Sharon Worcester

In 1966, Dr. Charles Hammond was wrapping up a 2-year stint at the National Institutes of Health where he served at the behest of the military draft board. He had graduated from medical school just 5 years prior, and was in the middle of his ob.gyn. residency training at Duke University in Durham, N.C. when he was called to serve.

His experience wasn’t unusual for the time.

Courtesy Dr. Charles Hammond

“When the draft board called, you went,” he said in an interview.

When he returned, he picked up where he left off. Residencies at that time were an “open-ended thing,” sometimes lasting 5 or 6 years, depending on staffing needs and other considerations.

Dr. Hammond, now an emeritus professor at Duke, regards his public service commission as an opportunity that advanced his academic career – despite the interruption of his residency training.

Such draft-related interruptions ended in the wake of the Vietnam War, of course, but the late 1960s and the 1970s ushered in a whole new era of changes in ob.gyn. residency training programs.

By 1968, residencies lasted 4 years, and fellowships were for 2 years. Ob.gyn. subspecialties hadn’t yet been introduced, explained Dr. Sandra A. Carson, vice president for education at the American College of Obstetricians and Gynecologists.

“That is essentially how things worked for a long time,” she said in an interview.

That’s not to say there weren’t numerous other changes taking place in the specialty. In a series of interviews with physicians and educators who discussed the myriad ways that residency training has evolved over the last 50 years, a number of themes emerged.

Women in medicine

A striking change over the past 5 decades has been the increasing number of women in medicine. Nowhere has that been in greater evidence than in obstetrics and gynecology.

“There were a few – but very few,” Dr. Hammond said of women in medicine in the 1960s.

There was “a philosophy that men did it better,” he said, adding, “That has been nicely shown to be inaccurate.”

Currently, about 80% of first-year ob.gyn. residents are women, compared with 15% in 1975.

“Maybe even 83% now,” Dr. Carson said, noting that even in the early 1980s when she was in training, women were “few and far between.”

According to a 2011 workforce report by Dr. William F. Rayburn, obstetrics and gynecology has the highest percentage of women residents of any medical specialty – 80% in 2009 versus an average of 46% for other specialties combined, and that figure has remained fairly constant.

Dr. Kasandra Scales, a fourth-year resident at the State University of New York, Syracuse, said she is glad to be part of this era of the specialty where women play an integral role in the advancement of women’s health care.

Courtesy Dr. Kasandra Scales

“I believe our voice and unique perspective to relate with common experiences, such as the physical birth of a child or personal choices in contraception... has enhanced our specialty,” she said.

That said, the fact that men are noticeably absent from the pool of ob.gyn. applicants and residents concerns her. “There should be a balance, she said. “I think it is important to have diversity of all types in the healthcare system.”

Dr. Hammond looked back on his days in residency training and recalled pockets of resistance to the increasing number of women in medicine, but the ultimate effect was good for the specialty, he said, explaining that the quality of the resident pool improved steadily, because the number of qualified candidates increased.

“It has been an interesting interval to watch,” he said, specifically mentioning the demands that women faced in terms of family obligations, childbirth, and childrearing.

Restrictions on work hours instituted in residency programs in more recent years may have played an important role in opening the door to more women, he said.

Work hours down, learning curve up

Dr. Carson agreed that work-hour restrictions instituted in 2003 and updated in 2011, which cap the work week at 80 hours and also apply limits on shift hours, likely encouraged more women to enter the field. One constant over the last 50 years is the biological clock, she said, explaining that the pressures and demands of residency before limits were put in place may have steered women away.

Work-hour restrictions provide more flexibility, but they aren’t without controversy.

Dr. Hammond said he sees the value in work hour restrictions, but working long hours as a resident – sometimes as many as 110 hours per week – had its benefits, too.

“I remember one time when I’d been on call for about 2 and a half days, and up and working the whole time,” Dr. Hammond said. “I left the hospital, walked out to a bench, sat down, and fell asleep. I woke up and distinctly remember thinking, ‘Why am I doing this?’ But I did do it, and that fatigue helped me with learning to endure. You learned from it.”

Not only have long hours been viewed as a rite of passage in medicine, he said, but there were concerns initially that the level of education would diminish and that the risk of patient errors would increase as patients were handed off from one shift to the next, he said.

Data on the effects of work-hour rules have been conflicting. In one study, Dr. Roger P. Smith found little overall effect on total technical experience among residents before and after the restrictions were put in place (there was no statistically significant difference in the average of median total cases in the 3 years before and after). Previous studies had documented increased costs and reduced faculty job satisfaction, while still others had shown no significant changes in 30-day readmission rates, in-hospital mortality, patient length of stay, or resident performance, he noted. “What is emerging is that both the great hopes and the great fears surrounding resident work-hour restrictions have not come to pass,” Dr. Smith wrote (Obstet Gynecol. 2010 Jun;115[6]:1166-71).

Dr. Scales, who is currently chair of the Junior Fellow District II Advisory Council for ACOG, comes down on the side of wishing for more hours.

“[The restrictions] do limit the things we can do and the exposure we may otherwise have,” she said, noting that it’s frustrating to have to leave when she’d rather stay and “see a cool case.”

“It’s a nice idea in principle, but the same amount of work has to be done. It’s not real life,” she said of work-hour restrictions. “It’s hard, at least for me, to want to give up my patients. Our job is to take in as much as you can before you leave to go out into the big bad world.”

It may be difficult to determine the actual impact of work hour limits on patient outcomes because the field of obstetrics and gynecology has changed so much over time.

Dr. David Forstein, vice chair of clinical operations in the department of obstetrics and gynecology at the University of South Carolina, Greenville, and a member of the Accreditation Council for Graduate Medical Education’s task force on work hours said that, for one thing, patients are generally sicker now than ever before, due in part to the obesity epidemic.

Further, changing trends mean that residents are getting less exposure to some procedures like operative vaginal deliveries, while also having to learn more ways to perform hysterectomy. Residents aren’t necessarily less prepared. They’re just having to work very hard because of the depth and breadth of the required knowledge has increased, Dr. Forstein said. “There’s a lot more to learn.”

Dr. Carson agreed that the approach to education has changed, and that those changes are largely a reflection of overall shifts in education and technology.

Technology trends

Every physician interviewed for this article cited laparoscopy and robotic surgery as key technological advances. Fifty years ago, the surgical tools were simpler, Dr. Carson said. Now residents must learn four approaches to hysterectomy: vaginal, abdominal, laparoscopic, and robotic-assisted laparoscopic hysterectomy.

From ultrasound and birth control to genetic screening and robotic surgery, the evolution of the field has been astounding during this time period. The effects of the birth control pill on family planning alone forced an expansion of curriculum not only to the physiology of these things, but also to the treatment of women as a whole person and often as part of a family unit, she said.

Many of the technologies have dramatically changed the landscape, both in terms of how learning is accomplished (for example, simulation), and how physicians interact with patients, Dr. Hammond agreed. With ultrasound, for example, there was a sense that part of the physician-patient relationship was lost.

“To a point, some of us old guys felt like they were doing ultrasound assessment of patients rather than the tried-and-true ‘talk to them and examine them’ [approach],” he said. “I guess whichever generation you are in seems to be the right one, but it’s probably somewhere in between.”

Residency in 2016

If Dr. Scales is any indication, concerns about the loss of a personal touch are unfounded. She says that for her, that’s what it’s all about.

“We were exposed to [technology] since we were 5 or 6 – it’s all we know,” she said of herself and her fellow residents. “It’s not a disadvantage. It’s about efficiency.”

“We have to get things done as quickly as possible and technology helps us with that,” said Dr. Scales, the daughter of a teacher and blue collar worker, who spent most of her life “surrounded by the underprivileged.”

She always desired to help lift that population up, and while she didn’t have a draft board directing her toward public service, she had her own calling of sorts. As a premed major in college, she worked with a nonprofit organization, and later she worked with Hurricane Katrina survivors.

“I liked that aspect of medicine. I wanted to be able to identify with people on an individual level,” she said.

Technology, work-hour restrictions, gender distribution – they’re just part of the journey.

“I’m glad I chose ob.gyn.,” she said. “Sometimes you go through ... reflection ... Am I ready? My answer is yes. I’m excited about the next step, I’m comfortable in the skill I learned in my residency program, I’m excited about the work I do every day, and I’m very excited about the next chapters.”

sworcester@frontlinemedcom.com

In 1966, Dr. Charles Hammond was wrapping up a 2-year stint at the National Institutes of Health where he served at the behest of the military draft board. He had graduated from medical school just 5 years prior, and was in the middle of his ob.gyn. residency training at Duke University in Durham, N.C. when he was called to serve.

His experience wasn’t unusual for the time.

Courtesy Dr. Charles Hammond

“When the draft board called, you went,” he said in an interview.

When he returned, he picked up where he left off. Residencies at that time were an “open-ended thing,” sometimes lasting 5 or 6 years, depending on staffing needs and other considerations.

Dr. Hammond, now an emeritus professor at Duke, regards his public service commission as an opportunity that advanced his academic career – despite the interruption of his residency training.

Such draft-related interruptions ended in the wake of the Vietnam War, of course, but the late 1960s and the 1970s ushered in a whole new era of changes in ob.gyn. residency training programs.

By 1968, residencies lasted 4 years, and fellowships were for 2 years. Ob.gyn. subspecialties hadn’t yet been introduced, explained Dr. Sandra A. Carson, vice president for education at the American College of Obstetricians and Gynecologists.

“That is essentially how things worked for a long time,” she said in an interview.

That’s not to say there weren’t numerous other changes taking place in the specialty. In a series of interviews with physicians and educators who discussed the myriad ways that residency training has evolved over the last 50 years, a number of themes emerged.

Women in medicine

A striking change over the past 5 decades has been the increasing number of women in medicine. Nowhere has that been in greater evidence than in obstetrics and gynecology.

“There were a few – but very few,” Dr. Hammond said of women in medicine in the 1960s.

There was “a philosophy that men did it better,” he said, adding, “That has been nicely shown to be inaccurate.”

Currently, about 80% of first-year ob.gyn. residents are women, compared with 15% in 1975.

“Maybe even 83% now,” Dr. Carson said, noting that even in the early 1980s when she was in training, women were “few and far between.”

According to a 2011 workforce report by Dr. William F. Rayburn, obstetrics and gynecology has the highest percentage of women residents of any medical specialty – 80% in 2009 versus an average of 46% for other specialties combined, and that figure has remained fairly constant.

Dr. Kasandra Scales, a fourth-year resident at the State University of New York, Syracuse, said she is glad to be part of this era of the specialty where women play an integral role in the advancement of women’s health care.

Courtesy Dr. Kasandra Scales

“I believe our voice and unique perspective to relate with common experiences, such as the physical birth of a child or personal choices in contraception... has enhanced our specialty,” she said.

That said, the fact that men are noticeably absent from the pool of ob.gyn. applicants and residents concerns her. “There should be a balance, she said. “I think it is important to have diversity of all types in the healthcare system.”

Dr. Hammond looked back on his days in residency training and recalled pockets of resistance to the increasing number of women in medicine, but the ultimate effect was good for the specialty, he said, explaining that the quality of the resident pool improved steadily, because the number of qualified candidates increased.

“It has been an interesting interval to watch,” he said, specifically mentioning the demands that women faced in terms of family obligations, childbirth, and childrearing.

Restrictions on work hours instituted in residency programs in more recent years may have played an important role in opening the door to more women, he said.

Work hours down, learning curve up

Dr. Carson agreed that work-hour restrictions instituted in 2003 and updated in 2011, which cap the work week at 80 hours and also apply limits on shift hours, likely encouraged more women to enter the field. One constant over the last 50 years is the biological clock, she said, explaining that the pressures and demands of residency before limits were put in place may have steered women away.

Work-hour restrictions provide more flexibility, but they aren’t without controversy.

Dr. Hammond said he sees the value in work hour restrictions, but working long hours as a resident – sometimes as many as 110 hours per week – had its benefits, too.

“I remember one time when I’d been on call for about 2 and a half days, and up and working the whole time,” Dr. Hammond said. “I left the hospital, walked out to a bench, sat down, and fell asleep. I woke up and distinctly remember thinking, ‘Why am I doing this?’ But I did do it, and that fatigue helped me with learning to endure. You learned from it.”

Not only have long hours been viewed as a rite of passage in medicine, he said, but there were concerns initially that the level of education would diminish and that the risk of patient errors would increase as patients were handed off from one shift to the next, he said.

Data on the effects of work-hour rules have been conflicting. In one study, Dr. Roger P. Smith found little overall effect on total technical experience among residents before and after the restrictions were put in place (there was no statistically significant difference in the average of median total cases in the 3 years before and after). Previous studies had documented increased costs and reduced faculty job satisfaction, while still others had shown no significant changes in 30-day readmission rates, in-hospital mortality, patient length of stay, or resident performance, he noted. “What is emerging is that both the great hopes and the great fears surrounding resident work-hour restrictions have not come to pass,” Dr. Smith wrote (Obstet Gynecol. 2010 Jun;115[6]:1166-71).

Dr. Scales, who is currently chair of the Junior Fellow District II Advisory Council for ACOG, comes down on the side of wishing for more hours.

“[The restrictions] do limit the things we can do and the exposure we may otherwise have,” she said, noting that it’s frustrating to have to leave when she’d rather stay and “see a cool case.”

“It’s a nice idea in principle, but the same amount of work has to be done. It’s not real life,” she said of work-hour restrictions. “It’s hard, at least for me, to want to give up my patients. Our job is to take in as much as you can before you leave to go out into the big bad world.”

It may be difficult to determine the actual impact of work hour limits on patient outcomes because the field of obstetrics and gynecology has changed so much over time.

Dr. David Forstein, vice chair of clinical operations in the department of obstetrics and gynecology at the University of South Carolina, Greenville, and a member of the Accreditation Council for Graduate Medical Education’s task force on work hours said that, for one thing, patients are generally sicker now than ever before, due in part to the obesity epidemic.

Further, changing trends mean that residents are getting less exposure to some procedures like operative vaginal deliveries, while also having to learn more ways to perform hysterectomy. Residents aren’t necessarily less prepared. They’re just having to work very hard because of the depth and breadth of the required knowledge has increased, Dr. Forstein said. “There’s a lot more to learn.”

Dr. Carson agreed that the approach to education has changed, and that those changes are largely a reflection of overall shifts in education and technology.

Technology trends

Every physician interviewed for this article cited laparoscopy and robotic surgery as key technological advances. Fifty years ago, the surgical tools were simpler, Dr. Carson said. Now residents must learn four approaches to hysterectomy: vaginal, abdominal, laparoscopic, and robotic-assisted laparoscopic hysterectomy.

From ultrasound and birth control to genetic screening and robotic surgery, the evolution of the field has been astounding during this time period. The effects of the birth control pill on family planning alone forced an expansion of curriculum not only to the physiology of these things, but also to the treatment of women as a whole person and often as part of a family unit, she said.

Many of the technologies have dramatically changed the landscape, both in terms of how learning is accomplished (for example, simulation), and how physicians interact with patients, Dr. Hammond agreed. With ultrasound, for example, there was a sense that part of the physician-patient relationship was lost.

“To a point, some of us old guys felt like they were doing ultrasound assessment of patients rather than the tried-and-true ‘talk to them and examine them’ [approach],” he said. “I guess whichever generation you are in seems to be the right one, but it’s probably somewhere in between.”

Residency in 2016

If Dr. Scales is any indication, concerns about the loss of a personal touch are unfounded. She says that for her, that’s what it’s all about.

“We were exposed to [technology] since we were 5 or 6 – it’s all we know,” she said of herself and her fellow residents. “It’s not a disadvantage. It’s about efficiency.”

“We have to get things done as quickly as possible and technology helps us with that,” said Dr. Scales, the daughter of a teacher and blue collar worker, who spent most of her life “surrounded by the underprivileged.”

She always desired to help lift that population up, and while she didn’t have a draft board directing her toward public service, she had her own calling of sorts. As a premed major in college, she worked with a nonprofit organization, and later she worked with Hurricane Katrina survivors.

“I liked that aspect of medicine. I wanted to be able to identify with people on an individual level,” she said.

Technology, work-hour restrictions, gender distribution – they’re just part of the journey.

“I’m glad I chose ob.gyn.,” she said. “Sometimes you go through ... reflection ... Am I ready? My answer is yes. I’m excited about the next step, I’m comfortable in the skill I learned in my residency program, I’m excited about the work I do every day, and I’m very excited about the next chapters.”

sworcester@frontlinemedcom.com

In 1966, Dr. Charles Hammond was wrapping up a 2-year stint at the National Institutes of Health where he served at the behest of the military draft board. He had graduated from medical school just 5 years prior, and was in the middle of his ob.gyn. residency training at Duke University in Durham, N.C. when he was called to serve.

His experience wasn’t unusual for the time.

Courtesy Dr. Charles Hammond

“When the draft board called, you went,” he said in an interview.

When he returned, he picked up where he left off. Residencies at that time were an “open-ended thing,” sometimes lasting 5 or 6 years, depending on staffing needs and other considerations.

Dr. Hammond, now an emeritus professor at Duke, regards his public service commission as an opportunity that advanced his academic career – despite the interruption of his residency training.

Such draft-related interruptions ended in the wake of the Vietnam War, of course, but the late 1960s and the 1970s ushered in a whole new era of changes in ob.gyn. residency training programs.

By 1968, residencies lasted 4 years, and fellowships were for 2 years. Ob.gyn. subspecialties hadn’t yet been introduced, explained Dr. Sandra A. Carson, vice president for education at the American College of Obstetricians and Gynecologists.

“That is essentially how things worked for a long time,” she said in an interview.

That’s not to say there weren’t numerous other changes taking place in the specialty. In a series of interviews with physicians and educators who discussed the myriad ways that residency training has evolved over the last 50 years, a number of themes emerged.

Women in medicine

A striking change over the past 5 decades has been the increasing number of women in medicine. Nowhere has that been in greater evidence than in obstetrics and gynecology.

“There were a few – but very few,” Dr. Hammond said of women in medicine in the 1960s.

There was “a philosophy that men did it better,” he said, adding, “That has been nicely shown to be inaccurate.”

Currently, about 80% of first-year ob.gyn. residents are women, compared with 15% in 1975.

“Maybe even 83% now,” Dr. Carson said, noting that even in the early 1980s when she was in training, women were “few and far between.”

According to a 2011 workforce report by Dr. William F. Rayburn, obstetrics and gynecology has the highest percentage of women residents of any medical specialty – 80% in 2009 versus an average of 46% for other specialties combined, and that figure has remained fairly constant.

Dr. Kasandra Scales, a fourth-year resident at the State University of New York, Syracuse, said she is glad to be part of this era of the specialty where women play an integral role in the advancement of women’s health care.

Courtesy Dr. Kasandra Scales

“I believe our voice and unique perspective to relate with common experiences, such as the physical birth of a child or personal choices in contraception... has enhanced our specialty,” she said.

That said, the fact that men are noticeably absent from the pool of ob.gyn. applicants and residents concerns her. “There should be a balance, she said. “I think it is important to have diversity of all types in the healthcare system.”

Dr. Hammond looked back on his days in residency training and recalled pockets of resistance to the increasing number of women in medicine, but the ultimate effect was good for the specialty, he said, explaining that the quality of the resident pool improved steadily, because the number of qualified candidates increased.

“It has been an interesting interval to watch,” he said, specifically mentioning the demands that women faced in terms of family obligations, childbirth, and childrearing.

Restrictions on work hours instituted in residency programs in more recent years may have played an important role in opening the door to more women, he said.

Work hours down, learning curve up

Dr. Carson agreed that work-hour restrictions instituted in 2003 and updated in 2011, which cap the work week at 80 hours and also apply limits on shift hours, likely encouraged more women to enter the field. One constant over the last 50 years is the biological clock, she said, explaining that the pressures and demands of residency before limits were put in place may have steered women away.

Work-hour restrictions provide more flexibility, but they aren’t without controversy.

Dr. Hammond said he sees the value in work hour restrictions, but working long hours as a resident – sometimes as many as 110 hours per week – had its benefits, too.

“I remember one time when I’d been on call for about 2 and a half days, and up and working the whole time,” Dr. Hammond said. “I left the hospital, walked out to a bench, sat down, and fell asleep. I woke up and distinctly remember thinking, ‘Why am I doing this?’ But I did do it, and that fatigue helped me with learning to endure. You learned from it.”

Not only have long hours been viewed as a rite of passage in medicine, he said, but there were concerns initially that the level of education would diminish and that the risk of patient errors would increase as patients were handed off from one shift to the next, he said.

Data on the effects of work-hour rules have been conflicting. In one study, Dr. Roger P. Smith found little overall effect on total technical experience among residents before and after the restrictions were put in place (there was no statistically significant difference in the average of median total cases in the 3 years before and after). Previous studies had documented increased costs and reduced faculty job satisfaction, while still others had shown no significant changes in 30-day readmission rates, in-hospital mortality, patient length of stay, or resident performance, he noted. “What is emerging is that both the great hopes and the great fears surrounding resident work-hour restrictions have not come to pass,” Dr. Smith wrote (Obstet Gynecol. 2010 Jun;115[6]:1166-71).

Dr. Scales, who is currently chair of the Junior Fellow District II Advisory Council for ACOG, comes down on the side of wishing for more hours.

“[The restrictions] do limit the things we can do and the exposure we may otherwise have,” she said, noting that it’s frustrating to have to leave when she’d rather stay and “see a cool case.”

“It’s a nice idea in principle, but the same amount of work has to be done. It’s not real life,” she said of work-hour restrictions. “It’s hard, at least for me, to want to give up my patients. Our job is to take in as much as you can before you leave to go out into the big bad world.”

It may be difficult to determine the actual impact of work hour limits on patient outcomes because the field of obstetrics and gynecology has changed so much over time.

Dr. David Forstein, vice chair of clinical operations in the department of obstetrics and gynecology at the University of South Carolina, Greenville, and a member of the Accreditation Council for Graduate Medical Education’s task force on work hours said that, for one thing, patients are generally sicker now than ever before, due in part to the obesity epidemic.

Further, changing trends mean that residents are getting less exposure to some procedures like operative vaginal deliveries, while also having to learn more ways to perform hysterectomy. Residents aren’t necessarily less prepared. They’re just having to work very hard because of the depth and breadth of the required knowledge has increased, Dr. Forstein said. “There’s a lot more to learn.”

Dr. Carson agreed that the approach to education has changed, and that those changes are largely a reflection of overall shifts in education and technology.

Technology trends

Every physician interviewed for this article cited laparoscopy and robotic surgery as key technological advances. Fifty years ago, the surgical tools were simpler, Dr. Carson said. Now residents must learn four approaches to hysterectomy: vaginal, abdominal, laparoscopic, and robotic-assisted laparoscopic hysterectomy.

From ultrasound and birth control to genetic screening and robotic surgery, the evolution of the field has been astounding during this time period. The effects of the birth control pill on family planning alone forced an expansion of curriculum not only to the physiology of these things, but also to the treatment of women as a whole person and often as part of a family unit, she said.

Many of the technologies have dramatically changed the landscape, both in terms of how learning is accomplished (for example, simulation), and how physicians interact with patients, Dr. Hammond agreed. With ultrasound, for example, there was a sense that part of the physician-patient relationship was lost.

“To a point, some of us old guys felt like they were doing ultrasound assessment of patients rather than the tried-and-true ‘talk to them and examine them’ [approach],” he said. “I guess whichever generation you are in seems to be the right one, but it’s probably somewhere in between.”

Residency in 2016

If Dr. Scales is any indication, concerns about the loss of a personal touch are unfounded. She says that for her, that’s what it’s all about.

“We were exposed to [technology] since we were 5 or 6 – it’s all we know,” she said of herself and her fellow residents. “It’s not a disadvantage. It’s about efficiency.”

“We have to get things done as quickly as possible and technology helps us with that,” said Dr. Scales, the daughter of a teacher and blue collar worker, who spent most of her life “surrounded by the underprivileged.”

She always desired to help lift that population up, and while she didn’t have a draft board directing her toward public service, she had her own calling of sorts. As a premed major in college, she worked with a nonprofit organization, and later she worked with Hurricane Katrina survivors.

“I liked that aspect of medicine. I wanted to be able to identify with people on an individual level,” she said.

Technology, work-hour restrictions, gender distribution – they’re just part of the journey.

“I’m glad I chose ob.gyn.,” she said. “Sometimes you go through ... reflection ... Am I ready? My answer is yes. I’m excited about the next step, I’m comfortable in the skill I learned in my residency program, I’m excited about the work I do every day, and I’m very excited about the next chapters.”

sworcester@frontlinemedcom.com

CHICAGO – A new American College of Cardiology expert consensus decision pathway for the use of nonstatin therapies to lower cholesterol in high-risk patients addresses situations not covered by an evidence-based 2013 guideline on managing atherosclerotic cardiovascular disease risk.

Like the 2013 guideline (the 2013 American College of Cardiology/American Heart Association Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Disease Risk in Adults), the new guidance emphasizes the importance of a healthy lifestyle, but also addresses the use of two monoclonal antibodies–proprotein convertase subtilisin/kexon 9 (PCSK9) inhibitors–approved for certain patient groups since the 2013 guideline was released, as well as other nonstatin therapies, including ezetimibe and bile acid sequestrants.

“At the time [the 2013 guideline was published] the only really good outcomes data ... were for statin medication and there were no data from clinical trials that showed additional benefit of medications over and above being on the maximally tolerated dose of a statin,” according to Dr. Donald M. Lloyd-Jones, a professor at Northwestern University, Chicago and chair of the writing committee for the new guidance. “However, since 2013, a number of trials have been published that actually move the field forward in our understanding of which patients might benefit from adding non statin therapy on top of effective statin therapy.”

The guidance was developed to address gaps in care until the guidelines can be updated, which will likely take a few years.

Based on findings from recent studies, including the IMPROVE IT trial, which examined ezetimibe as statin add-on therapy after acute coronary syndromes, the HPS2-THRIVE study, which examined use of niacin in high-risk patients, and short-term outcomes studies of PCSK9 inhibitors, which have been shown to dramatically reduce low-density lipoprotein cholesterol levels beyond the lowering provided by statin therapy, the committee developed algorithms for the four main high-risk statin benefit patient groups:

•Adults aged 21 years and older with clinical atherosclerotic cardiovascular disease (ASCVD), on statin for secondary prevention.

•Adults aged 21 years and older with LDL-C greater than or equal to 190 mg/dL not due to secondary modifiable causes, on statin for primary prevention.

•Adults aged 40-75 years without ASCVD but with diabetes and LDL-C of 70-189 mg/dL, on statin for primary prevention.

•Adults aged 40-75 years without clinical ASCVD or diabetes, with LDL-C of 70-189 mg/dL and an estimated 10-year risk for ASCVD of at least 7.5%, on statin for primary prevention.

The guidance suggests a number of steps to take with patients who fail to achieve treatment goals (such as addressing treatment adherence, intensifying lifestyle modifications, using a high-intensity stain, and evaluating for statin intolerance), and lists “clinician-patient discussion factors” to consider for each of a number of patient scenarios (including the potential benefits and risks associated with nonstatin therapies, as well as patient preferences).

Included for each of the patient scenarios is an algorithm for which nonstatin therapies to use in which order, building on the “rock-solid confidence” that for the four statin benefit groups, statins remain the starting point, Dr. Lloyd-Jones said. He discussed the guidance in a video interview.

In general, ezetimibe for those patients who are not achieving the types of reduction in LDL or the amount of risk reduction desired, “should probably be the first choice,” he said.

Bile acid sequestrants can be considered in those who are ezetimibe intolerant and who have triglycerides less than 300 mg/dL.

PCSK9 inhibitors are suggested for consideration only in very high-risk patients with ASCVD or with the familial hypercholesterolemia phenotype who are still not achieving the goal (ideally, a 50% reduction in LDL cholesterol), he said.

The committee did not recommend use of niacin, stating that there is no clear indication for the routine use of niacin preparations as additional nonstatin therapies due to an unfavorable risk-benefit profile.

Additionally, PCSK9 inhibitors are not recommended in any primary prevention scenarios, he noted.

Dr. Neil J. Stone, chair of the 2013 guideline writing committee, said the new guidance provides a useful tool for clinicians, extending, in a practical way, the current guideline as the field awaits the long-term outcomes data for PCSK9 inhibitors.

Despite some backlash in the wake of the 2013 guideline, which marked a move away from specific cholesterol treatment targets to a cardiovascular disease risk-based approach, the cardiovascular risk calculation formula introduced in that guideline has been shown to be useful and accurate, said Dr. Stone, also of Northwestern University.

“[The new guidance] is simply an amplification and extension of the guideline,” he said, adding that “it’s about a risk discussion, not automatic treatment.”

Dr. Lloyd-Jones and Dr. Stone each reported having no disclosures.

sworcester@frontlinemedcom.com

CHICAGO – A new American College of Cardiology expert consensus decision pathway for the use of nonstatin therapies to lower cholesterol in high-risk patients addresses situations not covered by an evidence-based 2013 guideline on managing atherosclerotic cardiovascular disease risk.

Like the 2013 guideline (the 2013 American College of Cardiology/American Heart Association Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Disease Risk in Adults), the new guidance emphasizes the importance of a healthy lifestyle, but also addresses the use of two monoclonal antibodies–proprotein convertase subtilisin/kexon 9 (PCSK9) inhibitors–approved for certain patient groups since the 2013 guideline was released, as well as other nonstatin therapies, including ezetimibe and bile acid sequestrants.

“At the time [the 2013 guideline was published] the only really good outcomes data ... were for statin medication and there were no data from clinical trials that showed additional benefit of medications over and above being on the maximally tolerated dose of a statin,” according to Dr. Donald M. Lloyd-Jones, a professor at Northwestern University, Chicago and chair of the writing committee for the new guidance. “However, since 2013, a number of trials have been published that actually move the field forward in our understanding of which patients might benefit from adding non statin therapy on top of effective statin therapy.”

The guidance was developed to address gaps in care until the guidelines can be updated, which will likely take a few years.

Based on findings from recent studies, including the IMPROVE IT trial, which examined ezetimibe as statin add-on therapy after acute coronary syndromes, the HPS2-THRIVE study, which examined use of niacin in high-risk patients, and short-term outcomes studies of PCSK9 inhibitors, which have been shown to dramatically reduce low-density lipoprotein cholesterol levels beyond the lowering provided by statin therapy, the committee developed algorithms for the four main high-risk statin benefit patient groups:

•Adults aged 21 years and older with clinical atherosclerotic cardiovascular disease (ASCVD), on statin for secondary prevention.

•Adults aged 21 years and older with LDL-C greater than or equal to 190 mg/dL not due to secondary modifiable causes, on statin for primary prevention.

•Adults aged 40-75 years without ASCVD but with diabetes and LDL-C of 70-189 mg/dL, on statin for primary prevention.

•Adults aged 40-75 years without clinical ASCVD or diabetes, with LDL-C of 70-189 mg/dL and an estimated 10-year risk for ASCVD of at least 7.5%, on statin for primary prevention.

The guidance suggests a number of steps to take with patients who fail to achieve treatment goals (such as addressing treatment adherence, intensifying lifestyle modifications, using a high-intensity stain, and evaluating for statin intolerance), and lists “clinician-patient discussion factors” to consider for each of a number of patient scenarios (including the potential benefits and risks associated with nonstatin therapies, as well as patient preferences).

Included for each of the patient scenarios is an algorithm for which nonstatin therapies to use in which order, building on the “rock-solid confidence” that for the four statin benefit groups, statins remain the starting point, Dr. Lloyd-Jones said. He discussed the guidance in a video interview.

In general, ezetimibe for those patients who are not achieving the types of reduction in LDL or the amount of risk reduction desired, “should probably be the first choice,” he said.

Bile acid sequestrants can be considered in those who are ezetimibe intolerant and who have triglycerides less than 300 mg/dL.

PCSK9 inhibitors are suggested for consideration only in very high-risk patients with ASCVD or with the familial hypercholesterolemia phenotype who are still not achieving the goal (ideally, a 50% reduction in LDL cholesterol), he said.

The committee did not recommend use of niacin, stating that there is no clear indication for the routine use of niacin preparations as additional nonstatin therapies due to an unfavorable risk-benefit profile.

Additionally, PCSK9 inhibitors are not recommended in any primary prevention scenarios, he noted.

Dr. Neil J. Stone, chair of the 2013 guideline writing committee, said the new guidance provides a useful tool for clinicians, extending, in a practical way, the current guideline as the field awaits the long-term outcomes data for PCSK9 inhibitors.

Despite some backlash in the wake of the 2013 guideline, which marked a move away from specific cholesterol treatment targets to a cardiovascular disease risk-based approach, the cardiovascular risk calculation formula introduced in that guideline has been shown to be useful and accurate, said Dr. Stone, also of Northwestern University.

“[The new guidance] is simply an amplification and extension of the guideline,” he said, adding that “it’s about a risk discussion, not automatic treatment.”

Dr. Lloyd-Jones and Dr. Stone each reported having no disclosures.

sworcester@frontlinemedcom.com

CHICAGO – A new American College of Cardiology expert consensus decision pathway for the use of nonstatin therapies to lower cholesterol in high-risk patients addresses situations not covered by an evidence-based 2013 guideline on managing atherosclerotic cardiovascular disease risk.

Like the 2013 guideline (the 2013 American College of Cardiology/American Heart Association Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Disease Risk in Adults), the new guidance emphasizes the importance of a healthy lifestyle, but also addresses the use of two monoclonal antibodies–proprotein convertase subtilisin/kexon 9 (PCSK9) inhibitors–approved for certain patient groups since the 2013 guideline was released, as well as other nonstatin therapies, including ezetimibe and bile acid sequestrants.

“At the time [the 2013 guideline was published] the only really good outcomes data ... were for statin medication and there were no data from clinical trials that showed additional benefit of medications over and above being on the maximally tolerated dose of a statin,” according to Dr. Donald M. Lloyd-Jones, a professor at Northwestern University, Chicago and chair of the writing committee for the new guidance. “However, since 2013, a number of trials have been published that actually move the field forward in our understanding of which patients might benefit from adding non statin therapy on top of effective statin therapy.”

The guidance was developed to address gaps in care until the guidelines can be updated, which will likely take a few years.

Based on findings from recent studies, including the IMPROVE IT trial, which examined ezetimibe as statin add-on therapy after acute coronary syndromes, the HPS2-THRIVE study, which examined use of niacin in high-risk patients, and short-term outcomes studies of PCSK9 inhibitors, which have been shown to dramatically reduce low-density lipoprotein cholesterol levels beyond the lowering provided by statin therapy, the committee developed algorithms for the four main high-risk statin benefit patient groups:

•Adults aged 21 years and older with clinical atherosclerotic cardiovascular disease (ASCVD), on statin for secondary prevention.

•Adults aged 21 years and older with LDL-C greater than or equal to 190 mg/dL not due to secondary modifiable causes, on statin for primary prevention.

•Adults aged 40-75 years without ASCVD but with diabetes and LDL-C of 70-189 mg/dL, on statin for primary prevention.

•Adults aged 40-75 years without clinical ASCVD or diabetes, with LDL-C of 70-189 mg/dL and an estimated 10-year risk for ASCVD of at least 7.5%, on statin for primary prevention.

The guidance suggests a number of steps to take with patients who fail to achieve treatment goals (such as addressing treatment adherence, intensifying lifestyle modifications, using a high-intensity stain, and evaluating for statin intolerance), and lists “clinician-patient discussion factors” to consider for each of a number of patient scenarios (including the potential benefits and risks associated with nonstatin therapies, as well as patient preferences).

Included for each of the patient scenarios is an algorithm for which nonstatin therapies to use in which order, building on the “rock-solid confidence” that for the four statin benefit groups, statins remain the starting point, Dr. Lloyd-Jones said. He discussed the guidance in a video interview.

In general, ezetimibe for those patients who are not achieving the types of reduction in LDL or the amount of risk reduction desired, “should probably be the first choice,” he said.

Bile acid sequestrants can be considered in those who are ezetimibe intolerant and who have triglycerides less than 300 mg/dL.

PCSK9 inhibitors are suggested for consideration only in very high-risk patients with ASCVD or with the familial hypercholesterolemia phenotype who are still not achieving the goal (ideally, a 50% reduction in LDL cholesterol), he said.

The committee did not recommend use of niacin, stating that there is no clear indication for the routine use of niacin preparations as additional nonstatin therapies due to an unfavorable risk-benefit profile.

Additionally, PCSK9 inhibitors are not recommended in any primary prevention scenarios, he noted.

Dr. Neil J. Stone, chair of the 2013 guideline writing committee, said the new guidance provides a useful tool for clinicians, extending, in a practical way, the current guideline as the field awaits the long-term outcomes data for PCSK9 inhibitors.

Despite some backlash in the wake of the 2013 guideline, which marked a move away from specific cholesterol treatment targets to a cardiovascular disease risk-based approach, the cardiovascular risk calculation formula introduced in that guideline has been shown to be useful and accurate, said Dr. Stone, also of Northwestern University.

“[The new guidance] is simply an amplification and extension of the guideline,” he said, adding that “it’s about a risk discussion, not automatic treatment.”

Dr. Lloyd-Jones and Dr. Stone each reported having no disclosures.

sworcester@frontlinemedcom.com

CHICAGO – The severity of heart failure in the setting of acute myocardial infarction predicts long-term cardiovascular death risk, according to a post hoc analysis of data from the IMPROVE IT Trial.

Among 11,185 individuals with MI and known Killip Classification who were part of that randomized, double-blind trial, those with Killip Class II or greater had more than double the risk of long-term cardiovascular death, compared with those with Killip Class I heart failure, Dr Michael G. Silverman, a cardiovascular medicine fellow at Brigham and Women’s Hospital, Boston and a research fellow at the Thrombolysis in MI (TIMI) Study Group reported in a poster at the annual meeting of the American College of Cardiology.

After adjusting for a number of factors, including age, gender, diabetes, hypertension, left ventricular ejection fraction (LVEF), beta blocker and ACE inhibitor/angiotensin receptor blocker use at randomization, and percutaneous coronary intervention at the index event, the 7-year event rate was 14.5% among those with Killip Class II or higher vs. 5.7% those with Killip Class I heart failure (adjusted hazard ratio, 1.9), Dr. Silverman reported on behalf of the TIMI Study Group.

The event rates from 30 days to 6 months were 4.85% and 1.25% in the groups, respectively (adjusted hazard ratio, 1.96), and from 6 months to 7 years they were 1.52% and 0.61%, in the groups, respectively, (adjusted hazard ratio, 1.85).

Further, the increased risk of cardiovascular death associated with Killip Class II or higher was also apparent among important subgroups, including those with ST Segment Elevation MI, those with non-STEMI, those with LVEF of 50 or greater, those with LVEF less than 50, those with diabetes, those without diabetes, men, and women (adjusted hazard ratios ranging from 1.6 to 2.1), Dr Silverman explained in an interview.

The severity of heart failure according to Killip Class is a strong independent predictor of mortality in the setting of acute MI, and the current findings demonstrate that it also predicts cardiovascular death for at least 7 years, suggesting a need for careful attention to the findings of the physical exam in AMI, as it can serve as an important biomarker of long-term cardiovascular death risk, he said.

“AMI patients with Killip Class II or greater warrant continued close medical follow-up and adherence to guideline -directed medial therapy beyond the acute hospitalization to prevent this potentially modifiable outcome,” he concluded.

Dr. Silverman reported having no disclosures.

sworcester@frontlinemedcom.com

CHICAGO – The severity of heart failure in the setting of acute myocardial infarction predicts long-term cardiovascular death risk, according to a post hoc analysis of data from the IMPROVE IT Trial.

Among 11,185 individuals with MI and known Killip Classification who were part of that randomized, double-blind trial, those with Killip Class II or greater had more than double the risk of long-term cardiovascular death, compared with those with Killip Class I heart failure, Dr Michael G. Silverman, a cardiovascular medicine fellow at Brigham and Women’s Hospital, Boston and a research fellow at the Thrombolysis in MI (TIMI) Study Group reported in a poster at the annual meeting of the American College of Cardiology.

After adjusting for a number of factors, including age, gender, diabetes, hypertension, left ventricular ejection fraction (LVEF), beta blocker and ACE inhibitor/angiotensin receptor blocker use at randomization, and percutaneous coronary intervention at the index event, the 7-year event rate was 14.5% among those with Killip Class II or higher vs. 5.7% those with Killip Class I heart failure (adjusted hazard ratio, 1.9), Dr. Silverman reported on behalf of the TIMI Study Group.

The event rates from 30 days to 6 months were 4.85% and 1.25% in the groups, respectively (adjusted hazard ratio, 1.96), and from 6 months to 7 years they were 1.52% and 0.61%, in the groups, respectively, (adjusted hazard ratio, 1.85).

Further, the increased risk of cardiovascular death associated with Killip Class II or higher was also apparent among important subgroups, including those with ST Segment Elevation MI, those with non-STEMI, those with LVEF of 50 or greater, those with LVEF less than 50, those with diabetes, those without diabetes, men, and women (adjusted hazard ratios ranging from 1.6 to 2.1), Dr Silverman explained in an interview.

The severity of heart failure according to Killip Class is a strong independent predictor of mortality in the setting of acute MI, and the current findings demonstrate that it also predicts cardiovascular death for at least 7 years, suggesting a need for careful attention to the findings of the physical exam in AMI, as it can serve as an important biomarker of long-term cardiovascular death risk, he said.

“AMI patients with Killip Class II or greater warrant continued close medical follow-up and adherence to guideline -directed medial therapy beyond the acute hospitalization to prevent this potentially modifiable outcome,” he concluded.

Dr. Silverman reported having no disclosures.

sworcester@frontlinemedcom.com

CHICAGO – The severity of heart failure in the setting of acute myocardial infarction predicts long-term cardiovascular death risk, according to a post hoc analysis of data from the IMPROVE IT Trial.

Among 11,185 individuals with MI and known Killip Classification who were part of that randomized, double-blind trial, those with Killip Class II or greater had more than double the risk of long-term cardiovascular death, compared with those with Killip Class I heart failure, Dr Michael G. Silverman, a cardiovascular medicine fellow at Brigham and Women’s Hospital, Boston and a research fellow at the Thrombolysis in MI (TIMI) Study Group reported in a poster at the annual meeting of the American College of Cardiology.

After adjusting for a number of factors, including age, gender, diabetes, hypertension, left ventricular ejection fraction (LVEF), beta blocker and ACE inhibitor/angiotensin receptor blocker use at randomization, and percutaneous coronary intervention at the index event, the 7-year event rate was 14.5% among those with Killip Class II or higher vs. 5.7% those with Killip Class I heart failure (adjusted hazard ratio, 1.9), Dr. Silverman reported on behalf of the TIMI Study Group.

The event rates from 30 days to 6 months were 4.85% and 1.25% in the groups, respectively (adjusted hazard ratio, 1.96), and from 6 months to 7 years they were 1.52% and 0.61%, in the groups, respectively, (adjusted hazard ratio, 1.85).

Further, the increased risk of cardiovascular death associated with Killip Class II or higher was also apparent among important subgroups, including those with ST Segment Elevation MI, those with non-STEMI, those with LVEF of 50 or greater, those with LVEF less than 50, those with diabetes, those without diabetes, men, and women (adjusted hazard ratios ranging from 1.6 to 2.1), Dr Silverman explained in an interview.

The severity of heart failure according to Killip Class is a strong independent predictor of mortality in the setting of acute MI, and the current findings demonstrate that it also predicts cardiovascular death for at least 7 years, suggesting a need for careful attention to the findings of the physical exam in AMI, as it can serve as an important biomarker of long-term cardiovascular death risk, he said.

“AMI patients with Killip Class II or greater warrant continued close medical follow-up and adherence to guideline -directed medial therapy beyond the acute hospitalization to prevent this potentially modifiable outcome,” he concluded.

Dr. Silverman reported having no disclosures.

sworcester@frontlinemedcom.com

The Food and Drug Administration has approved Idelvion, the first hemophilia B therapy with up to 14-day dosing intervals, and Kovaltry, an unmodified, full-length factor VIII compound for the treatment of hemophilia A.

Idelvion is a novel long-acting recombinant albumin fusion protein administered intravenously. In clinical trials from the PROLONG-9FP clinical development program – including phase I through III open-label, multicenter studies – the biotherapeutic agent maintained factor IX activity levels above 5% over 14 days at a dose of 75 IU/kg, resulting in a median annualized spontaneous bleeding rate of zero in patients, according to a statement by Idelvion’s manufacturer, CSL Behring. That “reduces the monthly number of units needed for prophylaxis therapy,” the company noted.

Idelvion is indicated in children and adults with hemophilia B for routine prophylaxis, as well as for on-demand control and prevention of bleeding episodes. It is also indicated for the perioperative management of bleeding. With on-demand treatment, 94% of bleeds were controlled with one infusion, and 99% were controlled with one or two infusions.

Appropriate patients 12 years and older can go up to 14 days between infusions, according to CSL Behring. The most common adverse reaction in the clinical trials was headache.

Idelvion is expected to be available later this month.

“The approval of this long-acting recombinant factor IX therapy for hemophilia B is vital, as physicians need more options to help their patients effectively and safely manage their bleeding disorder,” said Elena Santagostino, M.D., Ph.D., of the University of Milan/IRCCS Maggiore Hospital, and lead investigator of PROLONG-9FP, in a statement. “This provides them with greater freedom from frequent infusions.”

The FDA approved Kovaltry for children and adults with hemophilia A based on the results of the LEOPOLD (Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease) clinical trials. Kovaltry received approval in Europe and Canada earlier this year.

The LEOPOLD findings supported the approval for routine prophylaxis to reduce the frequency of bleeding episodes.

“In the LEOPOLD trials, Kovaltry reduced bleeding episodes in patients with hemophilia A when infused twice to three times per week with routine prophylaxis,” said Dr. Sanjay P. Ahuja, LEOPOLD investigator and director of the hemostasis and thrombosis center at University Hospitals Rainbow Babies & Children’s Hospital, Cleveland, in a statement by Kovaltry manufacturer Bayer. “Kovaltry may offer appropriate patients a twice-weekly prophylaxis dosing option.”

Dosing is 20-40 IU/kg of body weight 2-3 times per week in adolescents and adults, and 25-50 IU/kg of body weight 2-3 times per week or every other day in children aged 12 years or younger.

The most common adverse events associated with Kovaltry in the clinical trials were headache, fever, and pruritus.

sworcester@frontlinemedcom.com

The Food and Drug Administration has approved Idelvion, the first hemophilia B therapy with up to 14-day dosing intervals, and Kovaltry, an unmodified, full-length factor VIII compound for the treatment of hemophilia A.

Idelvion is a novel long-acting recombinant albumin fusion protein administered intravenously. In clinical trials from the PROLONG-9FP clinical development program – including phase I through III open-label, multicenter studies – the biotherapeutic agent maintained factor IX activity levels above 5% over 14 days at a dose of 75 IU/kg, resulting in a median annualized spontaneous bleeding rate of zero in patients, according to a statement by Idelvion’s manufacturer, CSL Behring. That “reduces the monthly number of units needed for prophylaxis therapy,” the company noted.

Idelvion is indicated in children and adults with hemophilia B for routine prophylaxis, as well as for on-demand control and prevention of bleeding episodes. It is also indicated for the perioperative management of bleeding. With on-demand treatment, 94% of bleeds were controlled with one infusion, and 99% were controlled with one or two infusions.

Appropriate patients 12 years and older can go up to 14 days between infusions, according to CSL Behring. The most common adverse reaction in the clinical trials was headache.

Idelvion is expected to be available later this month.

“The approval of this long-acting recombinant factor IX therapy for hemophilia B is vital, as physicians need more options to help their patients effectively and safely manage their bleeding disorder,” said Elena Santagostino, M.D., Ph.D., of the University of Milan/IRCCS Maggiore Hospital, and lead investigator of PROLONG-9FP, in a statement. “This provides them with greater freedom from frequent infusions.”

The FDA approved Kovaltry for children and adults with hemophilia A based on the results of the LEOPOLD (Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease) clinical trials. Kovaltry received approval in Europe and Canada earlier this year.

The LEOPOLD findings supported the approval for routine prophylaxis to reduce the frequency of bleeding episodes.

“In the LEOPOLD trials, Kovaltry reduced bleeding episodes in patients with hemophilia A when infused twice to three times per week with routine prophylaxis,” said Dr. Sanjay P. Ahuja, LEOPOLD investigator and director of the hemostasis and thrombosis center at University Hospitals Rainbow Babies & Children’s Hospital, Cleveland, in a statement by Kovaltry manufacturer Bayer. “Kovaltry may offer appropriate patients a twice-weekly prophylaxis dosing option.”

Dosing is 20-40 IU/kg of body weight 2-3 times per week in adolescents and adults, and 25-50 IU/kg of body weight 2-3 times per week or every other day in children aged 12 years or younger.

The most common adverse events associated with Kovaltry in the clinical trials were headache, fever, and pruritus.

sworcester@frontlinemedcom.com

The Food and Drug Administration has approved Idelvion, the first hemophilia B therapy with up to 14-day dosing intervals, and Kovaltry, an unmodified, full-length factor VIII compound for the treatment of hemophilia A.

Idelvion is a novel long-acting recombinant albumin fusion protein administered intravenously. In clinical trials from the PROLONG-9FP clinical development program – including phase I through III open-label, multicenter studies – the biotherapeutic agent maintained factor IX activity levels above 5% over 14 days at a dose of 75 IU/kg, resulting in a median annualized spontaneous bleeding rate of zero in patients, according to a statement by Idelvion’s manufacturer, CSL Behring. That “reduces the monthly number of units needed for prophylaxis therapy,” the company noted.

Idelvion is indicated in children and adults with hemophilia B for routine prophylaxis, as well as for on-demand control and prevention of bleeding episodes. It is also indicated for the perioperative management of bleeding. With on-demand treatment, 94% of bleeds were controlled with one infusion, and 99% were controlled with one or two infusions.

Appropriate patients 12 years and older can go up to 14 days between infusions, according to CSL Behring. The most common adverse reaction in the clinical trials was headache.

Idelvion is expected to be available later this month.

“The approval of this long-acting recombinant factor IX therapy for hemophilia B is vital, as physicians need more options to help their patients effectively and safely manage their bleeding disorder,” said Elena Santagostino, M.D., Ph.D., of the University of Milan/IRCCS Maggiore Hospital, and lead investigator of PROLONG-9FP, in a statement. “This provides them with greater freedom from frequent infusions.”

The FDA approved Kovaltry for children and adults with hemophilia A based on the results of the LEOPOLD (Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease) clinical trials. Kovaltry received approval in Europe and Canada earlier this year.

The LEOPOLD findings supported the approval for routine prophylaxis to reduce the frequency of bleeding episodes.

“In the LEOPOLD trials, Kovaltry reduced bleeding episodes in patients with hemophilia A when infused twice to three times per week with routine prophylaxis,” said Dr. Sanjay P. Ahuja, LEOPOLD investigator and director of the hemostasis and thrombosis center at University Hospitals Rainbow Babies & Children’s Hospital, Cleveland, in a statement by Kovaltry manufacturer Bayer. “Kovaltry may offer appropriate patients a twice-weekly prophylaxis dosing option.”

Dosing is 20-40 IU/kg of body weight 2-3 times per week in adolescents and adults, and 25-50 IU/kg of body weight 2-3 times per week or every other day in children aged 12 years or younger.

The most common adverse events associated with Kovaltry in the clinical trials were headache, fever, and pruritus.

sworcester@frontlinemedcom.com

Nonopioid therapy is the preferred approach for managing chronic pain outside of active cancer, palliative, and end-of-life care, according to a new guideline released today by the Centers for Disease Control and Prevention.

The 12 recommendations included in the guideline center around this principle and two others: using the lowest possible effective dosage when opioids are used, and exercising caution and monitoring patients closely when prescribing opioids.

Specifically, the guideline states that “clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient,” and that “treatment should be combined with nonpharmacologic and nonopioid therapy, as appropriate.”

The guideline also addresses steps to take before starting or continuing opioid therapy, and drug selection, dosage, duration, follow-up, and discontinuation. Recommendations for assessing risk and addressing harms of opioid use are also included.

The CDC developed the guideline as part of the U.S. government’s urgent response to the epidemic of overdose deaths, which has been fueled by a quadrupling of the prescribing and sales of opioids since 1999, according to a CDC press statement. The guideline’s purpose is to help prevent opioid misuse and overdose.

“The CDC Guideline for Prescribing Opioids for Chronic Pain, United States, 2016 will help primary care providers ensure the safest and most effective treatment for their patients,” according to the statement. The CDC’s director, Dr. Tom Frieden, noted that “overprescribing opioids – largely for chronic pain – is a key driver of America’s drug-overdose epidemic.”

In a CDC teleconference marking the release of the guideline, Dr. Frieden said it has become increasingly clear that opioids “carry substantial risks but only uncertain benefits, especially compared with other treatments for chronic pain.

“Beginning treatment with an opioid is a momentous decision, and it should only be done with full understanding by both the clinician and the patient of the substantial risks and uncertain benefits involved,” Dr. Frieden said. He added that he knows of no other medication “that’s routinely used for a nonfatal condition [and] that kills patients so frequently.

“With more than 250 million prescriptions written each year, it’s so important that doctors understand that any one of those prescriptions could potentially end a patient’s life,” he cautioned.

A 2015 study showed that 1 of every 550 patients treated with opioids for noncancer pain – and 1 of 32 who received the highest doses (more than 200 morphine milligram equivalents per day) – died within 2.5 years of the first prescription.

Dr. Frieden noted that opioids do have a place when the potential benefits outweigh the potential harms. “But for most patients – the vast majority of patients – the risks will outweigh the benefits,” he said.

The opioid epidemic is one of the most pressing public health issues in the United States today, said Sylvia M. Burwell, secretary of the Department of Health & Human Services. A year ago, she announced an HHS initiative to reduce prescription opioid and heroin-related drug overdose, death, and dependence.

“Last year, more Americans died from drug overdoses than car crashes,” Ms. Burwell said during the teleconference, noting that families across the nation and from all walks of life have been affected.

Combating the opioid epidemic is a national priority, she said, and the CDC guideline will help in that effort.

“We believe this guideline will help health care professionals provide safer and more effective care for patients dealing with chronic pain, and we also believe it will help these providers drive down the rates of opioid use disorder, overdose, and ... death,” she said.

The American Medical Association greeted the guideline with cautious support.

“While we are largely supportive of the guidelines, we remain concerned about the evidence base informing some of the recommendations,” noted Dr. Patrice A. Harris, chair-elect of the AMA board and chair of the AMA Task Force to Reduce Opioid Abuse, in a statement.

The AMA also cited potential conflicts between the guideline and product labeling and state laws, as well as obstacles such as insurance coverage limits on nonpharmacologic treatments.

“If these guidelines help reduce the deaths resulting from opioids, they will prove to be valuable,” Dr. Harris said in the statement. “If they produce unintended consequences, we will need to mitigate them.”

Of note, the guideline stresses the right of patients with chronic pain to receive safe and effective pain management, and focuses on giving primary care providers – who account for about half of all opioid prescriptions – a road map for providing such pain management by increasing the use of effective nonopioid and nonpharmacologic therapies.

It was developed through a “rigorous scientific process using the best available scientific evidence, consulting with experts, and listening to comments from the public and partner organizations,” according to the CDC statement. The organization “is dedicated to working with partners to improve the evidence base and will refine the recommendations as new research becomes available.

”In conjunction with the release of the guideline, the CDC has provided a checklist for prescribing opioids for chronic pain, and a website with additional tools for implementing the recommendations within the guideline.

The CDC's opioid recommendations

The Centers for Disease Control and Prevention’s new opioid prescription guideline includes 12 recommendations. Here they are, modified slightly for style:

1. Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Providers should only consider adding opioid therapy if expected benefits for both pain and function are anticipated to outweigh risks.

2. Before starting opioid therapy for chronic pain, providers should establish treatment goals with all patients, including realistic goals for pain and function. Providers should not initiate opioid therapy without consideration of how therapy will be discontinued if unsuccessful. Providers should continue opioid therapy only if there is clinically meaningful improvement in pain and function.

3. Before starting and periodically during opioid therapy, providers should discuss with patients known risks and realistic benefits of opioid therapy, and patient and provider responsibilities for managing therapy.

4. When starting opioid therapy for chronic pain, providers should prescribe immediate-release opioids instead of extended-release/long-acting opioids.

5. When opioids are started, providers should prescribe the lowest effective dosage. Providers should use caution when prescribing opioids at any dosage, should implement additional precautions when increasing dosage to 50 or more morphine milligram equivalents (MME) per day, and generally should avoid increasing dosage to 90 or more MME per day.

6. When opioids are used for acute pain, providers should prescribe the lowest effective dose of immediate-release opioids. Three or fewer days often will be sufficient.

7. Providers should evaluate the benefits and harms with patients within 1-4 weeks of starting opioid therapy for chronic pain or of dose escalation. They should reevaluate continued therapy’s benefits and harms every 3 months or more frequently. If continued therapy’s benefits do not outweigh harms, providers should work with patients to reduce dosages or discontinue opioids.

8. During therapy, providers should evaluate risk factors for opioid-related harm. Providers should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose – such as history of overdose, history of substance use disorder, or higher opioid dosage (50 MME or more) – are present.

9. Providers should review the patient’s history of controlled substance prescriptions using state prescription drug monitoring program (PDMP) data to determine whether the patient is receiving high opioid dosages or dangerous combinations that put him or her at high risk for overdose. Providers should review PDMP data when starting opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescription to every 3 months.

10. When prescribing opioids for chronic pain, providers should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications, as well as other controlled prescription drugs and illicit drugs.

11. Providers should avoid concurrent prescriptions of opioid pain medication and benzodiazepines whenever possible.

12. Providers should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid use disorder.

M. Alexander Otto contributed to this article.

sworcester@frontlinemedcom.com

Nonopioid therapy is the preferred approach for managing chronic pain outside of active cancer, palliative, and end-of-life care, according to a new guideline released today by the Centers for Disease Control and Prevention.

The 12 recommendations included in the guideline center around this principle and two others: using the lowest possible effective dosage when opioids are used, and exercising caution and monitoring patients closely when prescribing opioids.

Specifically, the guideline states that “clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient,” and that “treatment should be combined with nonpharmacologic and nonopioid therapy, as appropriate.”

The guideline also addresses steps to take before starting or continuing opioid therapy, and drug selection, dosage, duration, follow-up, and discontinuation. Recommendations for assessing risk and addressing harms of opioid use are also included.

The CDC developed the guideline as part of the U.S. government’s urgent response to the epidemic of overdose deaths, which has been fueled by a quadrupling of the prescribing and sales of opioids since 1999, according to a CDC press statement. The guideline’s purpose is to help prevent opioid misuse and overdose.

“The CDC Guideline for Prescribing Opioids for Chronic Pain, United States, 2016 will help primary care providers ensure the safest and most effective treatment for their patients,” according to the statement. The CDC’s director, Dr. Tom Frieden, noted that “overprescribing opioids – largely for chronic pain – is a key driver of America’s drug-overdose epidemic.”

In a CDC teleconference marking the release of the guideline, Dr. Frieden said it has become increasingly clear that opioids “carry substantial risks but only uncertain benefits, especially compared with other treatments for chronic pain.

“Beginning treatment with an opioid is a momentous decision, and it should only be done with full understanding by both the clinician and the patient of the substantial risks and uncertain benefits involved,” Dr. Frieden said. He added that he knows of no other medication “that’s routinely used for a nonfatal condition [and] that kills patients so frequently.

“With more than 250 million prescriptions written each year, it’s so important that doctors understand that any one of those prescriptions could potentially end a patient’s life,” he cautioned.

A 2015 study showed that 1 of every 550 patients treated with opioids for noncancer pain – and 1 of 32 who received the highest doses (more than 200 morphine milligram equivalents per day) – died within 2.5 years of the first prescription.

Dr. Frieden noted that opioids do have a place when the potential benefits outweigh the potential harms. “But for most patients – the vast majority of patients – the risks will outweigh the benefits,” he said.

The opioid epidemic is one of the most pressing public health issues in the United States today, said Sylvia M. Burwell, secretary of the Department of Health & Human Services. A year ago, she announced an HHS initiative to reduce prescription opioid and heroin-related drug overdose, death, and dependence.

“Last year, more Americans died from drug overdoses than car crashes,” Ms. Burwell said during the teleconference, noting that families across the nation and from all walks of life have been affected.

Combating the opioid epidemic is a national priority, she said, and the CDC guideline will help in that effort.

“We believe this guideline will help health care professionals provide safer and more effective care for patients dealing with chronic pain, and we also believe it will help these providers drive down the rates of opioid use disorder, overdose, and ... death,” she said.

The American Medical Association greeted the guideline with cautious support.

“While we are largely supportive of the guidelines, we remain concerned about the evidence base informing some of the recommendations,” noted Dr. Patrice A. Harris, chair-elect of the AMA board and chair of the AMA Task Force to Reduce Opioid Abuse, in a statement.

The AMA also cited potential conflicts between the guideline and product labeling and state laws, as well as obstacles such as insurance coverage limits on nonpharmacologic treatments.

“If these guidelines help reduce the deaths resulting from opioids, they will prove to be valuable,” Dr. Harris said in the statement. “If they produce unintended consequences, we will need to mitigate them.”

Of note, the guideline stresses the right of patients with chronic pain to receive safe and effective pain management, and focuses on giving primary care providers – who account for about half of all opioid prescriptions – a road map for providing such pain management by increasing the use of effective nonopioid and nonpharmacologic therapies.

It was developed through a “rigorous scientific process using the best available scientific evidence, consulting with experts, and listening to comments from the public and partner organizations,” according to the CDC statement. The organization “is dedicated to working with partners to improve the evidence base and will refine the recommendations as new research becomes available.

”In conjunction with the release of the guideline, the CDC has provided a checklist for prescribing opioids for chronic pain, and a website with additional tools for implementing the recommendations within the guideline.

The CDC's opioid recommendations

The Centers for Disease Control and Prevention’s new opioid prescription guideline includes 12 recommendations. Here they are, modified slightly for style:

1. Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Providers should only consider adding opioid therapy if expected benefits for both pain and function are anticipated to outweigh risks.

2. Before starting opioid therapy for chronic pain, providers should establish treatment goals with all patients, including realistic goals for pain and function. Providers should not initiate opioid therapy without consideration of how therapy will be discontinued if unsuccessful. Providers should continue opioid therapy only if there is clinically meaningful improvement in pain and function.

3. Before starting and periodically during opioid therapy, providers should discuss with patients known risks and realistic benefits of opioid therapy, and patient and provider responsibilities for managing therapy.

4. When starting opioid therapy for chronic pain, providers should prescribe immediate-release opioids instead of extended-release/long-acting opioids.

5. When opioids are started, providers should prescribe the lowest effective dosage. Providers should use caution when prescribing opioids at any dosage, should implement additional precautions when increasing dosage to 50 or more morphine milligram equivalents (MME) per day, and generally should avoid increasing dosage to 90 or more MME per day.

6. When opioids are used for acute pain, providers should prescribe the lowest effective dose of immediate-release opioids. Three or fewer days often will be sufficient.

7. Providers should evaluate the benefits and harms with patients within 1-4 weeks of starting opioid therapy for chronic pain or of dose escalation. They should reevaluate continued therapy’s benefits and harms every 3 months or more frequently. If continued therapy’s benefits do not outweigh harms, providers should work with patients to reduce dosages or discontinue opioids.

8. During therapy, providers should evaluate risk factors for opioid-related harm. Providers should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose – such as history of overdose, history of substance use disorder, or higher opioid dosage (50 MME or more) – are present.

9. Providers should review the patient’s history of controlled substance prescriptions using state prescription drug monitoring program (PDMP) data to determine whether the patient is receiving high opioid dosages or dangerous combinations that put him or her at high risk for overdose. Providers should review PDMP data when starting opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescription to every 3 months.

10. When prescribing opioids for chronic pain, providers should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications, as well as other controlled prescription drugs and illicit drugs.

11. Providers should avoid concurrent prescriptions of opioid pain medication and benzodiazepines whenever possible.

12. Providers should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid use disorder.

M. Alexander Otto contributed to this article.

sworcester@frontlinemedcom.com

Nonopioid therapy is the preferred approach for managing chronic pain outside of active cancer, palliative, and end-of-life care, according to a new guideline released today by the Centers for Disease Control and Prevention.

The 12 recommendations included in the guideline center around this principle and two others: using the lowest possible effective dosage when opioids are used, and exercising caution and monitoring patients closely when prescribing opioids.

Specifically, the guideline states that “clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient,” and that “treatment should be combined with nonpharmacologic and nonopioid therapy, as appropriate.”

The guideline also addresses steps to take before starting or continuing opioid therapy, and drug selection, dosage, duration, follow-up, and discontinuation. Recommendations for assessing risk and addressing harms of opioid use are also included.

The CDC developed the guideline as part of the U.S. government’s urgent response to the epidemic of overdose deaths, which has been fueled by a quadrupling of the prescribing and sales of opioids since 1999, according to a CDC press statement. The guideline’s purpose is to help prevent opioid misuse and overdose.

“The CDC Guideline for Prescribing Opioids for Chronic Pain, United States, 2016 will help primary care providers ensure the safest and most effective treatment for their patients,” according to the statement. The CDC’s director, Dr. Tom Frieden, noted that “overprescribing opioids – largely for chronic pain – is a key driver of America’s drug-overdose epidemic.”

In a CDC teleconference marking the release of the guideline, Dr. Frieden said it has become increasingly clear that opioids “carry substantial risks but only uncertain benefits, especially compared with other treatments for chronic pain.

“Beginning treatment with an opioid is a momentous decision, and it should only be done with full understanding by both the clinician and the patient of the substantial risks and uncertain benefits involved,” Dr. Frieden said. He added that he knows of no other medication “that’s routinely used for a nonfatal condition [and] that kills patients so frequently.

“With more than 250 million prescriptions written each year, it’s so important that doctors understand that any one of those prescriptions could potentially end a patient’s life,” he cautioned.

A 2015 study showed that 1 of every 550 patients treated with opioids for noncancer pain – and 1 of 32 who received the highest doses (more than 200 morphine milligram equivalents per day) – died within 2.5 years of the first prescription.

Dr. Frieden noted that opioids do have a place when the potential benefits outweigh the potential harms. “But for most patients – the vast majority of patients – the risks will outweigh the benefits,” he said.

The opioid epidemic is one of the most pressing public health issues in the United States today, said Sylvia M. Burwell, secretary of the Department of Health & Human Services. A year ago, she announced an HHS initiative to reduce prescription opioid and heroin-related drug overdose, death, and dependence.

“Last year, more Americans died from drug overdoses than car crashes,” Ms. Burwell said during the teleconference, noting that families across the nation and from all walks of life have been affected.

Combating the opioid epidemic is a national priority, she said, and the CDC guideline will help in that effort.

“We believe this guideline will help health care professionals provide safer and more effective care for patients dealing with chronic pain, and we also believe it will help these providers drive down the rates of opioid use disorder, overdose, and ... death,” she said.

The American Medical Association greeted the guideline with cautious support.

“While we are largely supportive of the guidelines, we remain concerned about the evidence base informing some of the recommendations,” noted Dr. Patrice A. Harris, chair-elect of the AMA board and chair of the AMA Task Force to Reduce Opioid Abuse, in a statement.

The AMA also cited potential conflicts between the guideline and product labeling and state laws, as well as obstacles such as insurance coverage limits on nonpharmacologic treatments.

“If these guidelines help reduce the deaths resulting from opioids, they will prove to be valuable,” Dr. Harris said in the statement. “If they produce unintended consequences, we will need to mitigate them.”

Of note, the guideline stresses the right of patients with chronic pain to receive safe and effective pain management, and focuses on giving primary care providers – who account for about half of all opioid prescriptions – a road map for providing such pain management by increasing the use of effective nonopioid and nonpharmacologic therapies.

It was developed through a “rigorous scientific process using the best available scientific evidence, consulting with experts, and listening to comments from the public and partner organizations,” according to the CDC statement. The organization “is dedicated to working with partners to improve the evidence base and will refine the recommendations as new research becomes available.

”In conjunction with the release of the guideline, the CDC has provided a checklist for prescribing opioids for chronic pain, and a website with additional tools for implementing the recommendations within the guideline.

The CDC's opioid recommendations

The Centers for Disease Control and Prevention’s new opioid prescription guideline includes 12 recommendations. Here they are, modified slightly for style:

1. Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Providers should only consider adding opioid therapy if expected benefits for both pain and function are anticipated to outweigh risks.

2. Before starting opioid therapy for chronic pain, providers should establish treatment goals with all patients, including realistic goals for pain and function. Providers should not initiate opioid therapy without consideration of how therapy will be discontinued if unsuccessful. Providers should continue opioid therapy only if there is clinically meaningful improvement in pain and function.

3. Before starting and periodically during opioid therapy, providers should discuss with patients known risks and realistic benefits of opioid therapy, and patient and provider responsibilities for managing therapy.

4. When starting opioid therapy for chronic pain, providers should prescribe immediate-release opioids instead of extended-release/long-acting opioids.

5. When opioids are started, providers should prescribe the lowest effective dosage. Providers should use caution when prescribing opioids at any dosage, should implement additional precautions when increasing dosage to 50 or more morphine milligram equivalents (MME) per day, and generally should avoid increasing dosage to 90 or more MME per day.

6. When opioids are used for acute pain, providers should prescribe the lowest effective dose of immediate-release opioids. Three or fewer days often will be sufficient.

7. Providers should evaluate the benefits and harms with patients within 1-4 weeks of starting opioid therapy for chronic pain or of dose escalation. They should reevaluate continued therapy’s benefits and harms every 3 months or more frequently. If continued therapy’s benefits do not outweigh harms, providers should work with patients to reduce dosages or discontinue opioids.

8. During therapy, providers should evaluate risk factors for opioid-related harm. Providers should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose – such as history of overdose, history of substance use disorder, or higher opioid dosage (50 MME or more) – are present.

9. Providers should review the patient’s history of controlled substance prescriptions using state prescription drug monitoring program (PDMP) data to determine whether the patient is receiving high opioid dosages or dangerous combinations that put him or her at high risk for overdose. Providers should review PDMP data when starting opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescription to every 3 months.

10. When prescribing opioids for chronic pain, providers should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications, as well as other controlled prescription drugs and illicit drugs.

11. Providers should avoid concurrent prescriptions of opioid pain medication and benzodiazepines whenever possible.

12. Providers should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid use disorder.

M. Alexander Otto contributed to this article.

sworcester@frontlinemedcom.com