Hospitalist movers and shakers

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Andrew Auerbach, MD, MPH, SFHM, and Vineet Arora, MD, MPP, MHM, recently were elected to the new member class of American Society for Clinical Investigation (ASCI) for 2017. Members must have “accomplished meritorious, original, creative, and independent investigations in the clinical or allied sciences of medicine and enjoy an unimpeachable moral standing in the medical profession.”

Dr. Auerbach and Dr. Arora are just the third and fourth hospitalists to become ASCI members. Dr. Auerbach is the professor of medicine in residence and director of the research division of hospital medicine at the University of California, San Francisco. Dr. Aurora is associate professor of medicine, assistant dean for scholarship and discovery, and director of graduate medical education’s clinical learning environment innovation at the University of Chicago.

Dr. Vineet Arora
Both honorees serve as members of the Journal of Hospital Medicine’s editorial board.

Dr. Andrew D. Auerbach

Mark V. Williams, MD, FACP, MHM, director of the University of Kentucky’s Center for Health Services Research (CHSR), recently presented at the International Conference of Hospital Medicine held in Taiwan.

Dr. Mark V. Williams
Dr. Williams’s presentation centered on the evolution of hospital medicine and the role hospitalists might play in the future. He was invited to speak by Ming-Chin Yang, DPH, the associate dean of National Taiwan University’s College of Public Health, and practicing Taiwanese hospitalist Nin-Chieh Hsu, MD.

Dr. Williams, director of the University of Kentucky's Center for Health Services Research, spoke recently at the International Conference of Hospital Medicine in Taiwan.
Dr. Williams has been director of the CHSR since 2014, while simultaneously serving as chief of UK HealthCare’s division of hospital medicine. He is the former president of the Society of Hospital Medicine.
 

Olevia M. Pitts, MD, SFHM, made history at Research Medical Center in Kansas City, becoming the first woman and the first person of color to be named the facility’s chief medical officer. Dr. Pitts assumed her role at the 131-year-old RMC on January 30.

Dr. Olevia M. Pitts
Dr. Pitts previously served as Kansas City/Wichita region senior vice president for IPC Healthcare and medical director at Kindred Traditional Care Hospital. Prior to that, she was lead physician hospitalist with Midwest Hospitalist Specialists in Overland Park, Mo.
 

Greta Boynton, MD, SFHM, was promoted to the role of associate chief medical officer of Sound Physicians’ northeast region. She was elevated from her position as regional medical director for Sound Physicians, a health care organization that serves as a provider practice in 225 hospitals in 38 states.

Dr. Boynton will be charged with overseeing clinical operation of 13 programs, 120 providers, and a team of regional medical directors. She joined Sound Physicians in 2013 as chief hospitalist and divisional chief at Baystate Medical Center in Springfield, Mass. She was, previously, chief of hospital medicine for Eastern Connecticut Health Network, Manchester, from 2008-2013.
 

Business Moves

Sound Physicians, Tacoma, Wash., added to its list of partners on March 1, when Eagle Hospital Medicine Practices, Atlanta, joined the Sound group’s organization. Eagle’s 150 providers in 16 hospitals across the United States raises Sound’s resume to more than 2,500 providers.

Eagle will continue to run its own Locum Connections and Telemedicine divisions.
 

The Society of Hospital Medicine’s Center for Quality Improvement recently was recognized and honored by the Centers for Medicare & Medicaid Services (CMS) for its patient-safety partnership with CMS. The two entities have maintained a relationship since August 2016.

SHM’s Center for QI has participated in weekly CMS webinars to generate strategies intended to limit opioid use, including SHM’s pilot RADEO – Reducing Adverse Drug Events Related to Opioids – program. In January 2017, CMS contacted SHM to provide best practices for patients receiving opioids and better use data to monitor those patients.
 

University of Iowa Health Care, Iowa City, and Van Buren County Hospital, Keosauqua, Iowa, have created a partnership, allowing patients at VBCH access to UI hospitalists through a telemedicine connection. The relationship will allow VBCH patients to remain at their local hospital – located 90 minutes from Iowa City – while getting care and treatment advice from UI hospitalists through videoconferencing and a shared electronic health record.

With their VBCH provider bedside, patients meet face-to–virtual face with the UI hospitalist during twice-daily virtual rounding.
 

Unity Medical Center, Manchester, Tenn., recently partnered with physician-owned and -operated Concord Medical Group, Knoxville, Tenn., to provide hospitalist services at its facility in Manchester. Unity now will have hospitalists on duty 24 hours per day thanks to the relationship with Concord, a hospital management and staffing specialist group.

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Andrew Auerbach, MD, MPH, SFHM, and Vineet Arora, MD, MPP, MHM, recently were elected to the new member class of American Society for Clinical Investigation (ASCI) for 2017. Members must have “accomplished meritorious, original, creative, and independent investigations in the clinical or allied sciences of medicine and enjoy an unimpeachable moral standing in the medical profession.”

Dr. Auerbach and Dr. Arora are just the third and fourth hospitalists to become ASCI members. Dr. Auerbach is the professor of medicine in residence and director of the research division of hospital medicine at the University of California, San Francisco. Dr. Aurora is associate professor of medicine, assistant dean for scholarship and discovery, and director of graduate medical education’s clinical learning environment innovation at the University of Chicago.

Dr. Vineet Arora
Both honorees serve as members of the Journal of Hospital Medicine’s editorial board.

Dr. Andrew D. Auerbach

Mark V. Williams, MD, FACP, MHM, director of the University of Kentucky’s Center for Health Services Research (CHSR), recently presented at the International Conference of Hospital Medicine held in Taiwan.

Dr. Mark V. Williams
Dr. Williams’s presentation centered on the evolution of hospital medicine and the role hospitalists might play in the future. He was invited to speak by Ming-Chin Yang, DPH, the associate dean of National Taiwan University’s College of Public Health, and practicing Taiwanese hospitalist Nin-Chieh Hsu, MD.

Dr. Williams, director of the University of Kentucky's Center for Health Services Research, spoke recently at the International Conference of Hospital Medicine in Taiwan.
Dr. Williams has been director of the CHSR since 2014, while simultaneously serving as chief of UK HealthCare’s division of hospital medicine. He is the former president of the Society of Hospital Medicine.
 

Olevia M. Pitts, MD, SFHM, made history at Research Medical Center in Kansas City, becoming the first woman and the first person of color to be named the facility’s chief medical officer. Dr. Pitts assumed her role at the 131-year-old RMC on January 30.

Dr. Olevia M. Pitts
Dr. Pitts previously served as Kansas City/Wichita region senior vice president for IPC Healthcare and medical director at Kindred Traditional Care Hospital. Prior to that, she was lead physician hospitalist with Midwest Hospitalist Specialists in Overland Park, Mo.
 

Greta Boynton, MD, SFHM, was promoted to the role of associate chief medical officer of Sound Physicians’ northeast region. She was elevated from her position as regional medical director for Sound Physicians, a health care organization that serves as a provider practice in 225 hospitals in 38 states.

Dr. Boynton will be charged with overseeing clinical operation of 13 programs, 120 providers, and a team of regional medical directors. She joined Sound Physicians in 2013 as chief hospitalist and divisional chief at Baystate Medical Center in Springfield, Mass. She was, previously, chief of hospital medicine for Eastern Connecticut Health Network, Manchester, from 2008-2013.
 

Business Moves

Sound Physicians, Tacoma, Wash., added to its list of partners on March 1, when Eagle Hospital Medicine Practices, Atlanta, joined the Sound group’s organization. Eagle’s 150 providers in 16 hospitals across the United States raises Sound’s resume to more than 2,500 providers.

Eagle will continue to run its own Locum Connections and Telemedicine divisions.
 

The Society of Hospital Medicine’s Center for Quality Improvement recently was recognized and honored by the Centers for Medicare & Medicaid Services (CMS) for its patient-safety partnership with CMS. The two entities have maintained a relationship since August 2016.

SHM’s Center for QI has participated in weekly CMS webinars to generate strategies intended to limit opioid use, including SHM’s pilot RADEO – Reducing Adverse Drug Events Related to Opioids – program. In January 2017, CMS contacted SHM to provide best practices for patients receiving opioids and better use data to monitor those patients.
 

University of Iowa Health Care, Iowa City, and Van Buren County Hospital, Keosauqua, Iowa, have created a partnership, allowing patients at VBCH access to UI hospitalists through a telemedicine connection. The relationship will allow VBCH patients to remain at their local hospital – located 90 minutes from Iowa City – while getting care and treatment advice from UI hospitalists through videoconferencing and a shared electronic health record.

With their VBCH provider bedside, patients meet face-to–virtual face with the UI hospitalist during twice-daily virtual rounding.
 

Unity Medical Center, Manchester, Tenn., recently partnered with physician-owned and -operated Concord Medical Group, Knoxville, Tenn., to provide hospitalist services at its facility in Manchester. Unity now will have hospitalists on duty 24 hours per day thanks to the relationship with Concord, a hospital management and staffing specialist group.

 

Andrew Auerbach, MD, MPH, SFHM, and Vineet Arora, MD, MPP, MHM, recently were elected to the new member class of American Society for Clinical Investigation (ASCI) for 2017. Members must have “accomplished meritorious, original, creative, and independent investigations in the clinical or allied sciences of medicine and enjoy an unimpeachable moral standing in the medical profession.”

Dr. Auerbach and Dr. Arora are just the third and fourth hospitalists to become ASCI members. Dr. Auerbach is the professor of medicine in residence and director of the research division of hospital medicine at the University of California, San Francisco. Dr. Aurora is associate professor of medicine, assistant dean for scholarship and discovery, and director of graduate medical education’s clinical learning environment innovation at the University of Chicago.

Dr. Vineet Arora
Both honorees serve as members of the Journal of Hospital Medicine’s editorial board.

Dr. Andrew D. Auerbach

Mark V. Williams, MD, FACP, MHM, director of the University of Kentucky’s Center for Health Services Research (CHSR), recently presented at the International Conference of Hospital Medicine held in Taiwan.

Dr. Mark V. Williams
Dr. Williams’s presentation centered on the evolution of hospital medicine and the role hospitalists might play in the future. He was invited to speak by Ming-Chin Yang, DPH, the associate dean of National Taiwan University’s College of Public Health, and practicing Taiwanese hospitalist Nin-Chieh Hsu, MD.

Dr. Williams, director of the University of Kentucky's Center for Health Services Research, spoke recently at the International Conference of Hospital Medicine in Taiwan.
Dr. Williams has been director of the CHSR since 2014, while simultaneously serving as chief of UK HealthCare’s division of hospital medicine. He is the former president of the Society of Hospital Medicine.
 

Olevia M. Pitts, MD, SFHM, made history at Research Medical Center in Kansas City, becoming the first woman and the first person of color to be named the facility’s chief medical officer. Dr. Pitts assumed her role at the 131-year-old RMC on January 30.

Dr. Olevia M. Pitts
Dr. Pitts previously served as Kansas City/Wichita region senior vice president for IPC Healthcare and medical director at Kindred Traditional Care Hospital. Prior to that, she was lead physician hospitalist with Midwest Hospitalist Specialists in Overland Park, Mo.
 

Greta Boynton, MD, SFHM, was promoted to the role of associate chief medical officer of Sound Physicians’ northeast region. She was elevated from her position as regional medical director for Sound Physicians, a health care organization that serves as a provider practice in 225 hospitals in 38 states.

Dr. Boynton will be charged with overseeing clinical operation of 13 programs, 120 providers, and a team of regional medical directors. She joined Sound Physicians in 2013 as chief hospitalist and divisional chief at Baystate Medical Center in Springfield, Mass. She was, previously, chief of hospital medicine for Eastern Connecticut Health Network, Manchester, from 2008-2013.
 

Business Moves

Sound Physicians, Tacoma, Wash., added to its list of partners on March 1, when Eagle Hospital Medicine Practices, Atlanta, joined the Sound group’s organization. Eagle’s 150 providers in 16 hospitals across the United States raises Sound’s resume to more than 2,500 providers.

Eagle will continue to run its own Locum Connections and Telemedicine divisions.
 

The Society of Hospital Medicine’s Center for Quality Improvement recently was recognized and honored by the Centers for Medicare & Medicaid Services (CMS) for its patient-safety partnership with CMS. The two entities have maintained a relationship since August 2016.

SHM’s Center for QI has participated in weekly CMS webinars to generate strategies intended to limit opioid use, including SHM’s pilot RADEO – Reducing Adverse Drug Events Related to Opioids – program. In January 2017, CMS contacted SHM to provide best practices for patients receiving opioids and better use data to monitor those patients.
 

University of Iowa Health Care, Iowa City, and Van Buren County Hospital, Keosauqua, Iowa, have created a partnership, allowing patients at VBCH access to UI hospitalists through a telemedicine connection. The relationship will allow VBCH patients to remain at their local hospital – located 90 minutes from Iowa City – while getting care and treatment advice from UI hospitalists through videoconferencing and a shared electronic health record.

With their VBCH provider bedside, patients meet face-to–virtual face with the UI hospitalist during twice-daily virtual rounding.
 

Unity Medical Center, Manchester, Tenn., recently partnered with physician-owned and -operated Concord Medical Group, Knoxville, Tenn., to provide hospitalist services at its facility in Manchester. Unity now will have hospitalists on duty 24 hours per day thanks to the relationship with Concord, a hospital management and staffing specialist group.

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Digoxin and heart failure mortality: The Swedes weigh in

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– The use of digoxin by Swedish Heart Failure Registry participants with heart failure with reduced ejection fraction was associated with significantly increased risk of all-cause mortality if they had concomitant paroxysmal atrial fibrillation or were in normal sinus rhythm, Gianluigi Savarese, MD, reported at the annual meeting of the American College of Cardiology.

In contrast, digoxin in Swedish patients with heart failure with reduced ejection fraction (HFrEF) and permanent atrial fibrillation (AF) was associated with a reduced risk of heart failure hospitalization but had no impact on mortality, added Dr. Savarese of the Karolinska Institute in Stockholm.

The Swedish Heart Failure Registry includes the majority of heart failure patients in that country. Data on 80 variables gets collected for each participant.

Dr. Savarese reported on 23,708 Swedes with HFrEF, 18% of whom were on digoxin. In a multivariate Cox regression analysis adjusted for numerous potential confounders, the use of digoxin was associated with an 8% increased risk of all-cause mortality and a 10% lower risk of heart failure hospitalizations during up to 11 years of follow-up.

In the 12,162 patients with HFrEF and comorbid AF, 30% of whom were on digoxin, the drug was associated with a 12% reduction in heart failure hospitalizations and had no effect on all-cause mortality.

In contrast, among patients with HFrEF without AF, 5% of whom were taking digoxin, use of the drug was associated with an adjusted 31% increase in mortality risk. But digoxin didn’t affect the risk of heart failure hospitalization one way or the other in this group.

Stratifying subjects by their type of AF, the use of digoxin in patients with HFrEF and permanent AF was associated with a 16% reduction in risk of heart failure hospitalization with no impact on mortality. In contrast, among the 2,723 patients with HFrEF and paroxysmal AF, digoxin was associated with a 29% increase in the risk of mortality and no effect on hospitalization.

Current ACC/American Heart Association heart failure guidelines give digoxin a strong Class IIa recommendation for reducing heart failure hospitalizations in patients with HFrEF. European Society of Cardiology guidelines provide a Class IIb recommendation for digoxin to reduce the risk of hospitalization in patients with symptomatic HFrEF in normal sinus rhythm.

Dr. Savarese said he and his coinvestigators decided to examine the impact of digoxin in the Swedish Heart Failure Registry because despite the guideline support for the drug’s use, recent years have brought conflicting data regarding digoxin’s impact on mortality. For example, a meta-analysis of nine studies in more than 235,000 AF patients, seven studies in patients with heart failure, and three in patients with both disorders showed that digoxin was associated with a 29% increased mortality risk in AF patients and a 14% increase in those with heart failure (Eur Heart J. 2015 Jul 21;36[28]:1831-8).

Moreover, at a late-breaking clinical trial session elsewhere at ACC 17, a secondary analysis of the roughly 18,000-patient ARISTOTLE trial came down emphatically on the side of avoiding the venerable drug in patients with AF, where it was found to be associated with a fourfold increased risk of sudden death.

Session comoderator Lee R. Goldberg, MD, medical director of the University of Pennsylvania Heart Failure and Transplantation Program in Philadelphia, observed that the use of digoxin has become quite controversial. He posed a question to Dr. Savarese: “Every few months someone writes the last paper on digoxin as they look at thousands of patients, and then there’s always a new paper. If you were to rewrite the guidelines now, what would you recommend for digoxin?”

Dr. Savarese replied that the current guidelines rely heavily upon the results of a 20-year-old randomized, double-blind, placebo-controlled trial of digoxin in heart failure (N Engl J Med. 1997 Feb 20;336[8]:525-33). Those study participants look nothing at all like the heart failure patients physicians see today in clinical practice. Hardly any of them were on what today is guideline-directed medical therapy with a beta-blocker or mineralocorticoid receptor antagonist. So the trial’s applicability is dubious.

“Our Swedish data are observational. They are hypothesis-generating. They should drive trialists to design a new trial of digoxin. But I think we all know that’s not going to happen. So actually I don’t think there is still space for a IIb or IIa recommendation for digoxin in the guidelines,” Dr. Savarese said.

He reported having no financial conflicts.

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– The use of digoxin by Swedish Heart Failure Registry participants with heart failure with reduced ejection fraction was associated with significantly increased risk of all-cause mortality if they had concomitant paroxysmal atrial fibrillation or were in normal sinus rhythm, Gianluigi Savarese, MD, reported at the annual meeting of the American College of Cardiology.

In contrast, digoxin in Swedish patients with heart failure with reduced ejection fraction (HFrEF) and permanent atrial fibrillation (AF) was associated with a reduced risk of heart failure hospitalization but had no impact on mortality, added Dr. Savarese of the Karolinska Institute in Stockholm.

The Swedish Heart Failure Registry includes the majority of heart failure patients in that country. Data on 80 variables gets collected for each participant.

Dr. Savarese reported on 23,708 Swedes with HFrEF, 18% of whom were on digoxin. In a multivariate Cox regression analysis adjusted for numerous potential confounders, the use of digoxin was associated with an 8% increased risk of all-cause mortality and a 10% lower risk of heart failure hospitalizations during up to 11 years of follow-up.

In the 12,162 patients with HFrEF and comorbid AF, 30% of whom were on digoxin, the drug was associated with a 12% reduction in heart failure hospitalizations and had no effect on all-cause mortality.

In contrast, among patients with HFrEF without AF, 5% of whom were taking digoxin, use of the drug was associated with an adjusted 31% increase in mortality risk. But digoxin didn’t affect the risk of heart failure hospitalization one way or the other in this group.

Stratifying subjects by their type of AF, the use of digoxin in patients with HFrEF and permanent AF was associated with a 16% reduction in risk of heart failure hospitalization with no impact on mortality. In contrast, among the 2,723 patients with HFrEF and paroxysmal AF, digoxin was associated with a 29% increase in the risk of mortality and no effect on hospitalization.

Current ACC/American Heart Association heart failure guidelines give digoxin a strong Class IIa recommendation for reducing heart failure hospitalizations in patients with HFrEF. European Society of Cardiology guidelines provide a Class IIb recommendation for digoxin to reduce the risk of hospitalization in patients with symptomatic HFrEF in normal sinus rhythm.

Dr. Savarese said he and his coinvestigators decided to examine the impact of digoxin in the Swedish Heart Failure Registry because despite the guideline support for the drug’s use, recent years have brought conflicting data regarding digoxin’s impact on mortality. For example, a meta-analysis of nine studies in more than 235,000 AF patients, seven studies in patients with heart failure, and three in patients with both disorders showed that digoxin was associated with a 29% increased mortality risk in AF patients and a 14% increase in those with heart failure (Eur Heart J. 2015 Jul 21;36[28]:1831-8).

Moreover, at a late-breaking clinical trial session elsewhere at ACC 17, a secondary analysis of the roughly 18,000-patient ARISTOTLE trial came down emphatically on the side of avoiding the venerable drug in patients with AF, where it was found to be associated with a fourfold increased risk of sudden death.

Session comoderator Lee R. Goldberg, MD, medical director of the University of Pennsylvania Heart Failure and Transplantation Program in Philadelphia, observed that the use of digoxin has become quite controversial. He posed a question to Dr. Savarese: “Every few months someone writes the last paper on digoxin as they look at thousands of patients, and then there’s always a new paper. If you were to rewrite the guidelines now, what would you recommend for digoxin?”

Dr. Savarese replied that the current guidelines rely heavily upon the results of a 20-year-old randomized, double-blind, placebo-controlled trial of digoxin in heart failure (N Engl J Med. 1997 Feb 20;336[8]:525-33). Those study participants look nothing at all like the heart failure patients physicians see today in clinical practice. Hardly any of them were on what today is guideline-directed medical therapy with a beta-blocker or mineralocorticoid receptor antagonist. So the trial’s applicability is dubious.

“Our Swedish data are observational. They are hypothesis-generating. They should drive trialists to design a new trial of digoxin. But I think we all know that’s not going to happen. So actually I don’t think there is still space for a IIb or IIa recommendation for digoxin in the guidelines,” Dr. Savarese said.

He reported having no financial conflicts.

 

– The use of digoxin by Swedish Heart Failure Registry participants with heart failure with reduced ejection fraction was associated with significantly increased risk of all-cause mortality if they had concomitant paroxysmal atrial fibrillation or were in normal sinus rhythm, Gianluigi Savarese, MD, reported at the annual meeting of the American College of Cardiology.

In contrast, digoxin in Swedish patients with heart failure with reduced ejection fraction (HFrEF) and permanent atrial fibrillation (AF) was associated with a reduced risk of heart failure hospitalization but had no impact on mortality, added Dr. Savarese of the Karolinska Institute in Stockholm.

The Swedish Heart Failure Registry includes the majority of heart failure patients in that country. Data on 80 variables gets collected for each participant.

Dr. Savarese reported on 23,708 Swedes with HFrEF, 18% of whom were on digoxin. In a multivariate Cox regression analysis adjusted for numerous potential confounders, the use of digoxin was associated with an 8% increased risk of all-cause mortality and a 10% lower risk of heart failure hospitalizations during up to 11 years of follow-up.

In the 12,162 patients with HFrEF and comorbid AF, 30% of whom were on digoxin, the drug was associated with a 12% reduction in heart failure hospitalizations and had no effect on all-cause mortality.

In contrast, among patients with HFrEF without AF, 5% of whom were taking digoxin, use of the drug was associated with an adjusted 31% increase in mortality risk. But digoxin didn’t affect the risk of heart failure hospitalization one way or the other in this group.

Stratifying subjects by their type of AF, the use of digoxin in patients with HFrEF and permanent AF was associated with a 16% reduction in risk of heart failure hospitalization with no impact on mortality. In contrast, among the 2,723 patients with HFrEF and paroxysmal AF, digoxin was associated with a 29% increase in the risk of mortality and no effect on hospitalization.

Current ACC/American Heart Association heart failure guidelines give digoxin a strong Class IIa recommendation for reducing heart failure hospitalizations in patients with HFrEF. European Society of Cardiology guidelines provide a Class IIb recommendation for digoxin to reduce the risk of hospitalization in patients with symptomatic HFrEF in normal sinus rhythm.

Dr. Savarese said he and his coinvestigators decided to examine the impact of digoxin in the Swedish Heart Failure Registry because despite the guideline support for the drug’s use, recent years have brought conflicting data regarding digoxin’s impact on mortality. For example, a meta-analysis of nine studies in more than 235,000 AF patients, seven studies in patients with heart failure, and three in patients with both disorders showed that digoxin was associated with a 29% increased mortality risk in AF patients and a 14% increase in those with heart failure (Eur Heart J. 2015 Jul 21;36[28]:1831-8).

Moreover, at a late-breaking clinical trial session elsewhere at ACC 17, a secondary analysis of the roughly 18,000-patient ARISTOTLE trial came down emphatically on the side of avoiding the venerable drug in patients with AF, where it was found to be associated with a fourfold increased risk of sudden death.

Session comoderator Lee R. Goldberg, MD, medical director of the University of Pennsylvania Heart Failure and Transplantation Program in Philadelphia, observed that the use of digoxin has become quite controversial. He posed a question to Dr. Savarese: “Every few months someone writes the last paper on digoxin as they look at thousands of patients, and then there’s always a new paper. If you were to rewrite the guidelines now, what would you recommend for digoxin?”

Dr. Savarese replied that the current guidelines rely heavily upon the results of a 20-year-old randomized, double-blind, placebo-controlled trial of digoxin in heart failure (N Engl J Med. 1997 Feb 20;336[8]:525-33). Those study participants look nothing at all like the heart failure patients physicians see today in clinical practice. Hardly any of them were on what today is guideline-directed medical therapy with a beta-blocker or mineralocorticoid receptor antagonist. So the trial’s applicability is dubious.

“Our Swedish data are observational. They are hypothesis-generating. They should drive trialists to design a new trial of digoxin. But I think we all know that’s not going to happen. So actually I don’t think there is still space for a IIb or IIa recommendation for digoxin in the guidelines,” Dr. Savarese said.

He reported having no financial conflicts.

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Key clinical point: Swedish investigators have driven another nail in the coffin containing digoxin for use in patients with heart failure.

Major finding: The use of digoxin in patients with heart failure with reduced ejection fraction was associated with significantly increased risk of all-cause mortality if they had concomitant paroxysmal atrial fibrillation or were in normal sinus rhythm.

Data source: An observational study of nearly 24,000 patients enrolled in the Swedish Heart Failure Registry, 18% of whom were on digoxin.

Disclosures: The study presenter reported having no financial conflicts.

Just over half of FPs accept Medicaid

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Medicaid acceptance was 55% among family physicians in the 2017 edition of an ongoing survey conducted in 15 large cities by physician recruitment firm Merritt Hawkins.

That was up from almost 52% in the previous survey, conducted in 2014, but lower than the average of 64% for FPs in 15 midsized cities that were included for the first time in 2017, the company reported.

There was one large city with a Medicaid acceptance rate of 100% – Minneapolis (up from 35% in 2014) – along with three midsized cities – Billings, Mt.; Dayton, Ohio; and Fargo, N.D. The lowest rate among the large cities was in Denver (20%), with the midsized basement occupied by Lafayette, La., at 20%, Merritt Hawkins reported.



Investigators called 273 randomly selected family physicians in the large cities and 115 FPs in the midsized cities in January and February. It was the fourth such survey the company has conducted since 2004.

The survey included four other specialties – cardiology, dermatology, ob.gyn., and orthopedic surgery. The Medicaid acceptance rate for all 1,414 physicians in all five specialties in the 15 large cities was 53%, and the average rate for all specialties in the midsized cities was 60% for the 494 offices surveyed, the company noted.

Cardiology had the highest rates by specialty and dermatology the lowest in both the large and midsized cities. For all five specialties combined, Minneapolis (97%) and Fargo (100%) had the highest acceptance rates, with the lowest rates coming from Dallas (17%) for large cities and Lafayette (11%) for midsized cities, the Merritt Hawkins data show.

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Medicaid acceptance was 55% among family physicians in the 2017 edition of an ongoing survey conducted in 15 large cities by physician recruitment firm Merritt Hawkins.

That was up from almost 52% in the previous survey, conducted in 2014, but lower than the average of 64% for FPs in 15 midsized cities that were included for the first time in 2017, the company reported.

There was one large city with a Medicaid acceptance rate of 100% – Minneapolis (up from 35% in 2014) – along with three midsized cities – Billings, Mt.; Dayton, Ohio; and Fargo, N.D. The lowest rate among the large cities was in Denver (20%), with the midsized basement occupied by Lafayette, La., at 20%, Merritt Hawkins reported.



Investigators called 273 randomly selected family physicians in the large cities and 115 FPs in the midsized cities in January and February. It was the fourth such survey the company has conducted since 2004.

The survey included four other specialties – cardiology, dermatology, ob.gyn., and orthopedic surgery. The Medicaid acceptance rate for all 1,414 physicians in all five specialties in the 15 large cities was 53%, and the average rate for all specialties in the midsized cities was 60% for the 494 offices surveyed, the company noted.

Cardiology had the highest rates by specialty and dermatology the lowest in both the large and midsized cities. For all five specialties combined, Minneapolis (97%) and Fargo (100%) had the highest acceptance rates, with the lowest rates coming from Dallas (17%) for large cities and Lafayette (11%) for midsized cities, the Merritt Hawkins data show.

 

Medicaid acceptance was 55% among family physicians in the 2017 edition of an ongoing survey conducted in 15 large cities by physician recruitment firm Merritt Hawkins.

That was up from almost 52% in the previous survey, conducted in 2014, but lower than the average of 64% for FPs in 15 midsized cities that were included for the first time in 2017, the company reported.

There was one large city with a Medicaid acceptance rate of 100% – Minneapolis (up from 35% in 2014) – along with three midsized cities – Billings, Mt.; Dayton, Ohio; and Fargo, N.D. The lowest rate among the large cities was in Denver (20%), with the midsized basement occupied by Lafayette, La., at 20%, Merritt Hawkins reported.



Investigators called 273 randomly selected family physicians in the large cities and 115 FPs in the midsized cities in January and February. It was the fourth such survey the company has conducted since 2004.

The survey included four other specialties – cardiology, dermatology, ob.gyn., and orthopedic surgery. The Medicaid acceptance rate for all 1,414 physicians in all five specialties in the 15 large cities was 53%, and the average rate for all specialties in the midsized cities was 60% for the 494 offices surveyed, the company noted.

Cardiology had the highest rates by specialty and dermatology the lowest in both the large and midsized cities. For all five specialties combined, Minneapolis (97%) and Fargo (100%) had the highest acceptance rates, with the lowest rates coming from Dallas (17%) for large cities and Lafayette (11%) for midsized cities, the Merritt Hawkins data show.

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Address procrastination, disorganization in hoarding disorder

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– Procrastination, disorganization, indecisiveness, and perfectionism each are significant independent predictors of hoarding severity, even though none of these associated factors is included in the DSM-5 diagnostic criteria for hoarding disorder, according to Sanjaya Saxena, MD.

Of these four associated factors, disorganization and procrastination had the strongest correlation with hoarding severity in his study. Patients meeting the DSM-5 criteria for hoarding disorder scored significantly higher on measures of disorganization and procrastination than did patients with nonhoarding obsessive-compulsive disorder or anxiety disorders, said Dr. Saxena, professor of psychiatry and director of the obsessive-compulsive disorders program at the University of California, San Diego.

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Dr. Sanjaya Saxena
“These results suggest that these associated features, particularly disorganization and procrastination, should be assessed and addressed in the treatment of patients with hoarding disorder. Future studies should investigate the validity and clinical utility of adding these associated features to the diagnostic criteria for hoarding disorder,” he said at the annual conference of the Anxiety and Depression Association of America.

The DSM-5 lists as the core symptoms of hoarding disorder difficulty in discarding possessions; perceived need to save items; excessive acquisition, clutter, and resultant distress; and impaired functioning. But while procrastination, disorganization, perfectionism, and indecisiveness aren’t included in the diagnostic criteria, Dr. Saxena said he and some other experts have considered those features to be characteristic of affected individuals. So he decided to formally test the strength of the associations.

He reported on 21 patients with hoarding disorder and 13 controls with nonhoarding OCD or an anxiety disorder. All subjects completed a battery of assessment tools, including the Beck Depression Inventory, the Beck Anxiety Inventory, the Frost Multidimensional Perfectionism Scale, the Frost Indecisiveness Scale, the Adult Inventory of Procrastination Scale, and three different measures of hoarding severity. Participants also completed a disorganization index based on their answers to three questions drawn from the Swanson, Nolan, and Pelham (SNAP-IV) Rating Scale: How often did you have difficulty organizing tasks and activities as a child? How disorganized are you in your thinking, planning, and time management? And how disorganized are your belongings at home?

Neither disorganization, procrastination, perfectionism, nor indecisiveness turned out to be associated with severity of nonhoarding OCD or anxiety disorder symptoms. Surprisingly, no significant differences were found between hoarding disorder patients and controls on the measures of indecisiveness or perfectionism, Dr. Saxena said. And the two groups did not differ in their levels of anxiety and depression.

However, levels of procrastination and disorganization were strongly correlated with hoarding severity as assessed via the Saving Inventory – Revised, the UCLA Hoarding Severity Scale, and the Hoarding Rating Scale. The hoarding disorder group’s average score on the disorganization index was 5.67, more than twice that of the 2.67 in the control group. And patients with hoarding disorder had an average Adult Inventory of Procrastination score of 50.9 out of a possible maximum of 75 points, compared with 41 in controls.

In a multivariate regression analysis, age and level of depression collectively explained 23.5% of the variance in hoarding severity scores in the study population. Disorganization independently explained an additional 29.9% of the variance, and procrastination accounted for another 19.1%, Dr. Saxena reported.

He reported having no financial conflicts regarding his study, which was funded by the university’s department of psychiatry.

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– Procrastination, disorganization, indecisiveness, and perfectionism each are significant independent predictors of hoarding severity, even though none of these associated factors is included in the DSM-5 diagnostic criteria for hoarding disorder, according to Sanjaya Saxena, MD.

Of these four associated factors, disorganization and procrastination had the strongest correlation with hoarding severity in his study. Patients meeting the DSM-5 criteria for hoarding disorder scored significantly higher on measures of disorganization and procrastination than did patients with nonhoarding obsessive-compulsive disorder or anxiety disorders, said Dr. Saxena, professor of psychiatry and director of the obsessive-compulsive disorders program at the University of California, San Diego.

Bruce Jancin/Frontline Medical News
Dr. Sanjaya Saxena
“These results suggest that these associated features, particularly disorganization and procrastination, should be assessed and addressed in the treatment of patients with hoarding disorder. Future studies should investigate the validity and clinical utility of adding these associated features to the diagnostic criteria for hoarding disorder,” he said at the annual conference of the Anxiety and Depression Association of America.

The DSM-5 lists as the core symptoms of hoarding disorder difficulty in discarding possessions; perceived need to save items; excessive acquisition, clutter, and resultant distress; and impaired functioning. But while procrastination, disorganization, perfectionism, and indecisiveness aren’t included in the diagnostic criteria, Dr. Saxena said he and some other experts have considered those features to be characteristic of affected individuals. So he decided to formally test the strength of the associations.

He reported on 21 patients with hoarding disorder and 13 controls with nonhoarding OCD or an anxiety disorder. All subjects completed a battery of assessment tools, including the Beck Depression Inventory, the Beck Anxiety Inventory, the Frost Multidimensional Perfectionism Scale, the Frost Indecisiveness Scale, the Adult Inventory of Procrastination Scale, and three different measures of hoarding severity. Participants also completed a disorganization index based on their answers to three questions drawn from the Swanson, Nolan, and Pelham (SNAP-IV) Rating Scale: How often did you have difficulty organizing tasks and activities as a child? How disorganized are you in your thinking, planning, and time management? And how disorganized are your belongings at home?

Neither disorganization, procrastination, perfectionism, nor indecisiveness turned out to be associated with severity of nonhoarding OCD or anxiety disorder symptoms. Surprisingly, no significant differences were found between hoarding disorder patients and controls on the measures of indecisiveness or perfectionism, Dr. Saxena said. And the two groups did not differ in their levels of anxiety and depression.

However, levels of procrastination and disorganization were strongly correlated with hoarding severity as assessed via the Saving Inventory – Revised, the UCLA Hoarding Severity Scale, and the Hoarding Rating Scale. The hoarding disorder group’s average score on the disorganization index was 5.67, more than twice that of the 2.67 in the control group. And patients with hoarding disorder had an average Adult Inventory of Procrastination score of 50.9 out of a possible maximum of 75 points, compared with 41 in controls.

In a multivariate regression analysis, age and level of depression collectively explained 23.5% of the variance in hoarding severity scores in the study population. Disorganization independently explained an additional 29.9% of the variance, and procrastination accounted for another 19.1%, Dr. Saxena reported.

He reported having no financial conflicts regarding his study, which was funded by the university’s department of psychiatry.

 

– Procrastination, disorganization, indecisiveness, and perfectionism each are significant independent predictors of hoarding severity, even though none of these associated factors is included in the DSM-5 diagnostic criteria for hoarding disorder, according to Sanjaya Saxena, MD.

Of these four associated factors, disorganization and procrastination had the strongest correlation with hoarding severity in his study. Patients meeting the DSM-5 criteria for hoarding disorder scored significantly higher on measures of disorganization and procrastination than did patients with nonhoarding obsessive-compulsive disorder or anxiety disorders, said Dr. Saxena, professor of psychiatry and director of the obsessive-compulsive disorders program at the University of California, San Diego.

Bruce Jancin/Frontline Medical News
Dr. Sanjaya Saxena
“These results suggest that these associated features, particularly disorganization and procrastination, should be assessed and addressed in the treatment of patients with hoarding disorder. Future studies should investigate the validity and clinical utility of adding these associated features to the diagnostic criteria for hoarding disorder,” he said at the annual conference of the Anxiety and Depression Association of America.

The DSM-5 lists as the core symptoms of hoarding disorder difficulty in discarding possessions; perceived need to save items; excessive acquisition, clutter, and resultant distress; and impaired functioning. But while procrastination, disorganization, perfectionism, and indecisiveness aren’t included in the diagnostic criteria, Dr. Saxena said he and some other experts have considered those features to be characteristic of affected individuals. So he decided to formally test the strength of the associations.

He reported on 21 patients with hoarding disorder and 13 controls with nonhoarding OCD or an anxiety disorder. All subjects completed a battery of assessment tools, including the Beck Depression Inventory, the Beck Anxiety Inventory, the Frost Multidimensional Perfectionism Scale, the Frost Indecisiveness Scale, the Adult Inventory of Procrastination Scale, and three different measures of hoarding severity. Participants also completed a disorganization index based on their answers to three questions drawn from the Swanson, Nolan, and Pelham (SNAP-IV) Rating Scale: How often did you have difficulty organizing tasks and activities as a child? How disorganized are you in your thinking, planning, and time management? And how disorganized are your belongings at home?

Neither disorganization, procrastination, perfectionism, nor indecisiveness turned out to be associated with severity of nonhoarding OCD or anxiety disorder symptoms. Surprisingly, no significant differences were found between hoarding disorder patients and controls on the measures of indecisiveness or perfectionism, Dr. Saxena said. And the two groups did not differ in their levels of anxiety and depression.

However, levels of procrastination and disorganization were strongly correlated with hoarding severity as assessed via the Saving Inventory – Revised, the UCLA Hoarding Severity Scale, and the Hoarding Rating Scale. The hoarding disorder group’s average score on the disorganization index was 5.67, more than twice that of the 2.67 in the control group. And patients with hoarding disorder had an average Adult Inventory of Procrastination score of 50.9 out of a possible maximum of 75 points, compared with 41 in controls.

In a multivariate regression analysis, age and level of depression collectively explained 23.5% of the variance in hoarding severity scores in the study population. Disorganization independently explained an additional 29.9% of the variance, and procrastination accounted for another 19.1%, Dr. Saxena reported.

He reported having no financial conflicts regarding his study, which was funded by the university’s department of psychiatry.

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Key clinical point: Procrastination and disorganization should be considered as indicators of hoarding symptom severity.

Major finding: Severity of procrastination explained 30% of the variance in hoarding severity scores between patients with hoarding disorder and controls with nonhoarding obsessive-compulsive disorder or an anxiety disorder.

Data source: A cross-sectional study involving 21 patients with hoarding disorder and 13 controls, all of whom completed a battery of tests assessing anxiety, depression, hoarding severity, disorganization, procrastination, indecisiveness, and perfectionism.

Disclosures: The presenter reported having no financial conflicts regarding the study, which was funded by a university psychiatry department.

Target self-medication of mood and anxiety symptoms

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– Drinking to alleviate mood or anxiety symptoms is responsible for 12%-16% of cases of new-onset alcohol use disorder in affected individuals, Jitender Sareen, MD, said at the annual conference of the Anxiety and Depression Association of America.

Similarly, the use of prescription or nonprescription drugs to self-medicate mood or anxiety symptoms accounts for 20% of new-onset drug use disorders in this population, added Dr. Sareen, professor and head of the department of psychiatry at the University of Manitoba in Winnipeg.

Bruce Jancin/Frontline Medical News
Dr. Jitender Sareen


He was a coauthor of two landmark longitudinal epidemiologic studies that support the concept of self-medication as a direct causal mechanism that explains a phenomenon often observed in clinical practice: namely, the high rate of comorbid mood or anxiety disorders accompanied by an alcohol or substance use disorder.

“The clinical implication is that questions about self-medication with alcohol or drugs should be included in the assessment of patients with anxiety and mood symptoms, because self-medication is a marker of higher likelihood of psychopathology. And psychologic therapies like cognitive-behavioral therapy and dialectical behavior therapy could prevent onset of substance use disorders by teaching patients emotion regulation skills to manage their mood and anxiety symptoms without self-medication,” Dr. Sareen said.

The first longitudinal study of the role of self-medication in the development of comorbid anxiety and substance use disorders included 34,653 nationally representative adults who completed both the initial face-to-face National Epidemiologic Survey on Alcohol and Related Conditions in 2001-2002 and a follow-up survey conducted 3 years later.

During the 3-year follow-up period, 9.7% of subjects developed a new-onset anxiety disorder, 5.9% of participants newly met DSM-IV diagnostic criteria for alcohol use disorder, and 2% developed a new-onset drug use disorder.

Among subjects who met the criteria for an anxiety disorder at baseline and at that time also reported self-medication with alcohol, 12.6% developed an incident alcohol use disorder during follow-up. Among those who self-medicated with drugs, 10.4% developed a drug use disorder.

In contrast, only 4.7% of subjects with a baseline anxiety disorder who did not self-medicate with alcohol at baseline developed an incident alcohol use disorder. And an incident drug use disorder occurred in 1.7% of patients with a baseline anxiety disorder who did not self-medicate with drugs.

Among patients with a baseline alcohol or other substance use disorder, self-medication with alcohol was associated with an adjusted 2.13-fold increased likelihood of developing social phobia during 3 years of follow-up, while self-medication with other drugs was independently associated with a 3.27-fold increased likelihood of subsequently developing social phobia.

In a multivariate logistic regression analysis, Dr. Sareen and his coinvestigators determined that self-medication with alcohol by patients with an anxiety disorder at baseline was associated with a 2.63-fold increased risk of incident alcohol use disorder during follow-up. Self-medication with drugs in patients with a baseline anxiety disorder was associated with a 4.99-fold risk of a new-onset substance use disorder during the 3 years of follow-up (Arch Gen Psychiatry. 2011;68[8]:800-7).

In a subsequent analysis of the same prospectively studied population, Dr. Sareen and his colleagues focused specifically on drinking to self-medicate mood symptoms. They found that self-medication with alcohol was associated with an adjusted 3.1-fold increased likelihood of new-onset alcohol dependence during the 3-year follow-up, as well as with a 3.45-fold increased risk of persistence of alcohol dependence. Roughly 12% of all cases of incident alcohol dependence arising during follow-up of patients with baseline mood symptoms were attributed to self-medication with alcohol. The increased risk of new-onset alcohol dependence was observed not only in subjects who met DSM-IV criteria for an affective disorder, but in those with subthreshold mood symptoms as well (JAMA Psychiatry. 2013 Jul;70[7]:718-26).

Again, this points to drinking as a behavior employed to self-medicate mood symptoms as a potential target for preventive interventions aimed at reducing the occurrence of alcohol dependence. As yet, however, no formal studies have been done to confirm the effectiveness of this strategy, the psychiatrist continued.

Dr. Sareen was not involved in the third iteration of the National Epidemiologic Survey on Alcohol and Related Conditions, in which a different group of 36,309 nationally representative adults was interviewed during 2011-2013 to assess the impact of the DSM-5 criteria for alcohol use disorder. Using DSM-5, 13.9% of the population met criteria for an alcohol use disorder during the past 12 months, and the lifetime prevalence of alcohol use disorder was 29.1%. Fewer than one in five subjects with a lifetime DSM-5 alcohol use disorder had ever been treated.

In the first national survey, which used DSM-IV criteria, the 12-month and lifetime prevalences of alcohol abuse and/or dependence were 8.5% and 30.3%, respectively.

DSM-5 alcohol use disorder was highly comorbid. Both lifetime and 12-month alcohol use disorder were associated with significantly increased likelihood of other substance use disorders, major depression, bipolar I disorder, borderline personality disorder, and antisocial personality disorder.

These data indicate “an urgent need to educate the public and policy makers about alcohol use disorder and its treatment alternatives, to destigmatize the disorder, and to encourage those who cannot reduce their alcohol consumption on their own, despite substantial harm to themselves and others, to seek treatment,” the investigators wrote (JAMA Psychiatry. 2015 Aug;72[8]:757-66).

The surveys were supported by the National Institute on Alcohol Abuse and Alcoholism. Dr. Sareen reported having no financial conflicts of interest.

 

 

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– Drinking to alleviate mood or anxiety symptoms is responsible for 12%-16% of cases of new-onset alcohol use disorder in affected individuals, Jitender Sareen, MD, said at the annual conference of the Anxiety and Depression Association of America.

Similarly, the use of prescription or nonprescription drugs to self-medicate mood or anxiety symptoms accounts for 20% of new-onset drug use disorders in this population, added Dr. Sareen, professor and head of the department of psychiatry at the University of Manitoba in Winnipeg.

Bruce Jancin/Frontline Medical News
Dr. Jitender Sareen


He was a coauthor of two landmark longitudinal epidemiologic studies that support the concept of self-medication as a direct causal mechanism that explains a phenomenon often observed in clinical practice: namely, the high rate of comorbid mood or anxiety disorders accompanied by an alcohol or substance use disorder.

“The clinical implication is that questions about self-medication with alcohol or drugs should be included in the assessment of patients with anxiety and mood symptoms, because self-medication is a marker of higher likelihood of psychopathology. And psychologic therapies like cognitive-behavioral therapy and dialectical behavior therapy could prevent onset of substance use disorders by teaching patients emotion regulation skills to manage their mood and anxiety symptoms without self-medication,” Dr. Sareen said.

The first longitudinal study of the role of self-medication in the development of comorbid anxiety and substance use disorders included 34,653 nationally representative adults who completed both the initial face-to-face National Epidemiologic Survey on Alcohol and Related Conditions in 2001-2002 and a follow-up survey conducted 3 years later.

During the 3-year follow-up period, 9.7% of subjects developed a new-onset anxiety disorder, 5.9% of participants newly met DSM-IV diagnostic criteria for alcohol use disorder, and 2% developed a new-onset drug use disorder.

Among subjects who met the criteria for an anxiety disorder at baseline and at that time also reported self-medication with alcohol, 12.6% developed an incident alcohol use disorder during follow-up. Among those who self-medicated with drugs, 10.4% developed a drug use disorder.

In contrast, only 4.7% of subjects with a baseline anxiety disorder who did not self-medicate with alcohol at baseline developed an incident alcohol use disorder. And an incident drug use disorder occurred in 1.7% of patients with a baseline anxiety disorder who did not self-medicate with drugs.

Among patients with a baseline alcohol or other substance use disorder, self-medication with alcohol was associated with an adjusted 2.13-fold increased likelihood of developing social phobia during 3 years of follow-up, while self-medication with other drugs was independently associated with a 3.27-fold increased likelihood of subsequently developing social phobia.

In a multivariate logistic regression analysis, Dr. Sareen and his coinvestigators determined that self-medication with alcohol by patients with an anxiety disorder at baseline was associated with a 2.63-fold increased risk of incident alcohol use disorder during follow-up. Self-medication with drugs in patients with a baseline anxiety disorder was associated with a 4.99-fold risk of a new-onset substance use disorder during the 3 years of follow-up (Arch Gen Psychiatry. 2011;68[8]:800-7).

In a subsequent analysis of the same prospectively studied population, Dr. Sareen and his colleagues focused specifically on drinking to self-medicate mood symptoms. They found that self-medication with alcohol was associated with an adjusted 3.1-fold increased likelihood of new-onset alcohol dependence during the 3-year follow-up, as well as with a 3.45-fold increased risk of persistence of alcohol dependence. Roughly 12% of all cases of incident alcohol dependence arising during follow-up of patients with baseline mood symptoms were attributed to self-medication with alcohol. The increased risk of new-onset alcohol dependence was observed not only in subjects who met DSM-IV criteria for an affective disorder, but in those with subthreshold mood symptoms as well (JAMA Psychiatry. 2013 Jul;70[7]:718-26).

Again, this points to drinking as a behavior employed to self-medicate mood symptoms as a potential target for preventive interventions aimed at reducing the occurrence of alcohol dependence. As yet, however, no formal studies have been done to confirm the effectiveness of this strategy, the psychiatrist continued.

Dr. Sareen was not involved in the third iteration of the National Epidemiologic Survey on Alcohol and Related Conditions, in which a different group of 36,309 nationally representative adults was interviewed during 2011-2013 to assess the impact of the DSM-5 criteria for alcohol use disorder. Using DSM-5, 13.9% of the population met criteria for an alcohol use disorder during the past 12 months, and the lifetime prevalence of alcohol use disorder was 29.1%. Fewer than one in five subjects with a lifetime DSM-5 alcohol use disorder had ever been treated.

In the first national survey, which used DSM-IV criteria, the 12-month and lifetime prevalences of alcohol abuse and/or dependence were 8.5% and 30.3%, respectively.

DSM-5 alcohol use disorder was highly comorbid. Both lifetime and 12-month alcohol use disorder were associated with significantly increased likelihood of other substance use disorders, major depression, bipolar I disorder, borderline personality disorder, and antisocial personality disorder.

These data indicate “an urgent need to educate the public and policy makers about alcohol use disorder and its treatment alternatives, to destigmatize the disorder, and to encourage those who cannot reduce their alcohol consumption on their own, despite substantial harm to themselves and others, to seek treatment,” the investigators wrote (JAMA Psychiatry. 2015 Aug;72[8]:757-66).

The surveys were supported by the National Institute on Alcohol Abuse and Alcoholism. Dr. Sareen reported having no financial conflicts of interest.

 

 

 

– Drinking to alleviate mood or anxiety symptoms is responsible for 12%-16% of cases of new-onset alcohol use disorder in affected individuals, Jitender Sareen, MD, said at the annual conference of the Anxiety and Depression Association of America.

Similarly, the use of prescription or nonprescription drugs to self-medicate mood or anxiety symptoms accounts for 20% of new-onset drug use disorders in this population, added Dr. Sareen, professor and head of the department of psychiatry at the University of Manitoba in Winnipeg.

Bruce Jancin/Frontline Medical News
Dr. Jitender Sareen


He was a coauthor of two landmark longitudinal epidemiologic studies that support the concept of self-medication as a direct causal mechanism that explains a phenomenon often observed in clinical practice: namely, the high rate of comorbid mood or anxiety disorders accompanied by an alcohol or substance use disorder.

“The clinical implication is that questions about self-medication with alcohol or drugs should be included in the assessment of patients with anxiety and mood symptoms, because self-medication is a marker of higher likelihood of psychopathology. And psychologic therapies like cognitive-behavioral therapy and dialectical behavior therapy could prevent onset of substance use disorders by teaching patients emotion regulation skills to manage their mood and anxiety symptoms without self-medication,” Dr. Sareen said.

The first longitudinal study of the role of self-medication in the development of comorbid anxiety and substance use disorders included 34,653 nationally representative adults who completed both the initial face-to-face National Epidemiologic Survey on Alcohol and Related Conditions in 2001-2002 and a follow-up survey conducted 3 years later.

During the 3-year follow-up period, 9.7% of subjects developed a new-onset anxiety disorder, 5.9% of participants newly met DSM-IV diagnostic criteria for alcohol use disorder, and 2% developed a new-onset drug use disorder.

Among subjects who met the criteria for an anxiety disorder at baseline and at that time also reported self-medication with alcohol, 12.6% developed an incident alcohol use disorder during follow-up. Among those who self-medicated with drugs, 10.4% developed a drug use disorder.

In contrast, only 4.7% of subjects with a baseline anxiety disorder who did not self-medicate with alcohol at baseline developed an incident alcohol use disorder. And an incident drug use disorder occurred in 1.7% of patients with a baseline anxiety disorder who did not self-medicate with drugs.

Among patients with a baseline alcohol or other substance use disorder, self-medication with alcohol was associated with an adjusted 2.13-fold increased likelihood of developing social phobia during 3 years of follow-up, while self-medication with other drugs was independently associated with a 3.27-fold increased likelihood of subsequently developing social phobia.

In a multivariate logistic regression analysis, Dr. Sareen and his coinvestigators determined that self-medication with alcohol by patients with an anxiety disorder at baseline was associated with a 2.63-fold increased risk of incident alcohol use disorder during follow-up. Self-medication with drugs in patients with a baseline anxiety disorder was associated with a 4.99-fold risk of a new-onset substance use disorder during the 3 years of follow-up (Arch Gen Psychiatry. 2011;68[8]:800-7).

In a subsequent analysis of the same prospectively studied population, Dr. Sareen and his colleagues focused specifically on drinking to self-medicate mood symptoms. They found that self-medication with alcohol was associated with an adjusted 3.1-fold increased likelihood of new-onset alcohol dependence during the 3-year follow-up, as well as with a 3.45-fold increased risk of persistence of alcohol dependence. Roughly 12% of all cases of incident alcohol dependence arising during follow-up of patients with baseline mood symptoms were attributed to self-medication with alcohol. The increased risk of new-onset alcohol dependence was observed not only in subjects who met DSM-IV criteria for an affective disorder, but in those with subthreshold mood symptoms as well (JAMA Psychiatry. 2013 Jul;70[7]:718-26).

Again, this points to drinking as a behavior employed to self-medicate mood symptoms as a potential target for preventive interventions aimed at reducing the occurrence of alcohol dependence. As yet, however, no formal studies have been done to confirm the effectiveness of this strategy, the psychiatrist continued.

Dr. Sareen was not involved in the third iteration of the National Epidemiologic Survey on Alcohol and Related Conditions, in which a different group of 36,309 nationally representative adults was interviewed during 2011-2013 to assess the impact of the DSM-5 criteria for alcohol use disorder. Using DSM-5, 13.9% of the population met criteria for an alcohol use disorder during the past 12 months, and the lifetime prevalence of alcohol use disorder was 29.1%. Fewer than one in five subjects with a lifetime DSM-5 alcohol use disorder had ever been treated.

In the first national survey, which used DSM-IV criteria, the 12-month and lifetime prevalences of alcohol abuse and/or dependence were 8.5% and 30.3%, respectively.

DSM-5 alcohol use disorder was highly comorbid. Both lifetime and 12-month alcohol use disorder were associated with significantly increased likelihood of other substance use disorders, major depression, bipolar I disorder, borderline personality disorder, and antisocial personality disorder.

These data indicate “an urgent need to educate the public and policy makers about alcohol use disorder and its treatment alternatives, to destigmatize the disorder, and to encourage those who cannot reduce their alcohol consumption on their own, despite substantial harm to themselves and others, to seek treatment,” the investigators wrote (JAMA Psychiatry. 2015 Aug;72[8]:757-66).

The surveys were supported by the National Institute on Alcohol Abuse and Alcoholism. Dr. Sareen reported having no financial conflicts of interest.

 

 

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Sarilumab showed sustained effect on RA progression at 3 years

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– A “durable clinical response and stabilization of structural damage” was observed at 3 years of follow-up in the Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND) study.

 

 

Sara Freeman/Frontline Medical News
Dr. Désirée van der Heijde
The study was an open-label, multicenter, uncontrolled extension of the previously reported SARIL-RA-MOBILITY trial that had shown that sarilumab added to methotrexate not only improved disease control at 24 weeks but also improved physical function at 16 weeks, and reduced radiological progression at 1 year (Arthritis Rheumatol. 2015;67:1424-37).

The aim of the EXTEND trial was to examine the continuity of response to sarilumab seen in the MOBILITY trial, said Dr. van der Heijde, professor of rheumatology at Leiden (The Netherlands) University Medical Center.

Sarilumab is a fully human (IgG1) monoclonal antibody that binds to interleukin (IL)-6 receptors, both soluble and membrane-bound, and thus inhibits IL-6-mediated signaling through the soluble IL-6R alpha and membrane-bound IL-6R alpha receptors. It is undergoing regulatory approval in the United States, European Union, and Japan, but was recently approved in Canada for treatment of adult patients with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response to one or more biologic or nonbiologic disease-modifying antirheumatic drugs (DMARDs) (Drugs. 2017;77:705-12).

In the MOBILITY trial, 1,197 patients who were being treated with methotrexate but who had an inadequate response were randomized to receive placebo (n = 398) or sarilumab given subcutaneously every 2 weeks at one of two doses: 150 mg (n = 400) or 200 mg (n = 399).

EXTEND allowed patients completing this trial who still had active disease to continue or start (if they had been given placebo) treatment with sarilumab at a dose of 200 mg given every 2 weeks, with dose reduction to 150 mg every 2 weeks if needed, in addition to methotrexate. A total of 901 patients participated in the extension study.

“In the MOBILITY trial, all three groups were very balanced, and if you then take the patients who entered the EXTEND trial, they are very similar to the patients who also were randomized into MOBILITY,” Dr. van der Heijde said.

This was a fairly typical RA population, she observed: About 80% were female, the mean age was 50 years, and the mean duration of RA was 9 years. About 20%-25% had prior treatment with a DMARD, more than 80% were rheumatoid factor or anti-CCP antibody positive. There were similar mean C-reactive protein (CRP) levels between the groups, and the 28-joint disease activity score (DAS28) with CRP was around 6, and Clinical Disease Activity Index (CDAI) score around 40.

Radiographs that were taken at baseline, at the end of year 2, and at the end of year 3 were reread by two independent readers and scored together in one session. Data had to be extrapolated for 29 patients who did not have a radiographs taken at year 3 but who had been seen during the third year of treatment.

The significant radiographic inhibition seen at the end of the MOBILITY trial in both the 150-mg and 200-mg active treatment groups was sustained in the EXTEND study.

“There is a small progression between year 2 and 3, and this progression is quite similar in all the three treatment arms,” Dr. van der Heijde reported, nothing that all patients were taking 200 mg of sarilumab at this point.

The mean change in the modified total Sharp score (mTSS) from year 2 to 3 was 0.35 in the patients who had originally been randomized to the placebo arm, 0.64 in patients originally randomized to 150 mg sarilumab every 2 weeks, and 0.44 in those originally taking 200 mg sarilumab every 2 weeks.

From baseline to year 3, the mean change in mTSS were a respective 3.3, 1.9, and 0.8.

“If you present the data in a different way, like the percentage of patients showing no progression, you see the differentiation between the patients who started on placebo versus those who were started on sarilumab 150 mg or 200 mg,” said Dr. van der Heijde.

At year 2, 67%, 59%, and 48% of patients treated with sarilumab 200 mg, sarilumab 150 mg, or placebo, respectively had no progression in mTSS (signified by a change from baseline of 0.5 points or more).

At year 3, corresponding rates were a respective 75%, 55%, and 49%.

DAS-28-CRP response at year 3 was similar across the initial treatment groups, Dr. van der Heijde observed. Reductions seen in the MOBILITY trial were clearly continued, she said. The percentage of patients achieving DAS-28-CRP of less than 2.6 was 22%, 34%, and 36% of placebo, sarilumab 150-mg, and sarilumab 200-mg treated patients at the end of the MOBILITY study. At the end of year 2, the corresponding numbers were 60%, 62%, and 62%, and by year 3, not much had changed in the percentage of patients achieving DAS-28-CRP of less than 2.6: 58% for placebo, 62% for sarilumab 150 mg, and 68% for sarilumab 200 mg.

Similar results were seen for patients achieving a CDAI of 2.8 or lower at years 2 and 3 in the extension study.

Treatment-emergent adverse events (TEAEs) occurred in 89.7% of patients over 3 years. One in five (20%) patients experienced serious adverse events, with 23% of patients discontinuing treatment because of TEAEs. There were 9 (0.8%) deaths during the trial.

TEAEs that occurred at rates of 5% or higher in any treatment group were neutropenia in 19.4%, increased alanine aminotransferase in 13.0%, and upper respiratory tract infections in 12.7%.

There were some changes in laboratory values, Dr. van der Heijde said, but “most of the changes were very small” and in line with the effects expected with IL-6 inhibition.

The study was sponsored by Sanofi Genzyme and Regeneron Pharmaceuticals. Dr. van der Heijde and coauthors disclosed receiving consulting fees, research grants, or both from multiple pharmaceutical companies, including the sponsors of the study. Dr. van der Heijde is director of Imaging Rheumatology.

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– A “durable clinical response and stabilization of structural damage” was observed at 3 years of follow-up in the Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND) study.

 

 

Sara Freeman/Frontline Medical News
Dr. Désirée van der Heijde
The study was an open-label, multicenter, uncontrolled extension of the previously reported SARIL-RA-MOBILITY trial that had shown that sarilumab added to methotrexate not only improved disease control at 24 weeks but also improved physical function at 16 weeks, and reduced radiological progression at 1 year (Arthritis Rheumatol. 2015;67:1424-37).

The aim of the EXTEND trial was to examine the continuity of response to sarilumab seen in the MOBILITY trial, said Dr. van der Heijde, professor of rheumatology at Leiden (The Netherlands) University Medical Center.

Sarilumab is a fully human (IgG1) monoclonal antibody that binds to interleukin (IL)-6 receptors, both soluble and membrane-bound, and thus inhibits IL-6-mediated signaling through the soluble IL-6R alpha and membrane-bound IL-6R alpha receptors. It is undergoing regulatory approval in the United States, European Union, and Japan, but was recently approved in Canada for treatment of adult patients with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response to one or more biologic or nonbiologic disease-modifying antirheumatic drugs (DMARDs) (Drugs. 2017;77:705-12).

In the MOBILITY trial, 1,197 patients who were being treated with methotrexate but who had an inadequate response were randomized to receive placebo (n = 398) or sarilumab given subcutaneously every 2 weeks at one of two doses: 150 mg (n = 400) or 200 mg (n = 399).

EXTEND allowed patients completing this trial who still had active disease to continue or start (if they had been given placebo) treatment with sarilumab at a dose of 200 mg given every 2 weeks, with dose reduction to 150 mg every 2 weeks if needed, in addition to methotrexate. A total of 901 patients participated in the extension study.

“In the MOBILITY trial, all three groups were very balanced, and if you then take the patients who entered the EXTEND trial, they are very similar to the patients who also were randomized into MOBILITY,” Dr. van der Heijde said.

This was a fairly typical RA population, she observed: About 80% were female, the mean age was 50 years, and the mean duration of RA was 9 years. About 20%-25% had prior treatment with a DMARD, more than 80% were rheumatoid factor or anti-CCP antibody positive. There were similar mean C-reactive protein (CRP) levels between the groups, and the 28-joint disease activity score (DAS28) with CRP was around 6, and Clinical Disease Activity Index (CDAI) score around 40.

Radiographs that were taken at baseline, at the end of year 2, and at the end of year 3 were reread by two independent readers and scored together in one session. Data had to be extrapolated for 29 patients who did not have a radiographs taken at year 3 but who had been seen during the third year of treatment.

The significant radiographic inhibition seen at the end of the MOBILITY trial in both the 150-mg and 200-mg active treatment groups was sustained in the EXTEND study.

“There is a small progression between year 2 and 3, and this progression is quite similar in all the three treatment arms,” Dr. van der Heijde reported, nothing that all patients were taking 200 mg of sarilumab at this point.

The mean change in the modified total Sharp score (mTSS) from year 2 to 3 was 0.35 in the patients who had originally been randomized to the placebo arm, 0.64 in patients originally randomized to 150 mg sarilumab every 2 weeks, and 0.44 in those originally taking 200 mg sarilumab every 2 weeks.

From baseline to year 3, the mean change in mTSS were a respective 3.3, 1.9, and 0.8.

“If you present the data in a different way, like the percentage of patients showing no progression, you see the differentiation between the patients who started on placebo versus those who were started on sarilumab 150 mg or 200 mg,” said Dr. van der Heijde.

At year 2, 67%, 59%, and 48% of patients treated with sarilumab 200 mg, sarilumab 150 mg, or placebo, respectively had no progression in mTSS (signified by a change from baseline of 0.5 points or more).

At year 3, corresponding rates were a respective 75%, 55%, and 49%.

DAS-28-CRP response at year 3 was similar across the initial treatment groups, Dr. van der Heijde observed. Reductions seen in the MOBILITY trial were clearly continued, she said. The percentage of patients achieving DAS-28-CRP of less than 2.6 was 22%, 34%, and 36% of placebo, sarilumab 150-mg, and sarilumab 200-mg treated patients at the end of the MOBILITY study. At the end of year 2, the corresponding numbers were 60%, 62%, and 62%, and by year 3, not much had changed in the percentage of patients achieving DAS-28-CRP of less than 2.6: 58% for placebo, 62% for sarilumab 150 mg, and 68% for sarilumab 200 mg.

Similar results were seen for patients achieving a CDAI of 2.8 or lower at years 2 and 3 in the extension study.

Treatment-emergent adverse events (TEAEs) occurred in 89.7% of patients over 3 years. One in five (20%) patients experienced serious adverse events, with 23% of patients discontinuing treatment because of TEAEs. There were 9 (0.8%) deaths during the trial.

TEAEs that occurred at rates of 5% or higher in any treatment group were neutropenia in 19.4%, increased alanine aminotransferase in 13.0%, and upper respiratory tract infections in 12.7%.

There were some changes in laboratory values, Dr. van der Heijde said, but “most of the changes were very small” and in line with the effects expected with IL-6 inhibition.

The study was sponsored by Sanofi Genzyme and Regeneron Pharmaceuticals. Dr. van der Heijde and coauthors disclosed receiving consulting fees, research grants, or both from multiple pharmaceutical companies, including the sponsors of the study. Dr. van der Heijde is director of Imaging Rheumatology.

 

– A “durable clinical response and stabilization of structural damage” was observed at 3 years of follow-up in the Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND) study.

 

 

Sara Freeman/Frontline Medical News
Dr. Désirée van der Heijde
The study was an open-label, multicenter, uncontrolled extension of the previously reported SARIL-RA-MOBILITY trial that had shown that sarilumab added to methotrexate not only improved disease control at 24 weeks but also improved physical function at 16 weeks, and reduced radiological progression at 1 year (Arthritis Rheumatol. 2015;67:1424-37).

The aim of the EXTEND trial was to examine the continuity of response to sarilumab seen in the MOBILITY trial, said Dr. van der Heijde, professor of rheumatology at Leiden (The Netherlands) University Medical Center.

Sarilumab is a fully human (IgG1) monoclonal antibody that binds to interleukin (IL)-6 receptors, both soluble and membrane-bound, and thus inhibits IL-6-mediated signaling through the soluble IL-6R alpha and membrane-bound IL-6R alpha receptors. It is undergoing regulatory approval in the United States, European Union, and Japan, but was recently approved in Canada for treatment of adult patients with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response to one or more biologic or nonbiologic disease-modifying antirheumatic drugs (DMARDs) (Drugs. 2017;77:705-12).

In the MOBILITY trial, 1,197 patients who were being treated with methotrexate but who had an inadequate response were randomized to receive placebo (n = 398) or sarilumab given subcutaneously every 2 weeks at one of two doses: 150 mg (n = 400) or 200 mg (n = 399).

EXTEND allowed patients completing this trial who still had active disease to continue or start (if they had been given placebo) treatment with sarilumab at a dose of 200 mg given every 2 weeks, with dose reduction to 150 mg every 2 weeks if needed, in addition to methotrexate. A total of 901 patients participated in the extension study.

“In the MOBILITY trial, all three groups were very balanced, and if you then take the patients who entered the EXTEND trial, they are very similar to the patients who also were randomized into MOBILITY,” Dr. van der Heijde said.

This was a fairly typical RA population, she observed: About 80% were female, the mean age was 50 years, and the mean duration of RA was 9 years. About 20%-25% had prior treatment with a DMARD, more than 80% were rheumatoid factor or anti-CCP antibody positive. There were similar mean C-reactive protein (CRP) levels between the groups, and the 28-joint disease activity score (DAS28) with CRP was around 6, and Clinical Disease Activity Index (CDAI) score around 40.

Radiographs that were taken at baseline, at the end of year 2, and at the end of year 3 were reread by two independent readers and scored together in one session. Data had to be extrapolated for 29 patients who did not have a radiographs taken at year 3 but who had been seen during the third year of treatment.

The significant radiographic inhibition seen at the end of the MOBILITY trial in both the 150-mg and 200-mg active treatment groups was sustained in the EXTEND study.

“There is a small progression between year 2 and 3, and this progression is quite similar in all the three treatment arms,” Dr. van der Heijde reported, nothing that all patients were taking 200 mg of sarilumab at this point.

The mean change in the modified total Sharp score (mTSS) from year 2 to 3 was 0.35 in the patients who had originally been randomized to the placebo arm, 0.64 in patients originally randomized to 150 mg sarilumab every 2 weeks, and 0.44 in those originally taking 200 mg sarilumab every 2 weeks.

From baseline to year 3, the mean change in mTSS were a respective 3.3, 1.9, and 0.8.

“If you present the data in a different way, like the percentage of patients showing no progression, you see the differentiation between the patients who started on placebo versus those who were started on sarilumab 150 mg or 200 mg,” said Dr. van der Heijde.

At year 2, 67%, 59%, and 48% of patients treated with sarilumab 200 mg, sarilumab 150 mg, or placebo, respectively had no progression in mTSS (signified by a change from baseline of 0.5 points or more).

At year 3, corresponding rates were a respective 75%, 55%, and 49%.

DAS-28-CRP response at year 3 was similar across the initial treatment groups, Dr. van der Heijde observed. Reductions seen in the MOBILITY trial were clearly continued, she said. The percentage of patients achieving DAS-28-CRP of less than 2.6 was 22%, 34%, and 36% of placebo, sarilumab 150-mg, and sarilumab 200-mg treated patients at the end of the MOBILITY study. At the end of year 2, the corresponding numbers were 60%, 62%, and 62%, and by year 3, not much had changed in the percentage of patients achieving DAS-28-CRP of less than 2.6: 58% for placebo, 62% for sarilumab 150 mg, and 68% for sarilumab 200 mg.

Similar results were seen for patients achieving a CDAI of 2.8 or lower at years 2 and 3 in the extension study.

Treatment-emergent adverse events (TEAEs) occurred in 89.7% of patients over 3 years. One in five (20%) patients experienced serious adverse events, with 23% of patients discontinuing treatment because of TEAEs. There were 9 (0.8%) deaths during the trial.

TEAEs that occurred at rates of 5% or higher in any treatment group were neutropenia in 19.4%, increased alanine aminotransferase in 13.0%, and upper respiratory tract infections in 12.7%.

There were some changes in laboratory values, Dr. van der Heijde said, but “most of the changes were very small” and in line with the effects expected with IL-6 inhibition.

The study was sponsored by Sanofi Genzyme and Regeneron Pharmaceuticals. Dr. van der Heijde and coauthors disclosed receiving consulting fees, research grants, or both from multiple pharmaceutical companies, including the sponsors of the study. Dr. van der Heijde is director of Imaging Rheumatology.

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Key clinical point: The investigational monoclonal antibody sarilumab showed sustained clinical and radiographic effects in RA patients after 3 years.

Major finding: The mean change in the modified total Sharp score (mTSS) from year 2 to 3 was 0.35 in the patients who had originally been randomized to the placebo arm, 0.64 in patients originally randomized to 150 mg sarilumab every 2 weeks, and 0.44 in those originally taking 200 mg sarilumab every 2 weeks.

Data source: SARIL-RA-EXTEND: a multicenter, uncontrolled extension study involving 1,197 patients who had participated in the phase III SARIL-RA-MOBILITY trial.

Disclosures: The study was sponsored by Sanofi Genzyme and Regeneron Pharmaceuticals. Dr. van der Heijde and her coauthors disclosed receiving consulting fees, research grants, or both from multiple pharmaceutical companies, including the sponsors of the study. Dr. van der Heijde is director of Imaging Rheumatology.

Here’s what’s trending at SHM

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Get the latest news about upcoming events, new programs and SHM initiatives

 

SHM gives QI a new look

SHM is proud to announce that its Center for Hospital Innovation & Improvement has a fresh look and name: SHM’s Center for Quality Improvement. While the name may have changed, SHM’s Center for QI will remain your partner in quality and patient safety.

“SHM’s Center for QI provides a comprehensive set of resources and programs to support hospitalists and other hospital clinicians as they work to improve quality and safety in their hospitals,” says Eric E. Howell, MD, MHM, senior physician advisor for SHM’s Center for QI.

SHM’s Center for QI’s mentored implementation programs are deployed in hundreds of hospitals and have been recognized with the John M. Eisenberg Award. More recently, its opioid-safety program (RADEO) was recognized by the CMS for its efforts to enhance patient safety.

Visit http://www.hospitalmedicine.org/QI to learn more about SHM’s Center for QI and about opportunities for partnerships, solutions, and tools to address your QI needs.

PHM 2017 is coming! Book your ticket to Nashville today

Pediatric Hospital Medicine (PHM) 2017 is the largest, leading educational event for health care professionals who specialize in the care of hospitalized children. This year’s meeting will be held July 20-23 at the Omni Nashville in Tennessee.

Attendees will have the opportunity to network with colleagues from across the nation, learn from renowned faculty from throughout the discipline, and acquire skills, tools, and resources to directly benefit their patients and practice.

PHM 2017 has been designed to provide participants with tools to improve clinical skills and practice, address management issues, lead change and innovation within their institutions, and network with thought leaders to collaborate and learn about new innovations.

View the full meeting schedule, educational objectives, and more at www.peds2017.org.

Benchmark your HMG appropriately with the State of Hospital Medicine Report

The State of Hospital Medicine Report continues to be the best source of detail regarding the configuration and operation of hospital medicine groups. The biennial report provides current data on hospitalist compensation and production, in addition to cutting-edge knowledge covering practice demographics, staffing levels, turnover, staff growth, compensation methods, and financial support for solid, evidence-based management decisions.

“We’ve used data from the report to hold more informed discussions with the group that provides our note-coding services and to determine how to benchmark our nocturnists’ workloads and pay,” said Andrew White, MD, SFHM, director of the Hospital Medicine Service at the University of Washington in Seattle. “The results are broken into region and academic practice type, which gives me the confidence that I’m looking at results from groups like mine, rather than comparing to the country-wide average.”

The report is designed for hospital medicine leaders (both physician leaders and nonphysician practice administrators and executives), as well as frontline hospitalists, nurse practitioners, physician assistants, pediatricians, and internal and family medicine physicians.

In addition to the print version, the 2016 State of Hospital Medicine Report is also available in an enhanced, fully searchable digital version. To order your copy in either print or digital, visit www.hospitalmedicine.org/survey.

Learn how to drive change as a leader in hospital medicine

A successful hospitalist program requires strong leadership from the floor to the C-suite. SHM’s Leadership Academy prepares clinical and academic leaders with vital skills that, traditionally, are not taught in medical school or typical residency programs. This year’s meeting will be held October 23-26 at the JW Marriott Camelback Inn in Scottsdale, Ariz.

New for Leadership Academy 2017, Strategic Essentials (formerly Leadership Foundations), Influential Management, and Mastering Teamwork will be available to all attendees, regardless of previous attendance. SHM provides recommendations for interested registrants so they can determine which course fits them best in their leadership journey.

Take the Strategic Essentials course to evaluate your personal leadership strengths and weaknesses, understand key hospital drivers, and more.

If you are looking to learn skills needed to drive culture change through specific leadership behaviors as well as financial storytelling, then Leadership: Influential Management would be a great course for you.

The third course, Leadership: Mastering Teamwork, will help attendees learn to critically assess program growth opportunities, lead and motivate teams, and design effective communication strategies. Learn more at www.shmleadershipacademy.org.

Stay ahead of the MACRA curve with SHM

The Medicare Access and CHIP Reauthorization Act (MACRA) put into motion the new Quality Payment Program, which replaces past pay-for-performance programs, such as the Physician Quality Reporting System and physician value-based modifier. The new program has many complicated requirements, and hospitalists will be impacted.

The first year of the program has flexible participation, yet hospitalists need to do at least one thing (report one quality measure, attest to one improvement activity) in the program in order to avoid a 4% penalty to Medicare payments. 2017 is the first reporting year, so now is the time for providers to familiarize themselves with the requirements.

To support hospitalists who are looking for hospital medicine–specific ways to participate and avoid penalties, SHM hosted a webinar that is now available at www.macraforhm.org under “Resources.” SHM’s policy staff broke down the program requirements and went into detail on ways in which hospitalists can and should participate in the new program. Updates and other resources are also available at www.macraforhm.org.

 

 

Looking to be a speaker at Hospital Medicine 2018?

The Society of Hospital Medicine reminds you to submit your workshop proposal for the 2018 Annual Meeting to be held April 8-11, 2018, at the Orlando World Center Marriott. Workshops should involve topics in one of ten categories: clinical, career development, research, academic, patient experience/communication, perioperative, information technology, practice management, quality and patient safety, and evidence‐based medicine/high‐value care. Each workshop should last 90 minutes.

Proposals that are the most likely to be accepted will be innovative as well as highly interactive, utilizing small groups and limiting didactic/lecture content. Workshops previously presented at national or regional meetings will be considered. Four faculty members from each workshop that is accepted will receive 50% off their annual meeting registration, although workshops may include a maximum of six additional facilitators.

The submission deadline is Friday, May 12, 2017 at 8:00 a.m. EST. Visit www.hospitalmedicine2018.org for more information.

Brett Radler is SHM’s communications specialist.

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Get the latest news about upcoming events, new programs and SHM initiatives
Get the latest news about upcoming events, new programs and SHM initiatives

 

SHM gives QI a new look

SHM is proud to announce that its Center for Hospital Innovation & Improvement has a fresh look and name: SHM’s Center for Quality Improvement. While the name may have changed, SHM’s Center for QI will remain your partner in quality and patient safety.

“SHM’s Center for QI provides a comprehensive set of resources and programs to support hospitalists and other hospital clinicians as they work to improve quality and safety in their hospitals,” says Eric E. Howell, MD, MHM, senior physician advisor for SHM’s Center for QI.

SHM’s Center for QI’s mentored implementation programs are deployed in hundreds of hospitals and have been recognized with the John M. Eisenberg Award. More recently, its opioid-safety program (RADEO) was recognized by the CMS for its efforts to enhance patient safety.

Visit http://www.hospitalmedicine.org/QI to learn more about SHM’s Center for QI and about opportunities for partnerships, solutions, and tools to address your QI needs.

PHM 2017 is coming! Book your ticket to Nashville today

Pediatric Hospital Medicine (PHM) 2017 is the largest, leading educational event for health care professionals who specialize in the care of hospitalized children. This year’s meeting will be held July 20-23 at the Omni Nashville in Tennessee.

Attendees will have the opportunity to network with colleagues from across the nation, learn from renowned faculty from throughout the discipline, and acquire skills, tools, and resources to directly benefit their patients and practice.

PHM 2017 has been designed to provide participants with tools to improve clinical skills and practice, address management issues, lead change and innovation within their institutions, and network with thought leaders to collaborate and learn about new innovations.

View the full meeting schedule, educational objectives, and more at www.peds2017.org.

Benchmark your HMG appropriately with the State of Hospital Medicine Report

The State of Hospital Medicine Report continues to be the best source of detail regarding the configuration and operation of hospital medicine groups. The biennial report provides current data on hospitalist compensation and production, in addition to cutting-edge knowledge covering practice demographics, staffing levels, turnover, staff growth, compensation methods, and financial support for solid, evidence-based management decisions.

“We’ve used data from the report to hold more informed discussions with the group that provides our note-coding services and to determine how to benchmark our nocturnists’ workloads and pay,” said Andrew White, MD, SFHM, director of the Hospital Medicine Service at the University of Washington in Seattle. “The results are broken into region and academic practice type, which gives me the confidence that I’m looking at results from groups like mine, rather than comparing to the country-wide average.”

The report is designed for hospital medicine leaders (both physician leaders and nonphysician practice administrators and executives), as well as frontline hospitalists, nurse practitioners, physician assistants, pediatricians, and internal and family medicine physicians.

In addition to the print version, the 2016 State of Hospital Medicine Report is also available in an enhanced, fully searchable digital version. To order your copy in either print or digital, visit www.hospitalmedicine.org/survey.

Learn how to drive change as a leader in hospital medicine

A successful hospitalist program requires strong leadership from the floor to the C-suite. SHM’s Leadership Academy prepares clinical and academic leaders with vital skills that, traditionally, are not taught in medical school or typical residency programs. This year’s meeting will be held October 23-26 at the JW Marriott Camelback Inn in Scottsdale, Ariz.

New for Leadership Academy 2017, Strategic Essentials (formerly Leadership Foundations), Influential Management, and Mastering Teamwork will be available to all attendees, regardless of previous attendance. SHM provides recommendations for interested registrants so they can determine which course fits them best in their leadership journey.

Take the Strategic Essentials course to evaluate your personal leadership strengths and weaknesses, understand key hospital drivers, and more.

If you are looking to learn skills needed to drive culture change through specific leadership behaviors as well as financial storytelling, then Leadership: Influential Management would be a great course for you.

The third course, Leadership: Mastering Teamwork, will help attendees learn to critically assess program growth opportunities, lead and motivate teams, and design effective communication strategies. Learn more at www.shmleadershipacademy.org.

Stay ahead of the MACRA curve with SHM

The Medicare Access and CHIP Reauthorization Act (MACRA) put into motion the new Quality Payment Program, which replaces past pay-for-performance programs, such as the Physician Quality Reporting System and physician value-based modifier. The new program has many complicated requirements, and hospitalists will be impacted.

The first year of the program has flexible participation, yet hospitalists need to do at least one thing (report one quality measure, attest to one improvement activity) in the program in order to avoid a 4% penalty to Medicare payments. 2017 is the first reporting year, so now is the time for providers to familiarize themselves with the requirements.

To support hospitalists who are looking for hospital medicine–specific ways to participate and avoid penalties, SHM hosted a webinar that is now available at www.macraforhm.org under “Resources.” SHM’s policy staff broke down the program requirements and went into detail on ways in which hospitalists can and should participate in the new program. Updates and other resources are also available at www.macraforhm.org.

 

 

Looking to be a speaker at Hospital Medicine 2018?

The Society of Hospital Medicine reminds you to submit your workshop proposal for the 2018 Annual Meeting to be held April 8-11, 2018, at the Orlando World Center Marriott. Workshops should involve topics in one of ten categories: clinical, career development, research, academic, patient experience/communication, perioperative, information technology, practice management, quality and patient safety, and evidence‐based medicine/high‐value care. Each workshop should last 90 minutes.

Proposals that are the most likely to be accepted will be innovative as well as highly interactive, utilizing small groups and limiting didactic/lecture content. Workshops previously presented at national or regional meetings will be considered. Four faculty members from each workshop that is accepted will receive 50% off their annual meeting registration, although workshops may include a maximum of six additional facilitators.

The submission deadline is Friday, May 12, 2017 at 8:00 a.m. EST. Visit www.hospitalmedicine2018.org for more information.

Brett Radler is SHM’s communications specialist.

 

SHM gives QI a new look

SHM is proud to announce that its Center for Hospital Innovation & Improvement has a fresh look and name: SHM’s Center for Quality Improvement. While the name may have changed, SHM’s Center for QI will remain your partner in quality and patient safety.

“SHM’s Center for QI provides a comprehensive set of resources and programs to support hospitalists and other hospital clinicians as they work to improve quality and safety in their hospitals,” says Eric E. Howell, MD, MHM, senior physician advisor for SHM’s Center for QI.

SHM’s Center for QI’s mentored implementation programs are deployed in hundreds of hospitals and have been recognized with the John M. Eisenberg Award. More recently, its opioid-safety program (RADEO) was recognized by the CMS for its efforts to enhance patient safety.

Visit http://www.hospitalmedicine.org/QI to learn more about SHM’s Center for QI and about opportunities for partnerships, solutions, and tools to address your QI needs.

PHM 2017 is coming! Book your ticket to Nashville today

Pediatric Hospital Medicine (PHM) 2017 is the largest, leading educational event for health care professionals who specialize in the care of hospitalized children. This year’s meeting will be held July 20-23 at the Omni Nashville in Tennessee.

Attendees will have the opportunity to network with colleagues from across the nation, learn from renowned faculty from throughout the discipline, and acquire skills, tools, and resources to directly benefit their patients and practice.

PHM 2017 has been designed to provide participants with tools to improve clinical skills and practice, address management issues, lead change and innovation within their institutions, and network with thought leaders to collaborate and learn about new innovations.

View the full meeting schedule, educational objectives, and more at www.peds2017.org.

Benchmark your HMG appropriately with the State of Hospital Medicine Report

The State of Hospital Medicine Report continues to be the best source of detail regarding the configuration and operation of hospital medicine groups. The biennial report provides current data on hospitalist compensation and production, in addition to cutting-edge knowledge covering practice demographics, staffing levels, turnover, staff growth, compensation methods, and financial support for solid, evidence-based management decisions.

“We’ve used data from the report to hold more informed discussions with the group that provides our note-coding services and to determine how to benchmark our nocturnists’ workloads and pay,” said Andrew White, MD, SFHM, director of the Hospital Medicine Service at the University of Washington in Seattle. “The results are broken into region and academic practice type, which gives me the confidence that I’m looking at results from groups like mine, rather than comparing to the country-wide average.”

The report is designed for hospital medicine leaders (both physician leaders and nonphysician practice administrators and executives), as well as frontline hospitalists, nurse practitioners, physician assistants, pediatricians, and internal and family medicine physicians.

In addition to the print version, the 2016 State of Hospital Medicine Report is also available in an enhanced, fully searchable digital version. To order your copy in either print or digital, visit www.hospitalmedicine.org/survey.

Learn how to drive change as a leader in hospital medicine

A successful hospitalist program requires strong leadership from the floor to the C-suite. SHM’s Leadership Academy prepares clinical and academic leaders with vital skills that, traditionally, are not taught in medical school or typical residency programs. This year’s meeting will be held October 23-26 at the JW Marriott Camelback Inn in Scottsdale, Ariz.

New for Leadership Academy 2017, Strategic Essentials (formerly Leadership Foundations), Influential Management, and Mastering Teamwork will be available to all attendees, regardless of previous attendance. SHM provides recommendations for interested registrants so they can determine which course fits them best in their leadership journey.

Take the Strategic Essentials course to evaluate your personal leadership strengths and weaknesses, understand key hospital drivers, and more.

If you are looking to learn skills needed to drive culture change through specific leadership behaviors as well as financial storytelling, then Leadership: Influential Management would be a great course for you.

The third course, Leadership: Mastering Teamwork, will help attendees learn to critically assess program growth opportunities, lead and motivate teams, and design effective communication strategies. Learn more at www.shmleadershipacademy.org.

Stay ahead of the MACRA curve with SHM

The Medicare Access and CHIP Reauthorization Act (MACRA) put into motion the new Quality Payment Program, which replaces past pay-for-performance programs, such as the Physician Quality Reporting System and physician value-based modifier. The new program has many complicated requirements, and hospitalists will be impacted.

The first year of the program has flexible participation, yet hospitalists need to do at least one thing (report one quality measure, attest to one improvement activity) in the program in order to avoid a 4% penalty to Medicare payments. 2017 is the first reporting year, so now is the time for providers to familiarize themselves with the requirements.

To support hospitalists who are looking for hospital medicine–specific ways to participate and avoid penalties, SHM hosted a webinar that is now available at www.macraforhm.org under “Resources.” SHM’s policy staff broke down the program requirements and went into detail on ways in which hospitalists can and should participate in the new program. Updates and other resources are also available at www.macraforhm.org.

 

 

Looking to be a speaker at Hospital Medicine 2018?

The Society of Hospital Medicine reminds you to submit your workshop proposal for the 2018 Annual Meeting to be held April 8-11, 2018, at the Orlando World Center Marriott. Workshops should involve topics in one of ten categories: clinical, career development, research, academic, patient experience/communication, perioperative, information technology, practice management, quality and patient safety, and evidence‐based medicine/high‐value care. Each workshop should last 90 minutes.

Proposals that are the most likely to be accepted will be innovative as well as highly interactive, utilizing small groups and limiting didactic/lecture content. Workshops previously presented at national or regional meetings will be considered. Four faculty members from each workshop that is accepted will receive 50% off their annual meeting registration, although workshops may include a maximum of six additional facilitators.

The submission deadline is Friday, May 12, 2017 at 8:00 a.m. EST. Visit www.hospitalmedicine2018.org for more information.

Brett Radler is SHM’s communications specialist.

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Scientists create online database to aid CML research

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Scientist in the lab

A newly launched online database provides researchers with access to data on gene expression in chronic myeloid leukemia (CML).

The LEUKomics database includes datasets relating to clinical parameters in CML, normal and leukemic stem cells, CML disease stages, treatments for the disease, and mouse models of CML.

The database is free for researchers to use and share.

The scientists who developed the database hope it will increase our understanding of CML and lead to new treatments for the disease.

“LEUKomics is a very valuable resource and could help us to reveal new underlying mechanisms that drive CML,” said Jeff Evans, Director of the Institute of Cancer Sciences at the University of Glasgow in Scotland.

“It has the potential to transform CML research on a global level, as the findings can be downloaded and shared with other researchers across the world.  We also hope it inspires new research ideas and ultimately fuels a global search into finding cures for CML.”

The LEUKomics database includes datasets with information on gene expression related to:

  • Clinical parameters in CML, such as disease aggressiveness and response to treatment
  • Stem and progenitor cells from CML patients and healthy individuals
  • Chronic, accelerated, and blast phases of CML
  • CML treatment (currently only tyrosine kinase inhibitors)
  • Stem and progenitor cells from mouse models of CML.

The LEUKomics database was launched by scientists at the University of Glasgow and the University of Melbourne.

The website has been built as part of the stem cell database Stemformatics, with funding from the Scottish Cancer Foundation and Bloodwise.

“Thanks to research, most patients with CML will now live a normal life by taking a single pill,” said Alasdair Rankin, Director of Research at Bloodwise in London, England.

“But treatment is life-long, and not everyone can tolerate the side effects from their treatment or may not respond and see their CML return. There remains a need to develop a permanent cure for all people with this blood cancer. LEUKomics is a highly innovative way to speed up this search for a cure and should be a valuable asset for the global blood cancer research community. We look forward to seeing its impact in the months to come.”

The LEUKomics database can be accessed at: www.stemformatics.org/leukomics.

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Photo by Darren Baker
Scientist in the lab

A newly launched online database provides researchers with access to data on gene expression in chronic myeloid leukemia (CML).

The LEUKomics database includes datasets relating to clinical parameters in CML, normal and leukemic stem cells, CML disease stages, treatments for the disease, and mouse models of CML.

The database is free for researchers to use and share.

The scientists who developed the database hope it will increase our understanding of CML and lead to new treatments for the disease.

“LEUKomics is a very valuable resource and could help us to reveal new underlying mechanisms that drive CML,” said Jeff Evans, Director of the Institute of Cancer Sciences at the University of Glasgow in Scotland.

“It has the potential to transform CML research on a global level, as the findings can be downloaded and shared with other researchers across the world.  We also hope it inspires new research ideas and ultimately fuels a global search into finding cures for CML.”

The LEUKomics database includes datasets with information on gene expression related to:

  • Clinical parameters in CML, such as disease aggressiveness and response to treatment
  • Stem and progenitor cells from CML patients and healthy individuals
  • Chronic, accelerated, and blast phases of CML
  • CML treatment (currently only tyrosine kinase inhibitors)
  • Stem and progenitor cells from mouse models of CML.

The LEUKomics database was launched by scientists at the University of Glasgow and the University of Melbourne.

The website has been built as part of the stem cell database Stemformatics, with funding from the Scottish Cancer Foundation and Bloodwise.

“Thanks to research, most patients with CML will now live a normal life by taking a single pill,” said Alasdair Rankin, Director of Research at Bloodwise in London, England.

“But treatment is life-long, and not everyone can tolerate the side effects from their treatment or may not respond and see their CML return. There remains a need to develop a permanent cure for all people with this blood cancer. LEUKomics is a highly innovative way to speed up this search for a cure and should be a valuable asset for the global blood cancer research community. We look forward to seeing its impact in the months to come.”

The LEUKomics database can be accessed at: www.stemformatics.org/leukomics.

Photo by Darren Baker
Scientist in the lab

A newly launched online database provides researchers with access to data on gene expression in chronic myeloid leukemia (CML).

The LEUKomics database includes datasets relating to clinical parameters in CML, normal and leukemic stem cells, CML disease stages, treatments for the disease, and mouse models of CML.

The database is free for researchers to use and share.

The scientists who developed the database hope it will increase our understanding of CML and lead to new treatments for the disease.

“LEUKomics is a very valuable resource and could help us to reveal new underlying mechanisms that drive CML,” said Jeff Evans, Director of the Institute of Cancer Sciences at the University of Glasgow in Scotland.

“It has the potential to transform CML research on a global level, as the findings can be downloaded and shared with other researchers across the world.  We also hope it inspires new research ideas and ultimately fuels a global search into finding cures for CML.”

The LEUKomics database includes datasets with information on gene expression related to:

  • Clinical parameters in CML, such as disease aggressiveness and response to treatment
  • Stem and progenitor cells from CML patients and healthy individuals
  • Chronic, accelerated, and blast phases of CML
  • CML treatment (currently only tyrosine kinase inhibitors)
  • Stem and progenitor cells from mouse models of CML.

The LEUKomics database was launched by scientists at the University of Glasgow and the University of Melbourne.

The website has been built as part of the stem cell database Stemformatics, with funding from the Scottish Cancer Foundation and Bloodwise.

“Thanks to research, most patients with CML will now live a normal life by taking a single pill,” said Alasdair Rankin, Director of Research at Bloodwise in London, England.

“But treatment is life-long, and not everyone can tolerate the side effects from their treatment or may not respond and see their CML return. There remains a need to develop a permanent cure for all people with this blood cancer. LEUKomics is a highly innovative way to speed up this search for a cure and should be a valuable asset for the global blood cancer research community. We look forward to seeing its impact in the months to come.”

The LEUKomics database can be accessed at: www.stemformatics.org/leukomics.

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England did not benefit from CDF, analysis suggests

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England did not benefit from CDF, analysis suggests

Photo courtesy of the CDC
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The National Health Service’s (NHS) Cancer Drugs Fund (CDF) has not benefitted the people of England and may have been detrimental for English cancer patients, according to researchers.

The group analyzed 29 drugs that were approved for use through the CDF and found the fund did not “deliver meaningful value for patients or society” and may have resulted in patients suffering unnecessarily from adverse effects.

The CDF is money the English government sets aside to pay for cancer drugs that haven’t been approved by the National Institute for Health and Care Excellence (NICE), the health technology assessment body in the UK, and aren’t available within the NHS, the publicly funded national healthcare system for England.

The original CDF was closed in March 2016, but a new CDF was opened at the end of July 2016.

In a study published in Annals of Oncology, researchers looked at 29 drugs that had been approved for use through the CDF for 47 specific indications and were available in January 2015.

The team said only 18 of the indications (38%) were based on clinical trials that reported a statistically significant benefit in terms of patients’ overall survival. The median overall survival benefit was 3.2 months, ranging from 1.4 months to 15.7 months.

The researchers also considered other factors, such as quality of life and adverse effects, to measure the drugs’ value to patients. And the team found that most of the drugs failed to show any evidence of meaningful clinical benefit.

In fact, the researchers said the benefit to patients in real-world situations was probably less than the benefit observed in the clinical trials, since trial participants are carefully selected, have fewer comorbidities, and tend to be younger than patients not included in trials.

“From 2010 when it started to 2016 when it closed, the Cancer Drugs Fund cost the UK taxpayer a total of £1.27 billion, the equivalent of 1 year’s total spending on all cancer drugs in the NHS,” said study author Ajay Aggarwal, of the London School of Hygiene & Tropical Medicine in England.

“The majority of cancer medicines funded through the CDF were found wanting with respect to what patients, clinicians, and NICE would count as clinically meaningful benefit. In addition, no data on the outcome of patients who used drugs accessed through the fund were collected.”

The researchers said basic information on patients who accessed the fund—including date of treatment cessation, side effects, deaths after 30 days of treatment, and date of death or relapse—was supposed to have been collected by April 2012.

However, even after it became mandatory to collect these data in 2014, 93% of outcome data were incomplete for 2014-2015.

“We also lost a major opportunity to understand how these medicines work in the real world,” said study author Richard Sullivan, MD, PhD, of King’s College London in England.

The original CDF was closed in March 2016 because it had become financially unsustainable, but a new CDF was opened at the end of July 2016.

The new CDF provides managed access to new cancer drugs for a limited period in circumstances where the clinical and cost-effectiveness of the drug is deemed uncertain by NICE. The new CDF works in close collaboration with NICE, to which all newly licensed drugs will be referred for appraisal first.

“This addresses some of the problems with the old CDF; namely, the fund would no longer support the provision of drugs that have been appraised but not recommended by NICE,” Dr Sullivan said.

 

 

“It still provides funding for new drugs awaiting NICE appraisal that have potential benefit. However, the issue here is one of fairness: why should cancer medicines be treated in this way and not all medicines and, indeed, all technologies?”

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Photo courtesy of the CDC
Prescription medications

The National Health Service’s (NHS) Cancer Drugs Fund (CDF) has not benefitted the people of England and may have been detrimental for English cancer patients, according to researchers.

The group analyzed 29 drugs that were approved for use through the CDF and found the fund did not “deliver meaningful value for patients or society” and may have resulted in patients suffering unnecessarily from adverse effects.

The CDF is money the English government sets aside to pay for cancer drugs that haven’t been approved by the National Institute for Health and Care Excellence (NICE), the health technology assessment body in the UK, and aren’t available within the NHS, the publicly funded national healthcare system for England.

The original CDF was closed in March 2016, but a new CDF was opened at the end of July 2016.

In a study published in Annals of Oncology, researchers looked at 29 drugs that had been approved for use through the CDF for 47 specific indications and were available in January 2015.

The team said only 18 of the indications (38%) were based on clinical trials that reported a statistically significant benefit in terms of patients’ overall survival. The median overall survival benefit was 3.2 months, ranging from 1.4 months to 15.7 months.

The researchers also considered other factors, such as quality of life and adverse effects, to measure the drugs’ value to patients. And the team found that most of the drugs failed to show any evidence of meaningful clinical benefit.

In fact, the researchers said the benefit to patients in real-world situations was probably less than the benefit observed in the clinical trials, since trial participants are carefully selected, have fewer comorbidities, and tend to be younger than patients not included in trials.

“From 2010 when it started to 2016 when it closed, the Cancer Drugs Fund cost the UK taxpayer a total of £1.27 billion, the equivalent of 1 year’s total spending on all cancer drugs in the NHS,” said study author Ajay Aggarwal, of the London School of Hygiene & Tropical Medicine in England.

“The majority of cancer medicines funded through the CDF were found wanting with respect to what patients, clinicians, and NICE would count as clinically meaningful benefit. In addition, no data on the outcome of patients who used drugs accessed through the fund were collected.”

The researchers said basic information on patients who accessed the fund—including date of treatment cessation, side effects, deaths after 30 days of treatment, and date of death or relapse—was supposed to have been collected by April 2012.

However, even after it became mandatory to collect these data in 2014, 93% of outcome data were incomplete for 2014-2015.

“We also lost a major opportunity to understand how these medicines work in the real world,” said study author Richard Sullivan, MD, PhD, of King’s College London in England.

The original CDF was closed in March 2016 because it had become financially unsustainable, but a new CDF was opened at the end of July 2016.

The new CDF provides managed access to new cancer drugs for a limited period in circumstances where the clinical and cost-effectiveness of the drug is deemed uncertain by NICE. The new CDF works in close collaboration with NICE, to which all newly licensed drugs will be referred for appraisal first.

“This addresses some of the problems with the old CDF; namely, the fund would no longer support the provision of drugs that have been appraised but not recommended by NICE,” Dr Sullivan said.

 

 

“It still provides funding for new drugs awaiting NICE appraisal that have potential benefit. However, the issue here is one of fairness: why should cancer medicines be treated in this way and not all medicines and, indeed, all technologies?”

Photo courtesy of the CDC
Prescription medications

The National Health Service’s (NHS) Cancer Drugs Fund (CDF) has not benefitted the people of England and may have been detrimental for English cancer patients, according to researchers.

The group analyzed 29 drugs that were approved for use through the CDF and found the fund did not “deliver meaningful value for patients or society” and may have resulted in patients suffering unnecessarily from adverse effects.

The CDF is money the English government sets aside to pay for cancer drugs that haven’t been approved by the National Institute for Health and Care Excellence (NICE), the health technology assessment body in the UK, and aren’t available within the NHS, the publicly funded national healthcare system for England.

The original CDF was closed in March 2016, but a new CDF was opened at the end of July 2016.

In a study published in Annals of Oncology, researchers looked at 29 drugs that had been approved for use through the CDF for 47 specific indications and were available in January 2015.

The team said only 18 of the indications (38%) were based on clinical trials that reported a statistically significant benefit in terms of patients’ overall survival. The median overall survival benefit was 3.2 months, ranging from 1.4 months to 15.7 months.

The researchers also considered other factors, such as quality of life and adverse effects, to measure the drugs’ value to patients. And the team found that most of the drugs failed to show any evidence of meaningful clinical benefit.

In fact, the researchers said the benefit to patients in real-world situations was probably less than the benefit observed in the clinical trials, since trial participants are carefully selected, have fewer comorbidities, and tend to be younger than patients not included in trials.

“From 2010 when it started to 2016 when it closed, the Cancer Drugs Fund cost the UK taxpayer a total of £1.27 billion, the equivalent of 1 year’s total spending on all cancer drugs in the NHS,” said study author Ajay Aggarwal, of the London School of Hygiene & Tropical Medicine in England.

“The majority of cancer medicines funded through the CDF were found wanting with respect to what patients, clinicians, and NICE would count as clinically meaningful benefit. In addition, no data on the outcome of patients who used drugs accessed through the fund were collected.”

The researchers said basic information on patients who accessed the fund—including date of treatment cessation, side effects, deaths after 30 days of treatment, and date of death or relapse—was supposed to have been collected by April 2012.

However, even after it became mandatory to collect these data in 2014, 93% of outcome data were incomplete for 2014-2015.

“We also lost a major opportunity to understand how these medicines work in the real world,” said study author Richard Sullivan, MD, PhD, of King’s College London in England.

The original CDF was closed in March 2016 because it had become financially unsustainable, but a new CDF was opened at the end of July 2016.

The new CDF provides managed access to new cancer drugs for a limited period in circumstances where the clinical and cost-effectiveness of the drug is deemed uncertain by NICE. The new CDF works in close collaboration with NICE, to which all newly licensed drugs will be referred for appraisal first.

“This addresses some of the problems with the old CDF; namely, the fund would no longer support the provision of drugs that have been appraised but not recommended by NICE,” Dr Sullivan said.

 

 

“It still provides funding for new drugs awaiting NICE appraisal that have potential benefit. However, the issue here is one of fairness: why should cancer medicines be treated in this way and not all medicines and, indeed, all technologies?”

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EMA recommends orphan status for drug for DLBCL

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Micrograph showing DLBCL

The European Medicines Agency (EMA) has recommended that PQR309 receive orphan drug designation for the treatment of patients with diffuse large B-cell lymphoma (DLBCL).

PQR309, is an oral, brain-penetrant, dual inhibitor of the PI3K/mTOR pathway being developed by PIQUR Therapeutics AG.

PQR309 is currently being investigated in phase 1 and 2 studies in relapsed or refractory lymphoma (NCT02249429), relapsed or refractory primary central nervous system lymphoma (NCT02669511), and other malignancies.

Preclinical research of PQR309 in lymphomas was presented at the AACR Annual Meeting 2017 (abstract 2652).

Researchers tested the drug in 40 cell lines—27 DLBCL, 10 mantle cell lymphoma, and 3 splenic marginal zone lymphoma.

The researchers reported that PQR309 had “potent antiproliferative activity” in most of the cell lines.

The median IC50 was 166 nM in DLBCL cell lines, 235 nM in mantle cell lymphoma cell lines, and 214 nM in splenic marginal zone lymphoma cell lines.

In addition, PQR309 demonstrated similar activity in activated B-cell like DLBCL and germinal center B-cell like DLBCL.

About orphan designation

Orphan designation provides regulatory and financial incentives for companies to develop and market therapies that treat life-threatening or chronically debilitating conditions affecting no more than 5 in 10,000 people in the European Union, and where no satisfactory treatment is available.

Orphan designation provides a 10-year period of marketing exclusivity if the drug receives regulatory approval. The designation also provides incentives for companies seeking protocol assistance from the EMA during the product development phase and direct access to the centralized authorization procedure.

The EMA adopts an opinion on the granting of orphan drug designation, and that opinion is submitted to the European Commission for a final decision. The European Commission typically makes a decision within 30 days.

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Micrograph showing DLBCL

The European Medicines Agency (EMA) has recommended that PQR309 receive orphan drug designation for the treatment of patients with diffuse large B-cell lymphoma (DLBCL).

PQR309, is an oral, brain-penetrant, dual inhibitor of the PI3K/mTOR pathway being developed by PIQUR Therapeutics AG.

PQR309 is currently being investigated in phase 1 and 2 studies in relapsed or refractory lymphoma (NCT02249429), relapsed or refractory primary central nervous system lymphoma (NCT02669511), and other malignancies.

Preclinical research of PQR309 in lymphomas was presented at the AACR Annual Meeting 2017 (abstract 2652).

Researchers tested the drug in 40 cell lines—27 DLBCL, 10 mantle cell lymphoma, and 3 splenic marginal zone lymphoma.

The researchers reported that PQR309 had “potent antiproliferative activity” in most of the cell lines.

The median IC50 was 166 nM in DLBCL cell lines, 235 nM in mantle cell lymphoma cell lines, and 214 nM in splenic marginal zone lymphoma cell lines.

In addition, PQR309 demonstrated similar activity in activated B-cell like DLBCL and germinal center B-cell like DLBCL.

About orphan designation

Orphan designation provides regulatory and financial incentives for companies to develop and market therapies that treat life-threatening or chronically debilitating conditions affecting no more than 5 in 10,000 people in the European Union, and where no satisfactory treatment is available.

Orphan designation provides a 10-year period of marketing exclusivity if the drug receives regulatory approval. The designation also provides incentives for companies seeking protocol assistance from the EMA during the product development phase and direct access to the centralized authorization procedure.

The EMA adopts an opinion on the granting of orphan drug designation, and that opinion is submitted to the European Commission for a final decision. The European Commission typically makes a decision within 30 days.

Micrograph showing DLBCL

The European Medicines Agency (EMA) has recommended that PQR309 receive orphan drug designation for the treatment of patients with diffuse large B-cell lymphoma (DLBCL).

PQR309, is an oral, brain-penetrant, dual inhibitor of the PI3K/mTOR pathway being developed by PIQUR Therapeutics AG.

PQR309 is currently being investigated in phase 1 and 2 studies in relapsed or refractory lymphoma (NCT02249429), relapsed or refractory primary central nervous system lymphoma (NCT02669511), and other malignancies.

Preclinical research of PQR309 in lymphomas was presented at the AACR Annual Meeting 2017 (abstract 2652).

Researchers tested the drug in 40 cell lines—27 DLBCL, 10 mantle cell lymphoma, and 3 splenic marginal zone lymphoma.

The researchers reported that PQR309 had “potent antiproliferative activity” in most of the cell lines.

The median IC50 was 166 nM in DLBCL cell lines, 235 nM in mantle cell lymphoma cell lines, and 214 nM in splenic marginal zone lymphoma cell lines.

In addition, PQR309 demonstrated similar activity in activated B-cell like DLBCL and germinal center B-cell like DLBCL.

About orphan designation

Orphan designation provides regulatory and financial incentives for companies to develop and market therapies that treat life-threatening or chronically debilitating conditions affecting no more than 5 in 10,000 people in the European Union, and where no satisfactory treatment is available.

Orphan designation provides a 10-year period of marketing exclusivity if the drug receives regulatory approval. The designation also provides incentives for companies seeking protocol assistance from the EMA during the product development phase and direct access to the centralized authorization procedure.

The EMA adopts an opinion on the granting of orphan drug designation, and that opinion is submitted to the European Commission for a final decision. The European Commission typically makes a decision within 30 days.

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