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Risk of condomless sex low if HIV-positive partner is well controlled on ART

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Risk of condomless sex low if HIV-positive partner is well controlled on ART

Public health experts do not condone the practice, but it appears that the risk of transmission from an HIV-positive person to an uninfected sex partner during condomless sex is low if the infected partner has good viral control on antiretroviral therapy.

That’s the tentative conclusion investigators in the PARTNER study have drawn from an interim analysis looking at HIV transmission among serodifferent couples in which the positive partner is taking antiretroviral therapy (ART) and has a plasma viral load below 200 copies/mL, said Dr. Alison Rodger from the Research Department of Infection & Population Health at University College London.

"Overall, we had no linked transmissions during eligible follow-up, giving a transmission rate of zero," she reported at the Conference on Retroviruses and Opportunistic Infections.

Dr. Alison Rodger

However, the investigators cannot say with certainty that the actual risk is zero, as the upper limit of the 95% confidence interval was 0.4 per 100 couple-years, translating into a 10-year risk of 4%, Dr. Rodger said.

Although HIV transmissions did occur during the study, the investigators were able to rule out linked transmissions – that is, transmissions that are phylogenetically confirmed to be the same viral strain.

"The uncertainty is particularly advanced for anal sex, where for the moment we do not have sufficient data to exclude that 1 in 10 [HIV-negative partners] would be infected over a 10-year period," commented coinvestigator Dr. Jens Lundgren from the Centre for Viral Diseases and the Copenhagen HIV Programme at the University of Copenhagen.

The investigators plan to continue the study and conduct new analyses each time an additional 1,000 couple-years have been reached, he said at a briefing following the presentation.

The investigators enrolled serodifferent heterosexual and men having sex with men (MSM) couples who reported having had condomless penetrative anal or vaginal sex in the month prior to study entry, and did not use pre- or postexposure HIV prophylaxis.

Every 6 months during follow-up, each partner fills out a sexual behaviors questionnaire, and the seronegative partner is tested for HIV.

The informed consent for the study included information on the need for consistent condom use and explicit reference to the fact that the HIV-negative partners knew that their partner was positive and that there was risk for HIV transmission.

A total of 767 couples have contributed a total of 894 eligible couple follow-up years (586 in heterosexual couples and 308 in MSM) as of November 2013.

Median ART duration at baseline was 4.8 years, and the median duration of condomless sex reported was 2 years.

Although the risk of transmission across all categories of penetrative anal or vaginal sex was zero, as noted before, the upper limit of the confidence interval for receptive anal sex with ejaculation – the type of sex that carries the highest risk of HIV transmission – extends to 4, which translates into 32% risk of transmission at 10 years, Dr. Rodger said.

"Additional follow-up in MSM is needed through PARTNER phase 2, which will extend through 2017 in gay men only to provide more precise estimates for transmission risk to inform policy, and also to involve individual choice on whether to use condoms or not," Dr. Rodger said.

The PARTNER study is supported by the U.K. National Institute for Health Research. Dr. Rodger and Dr. Lundgren reported having no financial conflicts of interest.

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Public health experts do not condone the practice, but it appears that the risk of transmission from an HIV-positive person to an uninfected sex partner during condomless sex is low if the infected partner has good viral control on antiretroviral therapy.

That’s the tentative conclusion investigators in the PARTNER study have drawn from an interim analysis looking at HIV transmission among serodifferent couples in which the positive partner is taking antiretroviral therapy (ART) and has a plasma viral load below 200 copies/mL, said Dr. Alison Rodger from the Research Department of Infection & Population Health at University College London.

"Overall, we had no linked transmissions during eligible follow-up, giving a transmission rate of zero," she reported at the Conference on Retroviruses and Opportunistic Infections.

Dr. Alison Rodger

However, the investigators cannot say with certainty that the actual risk is zero, as the upper limit of the 95% confidence interval was 0.4 per 100 couple-years, translating into a 10-year risk of 4%, Dr. Rodger said.

Although HIV transmissions did occur during the study, the investigators were able to rule out linked transmissions – that is, transmissions that are phylogenetically confirmed to be the same viral strain.

"The uncertainty is particularly advanced for anal sex, where for the moment we do not have sufficient data to exclude that 1 in 10 [HIV-negative partners] would be infected over a 10-year period," commented coinvestigator Dr. Jens Lundgren from the Centre for Viral Diseases and the Copenhagen HIV Programme at the University of Copenhagen.

The investigators plan to continue the study and conduct new analyses each time an additional 1,000 couple-years have been reached, he said at a briefing following the presentation.

The investigators enrolled serodifferent heterosexual and men having sex with men (MSM) couples who reported having had condomless penetrative anal or vaginal sex in the month prior to study entry, and did not use pre- or postexposure HIV prophylaxis.

Every 6 months during follow-up, each partner fills out a sexual behaviors questionnaire, and the seronegative partner is tested for HIV.

The informed consent for the study included information on the need for consistent condom use and explicit reference to the fact that the HIV-negative partners knew that their partner was positive and that there was risk for HIV transmission.

A total of 767 couples have contributed a total of 894 eligible couple follow-up years (586 in heterosexual couples and 308 in MSM) as of November 2013.

Median ART duration at baseline was 4.8 years, and the median duration of condomless sex reported was 2 years.

Although the risk of transmission across all categories of penetrative anal or vaginal sex was zero, as noted before, the upper limit of the confidence interval for receptive anal sex with ejaculation – the type of sex that carries the highest risk of HIV transmission – extends to 4, which translates into 32% risk of transmission at 10 years, Dr. Rodger said.

"Additional follow-up in MSM is needed through PARTNER phase 2, which will extend through 2017 in gay men only to provide more precise estimates for transmission risk to inform policy, and also to involve individual choice on whether to use condoms or not," Dr. Rodger said.

The PARTNER study is supported by the U.K. National Institute for Health Research. Dr. Rodger and Dr. Lundgren reported having no financial conflicts of interest.

Public health experts do not condone the practice, but it appears that the risk of transmission from an HIV-positive person to an uninfected sex partner during condomless sex is low if the infected partner has good viral control on antiretroviral therapy.

That’s the tentative conclusion investigators in the PARTNER study have drawn from an interim analysis looking at HIV transmission among serodifferent couples in which the positive partner is taking antiretroviral therapy (ART) and has a plasma viral load below 200 copies/mL, said Dr. Alison Rodger from the Research Department of Infection & Population Health at University College London.

"Overall, we had no linked transmissions during eligible follow-up, giving a transmission rate of zero," she reported at the Conference on Retroviruses and Opportunistic Infections.

Dr. Alison Rodger

However, the investigators cannot say with certainty that the actual risk is zero, as the upper limit of the 95% confidence interval was 0.4 per 100 couple-years, translating into a 10-year risk of 4%, Dr. Rodger said.

Although HIV transmissions did occur during the study, the investigators were able to rule out linked transmissions – that is, transmissions that are phylogenetically confirmed to be the same viral strain.

"The uncertainty is particularly advanced for anal sex, where for the moment we do not have sufficient data to exclude that 1 in 10 [HIV-negative partners] would be infected over a 10-year period," commented coinvestigator Dr. Jens Lundgren from the Centre for Viral Diseases and the Copenhagen HIV Programme at the University of Copenhagen.

The investigators plan to continue the study and conduct new analyses each time an additional 1,000 couple-years have been reached, he said at a briefing following the presentation.

The investigators enrolled serodifferent heterosexual and men having sex with men (MSM) couples who reported having had condomless penetrative anal or vaginal sex in the month prior to study entry, and did not use pre- or postexposure HIV prophylaxis.

Every 6 months during follow-up, each partner fills out a sexual behaviors questionnaire, and the seronegative partner is tested for HIV.

The informed consent for the study included information on the need for consistent condom use and explicit reference to the fact that the HIV-negative partners knew that their partner was positive and that there was risk for HIV transmission.

A total of 767 couples have contributed a total of 894 eligible couple follow-up years (586 in heterosexual couples and 308 in MSM) as of November 2013.

Median ART duration at baseline was 4.8 years, and the median duration of condomless sex reported was 2 years.

Although the risk of transmission across all categories of penetrative anal or vaginal sex was zero, as noted before, the upper limit of the confidence interval for receptive anal sex with ejaculation – the type of sex that carries the highest risk of HIV transmission – extends to 4, which translates into 32% risk of transmission at 10 years, Dr. Rodger said.

"Additional follow-up in MSM is needed through PARTNER phase 2, which will extend through 2017 in gay men only to provide more precise estimates for transmission risk to inform policy, and also to involve individual choice on whether to use condoms or not," Dr. Rodger said.

The PARTNER study is supported by the U.K. National Institute for Health Research. Dr. Rodger and Dr. Lundgren reported having no financial conflicts of interest.

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Risk of condomless sex low if HIV-positive partner is well controlled on ART
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FROM CROI 2014

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Inside the Article

Vitals

Major finding: When HIV-infected individuals were well controlled on antiretroviral therapy, the risk of HIV transmission to uninfected sex partners was zero, but confidence intervals indicate that there may still be some transmission risk.

Data source: An observational cohort study in which 767 couples reported 894 couple-years at 75 sites across Europe.

Disclosures: The PARTNER study is supported by the U.K. National Institute for Health Research. Dr. Rodger and Dr. Lundgren reported having no financial conflicts of interest.

AAN issues nonvalvular atrial fibrillation stroke prevention guideline

'Tepid guidelines' miss opportunity
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Fri, 01/18/2019 - 13:20
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AAN issues nonvalvular atrial fibrillation stroke prevention guideline

A new evidence-based guideline on how to identify and treat patients with nonvalvular atrial fibrillation to prevent cardioembolic stroke from the American Academy of Neurology suggests when to conduct cardiac rhythm monitoring and offer anticoagulation, including newer agents in place of warfarin.

But the guideline might already be outdated in not considering the results of the recent CRYSTAL-AF study, in which long-term cardiac rhythm monitoring of patients with a previous cryptogenic stroke detected asymptomatic patients at a significantly higher rate than did standard monitoring methods.

Dr. Antonio Culebras

The guideline also extends the routine use of anticoagulation for patients with nonvalvular atrial fibrillation (NVAF) who are generally undertreated or whose health was thought a possible barrier to their use, such as those aged 75 years or older, those with mild dementia, and those at moderate risk of falls.

"Cognizant of the global reach of the AAN [American Academy of Neurology], the guideline also examines the evidence base for a treatment alternative to warfarin or its analogues for patients in developing countries who may not have access to the new oral anticoagulants," said lead author Dr. Antonio Culebras in an interview.

"The World Health Organization has determined that atrial fibrillation has reached near-epidemic proportions," observed Dr. Culebras of the State University of New York, Syracuse. "Approximately 1 in 20 individuals with AF will have a stroke unless treated appropriately."

The risk for stroke among patients with NVAF is highest in those with a history of transient ischemic attack (TIA) or prior stroke, at an absolute value of around 10% per year. Patients with "lone NVAF," meaning they have no additional risk factors, have less than a 2% increased risk of stroke per year.

The AAN issued a practice parameter on this topic in 1998 (Neurology 1998;51:671-3). At the time, warfarin, adjusted to an international normalized ratio (INR) of 2.0, was, and largely remains, the recommended standard for patients at risk for cardioembolic stroke. Aspirin was the only recommended alterative for those unable to receive the vitamin K antagonist or who were deemed to be at low risk of stroke, although the evidence was scanty.

Since then, several new oral anticoagulant agents have become available, including the direct thrombin inhibitor dabigatran (Pradaxa), and two factor Xa inhibitors – rivaroxaban (Xarelto) and apixaban (Eliquis) – which have been shown to be at least as effective as, if not more effective than, warfarin. Cardiac rhythm monitoring via a variety of methods has also been introduced as a means to try to detect NVAF in asymptomatic patients.

The aim of the AAN guideline (Neurology 2014;82:716-24) was therefore to look at the latest evidence on the detection of AF using new technologies, as well as the use of treatments to reduce the risk of stroke without increasing the risk of hemorrhage versus the long-standing standard of therapy, warfarin. Data published from 1998 to March 2013 were considered in the preparation of the guideline.

Cardiac rhythm monitoring for NVAF

Seventeen studies were found that examined the use of cardiac monitoring technologies to detect new cases of NVAF. The most common methods used were 24-hour Holter monitoring and serial electrocardiograms, but some emerging evidence on newer technologies was included. The proportion of patients identified with NVAF ranged from 0% to 23%, with the average detection rate 10.7% in all of the studies included.

"The guideline addresses the question of long-term monitoring of patients with NVAF," Dr. Culebras said. "It recommends that clinicians ‘might’ [level C evidence] obtain outpatient cardiac rhythm studies in patients with cryptogenic stroke without known NVAF to identify patients with occult NVAF." He added that the guideline also recommends that monitoring might be needed for prolonged periods of 1 or more weeks rather than for shorter periods, such as 24 hours.

However, at the time the guideline was being prepared, recent data from the CRYSTAL-AF study were not available, and this means the guideline is already outdated, Dr. Richard A. Bernstein, professor of neurology at Northwestern University, Chicago, said in an interview. He was not a guideline author.

Dr. Bernstein was on the steering committee for the CRYSTAL-AF trial, which assessed the performance of Medtronic’s Reveal XT Insertable Cardiac Monitor and found that the implanted device could detect NVAF better than serial ECGs or Holter monitoring (8.6% vs. 1.4%; P = .0006); most (74%) cases of NVAF found were asymptomatic.*

"CRYSTAL-AF represents the state of the art for cardiac monitoring in cryptogenic stroke patients and makes the AAN guidelines obsolete," Dr. Berstein said. "[The study] shows that even intermediate-term monitoring (less than 1 month) will miss the majority of AF in this population, and that most of the AF we find with long-term (greater than 1 year) monitoring is likely to be clinically significant."

 

 

With regard to the AAN guideline, he added: "There is no discussion of truly long-term monitoring in the guideline, which is unfortunate." That said, "anything that gets neurologists thinking about long-term cardiac monitoring is likely to be beneficial."

Anticoagulation for stroke prevention

The AAN guideline also provides general recommendations on the use of novel oral anticoagulant agents (NOACs) as alternatives to warfarin. Specifically, it notes that in comparison with warfarin, these NOACs are probably at least as effective (rivaroxaban) or more effective (dabigatran and apixaban). Additionally, while apixaban is also likely to be more effective than aspirin, it is associated with a similar risk for bleeding. NOACs have the following advantages over warfarin: an overall lower risk of intracranial hemorrhage and no need for routine anticoagulant monitoring.

From a practical perspective, the AAN guideline suggests that clinicians have the following options available: warfarin to reach an INR of 2.0-3.0, dabigatran 150 mg twice daily, rivaroxaban 15-20 mg/dL, apixaban 2.5-5 mg twice a day, and triflusal 600 mg plus acenocoumarol to reach an INR target of 1.25-2.0. If a patient is already taking warfarin and is well controlled, then they should remain on that therapy and not switch to a newer oral anticoagulant.

The guideline also notes that clopidogrel plus aspirin is probably less effective than warfarin, but the combination is probably better than aspirin alone. However, the risk of hemorrhage is higher.

Where used, triflusal plus acenocoumarol is "likely more effective" than acenocoumarol alone. Triflusal is an antiplatelet drug related to aspirin, used in Europe, Latin America, and Southeast Asia. Acenocoumarol is mostly used in European countries.

Dr. Culebras explained that the guideline was not intended to dictate which treatment to use. "The guideline leaves room on purpose for clinicians to use their judgment," he said. "The overall objective of the guideline is to reduce therapeutic uncertainty and not to issue commandments for treatment."

Although Dr. Bernstein was critical of the guidelines for not advocating the use of anticoagulants strongly enough, he said that the recommendations on anticoagulant choice are "reasonable in that they impute potential clinical profiles of patients who might particularly benefit from one NOAC over another, without making a claim that these recommendations are based on solid data. This reflects how doctors make decisions when we don’t have direct comparative studies, and I think that is helpful."

The guideline was developed with financial support from the American Academy of Neurology. None of the authors received reimbursement, honoraria, or stipends for their participation in the development of the guideline.

Dr. Culebras has received one-time funding for travel from J. Uriach & Co, and he serves on the editorial boards of MedLink, UpToDate.com, and the International Journal of Stroke. He has received royalties from Informa Healthcare and Cambridge University Press, and has held stock in Clinical Stroke Research. Other authors reported current or past ties to companies marketing oral anticoagulants and stroke treatments.

Dr. Bernstein was on the steering committee for the CRYSTAL-AF study and is a paid speaker, researcher, and consultant for Medtronic, Bristol-Myers Squibb, Pfizer, Boehringer Ingelheim, and Lifewatch.

*Correction, 4/8/2014: The article previously misstated what the implantable device was detecting in the CRYSTAL-AF study.

Body


Dr. Richard Bernstein

These guidelines are a missed opportunity to empower neurologists to advocate in favor of anticoagulation to prevent stroke. The biggest public health problem in AF is that only half of patients who need anticoagulation are getting it. This disgraceful state of affairs results in patients having cardioembolic strokes that are fatal or worse and that could have been prevented. We neurologists see these complications of inadequate treatment and should be on the front lines of prevention. These tepid guidelines give as much space to bleeding as they do to ischemic stroke prevention, which is inappropriate, and I fear will make neurologists, who are not terribly assertive under any circumstances, even less willing to push doctors to use anticoagulants. 

I would have been happier with a single page that said: "Stop using aspirin. Patients fear major stroke more than they fear bleeding or death, and they are right. Stop undertreating your patients and start preventing strokes." 

Dr. Richard A. Bernstein is professor of neurology and director of the stroke program at Northwestern University, Chicago. 

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Dr. Richard Bernstein

These guidelines are a missed opportunity to empower neurologists to advocate in favor of anticoagulation to prevent stroke. The biggest public health problem in AF is that only half of patients who need anticoagulation are getting it. This disgraceful state of affairs results in patients having cardioembolic strokes that are fatal or worse and that could have been prevented. We neurologists see these complications of inadequate treatment and should be on the front lines of prevention. These tepid guidelines give as much space to bleeding as they do to ischemic stroke prevention, which is inappropriate, and I fear will make neurologists, who are not terribly assertive under any circumstances, even less willing to push doctors to use anticoagulants. 

I would have been happier with a single page that said: "Stop using aspirin. Patients fear major stroke more than they fear bleeding or death, and they are right. Stop undertreating your patients and start preventing strokes." 

Dr. Richard A. Bernstein is professor of neurology and director of the stroke program at Northwestern University, Chicago. 

Body


Dr. Richard Bernstein

These guidelines are a missed opportunity to empower neurologists to advocate in favor of anticoagulation to prevent stroke. The biggest public health problem in AF is that only half of patients who need anticoagulation are getting it. This disgraceful state of affairs results in patients having cardioembolic strokes that are fatal or worse and that could have been prevented. We neurologists see these complications of inadequate treatment and should be on the front lines of prevention. These tepid guidelines give as much space to bleeding as they do to ischemic stroke prevention, which is inappropriate, and I fear will make neurologists, who are not terribly assertive under any circumstances, even less willing to push doctors to use anticoagulants. 

I would have been happier with a single page that said: "Stop using aspirin. Patients fear major stroke more than they fear bleeding or death, and they are right. Stop undertreating your patients and start preventing strokes." 

Dr. Richard A. Bernstein is professor of neurology and director of the stroke program at Northwestern University, Chicago. 

Title
'Tepid guidelines' miss opportunity
'Tepid guidelines' miss opportunity

A new evidence-based guideline on how to identify and treat patients with nonvalvular atrial fibrillation to prevent cardioembolic stroke from the American Academy of Neurology suggests when to conduct cardiac rhythm monitoring and offer anticoagulation, including newer agents in place of warfarin.

But the guideline might already be outdated in not considering the results of the recent CRYSTAL-AF study, in which long-term cardiac rhythm monitoring of patients with a previous cryptogenic stroke detected asymptomatic patients at a significantly higher rate than did standard monitoring methods.

Dr. Antonio Culebras

The guideline also extends the routine use of anticoagulation for patients with nonvalvular atrial fibrillation (NVAF) who are generally undertreated or whose health was thought a possible barrier to their use, such as those aged 75 years or older, those with mild dementia, and those at moderate risk of falls.

"Cognizant of the global reach of the AAN [American Academy of Neurology], the guideline also examines the evidence base for a treatment alternative to warfarin or its analogues for patients in developing countries who may not have access to the new oral anticoagulants," said lead author Dr. Antonio Culebras in an interview.

"The World Health Organization has determined that atrial fibrillation has reached near-epidemic proportions," observed Dr. Culebras of the State University of New York, Syracuse. "Approximately 1 in 20 individuals with AF will have a stroke unless treated appropriately."

The risk for stroke among patients with NVAF is highest in those with a history of transient ischemic attack (TIA) or prior stroke, at an absolute value of around 10% per year. Patients with "lone NVAF," meaning they have no additional risk factors, have less than a 2% increased risk of stroke per year.

The AAN issued a practice parameter on this topic in 1998 (Neurology 1998;51:671-3). At the time, warfarin, adjusted to an international normalized ratio (INR) of 2.0, was, and largely remains, the recommended standard for patients at risk for cardioembolic stroke. Aspirin was the only recommended alterative for those unable to receive the vitamin K antagonist or who were deemed to be at low risk of stroke, although the evidence was scanty.

Since then, several new oral anticoagulant agents have become available, including the direct thrombin inhibitor dabigatran (Pradaxa), and two factor Xa inhibitors – rivaroxaban (Xarelto) and apixaban (Eliquis) – which have been shown to be at least as effective as, if not more effective than, warfarin. Cardiac rhythm monitoring via a variety of methods has also been introduced as a means to try to detect NVAF in asymptomatic patients.

The aim of the AAN guideline (Neurology 2014;82:716-24) was therefore to look at the latest evidence on the detection of AF using new technologies, as well as the use of treatments to reduce the risk of stroke without increasing the risk of hemorrhage versus the long-standing standard of therapy, warfarin. Data published from 1998 to March 2013 were considered in the preparation of the guideline.

Cardiac rhythm monitoring for NVAF

Seventeen studies were found that examined the use of cardiac monitoring technologies to detect new cases of NVAF. The most common methods used were 24-hour Holter monitoring and serial electrocardiograms, but some emerging evidence on newer technologies was included. The proportion of patients identified with NVAF ranged from 0% to 23%, with the average detection rate 10.7% in all of the studies included.

"The guideline addresses the question of long-term monitoring of patients with NVAF," Dr. Culebras said. "It recommends that clinicians ‘might’ [level C evidence] obtain outpatient cardiac rhythm studies in patients with cryptogenic stroke without known NVAF to identify patients with occult NVAF." He added that the guideline also recommends that monitoring might be needed for prolonged periods of 1 or more weeks rather than for shorter periods, such as 24 hours.

However, at the time the guideline was being prepared, recent data from the CRYSTAL-AF study were not available, and this means the guideline is already outdated, Dr. Richard A. Bernstein, professor of neurology at Northwestern University, Chicago, said in an interview. He was not a guideline author.

Dr. Bernstein was on the steering committee for the CRYSTAL-AF trial, which assessed the performance of Medtronic’s Reveal XT Insertable Cardiac Monitor and found that the implanted device could detect NVAF better than serial ECGs or Holter monitoring (8.6% vs. 1.4%; P = .0006); most (74%) cases of NVAF found were asymptomatic.*

"CRYSTAL-AF represents the state of the art for cardiac monitoring in cryptogenic stroke patients and makes the AAN guidelines obsolete," Dr. Berstein said. "[The study] shows that even intermediate-term monitoring (less than 1 month) will miss the majority of AF in this population, and that most of the AF we find with long-term (greater than 1 year) monitoring is likely to be clinically significant."

 

 

With regard to the AAN guideline, he added: "There is no discussion of truly long-term monitoring in the guideline, which is unfortunate." That said, "anything that gets neurologists thinking about long-term cardiac monitoring is likely to be beneficial."

Anticoagulation for stroke prevention

The AAN guideline also provides general recommendations on the use of novel oral anticoagulant agents (NOACs) as alternatives to warfarin. Specifically, it notes that in comparison with warfarin, these NOACs are probably at least as effective (rivaroxaban) or more effective (dabigatran and apixaban). Additionally, while apixaban is also likely to be more effective than aspirin, it is associated with a similar risk for bleeding. NOACs have the following advantages over warfarin: an overall lower risk of intracranial hemorrhage and no need for routine anticoagulant monitoring.

From a practical perspective, the AAN guideline suggests that clinicians have the following options available: warfarin to reach an INR of 2.0-3.0, dabigatran 150 mg twice daily, rivaroxaban 15-20 mg/dL, apixaban 2.5-5 mg twice a day, and triflusal 600 mg plus acenocoumarol to reach an INR target of 1.25-2.0. If a patient is already taking warfarin and is well controlled, then they should remain on that therapy and not switch to a newer oral anticoagulant.

The guideline also notes that clopidogrel plus aspirin is probably less effective than warfarin, but the combination is probably better than aspirin alone. However, the risk of hemorrhage is higher.

Where used, triflusal plus acenocoumarol is "likely more effective" than acenocoumarol alone. Triflusal is an antiplatelet drug related to aspirin, used in Europe, Latin America, and Southeast Asia. Acenocoumarol is mostly used in European countries.

Dr. Culebras explained that the guideline was not intended to dictate which treatment to use. "The guideline leaves room on purpose for clinicians to use their judgment," he said. "The overall objective of the guideline is to reduce therapeutic uncertainty and not to issue commandments for treatment."

Although Dr. Bernstein was critical of the guidelines for not advocating the use of anticoagulants strongly enough, he said that the recommendations on anticoagulant choice are "reasonable in that they impute potential clinical profiles of patients who might particularly benefit from one NOAC over another, without making a claim that these recommendations are based on solid data. This reflects how doctors make decisions when we don’t have direct comparative studies, and I think that is helpful."

The guideline was developed with financial support from the American Academy of Neurology. None of the authors received reimbursement, honoraria, or stipends for their participation in the development of the guideline.

Dr. Culebras has received one-time funding for travel from J. Uriach & Co, and he serves on the editorial boards of MedLink, UpToDate.com, and the International Journal of Stroke. He has received royalties from Informa Healthcare and Cambridge University Press, and has held stock in Clinical Stroke Research. Other authors reported current or past ties to companies marketing oral anticoagulants and stroke treatments.

Dr. Bernstein was on the steering committee for the CRYSTAL-AF study and is a paid speaker, researcher, and consultant for Medtronic, Bristol-Myers Squibb, Pfizer, Boehringer Ingelheim, and Lifewatch.

*Correction, 4/8/2014: The article previously misstated what the implantable device was detecting in the CRYSTAL-AF study.

A new evidence-based guideline on how to identify and treat patients with nonvalvular atrial fibrillation to prevent cardioembolic stroke from the American Academy of Neurology suggests when to conduct cardiac rhythm monitoring and offer anticoagulation, including newer agents in place of warfarin.

But the guideline might already be outdated in not considering the results of the recent CRYSTAL-AF study, in which long-term cardiac rhythm monitoring of patients with a previous cryptogenic stroke detected asymptomatic patients at a significantly higher rate than did standard monitoring methods.

Dr. Antonio Culebras

The guideline also extends the routine use of anticoagulation for patients with nonvalvular atrial fibrillation (NVAF) who are generally undertreated or whose health was thought a possible barrier to their use, such as those aged 75 years or older, those with mild dementia, and those at moderate risk of falls.

"Cognizant of the global reach of the AAN [American Academy of Neurology], the guideline also examines the evidence base for a treatment alternative to warfarin or its analogues for patients in developing countries who may not have access to the new oral anticoagulants," said lead author Dr. Antonio Culebras in an interview.

"The World Health Organization has determined that atrial fibrillation has reached near-epidemic proportions," observed Dr. Culebras of the State University of New York, Syracuse. "Approximately 1 in 20 individuals with AF will have a stroke unless treated appropriately."

The risk for stroke among patients with NVAF is highest in those with a history of transient ischemic attack (TIA) or prior stroke, at an absolute value of around 10% per year. Patients with "lone NVAF," meaning they have no additional risk factors, have less than a 2% increased risk of stroke per year.

The AAN issued a practice parameter on this topic in 1998 (Neurology 1998;51:671-3). At the time, warfarin, adjusted to an international normalized ratio (INR) of 2.0, was, and largely remains, the recommended standard for patients at risk for cardioembolic stroke. Aspirin was the only recommended alterative for those unable to receive the vitamin K antagonist or who were deemed to be at low risk of stroke, although the evidence was scanty.

Since then, several new oral anticoagulant agents have become available, including the direct thrombin inhibitor dabigatran (Pradaxa), and two factor Xa inhibitors – rivaroxaban (Xarelto) and apixaban (Eliquis) – which have been shown to be at least as effective as, if not more effective than, warfarin. Cardiac rhythm monitoring via a variety of methods has also been introduced as a means to try to detect NVAF in asymptomatic patients.

The aim of the AAN guideline (Neurology 2014;82:716-24) was therefore to look at the latest evidence on the detection of AF using new technologies, as well as the use of treatments to reduce the risk of stroke without increasing the risk of hemorrhage versus the long-standing standard of therapy, warfarin. Data published from 1998 to March 2013 were considered in the preparation of the guideline.

Cardiac rhythm monitoring for NVAF

Seventeen studies were found that examined the use of cardiac monitoring technologies to detect new cases of NVAF. The most common methods used were 24-hour Holter monitoring and serial electrocardiograms, but some emerging evidence on newer technologies was included. The proportion of patients identified with NVAF ranged from 0% to 23%, with the average detection rate 10.7% in all of the studies included.

"The guideline addresses the question of long-term monitoring of patients with NVAF," Dr. Culebras said. "It recommends that clinicians ‘might’ [level C evidence] obtain outpatient cardiac rhythm studies in patients with cryptogenic stroke without known NVAF to identify patients with occult NVAF." He added that the guideline also recommends that monitoring might be needed for prolonged periods of 1 or more weeks rather than for shorter periods, such as 24 hours.

However, at the time the guideline was being prepared, recent data from the CRYSTAL-AF study were not available, and this means the guideline is already outdated, Dr. Richard A. Bernstein, professor of neurology at Northwestern University, Chicago, said in an interview. He was not a guideline author.

Dr. Bernstein was on the steering committee for the CRYSTAL-AF trial, which assessed the performance of Medtronic’s Reveal XT Insertable Cardiac Monitor and found that the implanted device could detect NVAF better than serial ECGs or Holter monitoring (8.6% vs. 1.4%; P = .0006); most (74%) cases of NVAF found were asymptomatic.*

"CRYSTAL-AF represents the state of the art for cardiac monitoring in cryptogenic stroke patients and makes the AAN guidelines obsolete," Dr. Berstein said. "[The study] shows that even intermediate-term monitoring (less than 1 month) will miss the majority of AF in this population, and that most of the AF we find with long-term (greater than 1 year) monitoring is likely to be clinically significant."

 

 

With regard to the AAN guideline, he added: "There is no discussion of truly long-term monitoring in the guideline, which is unfortunate." That said, "anything that gets neurologists thinking about long-term cardiac monitoring is likely to be beneficial."

Anticoagulation for stroke prevention

The AAN guideline also provides general recommendations on the use of novel oral anticoagulant agents (NOACs) as alternatives to warfarin. Specifically, it notes that in comparison with warfarin, these NOACs are probably at least as effective (rivaroxaban) or more effective (dabigatran and apixaban). Additionally, while apixaban is also likely to be more effective than aspirin, it is associated with a similar risk for bleeding. NOACs have the following advantages over warfarin: an overall lower risk of intracranial hemorrhage and no need for routine anticoagulant monitoring.

From a practical perspective, the AAN guideline suggests that clinicians have the following options available: warfarin to reach an INR of 2.0-3.0, dabigatran 150 mg twice daily, rivaroxaban 15-20 mg/dL, apixaban 2.5-5 mg twice a day, and triflusal 600 mg plus acenocoumarol to reach an INR target of 1.25-2.0. If a patient is already taking warfarin and is well controlled, then they should remain on that therapy and not switch to a newer oral anticoagulant.

The guideline also notes that clopidogrel plus aspirin is probably less effective than warfarin, but the combination is probably better than aspirin alone. However, the risk of hemorrhage is higher.

Where used, triflusal plus acenocoumarol is "likely more effective" than acenocoumarol alone. Triflusal is an antiplatelet drug related to aspirin, used in Europe, Latin America, and Southeast Asia. Acenocoumarol is mostly used in European countries.

Dr. Culebras explained that the guideline was not intended to dictate which treatment to use. "The guideline leaves room on purpose for clinicians to use their judgment," he said. "The overall objective of the guideline is to reduce therapeutic uncertainty and not to issue commandments for treatment."

Although Dr. Bernstein was critical of the guidelines for not advocating the use of anticoagulants strongly enough, he said that the recommendations on anticoagulant choice are "reasonable in that they impute potential clinical profiles of patients who might particularly benefit from one NOAC over another, without making a claim that these recommendations are based on solid data. This reflects how doctors make decisions when we don’t have direct comparative studies, and I think that is helpful."

The guideline was developed with financial support from the American Academy of Neurology. None of the authors received reimbursement, honoraria, or stipends for their participation in the development of the guideline.

Dr. Culebras has received one-time funding for travel from J. Uriach & Co, and he serves on the editorial boards of MedLink, UpToDate.com, and the International Journal of Stroke. He has received royalties from Informa Healthcare and Cambridge University Press, and has held stock in Clinical Stroke Research. Other authors reported current or past ties to companies marketing oral anticoagulants and stroke treatments.

Dr. Bernstein was on the steering committee for the CRYSTAL-AF study and is a paid speaker, researcher, and consultant for Medtronic, Bristol-Myers Squibb, Pfizer, Boehringer Ingelheim, and Lifewatch.

*Correction, 4/8/2014: The article previously misstated what the implantable device was detecting in the CRYSTAL-AF study.

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AAN issues nonvalvular atrial fibrillation stroke prevention guideline
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Bevacizumab improved survival in advanced cervical cancer

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Adding bevacizumab to combination chemotherapy improved survival for women with advanced cervical cancer.

Women in the Gynecologic Oncology Group (GOG) trial who received bevacizumab in addition to chemotherapy lived about 4 months longer than their counterparts who received chemotherapy alone, Dr. Krishnansu S. Tewari and his associates reported Feb. 20 in the New England Journal of Medicine.

The trial was open to women who had chemotherapy-naive, recurrent, persistent, or metastatic cervical cancer. A total of 452 women were randomized in dual factorial design according to chemotherapy doublet (cisplatin plus paclitaxel vs. topotecan plus paclitaxel) and receipt of bevacizumab (yes vs. no). Treatment was on an open-label basis, and crossover was not allowed (N. Engl. J. Med. 2014;370:734-43).

Dr. Krishnansu S. Tewari

An interim analysis showed that the topotecan-paclitaxel regimen was neither superior nor inferior to the cisplatin-paclitaxel regimen that has been the standard in this setting.

With longer follow-up, to a median of 20.8 months, women who received added bevacizumab had a longer median overall survival than did their counterparts who received chemotherapy alone (17.0 vs. 13.3 months; hazard ratio, 0.71; P = .0035). Bevacizumab conferred a significant survival benefit when added to cisplatin-paclitaxel chemotherapy (HR, 0.68; P = .03) but not when added to topotecan-paclitaxel chemotherapy (HR, 0.74; P = .09).

Adverse effects were largely consistent with previous experience in other cancers with bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor, Dr. Tewari and his associates reported.

The study was presented last year at the annual meeting of the American Society of Clinical Oncology. See our full coverage here.

The trial was sponsored by the National Cancer Institute. Dr. Tewari disclosed no relevant conflicts of interest. Roche/Genentech provided bevacizumab for the trial.

lnikolaides@frontlinemedcom.com

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Adding bevacizumab to combination chemotherapy improved survival for women with advanced cervical cancer.

Women in the Gynecologic Oncology Group (GOG) trial who received bevacizumab in addition to chemotherapy lived about 4 months longer than their counterparts who received chemotherapy alone, Dr. Krishnansu S. Tewari and his associates reported Feb. 20 in the New England Journal of Medicine.

The trial was open to women who had chemotherapy-naive, recurrent, persistent, or metastatic cervical cancer. A total of 452 women were randomized in dual factorial design according to chemotherapy doublet (cisplatin plus paclitaxel vs. topotecan plus paclitaxel) and receipt of bevacizumab (yes vs. no). Treatment was on an open-label basis, and crossover was not allowed (N. Engl. J. Med. 2014;370:734-43).

Dr. Krishnansu S. Tewari

An interim analysis showed that the topotecan-paclitaxel regimen was neither superior nor inferior to the cisplatin-paclitaxel regimen that has been the standard in this setting.

With longer follow-up, to a median of 20.8 months, women who received added bevacizumab had a longer median overall survival than did their counterparts who received chemotherapy alone (17.0 vs. 13.3 months; hazard ratio, 0.71; P = .0035). Bevacizumab conferred a significant survival benefit when added to cisplatin-paclitaxel chemotherapy (HR, 0.68; P = .03) but not when added to topotecan-paclitaxel chemotherapy (HR, 0.74; P = .09).

Adverse effects were largely consistent with previous experience in other cancers with bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor, Dr. Tewari and his associates reported.

The study was presented last year at the annual meeting of the American Society of Clinical Oncology. See our full coverage here.

The trial was sponsored by the National Cancer Institute. Dr. Tewari disclosed no relevant conflicts of interest. Roche/Genentech provided bevacizumab for the trial.

lnikolaides@frontlinemedcom.com

Adding bevacizumab to combination chemotherapy improved survival for women with advanced cervical cancer.

Women in the Gynecologic Oncology Group (GOG) trial who received bevacizumab in addition to chemotherapy lived about 4 months longer than their counterparts who received chemotherapy alone, Dr. Krishnansu S. Tewari and his associates reported Feb. 20 in the New England Journal of Medicine.

The trial was open to women who had chemotherapy-naive, recurrent, persistent, or metastatic cervical cancer. A total of 452 women were randomized in dual factorial design according to chemotherapy doublet (cisplatin plus paclitaxel vs. topotecan plus paclitaxel) and receipt of bevacizumab (yes vs. no). Treatment was on an open-label basis, and crossover was not allowed (N. Engl. J. Med. 2014;370:734-43).

Dr. Krishnansu S. Tewari

An interim analysis showed that the topotecan-paclitaxel regimen was neither superior nor inferior to the cisplatin-paclitaxel regimen that has been the standard in this setting.

With longer follow-up, to a median of 20.8 months, women who received added bevacizumab had a longer median overall survival than did their counterparts who received chemotherapy alone (17.0 vs. 13.3 months; hazard ratio, 0.71; P = .0035). Bevacizumab conferred a significant survival benefit when added to cisplatin-paclitaxel chemotherapy (HR, 0.68; P = .03) but not when added to topotecan-paclitaxel chemotherapy (HR, 0.74; P = .09).

Adverse effects were largely consistent with previous experience in other cancers with bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor, Dr. Tewari and his associates reported.

The study was presented last year at the annual meeting of the American Society of Clinical Oncology. See our full coverage here.

The trial was sponsored by the National Cancer Institute. Dr. Tewari disclosed no relevant conflicts of interest. Roche/Genentech provided bevacizumab for the trial.

lnikolaides@frontlinemedcom.com

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Major finding: Women who received added bevacizumab had a longer median overall survival than women who received chemotherapy alone (17.0 vs. 13.3 months).

Data source: Phase III, randomized, factorial design study of 452 women with chemotherapy-naive, recurrent, persistent, or metastatic cervical cancer (GOG 240). Treatment was open label with no crossover.

Disclosures: The trial was sponsored by the National Cancer Institute. Dr. Tewari disclosed no relevant conflicts of interest. Roche/Genentech provided bevacizumab for the trial.

ADA backs second gestational diabetes screening option

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SAN FRANCISCO – Updated guidelines from the American Diabetes Association open the door to using a two-step approach to gestational diabetes screening.

Screening is still recommended for undiagnosed type 2 diabetes at the first prenatal visit in those with risk factors, and for gestational diabetes mellitus (GDM) between weeks 24 and 28 of gestation.

What’s changed in the 2014 Standards of Medical Care in Diabetes (Diabetes Care 2014;37(suppl 1):S14-80) is how that screening is accomplished, Dr. Richard W. Grant, chair of the ADA professional practice committee, said at the annual advanced postgraduate course held by the American Diabetes Association.

In prior years, the ADA adopted the International Association of Diabetes and Pregnancy Study Groups (IADPSG) 2009 recommendation that a 2-hour, 75-gram oral glucose tolerance test (OGTT) be performed the morning after a fast of at least an 8 hours.

A two-step approach was added this year to reflect the 2013 National Institutes of Health Consensus Guidelines recommendation for a 1-hour, 50-gram glucose tolerance screening test followed by a fasting OGTT on another day, if the test is abnormal.

One-step vs. two-step approach

"The issues for these two approaches are the sensitivity with which you can diagnose GDM and the difficulty in implementing these two approaches," said Dr. Grant, a research scientist with Kaiser Permanente Northern California, Oakland.

The one-step approach tends to be more sensitive and diagnoses a broader range of GDM, but it may be a barrier to screening because it requires the patient to fast for 8 hours, he said. Though the one-step approach allows for a diagnosis of GDM within the context of a single office visit, critics also argue its tight diagnostic glucose cut points could dramatically increase the prevalence of GDM from about 5%-6% to 15%-20%, and bring added health care costs and interventions without clear evidence of improved outcomes.

Dr. Richard W. Grant

On the other hand, the two-step approach may be more palatable to women because it avoids the up-front fasting requirement, but it could miss GDM in women with an abnormal screen who fail to return for a second visit.

"The bottom line is we need to make sure we do gestational diabetes screening, whichever method we use," Dr. Grant said. "What’s more important is that all women in early pregnancy get screened."

During a discussion following the presentation, a Canadian attendee said similar recommendations released last fall in Canada allowing two screening methods, albeit with different diagnostic thresholds, have resulted in confusion, particularly among referring obstetricians and endocrinologists.

Dr. Grant said there shouldn’t be confusion surrounding the new option as long as recommendations are consistent within an institution.

"I don’t think it’s actually going to make people change what they’re doing currently," he said in an interview. "There’s not a good reason to jump from one to another if you’ve already chosen an approach."

In a separate interview, Dr. R. Harsha Rao, with the Center for Diabetes and Endocrinology at the University of Pittsburgh, said he can see the rationale for the one-step method, but that the two-step approach is almost implanted in the DNA of American obstetricians and that this behavior pattern will be difficult to change for practical reasons alone.

"Patients don’t like 75 grams of Glucola; it’s an awful-tasting substance," he said. "I’ve had patients tell me they felt like [vomiting] when they got the 75-gram Glucola load, and as it is, ‘I’m pregnant and already feeling nauseated.’ "

In addition, there’s the added stress of waiting for a second appointment and a definitive diagnosis for women who screen positive.

The ADA’s bimodal approach to gestational screening reflects an overarching theme of individualized care for diabetes in the 2014 standards. The guidelines are updated annually and this year they contain 232 recommendations, of which 52% are based on high level A or B evidence.

Individualized diabetes care

"One of the themes that comes out in looking at the data very carefully is that you can’t have a one-size-fits-all approach," Dr. Grant observed.

To that end, the guidelines maintain an earlier recommendation raising the systolic blood pressure target goal for hypertension to 140 mm Hg, but also allow a target goal of less than 130 mm Hg in certain populations, such as younger patients.

Dr. Grant observed that the ADA’s position was confirmed by the U.S. Preventive Services Task Force’s recent endorsement of GDM screening using the two-step approach.

"The USPSTF said that the two-step method is an accurate approach, which is what the ADA also says," he remarked.

Based on the recently revised 2013 ADA nutrition position paper (described in the next section below), the guidelines also encourage individualized dietary approaches rather recommending one particular diet over another, Dr. Grant said.

 

 

Other revisions include:

• Clarification that the hemoglobin A1c test is just one of three methods to diagnose diabetes in asymptomatic patients, along with the fasting plasma glucose or 75-gram, 2-hour OGTT;

• An expanded chapter on neuropathy screening and treatment, including B level evidentiary support to test for distal symmetric polyneuropathy;

• Added emphasis on the need to ask patients about symptomatic and asymptomatic hypoglycemia and perform ongoing assessments of cognitive function; and

• Added emphasis on a patient-centered communication style that assesses literacy, but also the often overlooked issue of numeracy.

"It’s really quite impressive how many patients don’t get numbers, but we as physicians speak in numbers," Dr. Grant said.

The recent controversial 2013 American College of Cardiology/American Heart Association cholesterol guideline could not be reviewed in time to for this year’s guidelines, but it will be something to keep an eye out for next year.

ADA dodges dietary dogma

Highlights of the American Diabetes Association’s nutrition recommendations, updated in late 2013, and also presented at the meeting by Patti Urbanski, M.Ed., a member of the ADA Nutrition Recommendations Writing Group Committee, include:

• Select an "eating pattern" based on an individual’s personal and cultural preferences; literacy and numeracy; readiness; and ability to change, because no one dietary plan – be it the Mediterranean, low-carb, or DASH (Dietary Approaches to Stop Hypertension) diet – is best.

• In the absence of evidence supporting an ideal percentage of calories from carbohydrates, protein, or fat for all patients with diabetes, macronutrient distribution should be based on individualized assessment of current eating patterns, preferences, and goals.

• Reduce energy intake/carbohydrate portions and number of servings per meal, as indicated by individual assessment.

• Early referral to registered dietitians and nutritionists for nutrition therapy.

• First-ever call to avoid sugar-sweetened beverages.

• Continued support to limit sodium intake to 2,300 mg/day, as recommended for the general population, with lower sodium targets an option for those with comorbid hypertension.

• Routine supplementation with oxidants, such as vitamin E and C and carotene, is not advised, nor is routine use of micronutrients such as chromium, magnesium, and vitamin D to improve glycemic control.

Dr. Grant disclosed no conflicts of interest.

pwendling@frontlinemedcom.com

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SAN FRANCISCO – Updated guidelines from the American Diabetes Association open the door to using a two-step approach to gestational diabetes screening.

Screening is still recommended for undiagnosed type 2 diabetes at the first prenatal visit in those with risk factors, and for gestational diabetes mellitus (GDM) between weeks 24 and 28 of gestation.

What’s changed in the 2014 Standards of Medical Care in Diabetes (Diabetes Care 2014;37(suppl 1):S14-80) is how that screening is accomplished, Dr. Richard W. Grant, chair of the ADA professional practice committee, said at the annual advanced postgraduate course held by the American Diabetes Association.

In prior years, the ADA adopted the International Association of Diabetes and Pregnancy Study Groups (IADPSG) 2009 recommendation that a 2-hour, 75-gram oral glucose tolerance test (OGTT) be performed the morning after a fast of at least an 8 hours.

A two-step approach was added this year to reflect the 2013 National Institutes of Health Consensus Guidelines recommendation for a 1-hour, 50-gram glucose tolerance screening test followed by a fasting OGTT on another day, if the test is abnormal.

One-step vs. two-step approach

"The issues for these two approaches are the sensitivity with which you can diagnose GDM and the difficulty in implementing these two approaches," said Dr. Grant, a research scientist with Kaiser Permanente Northern California, Oakland.

The one-step approach tends to be more sensitive and diagnoses a broader range of GDM, but it may be a barrier to screening because it requires the patient to fast for 8 hours, he said. Though the one-step approach allows for a diagnosis of GDM within the context of a single office visit, critics also argue its tight diagnostic glucose cut points could dramatically increase the prevalence of GDM from about 5%-6% to 15%-20%, and bring added health care costs and interventions without clear evidence of improved outcomes.

Dr. Richard W. Grant

On the other hand, the two-step approach may be more palatable to women because it avoids the up-front fasting requirement, but it could miss GDM in women with an abnormal screen who fail to return for a second visit.

"The bottom line is we need to make sure we do gestational diabetes screening, whichever method we use," Dr. Grant said. "What’s more important is that all women in early pregnancy get screened."

During a discussion following the presentation, a Canadian attendee said similar recommendations released last fall in Canada allowing two screening methods, albeit with different diagnostic thresholds, have resulted in confusion, particularly among referring obstetricians and endocrinologists.

Dr. Grant said there shouldn’t be confusion surrounding the new option as long as recommendations are consistent within an institution.

"I don’t think it’s actually going to make people change what they’re doing currently," he said in an interview. "There’s not a good reason to jump from one to another if you’ve already chosen an approach."

In a separate interview, Dr. R. Harsha Rao, with the Center for Diabetes and Endocrinology at the University of Pittsburgh, said he can see the rationale for the one-step method, but that the two-step approach is almost implanted in the DNA of American obstetricians and that this behavior pattern will be difficult to change for practical reasons alone.

"Patients don’t like 75 grams of Glucola; it’s an awful-tasting substance," he said. "I’ve had patients tell me they felt like [vomiting] when they got the 75-gram Glucola load, and as it is, ‘I’m pregnant and already feeling nauseated.’ "

In addition, there’s the added stress of waiting for a second appointment and a definitive diagnosis for women who screen positive.

The ADA’s bimodal approach to gestational screening reflects an overarching theme of individualized care for diabetes in the 2014 standards. The guidelines are updated annually and this year they contain 232 recommendations, of which 52% are based on high level A or B evidence.

Individualized diabetes care

"One of the themes that comes out in looking at the data very carefully is that you can’t have a one-size-fits-all approach," Dr. Grant observed.

To that end, the guidelines maintain an earlier recommendation raising the systolic blood pressure target goal for hypertension to 140 mm Hg, but also allow a target goal of less than 130 mm Hg in certain populations, such as younger patients.

Dr. Grant observed that the ADA’s position was confirmed by the U.S. Preventive Services Task Force’s recent endorsement of GDM screening using the two-step approach.

"The USPSTF said that the two-step method is an accurate approach, which is what the ADA also says," he remarked.

Based on the recently revised 2013 ADA nutrition position paper (described in the next section below), the guidelines also encourage individualized dietary approaches rather recommending one particular diet over another, Dr. Grant said.

 

 

Other revisions include:

• Clarification that the hemoglobin A1c test is just one of three methods to diagnose diabetes in asymptomatic patients, along with the fasting plasma glucose or 75-gram, 2-hour OGTT;

• An expanded chapter on neuropathy screening and treatment, including B level evidentiary support to test for distal symmetric polyneuropathy;

• Added emphasis on the need to ask patients about symptomatic and asymptomatic hypoglycemia and perform ongoing assessments of cognitive function; and

• Added emphasis on a patient-centered communication style that assesses literacy, but also the often overlooked issue of numeracy.

"It’s really quite impressive how many patients don’t get numbers, but we as physicians speak in numbers," Dr. Grant said.

The recent controversial 2013 American College of Cardiology/American Heart Association cholesterol guideline could not be reviewed in time to for this year’s guidelines, but it will be something to keep an eye out for next year.

ADA dodges dietary dogma

Highlights of the American Diabetes Association’s nutrition recommendations, updated in late 2013, and also presented at the meeting by Patti Urbanski, M.Ed., a member of the ADA Nutrition Recommendations Writing Group Committee, include:

• Select an "eating pattern" based on an individual’s personal and cultural preferences; literacy and numeracy; readiness; and ability to change, because no one dietary plan – be it the Mediterranean, low-carb, or DASH (Dietary Approaches to Stop Hypertension) diet – is best.

• In the absence of evidence supporting an ideal percentage of calories from carbohydrates, protein, or fat for all patients with diabetes, macronutrient distribution should be based on individualized assessment of current eating patterns, preferences, and goals.

• Reduce energy intake/carbohydrate portions and number of servings per meal, as indicated by individual assessment.

• Early referral to registered dietitians and nutritionists for nutrition therapy.

• First-ever call to avoid sugar-sweetened beverages.

• Continued support to limit sodium intake to 2,300 mg/day, as recommended for the general population, with lower sodium targets an option for those with comorbid hypertension.

• Routine supplementation with oxidants, such as vitamin E and C and carotene, is not advised, nor is routine use of micronutrients such as chromium, magnesium, and vitamin D to improve glycemic control.

Dr. Grant disclosed no conflicts of interest.

pwendling@frontlinemedcom.com

SAN FRANCISCO – Updated guidelines from the American Diabetes Association open the door to using a two-step approach to gestational diabetes screening.

Screening is still recommended for undiagnosed type 2 diabetes at the first prenatal visit in those with risk factors, and for gestational diabetes mellitus (GDM) between weeks 24 and 28 of gestation.

What’s changed in the 2014 Standards of Medical Care in Diabetes (Diabetes Care 2014;37(suppl 1):S14-80) is how that screening is accomplished, Dr. Richard W. Grant, chair of the ADA professional practice committee, said at the annual advanced postgraduate course held by the American Diabetes Association.

In prior years, the ADA adopted the International Association of Diabetes and Pregnancy Study Groups (IADPSG) 2009 recommendation that a 2-hour, 75-gram oral glucose tolerance test (OGTT) be performed the morning after a fast of at least an 8 hours.

A two-step approach was added this year to reflect the 2013 National Institutes of Health Consensus Guidelines recommendation for a 1-hour, 50-gram glucose tolerance screening test followed by a fasting OGTT on another day, if the test is abnormal.

One-step vs. two-step approach

"The issues for these two approaches are the sensitivity with which you can diagnose GDM and the difficulty in implementing these two approaches," said Dr. Grant, a research scientist with Kaiser Permanente Northern California, Oakland.

The one-step approach tends to be more sensitive and diagnoses a broader range of GDM, but it may be a barrier to screening because it requires the patient to fast for 8 hours, he said. Though the one-step approach allows for a diagnosis of GDM within the context of a single office visit, critics also argue its tight diagnostic glucose cut points could dramatically increase the prevalence of GDM from about 5%-6% to 15%-20%, and bring added health care costs and interventions without clear evidence of improved outcomes.

Dr. Richard W. Grant

On the other hand, the two-step approach may be more palatable to women because it avoids the up-front fasting requirement, but it could miss GDM in women with an abnormal screen who fail to return for a second visit.

"The bottom line is we need to make sure we do gestational diabetes screening, whichever method we use," Dr. Grant said. "What’s more important is that all women in early pregnancy get screened."

During a discussion following the presentation, a Canadian attendee said similar recommendations released last fall in Canada allowing two screening methods, albeit with different diagnostic thresholds, have resulted in confusion, particularly among referring obstetricians and endocrinologists.

Dr. Grant said there shouldn’t be confusion surrounding the new option as long as recommendations are consistent within an institution.

"I don’t think it’s actually going to make people change what they’re doing currently," he said in an interview. "There’s not a good reason to jump from one to another if you’ve already chosen an approach."

In a separate interview, Dr. R. Harsha Rao, with the Center for Diabetes and Endocrinology at the University of Pittsburgh, said he can see the rationale for the one-step method, but that the two-step approach is almost implanted in the DNA of American obstetricians and that this behavior pattern will be difficult to change for practical reasons alone.

"Patients don’t like 75 grams of Glucola; it’s an awful-tasting substance," he said. "I’ve had patients tell me they felt like [vomiting] when they got the 75-gram Glucola load, and as it is, ‘I’m pregnant and already feeling nauseated.’ "

In addition, there’s the added stress of waiting for a second appointment and a definitive diagnosis for women who screen positive.

The ADA’s bimodal approach to gestational screening reflects an overarching theme of individualized care for diabetes in the 2014 standards. The guidelines are updated annually and this year they contain 232 recommendations, of which 52% are based on high level A or B evidence.

Individualized diabetes care

"One of the themes that comes out in looking at the data very carefully is that you can’t have a one-size-fits-all approach," Dr. Grant observed.

To that end, the guidelines maintain an earlier recommendation raising the systolic blood pressure target goal for hypertension to 140 mm Hg, but also allow a target goal of less than 130 mm Hg in certain populations, such as younger patients.

Dr. Grant observed that the ADA’s position was confirmed by the U.S. Preventive Services Task Force’s recent endorsement of GDM screening using the two-step approach.

"The USPSTF said that the two-step method is an accurate approach, which is what the ADA also says," he remarked.

Based on the recently revised 2013 ADA nutrition position paper (described in the next section below), the guidelines also encourage individualized dietary approaches rather recommending one particular diet over another, Dr. Grant said.

 

 

Other revisions include:

• Clarification that the hemoglobin A1c test is just one of three methods to diagnose diabetes in asymptomatic patients, along with the fasting plasma glucose or 75-gram, 2-hour OGTT;

• An expanded chapter on neuropathy screening and treatment, including B level evidentiary support to test for distal symmetric polyneuropathy;

• Added emphasis on the need to ask patients about symptomatic and asymptomatic hypoglycemia and perform ongoing assessments of cognitive function; and

• Added emphasis on a patient-centered communication style that assesses literacy, but also the often overlooked issue of numeracy.

"It’s really quite impressive how many patients don’t get numbers, but we as physicians speak in numbers," Dr. Grant said.

The recent controversial 2013 American College of Cardiology/American Heart Association cholesterol guideline could not be reviewed in time to for this year’s guidelines, but it will be something to keep an eye out for next year.

ADA dodges dietary dogma

Highlights of the American Diabetes Association’s nutrition recommendations, updated in late 2013, and also presented at the meeting by Patti Urbanski, M.Ed., a member of the ADA Nutrition Recommendations Writing Group Committee, include:

• Select an "eating pattern" based on an individual’s personal and cultural preferences; literacy and numeracy; readiness; and ability to change, because no one dietary plan – be it the Mediterranean, low-carb, or DASH (Dietary Approaches to Stop Hypertension) diet – is best.

• In the absence of evidence supporting an ideal percentage of calories from carbohydrates, protein, or fat for all patients with diabetes, macronutrient distribution should be based on individualized assessment of current eating patterns, preferences, and goals.

• Reduce energy intake/carbohydrate portions and number of servings per meal, as indicated by individual assessment.

• Early referral to registered dietitians and nutritionists for nutrition therapy.

• First-ever call to avoid sugar-sweetened beverages.

• Continued support to limit sodium intake to 2,300 mg/day, as recommended for the general population, with lower sodium targets an option for those with comorbid hypertension.

• Routine supplementation with oxidants, such as vitamin E and C and carotene, is not advised, nor is routine use of micronutrients such as chromium, magnesium, and vitamin D to improve glycemic control.

Dr. Grant disclosed no conflicts of interest.

pwendling@frontlinemedcom.com

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New stroke guidelines focus on women’s risks

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Newly released guidelines provide the first evidence-based recommendations for preventing stroke in women.

The document addresses the issues that uniquely increase stroke risk in women – pregnancy, hormonal therapy, contraception, and migraine – along with factors like atrial fibrillation and obesity, Dr. Cheryl Bushnell and her colleagues wrote in the February issue of Stroke.

"If you are a woman, you share many of the same risk factors for stroke with men, but your risk is also influenced by hormones, reproductive health, pregnancy, childbirth, and other sex-related factors," Dr. Bushnell noted in a press statement.

The document – created by the American Heart Association and American Stroke Association – is the first to look at these gender-specific issues, wrote Dr. Bushnell, director of the Stroke Center at Wake Forest Baptist Medical Center in Winston-Salem, N.C. (Stroke 2014 [doi:10.1161/01.str.0000442009.06663.48]).

It provides graded evidence for preventive strategies in a number of risk categories. Evidence was obtained by examining dozens of studies numbering hundreds of thousands of women. But despite the extant literature, Dr. Bushnell and her colleagues said more research needs to be conducted.

©moodboard/thinkstockphotos.com
Few studies have examined the link between migraine with aura and stroke, although current data suggests that the risk may be doubled overall.

"There is a need for recognition of women’s unique, sex-specific stroke risk factors, and a risk score that includes these factors would thereby identify women at risk," they wrote. "Similarly, it is important to improve stroke awareness and provide more rigorous education to women at younger ages, including childbearing ages."

The guidelines are aimed at primary care providers, who have the biggest interface with women at a prevention level – and intended to help them forge an active partnership with patients.

"More importantly," the authors wrote, "this guideline may empower women and their families to understand their own risk and how they can minimize the chances of having a stroke."

Pregnancy

For recommendations on pregnancy outcomes and stroke related to preeclampsia, the guidelines drew on evidence from 17 studies.

For women with chronic primary or secondary hypertension, or with a history of pregnancy-related hypertension, Level A evidence supports using low-dose aspirin during the second and third trimester. Level A evidence also supports calcium supplementation to prevent preeclampsia in women with low dietary intake.

There was also a Level A recommendation to treat severe hypertension during pregnancy with safe antihypertensives (methyldopa, labetalol, and nifedipine). Level B evidence supported treating moderate hypertension. The use of atenolol, angiotensin receptor blockers, and direct renin inhibitors is contraindicated because of teratogenicity.

Because preeclampsia increases lifelong stroke risk, the guidelines also recommended evaluating these women within 1 year of giving birth, and, based on their individual and family risk factors, possibly treating them for cardiovascular risk factors.

Oral contraceptives

Four studies comprising about 800,000 women examined the risk of stroke in women using hormonal birth control.

Level A evidence did not support routine screening for prothrombotic mutations before starting oral contraception. But there was Level B evidence that oral contraceptives may be harmful in women who had risk factors, including cigarette use and prior thromboembolic events.

Menopause-related hormone therapy

Seven studies – including the Women’s Health Initiative – examined the links between stroke and hormone therapy in about 37,000 women. Two recommendations supported by Level A evidence were made.

Hormone therapy should not be used for either primary or secondary stroke prevention in postmenopausal women.

Selective estrogen receptor modulators (raloxifene, tamoxifen, and tibolone) should not be used for primary prevention of stroke.

Migraine with aura

There is scant literature examining the link between migraine with aura and stroke, although what does exist suggests that the risk may be doubled overall. The addition of another factor, like pregnancy or preeclampsia, dramatically increases the risk. But because these data are low in number, the recommendations are the same as they are for men.

Level B evidence supports smoking cessation in women with migraine and aura. Level C evidence suggests that treatments that reduce the frequency of migraine may also reduce the risk of stroke.

Obesity and metabolic syndrome

A healthy lifestyle of eating whole foods, exercise, and abstaining from tobacco has been shown to lower stroke incidence in both women and men. But subgroup analyses hint that men derive the most benefit. Women-only studies of these interventions have posted mixed results about their ability to reduce stroke in women.

The authors said much more research is necessary to target interventions that are especially beneficial for women. Until then, Level B evidence supports maintaining a lifestyle of exercise, healthy eating, no tobacco use, and moderate alcohol intake (a drink a day or less) for women who aren’t pregnant.

 

 

Atrial fibrillation

Overall, similar numbers of women and men have atrial fibrillation. But the condition becomes more common with age, and women have a longer life expectancy than do men. Therefore, the authors noted, atrial fibrillation will become more common as the population of elderly women increases.

They recommend that primary care physicians actively screen women for atrial fibrillation once they reach age 75 years. The screening method, supported by Level B evidence, should be pulse followed by an electrocardiogram.

For women aged 65 years and younger who have atrial fibrillation but no other risk factors, there is no evidence supporting oral anticoagulation. Level B evidence does support antiplatelet therapy.

Dr. Bushnell had no financial disclosures. One of the 16 coauthors reported relationships with several pharmaceutical companies

msullivan@frontlinemedcom.com

On Twitter @alz_gal

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Newly released guidelines provide the first evidence-based recommendations for preventing stroke in women.

The document addresses the issues that uniquely increase stroke risk in women – pregnancy, hormonal therapy, contraception, and migraine – along with factors like atrial fibrillation and obesity, Dr. Cheryl Bushnell and her colleagues wrote in the February issue of Stroke.

"If you are a woman, you share many of the same risk factors for stroke with men, but your risk is also influenced by hormones, reproductive health, pregnancy, childbirth, and other sex-related factors," Dr. Bushnell noted in a press statement.

The document – created by the American Heart Association and American Stroke Association – is the first to look at these gender-specific issues, wrote Dr. Bushnell, director of the Stroke Center at Wake Forest Baptist Medical Center in Winston-Salem, N.C. (Stroke 2014 [doi:10.1161/01.str.0000442009.06663.48]).

It provides graded evidence for preventive strategies in a number of risk categories. Evidence was obtained by examining dozens of studies numbering hundreds of thousands of women. But despite the extant literature, Dr. Bushnell and her colleagues said more research needs to be conducted.

©moodboard/thinkstockphotos.com
Few studies have examined the link between migraine with aura and stroke, although current data suggests that the risk may be doubled overall.

"There is a need for recognition of women’s unique, sex-specific stroke risk factors, and a risk score that includes these factors would thereby identify women at risk," they wrote. "Similarly, it is important to improve stroke awareness and provide more rigorous education to women at younger ages, including childbearing ages."

The guidelines are aimed at primary care providers, who have the biggest interface with women at a prevention level – and intended to help them forge an active partnership with patients.

"More importantly," the authors wrote, "this guideline may empower women and their families to understand their own risk and how they can minimize the chances of having a stroke."

Pregnancy

For recommendations on pregnancy outcomes and stroke related to preeclampsia, the guidelines drew on evidence from 17 studies.

For women with chronic primary or secondary hypertension, or with a history of pregnancy-related hypertension, Level A evidence supports using low-dose aspirin during the second and third trimester. Level A evidence also supports calcium supplementation to prevent preeclampsia in women with low dietary intake.

There was also a Level A recommendation to treat severe hypertension during pregnancy with safe antihypertensives (methyldopa, labetalol, and nifedipine). Level B evidence supported treating moderate hypertension. The use of atenolol, angiotensin receptor blockers, and direct renin inhibitors is contraindicated because of teratogenicity.

Because preeclampsia increases lifelong stroke risk, the guidelines also recommended evaluating these women within 1 year of giving birth, and, based on their individual and family risk factors, possibly treating them for cardiovascular risk factors.

Oral contraceptives

Four studies comprising about 800,000 women examined the risk of stroke in women using hormonal birth control.

Level A evidence did not support routine screening for prothrombotic mutations before starting oral contraception. But there was Level B evidence that oral contraceptives may be harmful in women who had risk factors, including cigarette use and prior thromboembolic events.

Menopause-related hormone therapy

Seven studies – including the Women’s Health Initiative – examined the links between stroke and hormone therapy in about 37,000 women. Two recommendations supported by Level A evidence were made.

Hormone therapy should not be used for either primary or secondary stroke prevention in postmenopausal women.

Selective estrogen receptor modulators (raloxifene, tamoxifen, and tibolone) should not be used for primary prevention of stroke.

Migraine with aura

There is scant literature examining the link between migraine with aura and stroke, although what does exist suggests that the risk may be doubled overall. The addition of another factor, like pregnancy or preeclampsia, dramatically increases the risk. But because these data are low in number, the recommendations are the same as they are for men.

Level B evidence supports smoking cessation in women with migraine and aura. Level C evidence suggests that treatments that reduce the frequency of migraine may also reduce the risk of stroke.

Obesity and metabolic syndrome

A healthy lifestyle of eating whole foods, exercise, and abstaining from tobacco has been shown to lower stroke incidence in both women and men. But subgroup analyses hint that men derive the most benefit. Women-only studies of these interventions have posted mixed results about their ability to reduce stroke in women.

The authors said much more research is necessary to target interventions that are especially beneficial for women. Until then, Level B evidence supports maintaining a lifestyle of exercise, healthy eating, no tobacco use, and moderate alcohol intake (a drink a day or less) for women who aren’t pregnant.

 

 

Atrial fibrillation

Overall, similar numbers of women and men have atrial fibrillation. But the condition becomes more common with age, and women have a longer life expectancy than do men. Therefore, the authors noted, atrial fibrillation will become more common as the population of elderly women increases.

They recommend that primary care physicians actively screen women for atrial fibrillation once they reach age 75 years. The screening method, supported by Level B evidence, should be pulse followed by an electrocardiogram.

For women aged 65 years and younger who have atrial fibrillation but no other risk factors, there is no evidence supporting oral anticoagulation. Level B evidence does support antiplatelet therapy.

Dr. Bushnell had no financial disclosures. One of the 16 coauthors reported relationships with several pharmaceutical companies

msullivan@frontlinemedcom.com

On Twitter @alz_gal

Newly released guidelines provide the first evidence-based recommendations for preventing stroke in women.

The document addresses the issues that uniquely increase stroke risk in women – pregnancy, hormonal therapy, contraception, and migraine – along with factors like atrial fibrillation and obesity, Dr. Cheryl Bushnell and her colleagues wrote in the February issue of Stroke.

"If you are a woman, you share many of the same risk factors for stroke with men, but your risk is also influenced by hormones, reproductive health, pregnancy, childbirth, and other sex-related factors," Dr. Bushnell noted in a press statement.

The document – created by the American Heart Association and American Stroke Association – is the first to look at these gender-specific issues, wrote Dr. Bushnell, director of the Stroke Center at Wake Forest Baptist Medical Center in Winston-Salem, N.C. (Stroke 2014 [doi:10.1161/01.str.0000442009.06663.48]).

It provides graded evidence for preventive strategies in a number of risk categories. Evidence was obtained by examining dozens of studies numbering hundreds of thousands of women. But despite the extant literature, Dr. Bushnell and her colleagues said more research needs to be conducted.

©moodboard/thinkstockphotos.com
Few studies have examined the link between migraine with aura and stroke, although current data suggests that the risk may be doubled overall.

"There is a need for recognition of women’s unique, sex-specific stroke risk factors, and a risk score that includes these factors would thereby identify women at risk," they wrote. "Similarly, it is important to improve stroke awareness and provide more rigorous education to women at younger ages, including childbearing ages."

The guidelines are aimed at primary care providers, who have the biggest interface with women at a prevention level – and intended to help them forge an active partnership with patients.

"More importantly," the authors wrote, "this guideline may empower women and their families to understand their own risk and how they can minimize the chances of having a stroke."

Pregnancy

For recommendations on pregnancy outcomes and stroke related to preeclampsia, the guidelines drew on evidence from 17 studies.

For women with chronic primary or secondary hypertension, or with a history of pregnancy-related hypertension, Level A evidence supports using low-dose aspirin during the second and third trimester. Level A evidence also supports calcium supplementation to prevent preeclampsia in women with low dietary intake.

There was also a Level A recommendation to treat severe hypertension during pregnancy with safe antihypertensives (methyldopa, labetalol, and nifedipine). Level B evidence supported treating moderate hypertension. The use of atenolol, angiotensin receptor blockers, and direct renin inhibitors is contraindicated because of teratogenicity.

Because preeclampsia increases lifelong stroke risk, the guidelines also recommended evaluating these women within 1 year of giving birth, and, based on their individual and family risk factors, possibly treating them for cardiovascular risk factors.

Oral contraceptives

Four studies comprising about 800,000 women examined the risk of stroke in women using hormonal birth control.

Level A evidence did not support routine screening for prothrombotic mutations before starting oral contraception. But there was Level B evidence that oral contraceptives may be harmful in women who had risk factors, including cigarette use and prior thromboembolic events.

Menopause-related hormone therapy

Seven studies – including the Women’s Health Initiative – examined the links between stroke and hormone therapy in about 37,000 women. Two recommendations supported by Level A evidence were made.

Hormone therapy should not be used for either primary or secondary stroke prevention in postmenopausal women.

Selective estrogen receptor modulators (raloxifene, tamoxifen, and tibolone) should not be used for primary prevention of stroke.

Migraine with aura

There is scant literature examining the link between migraine with aura and stroke, although what does exist suggests that the risk may be doubled overall. The addition of another factor, like pregnancy or preeclampsia, dramatically increases the risk. But because these data are low in number, the recommendations are the same as they are for men.

Level B evidence supports smoking cessation in women with migraine and aura. Level C evidence suggests that treatments that reduce the frequency of migraine may also reduce the risk of stroke.

Obesity and metabolic syndrome

A healthy lifestyle of eating whole foods, exercise, and abstaining from tobacco has been shown to lower stroke incidence in both women and men. But subgroup analyses hint that men derive the most benefit. Women-only studies of these interventions have posted mixed results about their ability to reduce stroke in women.

The authors said much more research is necessary to target interventions that are especially beneficial for women. Until then, Level B evidence supports maintaining a lifestyle of exercise, healthy eating, no tobacco use, and moderate alcohol intake (a drink a day or less) for women who aren’t pregnant.

 

 

Atrial fibrillation

Overall, similar numbers of women and men have atrial fibrillation. But the condition becomes more common with age, and women have a longer life expectancy than do men. Therefore, the authors noted, atrial fibrillation will become more common as the population of elderly women increases.

They recommend that primary care physicians actively screen women for atrial fibrillation once they reach age 75 years. The screening method, supported by Level B evidence, should be pulse followed by an electrocardiogram.

For women aged 65 years and younger who have atrial fibrillation but no other risk factors, there is no evidence supporting oral anticoagulation. Level B evidence does support antiplatelet therapy.

Dr. Bushnell had no financial disclosures. One of the 16 coauthors reported relationships with several pharmaceutical companies

msullivan@frontlinemedcom.com

On Twitter @alz_gal

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Screening for intimate partner violence and abuse of elderly and vulnerable adults

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The U.S. Preventive Services Task Force has released updated recommendations regarding screening for intimate partner violence and abuse of elderly and vulnerable adults. While their previous recommendations in 2004 gave intimate partner violence screening an "I" recommendation, meaning that the evidence was inconclusive regarding the balance of benefits and intimate partner violence harms, the current recommendation has been upgraded to a "B" recommendation, meaning there is moderate certainty that there is a net benefit from screening. This puts the USPSTF recommendation in alignment with those of most other groups, including the American Medical Association and the *American College of Obstetricians and Gynecologists.

Forms of abuse

The recommendations regarding intimate partner violence in these guidelines refer to physical, sexual, or psychological abuse of women of reproductive age by a current or former partner or spouse. The issue of intimate partner violence is important because research shows that approximately 31% of women and 26% of men have experienced intimate partner violence within their lifetime, and that intimate partner violence is usually undetected. It is also estimated that these numbers are likely to be low because of underreporting. In one large study, the 1-year incidence of abuse was 8% within the last year and 15% within the last 5 years. Approximately 1.5%-5% of pregnant women report being abused. Among older and vulnerable adults, the rate of physical, psychological, or sexual abuse; neglect; or financial exploitation is estimated to be between 2% and 10%.

Ava Skolnik and Dr. Amy Clouse

Intimate partner violence has important and long-lasting effects on victims. Harmful effects include immediate injuries resulting from direct trauma as well as long-term physical and mental health consequences. Long-term physical consequences include sexually transmitted diseases, unintended pregnancy, and worse pregnancy outcomes, as well as higher rates of chronic pain, gastrointestinal disorders, migraine headaches, and disability. Long-term mental health consequences include depression, post-traumatic stress disorder, anxiety disorders, substance abuse, and a higher rate of suicide.

Screening of women

Intimate partner violence in women can be detected with a high level of certainty. There are specific factors that can influence the chances that an individual is at risk for intimate partner violence and can alert clinicians to have increased vigilance for abuse. These risk factors have four categories. The first category is individual, focusing on an individual’s self-esteem. The second is relationship, which focuses on marriage conflict and stability within relationships. Third is community, which is looking at socioeconomic background. Fourth are the societal factors of traditional gender roles.

Many screening instruments exist that have been carefully studied. For instance, the HITS instrument, available in English and Spanish, is a four-item questionnaire that asks about being hurt, insulted, screamed at, or threatened. In one study, it had a sensitivity of 86% and a specificity of 99% for detecting intimate partner violence. The interval for screening is not clear.

Treatment

Once intimate partner violence among women is detected, many approaches are available to help these women. For example, one trial was set up to test the effectiveness of a mentoring support group vs. usual care. All women who entered this trial had discussed intimate partner violence with their primary care physician. After the intervention program, the women who were in the intervention group had significantly reduced scores of abuse as opposed to the comparison group. Another example is a study of pregnant women who reported abuse, who were then randomized to a counseling intervention vs. usual care. Women in the counseling group had decreased pregnancy coercion and were more likely to discontinue an unhealthy or unsafe relationship.

Approaches vary from counseling to social work interventions brought to peoples’ homes, information cards, referral to community services, and mentoring support services. It appears that varied interventions decrease recurrent abuse. There is no reported harm in screening for intimate partner violence. It is necessary for the primary care doctor to be aware of the laws specific to intimate partner violence reporting and privacy within the doctor’s specific region.

Elderly and vulnerable adults

In contrast to screening for intimate partner violence in women, there is a lack of evidence for abuse screening in elderly and vulnerable adult populations. There is a lack of evidence on the benefits of detection and, surprisingly, a lack of evidence on the benefits of early intervention. It is also possible that the harms of detecting abuse in this group may be different, although the risk appears to be small. Some potential harm includes shame, guilt, fear of retaliation, and abandonment by caretakers who have been accused of abuse.

 

 

While the evidence to support screening elderly and vulnerable adults is limited, state and local laws vary about the obligation and logistics of reporting elderly abuse. A main conclusion of the USPSTF is that more evidence-based research needs to be done for the population of elderly and vulnerable adults.

Bottom line

Intimate partner violence is common, affecting a quarter of all adults at some point in their life. The mental and physical effects of intimate partner violence can be severe and long-lasting. Screening for intimate partner violence is effective, and effective interventions can be carried out to help women who are victims of intimate partner violence. The USPSTF recommends routine screening of women of reproductive age for intimate partner violence. The data on screening for abuse in the elderly and vulnerable adults is insufficient for the USPSTF to make a recommendation for or against screening.

Reference

• Screening for Intimate Partner Violence and Abuse of Elderly and Vulnerable Adults: U.S. Preventive Services Task Force Recommendation Statement. (Ann. Intern. Med. 2013:158;478-86).

Ms. Skolnik attends Drexel University, Philadelphia, and is a research assistant at the Children’s Hospital of Pennsylvania. Dr. Clouse is an associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital.

*Correction 1/23/14: A previous version of this article misstated the name of the American College of Obstetricians and Gynecologists. This version has been updated. 

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The U.S. Preventive Services Task Force has released updated recommendations regarding screening for intimate partner violence and abuse of elderly and vulnerable adults. While their previous recommendations in 2004 gave intimate partner violence screening an "I" recommendation, meaning that the evidence was inconclusive regarding the balance of benefits and intimate partner violence harms, the current recommendation has been upgraded to a "B" recommendation, meaning there is moderate certainty that there is a net benefit from screening. This puts the USPSTF recommendation in alignment with those of most other groups, including the American Medical Association and the *American College of Obstetricians and Gynecologists.

Forms of abuse

The recommendations regarding intimate partner violence in these guidelines refer to physical, sexual, or psychological abuse of women of reproductive age by a current or former partner or spouse. The issue of intimate partner violence is important because research shows that approximately 31% of women and 26% of men have experienced intimate partner violence within their lifetime, and that intimate partner violence is usually undetected. It is also estimated that these numbers are likely to be low because of underreporting. In one large study, the 1-year incidence of abuse was 8% within the last year and 15% within the last 5 years. Approximately 1.5%-5% of pregnant women report being abused. Among older and vulnerable adults, the rate of physical, psychological, or sexual abuse; neglect; or financial exploitation is estimated to be between 2% and 10%.

Ava Skolnik and Dr. Amy Clouse

Intimate partner violence has important and long-lasting effects on victims. Harmful effects include immediate injuries resulting from direct trauma as well as long-term physical and mental health consequences. Long-term physical consequences include sexually transmitted diseases, unintended pregnancy, and worse pregnancy outcomes, as well as higher rates of chronic pain, gastrointestinal disorders, migraine headaches, and disability. Long-term mental health consequences include depression, post-traumatic stress disorder, anxiety disorders, substance abuse, and a higher rate of suicide.

Screening of women

Intimate partner violence in women can be detected with a high level of certainty. There are specific factors that can influence the chances that an individual is at risk for intimate partner violence and can alert clinicians to have increased vigilance for abuse. These risk factors have four categories. The first category is individual, focusing on an individual’s self-esteem. The second is relationship, which focuses on marriage conflict and stability within relationships. Third is community, which is looking at socioeconomic background. Fourth are the societal factors of traditional gender roles.

Many screening instruments exist that have been carefully studied. For instance, the HITS instrument, available in English and Spanish, is a four-item questionnaire that asks about being hurt, insulted, screamed at, or threatened. In one study, it had a sensitivity of 86% and a specificity of 99% for detecting intimate partner violence. The interval for screening is not clear.

Treatment

Once intimate partner violence among women is detected, many approaches are available to help these women. For example, one trial was set up to test the effectiveness of a mentoring support group vs. usual care. All women who entered this trial had discussed intimate partner violence with their primary care physician. After the intervention program, the women who were in the intervention group had significantly reduced scores of abuse as opposed to the comparison group. Another example is a study of pregnant women who reported abuse, who were then randomized to a counseling intervention vs. usual care. Women in the counseling group had decreased pregnancy coercion and were more likely to discontinue an unhealthy or unsafe relationship.

Approaches vary from counseling to social work interventions brought to peoples’ homes, information cards, referral to community services, and mentoring support services. It appears that varied interventions decrease recurrent abuse. There is no reported harm in screening for intimate partner violence. It is necessary for the primary care doctor to be aware of the laws specific to intimate partner violence reporting and privacy within the doctor’s specific region.

Elderly and vulnerable adults

In contrast to screening for intimate partner violence in women, there is a lack of evidence for abuse screening in elderly and vulnerable adult populations. There is a lack of evidence on the benefits of detection and, surprisingly, a lack of evidence on the benefits of early intervention. It is also possible that the harms of detecting abuse in this group may be different, although the risk appears to be small. Some potential harm includes shame, guilt, fear of retaliation, and abandonment by caretakers who have been accused of abuse.

 

 

While the evidence to support screening elderly and vulnerable adults is limited, state and local laws vary about the obligation and logistics of reporting elderly abuse. A main conclusion of the USPSTF is that more evidence-based research needs to be done for the population of elderly and vulnerable adults.

Bottom line

Intimate partner violence is common, affecting a quarter of all adults at some point in their life. The mental and physical effects of intimate partner violence can be severe and long-lasting. Screening for intimate partner violence is effective, and effective interventions can be carried out to help women who are victims of intimate partner violence. The USPSTF recommends routine screening of women of reproductive age for intimate partner violence. The data on screening for abuse in the elderly and vulnerable adults is insufficient for the USPSTF to make a recommendation for or against screening.

Reference

• Screening for Intimate Partner Violence and Abuse of Elderly and Vulnerable Adults: U.S. Preventive Services Task Force Recommendation Statement. (Ann. Intern. Med. 2013:158;478-86).

Ms. Skolnik attends Drexel University, Philadelphia, and is a research assistant at the Children’s Hospital of Pennsylvania. Dr. Clouse is an associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital.

*Correction 1/23/14: A previous version of this article misstated the name of the American College of Obstetricians and Gynecologists. This version has been updated. 

The U.S. Preventive Services Task Force has released updated recommendations regarding screening for intimate partner violence and abuse of elderly and vulnerable adults. While their previous recommendations in 2004 gave intimate partner violence screening an "I" recommendation, meaning that the evidence was inconclusive regarding the balance of benefits and intimate partner violence harms, the current recommendation has been upgraded to a "B" recommendation, meaning there is moderate certainty that there is a net benefit from screening. This puts the USPSTF recommendation in alignment with those of most other groups, including the American Medical Association and the *American College of Obstetricians and Gynecologists.

Forms of abuse

The recommendations regarding intimate partner violence in these guidelines refer to physical, sexual, or psychological abuse of women of reproductive age by a current or former partner or spouse. The issue of intimate partner violence is important because research shows that approximately 31% of women and 26% of men have experienced intimate partner violence within their lifetime, and that intimate partner violence is usually undetected. It is also estimated that these numbers are likely to be low because of underreporting. In one large study, the 1-year incidence of abuse was 8% within the last year and 15% within the last 5 years. Approximately 1.5%-5% of pregnant women report being abused. Among older and vulnerable adults, the rate of physical, psychological, or sexual abuse; neglect; or financial exploitation is estimated to be between 2% and 10%.

Ava Skolnik and Dr. Amy Clouse

Intimate partner violence has important and long-lasting effects on victims. Harmful effects include immediate injuries resulting from direct trauma as well as long-term physical and mental health consequences. Long-term physical consequences include sexually transmitted diseases, unintended pregnancy, and worse pregnancy outcomes, as well as higher rates of chronic pain, gastrointestinal disorders, migraine headaches, and disability. Long-term mental health consequences include depression, post-traumatic stress disorder, anxiety disorders, substance abuse, and a higher rate of suicide.

Screening of women

Intimate partner violence in women can be detected with a high level of certainty. There are specific factors that can influence the chances that an individual is at risk for intimate partner violence and can alert clinicians to have increased vigilance for abuse. These risk factors have four categories. The first category is individual, focusing on an individual’s self-esteem. The second is relationship, which focuses on marriage conflict and stability within relationships. Third is community, which is looking at socioeconomic background. Fourth are the societal factors of traditional gender roles.

Many screening instruments exist that have been carefully studied. For instance, the HITS instrument, available in English and Spanish, is a four-item questionnaire that asks about being hurt, insulted, screamed at, or threatened. In one study, it had a sensitivity of 86% and a specificity of 99% for detecting intimate partner violence. The interval for screening is not clear.

Treatment

Once intimate partner violence among women is detected, many approaches are available to help these women. For example, one trial was set up to test the effectiveness of a mentoring support group vs. usual care. All women who entered this trial had discussed intimate partner violence with their primary care physician. After the intervention program, the women who were in the intervention group had significantly reduced scores of abuse as opposed to the comparison group. Another example is a study of pregnant women who reported abuse, who were then randomized to a counseling intervention vs. usual care. Women in the counseling group had decreased pregnancy coercion and were more likely to discontinue an unhealthy or unsafe relationship.

Approaches vary from counseling to social work interventions brought to peoples’ homes, information cards, referral to community services, and mentoring support services. It appears that varied interventions decrease recurrent abuse. There is no reported harm in screening for intimate partner violence. It is necessary for the primary care doctor to be aware of the laws specific to intimate partner violence reporting and privacy within the doctor’s specific region.

Elderly and vulnerable adults

In contrast to screening for intimate partner violence in women, there is a lack of evidence for abuse screening in elderly and vulnerable adult populations. There is a lack of evidence on the benefits of detection and, surprisingly, a lack of evidence on the benefits of early intervention. It is also possible that the harms of detecting abuse in this group may be different, although the risk appears to be small. Some potential harm includes shame, guilt, fear of retaliation, and abandonment by caretakers who have been accused of abuse.

 

 

While the evidence to support screening elderly and vulnerable adults is limited, state and local laws vary about the obligation and logistics of reporting elderly abuse. A main conclusion of the USPSTF is that more evidence-based research needs to be done for the population of elderly and vulnerable adults.

Bottom line

Intimate partner violence is common, affecting a quarter of all adults at some point in their life. The mental and physical effects of intimate partner violence can be severe and long-lasting. Screening for intimate partner violence is effective, and effective interventions can be carried out to help women who are victims of intimate partner violence. The USPSTF recommends routine screening of women of reproductive age for intimate partner violence. The data on screening for abuse in the elderly and vulnerable adults is insufficient for the USPSTF to make a recommendation for or against screening.

Reference

• Screening for Intimate Partner Violence and Abuse of Elderly and Vulnerable Adults: U.S. Preventive Services Task Force Recommendation Statement. (Ann. Intern. Med. 2013:158;478-86).

Ms. Skolnik attends Drexel University, Philadelphia, and is a research assistant at the Children’s Hospital of Pennsylvania. Dr. Clouse is an associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital.

*Correction 1/23/14: A previous version of this article misstated the name of the American College of Obstetricians and Gynecologists. This version has been updated. 

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Competing medical abortion regimens differ in efficacy

More effective, fewer side effects
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SAN FRANCISCO – The medical abortion regimen approved by the Food and Drug Administration is less effective and less convenient than an alternative evidence-based regimen, yet in some areas women are being denied access to the more effective regimen, Dr. Jody Steinauer said.

Some U.S. states are mandating that only the FDA-approved regimen be offered to women. "That is going to have a real impact on women’s care," she said at a conference on women’s health sponsored by the University of California, San Francisco.

The FDA-approved regimen is 92%-96% effective in causing abortions in pregnancies of less than 49 days, and in 50% of cases the abortion will be complete within 4 hours. The alternative regimen is 96%-99% effective for gestations of less than 63 days, with complete abortions in less than 4 hours in 93% of cases, said Dr. Steinauer of the university.

Sherry Boschert/Frontline Medical News
Dr. Jody Steinauer

Two states – Arizona and Ohio – require that the FDA-approved regimen be used when prescribing the progesterone antagonist mifepristone for abortion, according to the Guttmacher Institute, which seeks to advance reproductive rights. Two other states – North Dakota and Oklahoma – passed similar laws that have been stayed by the courts.

Under the FDA-approved regimen, the woman is given 600 mg of mifepristone orally (three tablets of Mifeprex) in the clinic. That’s a higher dose than the 200 mg (one tablet) of mifepristone that has been shown to be effective and is also is taken in the clinic under the alternative regimen, Dr. Steinauer said. In both scenarios, the woman then goes home with pain medications to use as needed.

Two days later, according to the FDA-approved regimen, the woman is given 400 mcg of the prostaglandin misoprostol orally in the clinic to induce bleeding over the next 4-24 hours or more. "In the FDA-approved regimen as modeled by France, women have to pass the pregnancy in the clinic, so you would have to have a place for her to be bleeding," Dr. Steinauer said.

Under the alternative regimen, the woman places 800 mcg of misoprostol pills in the vagina or buccally to induce bleeding, but she can decide to take it anywhere from 6 hours to 3 days after taking the mifepristone and she can take the misoprostol at home. "There’s a lot of flexibility in when women take `miso,’ so they can decide when they will have bleeding," which can happen at home, she said.

The vaginal or buccal administration of misoprostol in the alternative regimen is "much more effective" than oral administration, she added.

The FDA regimen calls for follow-up on day 14. The alternative regimen again is more flexible, allowing follow-up in the range of days 3-14. The FDA says that the approved regimen can be used for gestations up to 7 weeks, while the gestational limit for the alternative regimen is 9 weeks.

Dr. Steinauer’s institution follows the alternative regimen. Patients may return for follow-up as soon as 3 days after taking the misoprostol, and they are instructed to call earlier if they experience unexpected symptoms.

Both the FDA regimen and the alternative regimen are safe, "and, given the higher efficacy of the evidence-based regimen," it might be safer than the FDA-approved one, she said.

On average, the alternative regimen is 97% effective, with incomplete abortion in 2% and continuing pregnancy in 1%, Dr. Steinauer said.

Studies on side effects from medical abortions show bleeding longer than 30 days in 9% of cases, bleeding before misoprostol (after mifepristone) in 21%-47%, abdominal pain requiring narcotics in 29%-73%, nausea in 20%-65%, vomiting in 10%-44%, diarrhea in 3%-29%, chills or fever in 7%-44%, headache in 27%-32%, dizziness in 12%-38%, and passage of the pregnancy before misoprostol in 4%, she said.

When asked to comment on the comparison of regimens, Dr. Eve Espey said that fewer side effects are seen with buccal or vaginal administration of misoprostol compared with taking the drug orally, and that the lower dose of mifepristone in the alternative regimen also may reduce side effects.

The comparison of regimens "is useful to clinicians who may be confused about the legal challenges to the ‘alternative’ or ‘evidence-based’ medical abortion regimen. Dr. Steinauer highlights the superiority of the alternative regimen: it uses less medication, making it less expensive with fewer side effects, and offers a more convenient schedule with fewer total visits for the patient," said Dr. Espey, an ob.gyn. at the University of New Mexico, Albuquerque. "Legal restrictions on the alternative medical abortion regimen are non–evidence based and are harmful to women."

 

 

When asked why the alternative regimen has not been reviewed by the FDA, an FDA spokeswoman responded in an e-mail, “The Agency reviews applications for changes to approved applications that are submitted by drug manufacturers.” The FDA cannot comment on whether or not it has received an application, added Andrea Fischer of the FDA’s Office of Media Affairs.

When asked to comment on moves by some politicians to restrict medical abortions to the FDA-approved regimen, she wrote, “FDA works to ensure that approved products are appropriately labeled based on data submitted in applications for the drugs’ approvals; this provides health care practitioners with accurate information about the safety and effectiveness data supporting each approval.”*

Dr. Steinauer and Dr. Espey reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

* This story was updated 1/27/2014


Body

Medicine is a continuously evolving science, and as new evidence emerges based on good study data, it is critical that medical practice also evolve to provide the best possible care for people. By insisting that medical practitioners continue to use an outdated treatment regimen, legislators are trying to restrict access to best care for women.

All fields of medicine use medications in evidence-based ways that are not FDA approved when subsequent data supports that. The newer regimens for medical abortion are more effective, can be used later in pregnancy, and have fewer negative side effects, especially if you consider how many more women are able to avoid a surgical procedure because of greater efficacy of the medical regimen.

A Cochrane review found that oral misoprostol may be associated with more frequent side effects such as nausea and diarrhoea, compared with the vaginal route. Sublingual and buccal routes also had higher rates of side effects, compared with vaginal administration (Cochrane Database Syst. Rev. 2011;11: CD002855 [doi:10.1002/14651858.CD002855.pub4].

Everyone I know who practices medical abortion (including me) uses the evidence-based method unless they are legally constrained from doing so.

Dr. Sarah W. Prager is associate professor of ob.gyn. at the University of Washington, Seattle. She provided these comments in an interview. Dr. Prager conducts trainings for insertion/removal of the implantable contraceptives Implanon and Nexplanon; she reported having no other financial disclosures.

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Body

Medicine is a continuously evolving science, and as new evidence emerges based on good study data, it is critical that medical practice also evolve to provide the best possible care for people. By insisting that medical practitioners continue to use an outdated treatment regimen, legislators are trying to restrict access to best care for women.

All fields of medicine use medications in evidence-based ways that are not FDA approved when subsequent data supports that. The newer regimens for medical abortion are more effective, can be used later in pregnancy, and have fewer negative side effects, especially if you consider how many more women are able to avoid a surgical procedure because of greater efficacy of the medical regimen.

A Cochrane review found that oral misoprostol may be associated with more frequent side effects such as nausea and diarrhoea, compared with the vaginal route. Sublingual and buccal routes also had higher rates of side effects, compared with vaginal administration (Cochrane Database Syst. Rev. 2011;11: CD002855 [doi:10.1002/14651858.CD002855.pub4].

Everyone I know who practices medical abortion (including me) uses the evidence-based method unless they are legally constrained from doing so.

Dr. Sarah W. Prager is associate professor of ob.gyn. at the University of Washington, Seattle. She provided these comments in an interview. Dr. Prager conducts trainings for insertion/removal of the implantable contraceptives Implanon and Nexplanon; she reported having no other financial disclosures.

Body

Medicine is a continuously evolving science, and as new evidence emerges based on good study data, it is critical that medical practice also evolve to provide the best possible care for people. By insisting that medical practitioners continue to use an outdated treatment regimen, legislators are trying to restrict access to best care for women.

All fields of medicine use medications in evidence-based ways that are not FDA approved when subsequent data supports that. The newer regimens for medical abortion are more effective, can be used later in pregnancy, and have fewer negative side effects, especially if you consider how many more women are able to avoid a surgical procedure because of greater efficacy of the medical regimen.

A Cochrane review found that oral misoprostol may be associated with more frequent side effects such as nausea and diarrhoea, compared with the vaginal route. Sublingual and buccal routes also had higher rates of side effects, compared with vaginal administration (Cochrane Database Syst. Rev. 2011;11: CD002855 [doi:10.1002/14651858.CD002855.pub4].

Everyone I know who practices medical abortion (including me) uses the evidence-based method unless they are legally constrained from doing so.

Dr. Sarah W. Prager is associate professor of ob.gyn. at the University of Washington, Seattle. She provided these comments in an interview. Dr. Prager conducts trainings for insertion/removal of the implantable contraceptives Implanon and Nexplanon; she reported having no other financial disclosures.

Title
More effective, fewer side effects
More effective, fewer side effects

SAN FRANCISCO – The medical abortion regimen approved by the Food and Drug Administration is less effective and less convenient than an alternative evidence-based regimen, yet in some areas women are being denied access to the more effective regimen, Dr. Jody Steinauer said.

Some U.S. states are mandating that only the FDA-approved regimen be offered to women. "That is going to have a real impact on women’s care," she said at a conference on women’s health sponsored by the University of California, San Francisco.

The FDA-approved regimen is 92%-96% effective in causing abortions in pregnancies of less than 49 days, and in 50% of cases the abortion will be complete within 4 hours. The alternative regimen is 96%-99% effective for gestations of less than 63 days, with complete abortions in less than 4 hours in 93% of cases, said Dr. Steinauer of the university.

Sherry Boschert/Frontline Medical News
Dr. Jody Steinauer

Two states – Arizona and Ohio – require that the FDA-approved regimen be used when prescribing the progesterone antagonist mifepristone for abortion, according to the Guttmacher Institute, which seeks to advance reproductive rights. Two other states – North Dakota and Oklahoma – passed similar laws that have been stayed by the courts.

Under the FDA-approved regimen, the woman is given 600 mg of mifepristone orally (three tablets of Mifeprex) in the clinic. That’s a higher dose than the 200 mg (one tablet) of mifepristone that has been shown to be effective and is also is taken in the clinic under the alternative regimen, Dr. Steinauer said. In both scenarios, the woman then goes home with pain medications to use as needed.

Two days later, according to the FDA-approved regimen, the woman is given 400 mcg of the prostaglandin misoprostol orally in the clinic to induce bleeding over the next 4-24 hours or more. "In the FDA-approved regimen as modeled by France, women have to pass the pregnancy in the clinic, so you would have to have a place for her to be bleeding," Dr. Steinauer said.

Under the alternative regimen, the woman places 800 mcg of misoprostol pills in the vagina or buccally to induce bleeding, but she can decide to take it anywhere from 6 hours to 3 days after taking the mifepristone and she can take the misoprostol at home. "There’s a lot of flexibility in when women take `miso,’ so they can decide when they will have bleeding," which can happen at home, she said.

The vaginal or buccal administration of misoprostol in the alternative regimen is "much more effective" than oral administration, she added.

The FDA regimen calls for follow-up on day 14. The alternative regimen again is more flexible, allowing follow-up in the range of days 3-14. The FDA says that the approved regimen can be used for gestations up to 7 weeks, while the gestational limit for the alternative regimen is 9 weeks.

Dr. Steinauer’s institution follows the alternative regimen. Patients may return for follow-up as soon as 3 days after taking the misoprostol, and they are instructed to call earlier if they experience unexpected symptoms.

Both the FDA regimen and the alternative regimen are safe, "and, given the higher efficacy of the evidence-based regimen," it might be safer than the FDA-approved one, she said.

On average, the alternative regimen is 97% effective, with incomplete abortion in 2% and continuing pregnancy in 1%, Dr. Steinauer said.

Studies on side effects from medical abortions show bleeding longer than 30 days in 9% of cases, bleeding before misoprostol (after mifepristone) in 21%-47%, abdominal pain requiring narcotics in 29%-73%, nausea in 20%-65%, vomiting in 10%-44%, diarrhea in 3%-29%, chills or fever in 7%-44%, headache in 27%-32%, dizziness in 12%-38%, and passage of the pregnancy before misoprostol in 4%, she said.

When asked to comment on the comparison of regimens, Dr. Eve Espey said that fewer side effects are seen with buccal or vaginal administration of misoprostol compared with taking the drug orally, and that the lower dose of mifepristone in the alternative regimen also may reduce side effects.

The comparison of regimens "is useful to clinicians who may be confused about the legal challenges to the ‘alternative’ or ‘evidence-based’ medical abortion regimen. Dr. Steinauer highlights the superiority of the alternative regimen: it uses less medication, making it less expensive with fewer side effects, and offers a more convenient schedule with fewer total visits for the patient," said Dr. Espey, an ob.gyn. at the University of New Mexico, Albuquerque. "Legal restrictions on the alternative medical abortion regimen are non–evidence based and are harmful to women."

 

 

When asked why the alternative regimen has not been reviewed by the FDA, an FDA spokeswoman responded in an e-mail, “The Agency reviews applications for changes to approved applications that are submitted by drug manufacturers.” The FDA cannot comment on whether or not it has received an application, added Andrea Fischer of the FDA’s Office of Media Affairs.

When asked to comment on moves by some politicians to restrict medical abortions to the FDA-approved regimen, she wrote, “FDA works to ensure that approved products are appropriately labeled based on data submitted in applications for the drugs’ approvals; this provides health care practitioners with accurate information about the safety and effectiveness data supporting each approval.”*

Dr. Steinauer and Dr. Espey reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

* This story was updated 1/27/2014


SAN FRANCISCO – The medical abortion regimen approved by the Food and Drug Administration is less effective and less convenient than an alternative evidence-based regimen, yet in some areas women are being denied access to the more effective regimen, Dr. Jody Steinauer said.

Some U.S. states are mandating that only the FDA-approved regimen be offered to women. "That is going to have a real impact on women’s care," she said at a conference on women’s health sponsored by the University of California, San Francisco.

The FDA-approved regimen is 92%-96% effective in causing abortions in pregnancies of less than 49 days, and in 50% of cases the abortion will be complete within 4 hours. The alternative regimen is 96%-99% effective for gestations of less than 63 days, with complete abortions in less than 4 hours in 93% of cases, said Dr. Steinauer of the university.

Sherry Boschert/Frontline Medical News
Dr. Jody Steinauer

Two states – Arizona and Ohio – require that the FDA-approved regimen be used when prescribing the progesterone antagonist mifepristone for abortion, according to the Guttmacher Institute, which seeks to advance reproductive rights. Two other states – North Dakota and Oklahoma – passed similar laws that have been stayed by the courts.

Under the FDA-approved regimen, the woman is given 600 mg of mifepristone orally (three tablets of Mifeprex) in the clinic. That’s a higher dose than the 200 mg (one tablet) of mifepristone that has been shown to be effective and is also is taken in the clinic under the alternative regimen, Dr. Steinauer said. In both scenarios, the woman then goes home with pain medications to use as needed.

Two days later, according to the FDA-approved regimen, the woman is given 400 mcg of the prostaglandin misoprostol orally in the clinic to induce bleeding over the next 4-24 hours or more. "In the FDA-approved regimen as modeled by France, women have to pass the pregnancy in the clinic, so you would have to have a place for her to be bleeding," Dr. Steinauer said.

Under the alternative regimen, the woman places 800 mcg of misoprostol pills in the vagina or buccally to induce bleeding, but she can decide to take it anywhere from 6 hours to 3 days after taking the mifepristone and she can take the misoprostol at home. "There’s a lot of flexibility in when women take `miso,’ so they can decide when they will have bleeding," which can happen at home, she said.

The vaginal or buccal administration of misoprostol in the alternative regimen is "much more effective" than oral administration, she added.

The FDA regimen calls for follow-up on day 14. The alternative regimen again is more flexible, allowing follow-up in the range of days 3-14. The FDA says that the approved regimen can be used for gestations up to 7 weeks, while the gestational limit for the alternative regimen is 9 weeks.

Dr. Steinauer’s institution follows the alternative regimen. Patients may return for follow-up as soon as 3 days after taking the misoprostol, and they are instructed to call earlier if they experience unexpected symptoms.

Both the FDA regimen and the alternative regimen are safe, "and, given the higher efficacy of the evidence-based regimen," it might be safer than the FDA-approved one, she said.

On average, the alternative regimen is 97% effective, with incomplete abortion in 2% and continuing pregnancy in 1%, Dr. Steinauer said.

Studies on side effects from medical abortions show bleeding longer than 30 days in 9% of cases, bleeding before misoprostol (after mifepristone) in 21%-47%, abdominal pain requiring narcotics in 29%-73%, nausea in 20%-65%, vomiting in 10%-44%, diarrhea in 3%-29%, chills or fever in 7%-44%, headache in 27%-32%, dizziness in 12%-38%, and passage of the pregnancy before misoprostol in 4%, she said.

When asked to comment on the comparison of regimens, Dr. Eve Espey said that fewer side effects are seen with buccal or vaginal administration of misoprostol compared with taking the drug orally, and that the lower dose of mifepristone in the alternative regimen also may reduce side effects.

The comparison of regimens "is useful to clinicians who may be confused about the legal challenges to the ‘alternative’ or ‘evidence-based’ medical abortion regimen. Dr. Steinauer highlights the superiority of the alternative regimen: it uses less medication, making it less expensive with fewer side effects, and offers a more convenient schedule with fewer total visits for the patient," said Dr. Espey, an ob.gyn. at the University of New Mexico, Albuquerque. "Legal restrictions on the alternative medical abortion regimen are non–evidence based and are harmful to women."

 

 

When asked why the alternative regimen has not been reviewed by the FDA, an FDA spokeswoman responded in an e-mail, “The Agency reviews applications for changes to approved applications that are submitted by drug manufacturers.” The FDA cannot comment on whether or not it has received an application, added Andrea Fischer of the FDA’s Office of Media Affairs.

When asked to comment on moves by some politicians to restrict medical abortions to the FDA-approved regimen, she wrote, “FDA works to ensure that approved products are appropriately labeled based on data submitted in applications for the drugs’ approvals; this provides health care practitioners with accurate information about the safety and effectiveness data supporting each approval.”*

Dr. Steinauer and Dr. Espey reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

* This story was updated 1/27/2014


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EXPERT ANALYSIS FROM A CONFERENCE ON WOMEN’S HEALTH

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Luteal-phase antidepressant an option in recalcitrant PMS, PMDD

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Luteal-phase antidepressant an option in recalcitrant PMS, PMDD

SAN FRANCISCO – Selective serotonin reuptake inhibitor antidepressants can alleviate symptoms of premenstrual syndrome or premenstrual dysphoric disorder, but are far from first-line therapies for either disorder, according to Dr. Ellen Haller.

The first steps in treating PMS and PMDD are basic wellness strategies such as a healthy diet, smoking cessation, exercise, adequate sleep, and stress management, Dr. Haller said at a conference on women’s health sponsored by the University of California, San Francisco.

Dr. Ellen Haller

Calcium supplementation also has been shown to reduce total emotional and physical symptom scores by 48% in women with PMS compared with a 30% reduction from placebo in a multicenter, randomized placebo-controlled study of 497 patients. That study used 600 mg, twice daily, of calcium carbonate or placebo for three menstrual cycles, said Dr. Haller, professor of clinical psychiatry at the university.

The results of that study (Am. J. Obstet.Gynecol. 1998;179:444-52) have not been replicated, she added.

If wellness treatments and calcium supplementation don’t work, the next step for treating women with PMS may be an SSRI. A Cochrane review of 31 randomized controlled trials found that SSRIs are more effective than placebo in treating PMS (Cochrane Database Syst. Rev. 2013;6:CD001396). Treatment should be an SSRI antidepressant, Dr. Haller emphasized. Bupropion, which is a norepinephrine dopamine reuptake inhibitor, is not effective for these women.

Low-dose SSRIs may be taken daily or can be effective against emotional and physical symptoms if taken only during the luteal phase of menstruation, starting on day 14 of the cycle and stopping on day 1, the first day of menses, Dr. Haller said. Patients with PMS tend to respond more quickly and at lower doses than patients with depression, and usually don’t get withdrawal symptoms when stopping the SSRI on the luteal-phase dosing regimen.

In women with PMDD, there is a preliminary suggestion that an SSRI may be more effective than calcium supplements. A pilot study of 39 women with PMDD found that the SSRI fluoxetine was more effective than calcium or placebo for PMDD, though scores were significantly better than calcium only on just two of five symptom scales. The study compared fluoxetine 10 mg b.i.d., calcium carbonate 600 mg b.i.d., and placebo (J. Clin. Psychopharmacol. 2013;33:614-20).

Dr. Haller also advised avoiding progesterone-only or other combination oral contraceptives, most of which can worsen PMDD symptoms. The oral contraceptive Yaz (drospirenone 3 mg plus ethinyl estradiol 20 mcg) is an evidence-based option that is approved to treat PMDD.

In a double-blind, randomized placebo-controlled trial, 450 women with rigorously diagnosed PMDD spent 24 days on Yaz or placebo and 4 days on an inert pill per cycle for three menstrual cycles. The Yaz group had a significant 47% decrease in total symptom scores compared with a 38% decrease in the placebo group. Side effects, most commonly nausea and intermenstrual bleeding, prompted 15% on Yaz and 4% on placebo to drop out of the study (Obstet. Gynecol. 2005;106:492-501).

Significant PMS symptoms affect approximately 30% of women, but PMDD affects perhaps 3%-8%. PMDD typically starts in a woman’s 3rd decade (in her 20s) and worsens over time, Dr. Haller said. PMDD is a formal diagnosis in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). The illness reduces quality of life and level of functioning during the late luteal phase of the menstrual cycle, affecting relationships, work, or school.

"We miss this diagnosis a lot of the time," she said. Missed diagnosis rates for PMDD are estimated to be as high as 90%.

Conversely, approximately 40% of patients who think they have PMDD actually experience premenstrual exacerbations of bipolar disorder, major depression, anxiety, or other psychiatric disorders with symptoms that can get worse during the late luteal phase.

To diagnose PMDD, first rule out other psychiatric disorders and other medical disorders such as hypothyroidism, Dr. Haller advised. Then, have patients prospectively record their symptoms on a daily symptom diary to track associations with the menstrual cycle.

Dr. Haller reported having no relevant financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

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SAN FRANCISCO – Selective serotonin reuptake inhibitor antidepressants can alleviate symptoms of premenstrual syndrome or premenstrual dysphoric disorder, but are far from first-line therapies for either disorder, according to Dr. Ellen Haller.

The first steps in treating PMS and PMDD are basic wellness strategies such as a healthy diet, smoking cessation, exercise, adequate sleep, and stress management, Dr. Haller said at a conference on women’s health sponsored by the University of California, San Francisco.

Dr. Ellen Haller

Calcium supplementation also has been shown to reduce total emotional and physical symptom scores by 48% in women with PMS compared with a 30% reduction from placebo in a multicenter, randomized placebo-controlled study of 497 patients. That study used 600 mg, twice daily, of calcium carbonate or placebo for three menstrual cycles, said Dr. Haller, professor of clinical psychiatry at the university.

The results of that study (Am. J. Obstet.Gynecol. 1998;179:444-52) have not been replicated, she added.

If wellness treatments and calcium supplementation don’t work, the next step for treating women with PMS may be an SSRI. A Cochrane review of 31 randomized controlled trials found that SSRIs are more effective than placebo in treating PMS (Cochrane Database Syst. Rev. 2013;6:CD001396). Treatment should be an SSRI antidepressant, Dr. Haller emphasized. Bupropion, which is a norepinephrine dopamine reuptake inhibitor, is not effective for these women.

Low-dose SSRIs may be taken daily or can be effective against emotional and physical symptoms if taken only during the luteal phase of menstruation, starting on day 14 of the cycle and stopping on day 1, the first day of menses, Dr. Haller said. Patients with PMS tend to respond more quickly and at lower doses than patients with depression, and usually don’t get withdrawal symptoms when stopping the SSRI on the luteal-phase dosing regimen.

In women with PMDD, there is a preliminary suggestion that an SSRI may be more effective than calcium supplements. A pilot study of 39 women with PMDD found that the SSRI fluoxetine was more effective than calcium or placebo for PMDD, though scores were significantly better than calcium only on just two of five symptom scales. The study compared fluoxetine 10 mg b.i.d., calcium carbonate 600 mg b.i.d., and placebo (J. Clin. Psychopharmacol. 2013;33:614-20).

Dr. Haller also advised avoiding progesterone-only or other combination oral contraceptives, most of which can worsen PMDD symptoms. The oral contraceptive Yaz (drospirenone 3 mg plus ethinyl estradiol 20 mcg) is an evidence-based option that is approved to treat PMDD.

In a double-blind, randomized placebo-controlled trial, 450 women with rigorously diagnosed PMDD spent 24 days on Yaz or placebo and 4 days on an inert pill per cycle for three menstrual cycles. The Yaz group had a significant 47% decrease in total symptom scores compared with a 38% decrease in the placebo group. Side effects, most commonly nausea and intermenstrual bleeding, prompted 15% on Yaz and 4% on placebo to drop out of the study (Obstet. Gynecol. 2005;106:492-501).

Significant PMS symptoms affect approximately 30% of women, but PMDD affects perhaps 3%-8%. PMDD typically starts in a woman’s 3rd decade (in her 20s) and worsens over time, Dr. Haller said. PMDD is a formal diagnosis in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). The illness reduces quality of life and level of functioning during the late luteal phase of the menstrual cycle, affecting relationships, work, or school.

"We miss this diagnosis a lot of the time," she said. Missed diagnosis rates for PMDD are estimated to be as high as 90%.

Conversely, approximately 40% of patients who think they have PMDD actually experience premenstrual exacerbations of bipolar disorder, major depression, anxiety, or other psychiatric disorders with symptoms that can get worse during the late luteal phase.

To diagnose PMDD, first rule out other psychiatric disorders and other medical disorders such as hypothyroidism, Dr. Haller advised. Then, have patients prospectively record their symptoms on a daily symptom diary to track associations with the menstrual cycle.

Dr. Haller reported having no relevant financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Selective serotonin reuptake inhibitor antidepressants can alleviate symptoms of premenstrual syndrome or premenstrual dysphoric disorder, but are far from first-line therapies for either disorder, according to Dr. Ellen Haller.

The first steps in treating PMS and PMDD are basic wellness strategies such as a healthy diet, smoking cessation, exercise, adequate sleep, and stress management, Dr. Haller said at a conference on women’s health sponsored by the University of California, San Francisco.

Dr. Ellen Haller

Calcium supplementation also has been shown to reduce total emotional and physical symptom scores by 48% in women with PMS compared with a 30% reduction from placebo in a multicenter, randomized placebo-controlled study of 497 patients. That study used 600 mg, twice daily, of calcium carbonate or placebo for three menstrual cycles, said Dr. Haller, professor of clinical psychiatry at the university.

The results of that study (Am. J. Obstet.Gynecol. 1998;179:444-52) have not been replicated, she added.

If wellness treatments and calcium supplementation don’t work, the next step for treating women with PMS may be an SSRI. A Cochrane review of 31 randomized controlled trials found that SSRIs are more effective than placebo in treating PMS (Cochrane Database Syst. Rev. 2013;6:CD001396). Treatment should be an SSRI antidepressant, Dr. Haller emphasized. Bupropion, which is a norepinephrine dopamine reuptake inhibitor, is not effective for these women.

Low-dose SSRIs may be taken daily or can be effective against emotional and physical symptoms if taken only during the luteal phase of menstruation, starting on day 14 of the cycle and stopping on day 1, the first day of menses, Dr. Haller said. Patients with PMS tend to respond more quickly and at lower doses than patients with depression, and usually don’t get withdrawal symptoms when stopping the SSRI on the luteal-phase dosing regimen.

In women with PMDD, there is a preliminary suggestion that an SSRI may be more effective than calcium supplements. A pilot study of 39 women with PMDD found that the SSRI fluoxetine was more effective than calcium or placebo for PMDD, though scores were significantly better than calcium only on just two of five symptom scales. The study compared fluoxetine 10 mg b.i.d., calcium carbonate 600 mg b.i.d., and placebo (J. Clin. Psychopharmacol. 2013;33:614-20).

Dr. Haller also advised avoiding progesterone-only or other combination oral contraceptives, most of which can worsen PMDD symptoms. The oral contraceptive Yaz (drospirenone 3 mg plus ethinyl estradiol 20 mcg) is an evidence-based option that is approved to treat PMDD.

In a double-blind, randomized placebo-controlled trial, 450 women with rigorously diagnosed PMDD spent 24 days on Yaz or placebo and 4 days on an inert pill per cycle for three menstrual cycles. The Yaz group had a significant 47% decrease in total symptom scores compared with a 38% decrease in the placebo group. Side effects, most commonly nausea and intermenstrual bleeding, prompted 15% on Yaz and 4% on placebo to drop out of the study (Obstet. Gynecol. 2005;106:492-501).

Significant PMS symptoms affect approximately 30% of women, but PMDD affects perhaps 3%-8%. PMDD typically starts in a woman’s 3rd decade (in her 20s) and worsens over time, Dr. Haller said. PMDD is a formal diagnosis in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). The illness reduces quality of life and level of functioning during the late luteal phase of the menstrual cycle, affecting relationships, work, or school.

"We miss this diagnosis a lot of the time," she said. Missed diagnosis rates for PMDD are estimated to be as high as 90%.

Conversely, approximately 40% of patients who think they have PMDD actually experience premenstrual exacerbations of bipolar disorder, major depression, anxiety, or other psychiatric disorders with symptoms that can get worse during the late luteal phase.

To diagnose PMDD, first rule out other psychiatric disorders and other medical disorders such as hypothyroidism, Dr. Haller advised. Then, have patients prospectively record their symptoms on a daily symptom diary to track associations with the menstrual cycle.

Dr. Haller reported having no relevant financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

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EXPERT ANALYSIS FROM A CONFERENCE ON WOMEN’S HEALTH

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Opportunities to boost cardiovascular disease awareness

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DALLAS – A mere 28% of 1,013 surveyed New York–area women correctly identified cardiovascular disease as the No. 1 killer of women. And two-thirds of those women said their primary care provider is an obstetrician-gynecologist who does not discuss heart health as part of preventive care, Dr. Allison J. Brusati reported at the American Heart Association scientific sessions.

"In a population with extremely low levels of awareness of cardiovascular disease and a high reliance on ob.gyn. care – and particularly young, reproductive-age women – ob.gyns. are not only well poised but [also are as] obligated as primary care physicians to provide heart-health education to their patients. Without adding much time to a patient’s annual visit, an ob.gyn. can discuss a woman’s risk factors and advise lifestyle changes that may prove essential in preventing heart disease as well as other chronic diseases," asserted Dr. Brusati of Albert Einstein College of Medicine in New York.

Dr. Allison Brusati

The 28% rate of awareness of heart disease as the top killer of women in this New York survey is exactly half the rate found in a recent AHA-sponsored national survey of women (Circulation 2013;127:1254-63). The survey was conducted at five ob.gyn. clinics affiliated with Montefiore Medical Center, four situated in largely impoverished sections of the Bronx and one in wealthy Westchester County. The survey population was 40% Hispanic, 31% black, and 20% white. Only 21% of non-white women, compared with 55% of white women, were able to identify cardiovascular disease as the top killer of women.

"Younger women with lower income levels and without a higher degree of education were more likely to be unaware of their risk of heart disease," said Dr. Brusati. Still, education was no guarantee of being heart-health savvy. Of survey respondents who had a college degree or higher, 44% identified cardiovascular disease as the top cause of mortality in women, 42% thought cancer was the top cause of death in women, and 20% had no idea of the No. 1 cause of death.

The survey also found that most of the ob.gyns. who served as primary care providers for the New York women also failed to discuss other key aspects of primary prevention beyond heart health. Smoking was discussed by 51% of ob.gyns, exercise by 42%, diet by 38%, and colonoscopy by 32%. Mammography was discussed by 75% of ob.gyns.

Dr. Brusati’s coinvestigator in this unfunded study was Dr. Mary L. Rosser, an ob.gyn. at Montefiore Medical Center. They reported having no financial conflicts.

bjancin@frontlinemedcom.com

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DALLAS – A mere 28% of 1,013 surveyed New York–area women correctly identified cardiovascular disease as the No. 1 killer of women. And two-thirds of those women said their primary care provider is an obstetrician-gynecologist who does not discuss heart health as part of preventive care, Dr. Allison J. Brusati reported at the American Heart Association scientific sessions.

"In a population with extremely low levels of awareness of cardiovascular disease and a high reliance on ob.gyn. care – and particularly young, reproductive-age women – ob.gyns. are not only well poised but [also are as] obligated as primary care physicians to provide heart-health education to their patients. Without adding much time to a patient’s annual visit, an ob.gyn. can discuss a woman’s risk factors and advise lifestyle changes that may prove essential in preventing heart disease as well as other chronic diseases," asserted Dr. Brusati of Albert Einstein College of Medicine in New York.

Dr. Allison Brusati

The 28% rate of awareness of heart disease as the top killer of women in this New York survey is exactly half the rate found in a recent AHA-sponsored national survey of women (Circulation 2013;127:1254-63). The survey was conducted at five ob.gyn. clinics affiliated with Montefiore Medical Center, four situated in largely impoverished sections of the Bronx and one in wealthy Westchester County. The survey population was 40% Hispanic, 31% black, and 20% white. Only 21% of non-white women, compared with 55% of white women, were able to identify cardiovascular disease as the top killer of women.

"Younger women with lower income levels and without a higher degree of education were more likely to be unaware of their risk of heart disease," said Dr. Brusati. Still, education was no guarantee of being heart-health savvy. Of survey respondents who had a college degree or higher, 44% identified cardiovascular disease as the top cause of mortality in women, 42% thought cancer was the top cause of death in women, and 20% had no idea of the No. 1 cause of death.

The survey also found that most of the ob.gyns. who served as primary care providers for the New York women also failed to discuss other key aspects of primary prevention beyond heart health. Smoking was discussed by 51% of ob.gyns, exercise by 42%, diet by 38%, and colonoscopy by 32%. Mammography was discussed by 75% of ob.gyns.

Dr. Brusati’s coinvestigator in this unfunded study was Dr. Mary L. Rosser, an ob.gyn. at Montefiore Medical Center. They reported having no financial conflicts.

bjancin@frontlinemedcom.com

DALLAS – A mere 28% of 1,013 surveyed New York–area women correctly identified cardiovascular disease as the No. 1 killer of women. And two-thirds of those women said their primary care provider is an obstetrician-gynecologist who does not discuss heart health as part of preventive care, Dr. Allison J. Brusati reported at the American Heart Association scientific sessions.

"In a population with extremely low levels of awareness of cardiovascular disease and a high reliance on ob.gyn. care – and particularly young, reproductive-age women – ob.gyns. are not only well poised but [also are as] obligated as primary care physicians to provide heart-health education to their patients. Without adding much time to a patient’s annual visit, an ob.gyn. can discuss a woman’s risk factors and advise lifestyle changes that may prove essential in preventing heart disease as well as other chronic diseases," asserted Dr. Brusati of Albert Einstein College of Medicine in New York.

Dr. Allison Brusati

The 28% rate of awareness of heart disease as the top killer of women in this New York survey is exactly half the rate found in a recent AHA-sponsored national survey of women (Circulation 2013;127:1254-63). The survey was conducted at five ob.gyn. clinics affiliated with Montefiore Medical Center, four situated in largely impoverished sections of the Bronx and one in wealthy Westchester County. The survey population was 40% Hispanic, 31% black, and 20% white. Only 21% of non-white women, compared with 55% of white women, were able to identify cardiovascular disease as the top killer of women.

"Younger women with lower income levels and without a higher degree of education were more likely to be unaware of their risk of heart disease," said Dr. Brusati. Still, education was no guarantee of being heart-health savvy. Of survey respondents who had a college degree or higher, 44% identified cardiovascular disease as the top cause of mortality in women, 42% thought cancer was the top cause of death in women, and 20% had no idea of the No. 1 cause of death.

The survey also found that most of the ob.gyns. who served as primary care providers for the New York women also failed to discuss other key aspects of primary prevention beyond heart health. Smoking was discussed by 51% of ob.gyns, exercise by 42%, diet by 38%, and colonoscopy by 32%. Mammography was discussed by 75% of ob.gyns.

Dr. Brusati’s coinvestigator in this unfunded study was Dr. Mary L. Rosser, an ob.gyn. at Montefiore Medical Center. They reported having no financial conflicts.

bjancin@frontlinemedcom.com

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AT THE AHA SCIENTIFIC SESSIONS

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Major finding: Two-thirds of the women whose primary care provider was an ob.gyn. said their physician does not discuss heart health with them.

Data source: This was a survey of 1,013 women attending five ob.gyn. clinics affiliated with Montefiore Medical Center in New York.

Disclosures: The presenter of this unfunded study reported having no financial conflicts.

Exposure therapy trumped supportive counseling for adolescent PTSD

Exposure therapy doesn’t worsen childhood PTSD
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Exposure therapy trumped supportive counseling for adolescent PTSD

Prolonged-exposure therapy – a standard treatment for posttraumatic stress disorder in adults – worked better than supportive counseling did to help adolescent girls to recover from sexual abuse, based on the results of a randomized trial comparing 3 months of weekly exposure therapy in 31 girls to supportive counseling in 30 others.

Further, the technique succeeded with master’s level mental health counselors who provided the exposure therapy after a 4-day training session, plus two follow-up sessions.

Dr. Edna Foa

Those in the prolonged-exposure group improved from a baseline mean of 27.3 points to 6.7 points, an overall shift from moderately severe to below-threshold PTSD, on the clinician-assessed 51-point Child PTSD Symptom Scale–Interview. The supportive counseling group improved from a mean of 29.4 points to 16.1 points, going from an overall score of moderately severe to mild PTSD. The difference in outcomes was significant.

Prolonged-exposure therapy is rarely provided to adolescents because of concern that it may exacerbate PTSD symptoms or because of the belief that patients must master coping skills before exposure can safely be provided, noted study researcher Edna Foa, Ph.D., of the department of psychiatry at the University of Pennsylvania, Philadelphia, and her colleagues.

The findings imply that prolonged exposure therapy can be successfully administered by newly trained counselors at community mental health and rape crisis clinics. "This is important because the need for evidence-based treatment of PTSD far exceeds the availability of these services," the researchers wrote in a study published online Dec. 24 in JAMA.

The study subjects were recruited from Women Organized Against Rape, a rape crisis center in Philadelphia. They were 13-18 years old, with a mean age of about 15 years. More than half had at least one comorbid psychiatric diagnosis. Actively suicidal girls and those with uncontrolled bipolar disorder, schizophrenia, conduct disorder, or pervasive developmental disorder were excluded from the study, along with those who had started psychiatric drugs within 3 months.

Treatment included discussing the rationale for exposure, recounting the event, breathing exercises, and homework, plus a final project, such as making a booklet about the trauma and gains made in treatment. Counselors listened actively and with empathy during sessions, encouraged the girls to talk about their feelings, and told them they believed in their ability to cope. Not one of the girls in supportive counseling described their trauma during the sessions.

The exposure group completed a mean of 12 sessions; the supportive group, 11 sessions. Up to 14 sessions were available for both groups. More than 90% (28) of exposure subjects completed their sessions; 83.3% (25) of supportive counseling patients completed theirs.

Participants who received prolonged-exposure therapy had greater improvement in PTSD symptoms and were more likely to lose their PTSD diagnosis than were those who received supportive counseling. By the end of their sessions, about three-quarters (24) of the prolonged-exposure girls – but less than half (13) of the supportive counseling subjects – no longer met DSM-IV criteria for PTSD, also a significant difference.

The results of prolonged exposure also were superior to those of supportive counseling at 12-month follow-up, said Dr. Foa (JAMA 2013;310:2650-57 [doi:10.1001/jama.2013.282829]).

Those given exposure therapy also did significantly better on clinician- or subject-assessed measures of symptoms, depression, and function; the differences persisted through 12-months of follow-up.

The National Institutes of Health funded the work. The authors said they had no relevant commercial disclosures.

aotto@frontlinemedcom.com

Body

Although more trials of prolonged exposure for sexually abused children and adolescents are needed, there is no theoretical or practical reason to assume that prolonged exposure will not be equally effective for PTSD arising from other types of traumas or in children.

The findings from this study should allay therapist concerns about any potential harmful effects of exposure and the need for extensive preparation of the patient for exposure. The heightened arousal that many therapists fear they will cause by leading the patients through exposure exercises is an expected and integral part of the recovery process; it usually dissipates within a few sessions and leads to rapid reductions in symptoms between sessions.

Research is also needed to determine the minimum amount of training and supervision for therapists to effectively deliver prolonged exposure and similar exposure-focused treatments to patients with PTSD and other anxiety disorders.

Dr. Sean Perrin is a lecturer at Lund (Sweden) University and King’s College London. He said he had no relevant financial disclosures. He made these remarks in an editorial accompanying Dr. Foa’s study (JAMA 2013;310:2619-20 [doi:10.1001/jama.2013.283944]).

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Although more trials of prolonged exposure for sexually abused children and adolescents are needed, there is no theoretical or practical reason to assume that prolonged exposure will not be equally effective for PTSD arising from other types of traumas or in children.

The findings from this study should allay therapist concerns about any potential harmful effects of exposure and the need for extensive preparation of the patient for exposure. The heightened arousal that many therapists fear they will cause by leading the patients through exposure exercises is an expected and integral part of the recovery process; it usually dissipates within a few sessions and leads to rapid reductions in symptoms between sessions.

Research is also needed to determine the minimum amount of training and supervision for therapists to effectively deliver prolonged exposure and similar exposure-focused treatments to patients with PTSD and other anxiety disorders.

Dr. Sean Perrin is a lecturer at Lund (Sweden) University and King’s College London. He said he had no relevant financial disclosures. He made these remarks in an editorial accompanying Dr. Foa’s study (JAMA 2013;310:2619-20 [doi:10.1001/jama.2013.283944]).

Body

Although more trials of prolonged exposure for sexually abused children and adolescents are needed, there is no theoretical or practical reason to assume that prolonged exposure will not be equally effective for PTSD arising from other types of traumas or in children.

The findings from this study should allay therapist concerns about any potential harmful effects of exposure and the need for extensive preparation of the patient for exposure. The heightened arousal that many therapists fear they will cause by leading the patients through exposure exercises is an expected and integral part of the recovery process; it usually dissipates within a few sessions and leads to rapid reductions in symptoms between sessions.

Research is also needed to determine the minimum amount of training and supervision for therapists to effectively deliver prolonged exposure and similar exposure-focused treatments to patients with PTSD and other anxiety disorders.

Dr. Sean Perrin is a lecturer at Lund (Sweden) University and King’s College London. He said he had no relevant financial disclosures. He made these remarks in an editorial accompanying Dr. Foa’s study (JAMA 2013;310:2619-20 [doi:10.1001/jama.2013.283944]).

Title
Exposure therapy doesn’t worsen childhood PTSD
Exposure therapy doesn’t worsen childhood PTSD

Prolonged-exposure therapy – a standard treatment for posttraumatic stress disorder in adults – worked better than supportive counseling did to help adolescent girls to recover from sexual abuse, based on the results of a randomized trial comparing 3 months of weekly exposure therapy in 31 girls to supportive counseling in 30 others.

Further, the technique succeeded with master’s level mental health counselors who provided the exposure therapy after a 4-day training session, plus two follow-up sessions.

Dr. Edna Foa

Those in the prolonged-exposure group improved from a baseline mean of 27.3 points to 6.7 points, an overall shift from moderately severe to below-threshold PTSD, on the clinician-assessed 51-point Child PTSD Symptom Scale–Interview. The supportive counseling group improved from a mean of 29.4 points to 16.1 points, going from an overall score of moderately severe to mild PTSD. The difference in outcomes was significant.

Prolonged-exposure therapy is rarely provided to adolescents because of concern that it may exacerbate PTSD symptoms or because of the belief that patients must master coping skills before exposure can safely be provided, noted study researcher Edna Foa, Ph.D., of the department of psychiatry at the University of Pennsylvania, Philadelphia, and her colleagues.

The findings imply that prolonged exposure therapy can be successfully administered by newly trained counselors at community mental health and rape crisis clinics. "This is important because the need for evidence-based treatment of PTSD far exceeds the availability of these services," the researchers wrote in a study published online Dec. 24 in JAMA.

The study subjects were recruited from Women Organized Against Rape, a rape crisis center in Philadelphia. They were 13-18 years old, with a mean age of about 15 years. More than half had at least one comorbid psychiatric diagnosis. Actively suicidal girls and those with uncontrolled bipolar disorder, schizophrenia, conduct disorder, or pervasive developmental disorder were excluded from the study, along with those who had started psychiatric drugs within 3 months.

Treatment included discussing the rationale for exposure, recounting the event, breathing exercises, and homework, plus a final project, such as making a booklet about the trauma and gains made in treatment. Counselors listened actively and with empathy during sessions, encouraged the girls to talk about their feelings, and told them they believed in their ability to cope. Not one of the girls in supportive counseling described their trauma during the sessions.

The exposure group completed a mean of 12 sessions; the supportive group, 11 sessions. Up to 14 sessions were available for both groups. More than 90% (28) of exposure subjects completed their sessions; 83.3% (25) of supportive counseling patients completed theirs.

Participants who received prolonged-exposure therapy had greater improvement in PTSD symptoms and were more likely to lose their PTSD diagnosis than were those who received supportive counseling. By the end of their sessions, about three-quarters (24) of the prolonged-exposure girls – but less than half (13) of the supportive counseling subjects – no longer met DSM-IV criteria for PTSD, also a significant difference.

The results of prolonged exposure also were superior to those of supportive counseling at 12-month follow-up, said Dr. Foa (JAMA 2013;310:2650-57 [doi:10.1001/jama.2013.282829]).

Those given exposure therapy also did significantly better on clinician- or subject-assessed measures of symptoms, depression, and function; the differences persisted through 12-months of follow-up.

The National Institutes of Health funded the work. The authors said they had no relevant commercial disclosures.

aotto@frontlinemedcom.com

Prolonged-exposure therapy – a standard treatment for posttraumatic stress disorder in adults – worked better than supportive counseling did to help adolescent girls to recover from sexual abuse, based on the results of a randomized trial comparing 3 months of weekly exposure therapy in 31 girls to supportive counseling in 30 others.

Further, the technique succeeded with master’s level mental health counselors who provided the exposure therapy after a 4-day training session, plus two follow-up sessions.

Dr. Edna Foa

Those in the prolonged-exposure group improved from a baseline mean of 27.3 points to 6.7 points, an overall shift from moderately severe to below-threshold PTSD, on the clinician-assessed 51-point Child PTSD Symptom Scale–Interview. The supportive counseling group improved from a mean of 29.4 points to 16.1 points, going from an overall score of moderately severe to mild PTSD. The difference in outcomes was significant.

Prolonged-exposure therapy is rarely provided to adolescents because of concern that it may exacerbate PTSD symptoms or because of the belief that patients must master coping skills before exposure can safely be provided, noted study researcher Edna Foa, Ph.D., of the department of psychiatry at the University of Pennsylvania, Philadelphia, and her colleagues.

The findings imply that prolonged exposure therapy can be successfully administered by newly trained counselors at community mental health and rape crisis clinics. "This is important because the need for evidence-based treatment of PTSD far exceeds the availability of these services," the researchers wrote in a study published online Dec. 24 in JAMA.

The study subjects were recruited from Women Organized Against Rape, a rape crisis center in Philadelphia. They were 13-18 years old, with a mean age of about 15 years. More than half had at least one comorbid psychiatric diagnosis. Actively suicidal girls and those with uncontrolled bipolar disorder, schizophrenia, conduct disorder, or pervasive developmental disorder were excluded from the study, along with those who had started psychiatric drugs within 3 months.

Treatment included discussing the rationale for exposure, recounting the event, breathing exercises, and homework, plus a final project, such as making a booklet about the trauma and gains made in treatment. Counselors listened actively and with empathy during sessions, encouraged the girls to talk about their feelings, and told them they believed in their ability to cope. Not one of the girls in supportive counseling described their trauma during the sessions.

The exposure group completed a mean of 12 sessions; the supportive group, 11 sessions. Up to 14 sessions were available for both groups. More than 90% (28) of exposure subjects completed their sessions; 83.3% (25) of supportive counseling patients completed theirs.

Participants who received prolonged-exposure therapy had greater improvement in PTSD symptoms and were more likely to lose their PTSD diagnosis than were those who received supportive counseling. By the end of their sessions, about three-quarters (24) of the prolonged-exposure girls – but less than half (13) of the supportive counseling subjects – no longer met DSM-IV criteria for PTSD, also a significant difference.

The results of prolonged exposure also were superior to those of supportive counseling at 12-month follow-up, said Dr. Foa (JAMA 2013;310:2650-57 [doi:10.1001/jama.2013.282829]).

Those given exposure therapy also did significantly better on clinician- or subject-assessed measures of symptoms, depression, and function; the differences persisted through 12-months of follow-up.

The National Institutes of Health funded the work. The authors said they had no relevant commercial disclosures.

aotto@frontlinemedcom.com

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Major finding: Child PTSD Symptom Scale–Interview scores fell from a mean of 27.3 to 6.7 points after 3 months of prolonged-exposure PTSD therapy in 31 sexually abused adolescent girls; scores fell from a mean of 29.4 points to 16.1 points among 30 adolescent girls treated with supportive counseling.

Data source: A randomized trial of 61 sexually abused adolescents.

Disclosures: The National Institutes of Health funded the work. The investigators said they had no relevant financial commercial disclosures.