timing – and contraception – are key. Antiphospholipid antibodies, common in lupus, complicate matters, but there are workarounds, she said.
AT LUPUS 2019
