The Hospitalist

For patients with mild to moderate ulcerative colitis, a three-dose, 1-week induction course of anaerobically prepared donor fecal microbiota transplantation (FMT) produced steroid-free remission in 32% of patients, compared with 9% of those who received autologous aerobically prepared FMT in a randomized, double-blind, clinical trial.

Eight weeks after FMT, the odds of steroid-free remission were fivefold higher with anaerobically prepared donor versus aerobically prepared autologous FMT (odds ratio, 5; 95% confidence interval, 1.2-20.1; P = .03), reported Samuel P. Costello, MD, of the Queen Elizabeth Hospital in Woodville, Australia, and his associates. Donor FMT also significantly increased the likelihood of clinical remission and clinical response, the researchers said. “Further research is needed to assess longer-term maintenance of remission and safety,” they wrote in JAMA.

In prior studies, high-intensity FMT with aerobically prepared donor material remitted some cases of mild to moderate ulcerative colitis. However, anaerobic processing has been found to improve microbial viability, which might allow patients to remit with less intensive FMT, the researchers wrote. In their multicenter study, 73 adults with mildly to moderately active ulcerative colitis (total Mayo score, 3-10 points, with endoscopic subscore of at least 2) received either anaerobically prepared stool pooled from three to four highly screened donors or aerobically processed autologous stool. Patients in both arms received two enemas in the 7 days after FMT – a less dose-intensive treatment protocol than in prior FMT trials of patients with ulcerative colitis.

Among 38 patients in the intervention group, 12 (32%) achieved remission, defined as total Mayo score no greater than 2 with an endoscopic score no greater than 1. Strikingly, five (42%) of these patients remained in remission at 12 months, the researchers said. Additionally, 55% of the intervention group but only 23% of the comparator group (P = .007) achieved clinical response at 8 weeks, defined as at least a 3-point decrease in total Mayo score. Rates of clinical remission (Simple Colitis Activity Index score no greater than 2) were 47% and 17%, respectively (P = .01).

The study population averaged 39 years of age, 45% were women, and 95% completed the trial. Serious adverse events included one case each of worsening colitis, Clostridium difficile colitis requiring colectomy, and pneumonia in the donor FMT group, and two cases of worsening colitis in the comparator group. However, the study “was not powered to assess safety, and and thus further larger studies are required to assess this,” the researchers said. The study also suffered from a significant loss to follow-up at 12 months, so additional studies should assess long-term remission, they added.

The National Health and Medical Research Council and the Gutsy Foundation provided funding. Dr. Costello disclosed ties to Janssen, Shire, Ferring, Microbiotica, and Pfizer.

SOURCE: Costello SP et al. JAMA. 2019;321(2):156-64. doi: 10.1001/jama.2018.20046.

For patients with mild to moderate ulcerative colitis, a three-dose, 1-week induction course of anaerobically prepared donor fecal microbiota transplantation (FMT) produced steroid-free remission in 32% of patients, compared with 9% of those who received autologous aerobically prepared FMT in a randomized, double-blind, clinical trial.

Eight weeks after FMT, the odds of steroid-free remission were fivefold higher with anaerobically prepared donor versus aerobically prepared autologous FMT (odds ratio, 5; 95% confidence interval, 1.2-20.1; P = .03), reported Samuel P. Costello, MD, of the Queen Elizabeth Hospital in Woodville, Australia, and his associates. Donor FMT also significantly increased the likelihood of clinical remission and clinical response, the researchers said. “Further research is needed to assess longer-term maintenance of remission and safety,” they wrote in JAMA.

In prior studies, high-intensity FMT with aerobically prepared donor material remitted some cases of mild to moderate ulcerative colitis. However, anaerobic processing has been found to improve microbial viability, which might allow patients to remit with less intensive FMT, the researchers wrote. In their multicenter study, 73 adults with mildly to moderately active ulcerative colitis (total Mayo score, 3-10 points, with endoscopic subscore of at least 2) received either anaerobically prepared stool pooled from three to four highly screened donors or aerobically processed autologous stool. Patients in both arms received two enemas in the 7 days after FMT – a less dose-intensive treatment protocol than in prior FMT trials of patients with ulcerative colitis.

Among 38 patients in the intervention group, 12 (32%) achieved remission, defined as total Mayo score no greater than 2 with an endoscopic score no greater than 1. Strikingly, five (42%) of these patients remained in remission at 12 months, the researchers said. Additionally, 55% of the intervention group but only 23% of the comparator group (P = .007) achieved clinical response at 8 weeks, defined as at least a 3-point decrease in total Mayo score. Rates of clinical remission (Simple Colitis Activity Index score no greater than 2) were 47% and 17%, respectively (P = .01).

The study population averaged 39 years of age, 45% were women, and 95% completed the trial. Serious adverse events included one case each of worsening colitis, Clostridium difficile colitis requiring colectomy, and pneumonia in the donor FMT group, and two cases of worsening colitis in the comparator group. However, the study “was not powered to assess safety, and and thus further larger studies are required to assess this,” the researchers said. The study also suffered from a significant loss to follow-up at 12 months, so additional studies should assess long-term remission, they added.

The National Health and Medical Research Council and the Gutsy Foundation provided funding. Dr. Costello disclosed ties to Janssen, Shire, Ferring, Microbiotica, and Pfizer.

SOURCE: Costello SP et al. JAMA. 2019;321(2):156-64. doi: 10.1001/jama.2018.20046.

For patients with mild to moderate ulcerative colitis, a three-dose, 1-week induction course of anaerobically prepared donor fecal microbiota transplantation (FMT) produced steroid-free remission in 32% of patients, compared with 9% of those who received autologous aerobically prepared FMT in a randomized, double-blind, clinical trial.

Eight weeks after FMT, the odds of steroid-free remission were fivefold higher with anaerobically prepared donor versus aerobically prepared autologous FMT (odds ratio, 5; 95% confidence interval, 1.2-20.1; P = .03), reported Samuel P. Costello, MD, of the Queen Elizabeth Hospital in Woodville, Australia, and his associates. Donor FMT also significantly increased the likelihood of clinical remission and clinical response, the researchers said. “Further research is needed to assess longer-term maintenance of remission and safety,” they wrote in JAMA.

In prior studies, high-intensity FMT with aerobically prepared donor material remitted some cases of mild to moderate ulcerative colitis. However, anaerobic processing has been found to improve microbial viability, which might allow patients to remit with less intensive FMT, the researchers wrote. In their multicenter study, 73 adults with mildly to moderately active ulcerative colitis (total Mayo score, 3-10 points, with endoscopic subscore of at least 2) received either anaerobically prepared stool pooled from three to four highly screened donors or aerobically processed autologous stool. Patients in both arms received two enemas in the 7 days after FMT – a less dose-intensive treatment protocol than in prior FMT trials of patients with ulcerative colitis.

Among 38 patients in the intervention group, 12 (32%) achieved remission, defined as total Mayo score no greater than 2 with an endoscopic score no greater than 1. Strikingly, five (42%) of these patients remained in remission at 12 months, the researchers said. Additionally, 55% of the intervention group but only 23% of the comparator group (P = .007) achieved clinical response at 8 weeks, defined as at least a 3-point decrease in total Mayo score. Rates of clinical remission (Simple Colitis Activity Index score no greater than 2) were 47% and 17%, respectively (P = .01).

The study population averaged 39 years of age, 45% were women, and 95% completed the trial. Serious adverse events included one case each of worsening colitis, Clostridium difficile colitis requiring colectomy, and pneumonia in the donor FMT group, and two cases of worsening colitis in the comparator group. However, the study “was not powered to assess safety, and and thus further larger studies are required to assess this,” the researchers said. The study also suffered from a significant loss to follow-up at 12 months, so additional studies should assess long-term remission, they added.

The National Health and Medical Research Council and the Gutsy Foundation provided funding. Dr. Costello disclosed ties to Janssen, Shire, Ferring, Microbiotica, and Pfizer.

SOURCE: Costello SP et al. JAMA. 2019;321(2):156-64. doi: 10.1001/jama.2018.20046.

Background: Per Chest guidelines, VTE prophylaxis is recommended for hospitalized patients at increased risk for VTE but is not recommended for low-risk patients. Risk stratification can be guided by the Padua Prediction Score to categorize patients.

Dr. Marr is assistant professor of medicine and an academic hospitalist, University of Utah, Salt Lake City.

Background: Per Chest guidelines, VTE prophylaxis is recommended for hospitalized patients at increased risk for VTE but is not recommended for low-risk patients. Risk stratification can be guided by the Padua Prediction Score to categorize patients.

Dr. Marr is assistant professor of medicine and an academic hospitalist, University of Utah, Salt Lake City.

Background: Per Chest guidelines, VTE prophylaxis is recommended for hospitalized patients at increased risk for VTE but is not recommended for low-risk patients. Risk stratification can be guided by the Padua Prediction Score to categorize patients.

Dr. Marr is assistant professor of medicine and an academic hospitalist, University of Utah, Salt Lake City.

In heart failure, derangements in HDL cholesterol particle (HDL-P) subfractions have prognostic implications beyond those of conventional cardiovascular risk factors, according to investigators who analyzed plasma samples from more than 6,500 patients.

The study revealed derangements that were shared and more severe in heart failure with reduced ejection fraction (HFrEF) as compared to heart failure with preserved ejection fraction (HFpEF), according to the researchers, who said their study is the largest to date of HDL-P subfractions in heart failure.

Both total HDL-P and small HDL-P had a strong inverse association with adverse outcomes, consistent with the conclusions of previous studies, they said in a report on their study in the Journal of the American College of Cardiology.

“Altogether, our findings support total and small HDL-P as important markers of residual risk in both HFrEF and HFpEF,” said the investigators, led by Wynn G. Hunter, MD, of Duke University, Durham, N.C.

Dr. Hunter and colleagues used the CATHGEN (Catheterization Genetics) biorepository to identify plasma samples obtained at catheterization for 782 patients with HFrEF, 1,004 with HFpEF, and 4,742 with no heart failure.


Lipoprotein profiling of the samples revealed that mean HDL-P size was greater in HFrEF than in HFpEF, and in both of those cases, mean HDL-P size was greater than in patients with no heart failure (P less than .0001), investigators reported.

Concentrations of small HDL-P and total HDL-P were by contrast lower in HFrEF versus HFpEF, and again, the values for both HFrEF and HFpEF were lower than in patients without heart failure (P less than .0001), they added.

Small HDL-P and total HDL-P had an inverse association with time to adverse events and all-cause mortality for both the HFrEF and HFpEF groups, according to investigators, who said those links remained robust even after multivariate adjustment for 14 cardiovascular risk factors, including diabetes, LDL particle, and GlycA, a marker of inflammation.

For example, small HDL-P and total HDL-P were inversely associated with all-cause mortality risk, with adjusted hazard ratios of 0.69-0.79 (P less than .0001), they reported. Similarly, a greater mean HDL-P size was associated with increased risk of all-cause mortality, yielding adjusted hazard ratios of 1.23-1.46 (P less than .0001).

Further studies are needed to clarify the role of HDL-P in the pathophysiology of heart failure, and to identify treatments that might increase total and small HDL-P in heart failure patients, Dr. Hunter and coauthors concluded.

Dr. Hunter reported no disclosures related to the study. Coauthors provided disclosures related to Amgen, Ostuka, Roche Diagnostics, Novartis, Trevena, Singulex, Medtronic, AstraZeneca, Bristol-Myers Squibb, Janssen, Portola, Boston Scientific, Gilead, GlaxoSmithKline, Merck, Alnylam, Ikaria Pharmaceuticals, Pfizer, Philips, LipoScience, and Pfizer, among others.

SOURCE: Hunter WG et al. J Am Coll Cardiol. 2019 Jan 22;73(2):177-86.

In heart failure, derangements in HDL cholesterol particle (HDL-P) subfractions have prognostic implications beyond those of conventional cardiovascular risk factors, according to investigators who analyzed plasma samples from more than 6,500 patients.

The study revealed derangements that were shared and more severe in heart failure with reduced ejection fraction (HFrEF) as compared to heart failure with preserved ejection fraction (HFpEF), according to the researchers, who said their study is the largest to date of HDL-P subfractions in heart failure.

Both total HDL-P and small HDL-P had a strong inverse association with adverse outcomes, consistent with the conclusions of previous studies, they said in a report on their study in the Journal of the American College of Cardiology.

“Altogether, our findings support total and small HDL-P as important markers of residual risk in both HFrEF and HFpEF,” said the investigators, led by Wynn G. Hunter, MD, of Duke University, Durham, N.C.

Dr. Hunter and colleagues used the CATHGEN (Catheterization Genetics) biorepository to identify plasma samples obtained at catheterization for 782 patients with HFrEF, 1,004 with HFpEF, and 4,742 with no heart failure.


Lipoprotein profiling of the samples revealed that mean HDL-P size was greater in HFrEF than in HFpEF, and in both of those cases, mean HDL-P size was greater than in patients with no heart failure (P less than .0001), investigators reported.

Concentrations of small HDL-P and total HDL-P were by contrast lower in HFrEF versus HFpEF, and again, the values for both HFrEF and HFpEF were lower than in patients without heart failure (P less than .0001), they added.

Small HDL-P and total HDL-P had an inverse association with time to adverse events and all-cause mortality for both the HFrEF and HFpEF groups, according to investigators, who said those links remained robust even after multivariate adjustment for 14 cardiovascular risk factors, including diabetes, LDL particle, and GlycA, a marker of inflammation.

For example, small HDL-P and total HDL-P were inversely associated with all-cause mortality risk, with adjusted hazard ratios of 0.69-0.79 (P less than .0001), they reported. Similarly, a greater mean HDL-P size was associated with increased risk of all-cause mortality, yielding adjusted hazard ratios of 1.23-1.46 (P less than .0001).

Further studies are needed to clarify the role of HDL-P in the pathophysiology of heart failure, and to identify treatments that might increase total and small HDL-P in heart failure patients, Dr. Hunter and coauthors concluded.

Dr. Hunter reported no disclosures related to the study. Coauthors provided disclosures related to Amgen, Ostuka, Roche Diagnostics, Novartis, Trevena, Singulex, Medtronic, AstraZeneca, Bristol-Myers Squibb, Janssen, Portola, Boston Scientific, Gilead, GlaxoSmithKline, Merck, Alnylam, Ikaria Pharmaceuticals, Pfizer, Philips, LipoScience, and Pfizer, among others.

SOURCE: Hunter WG et al. J Am Coll Cardiol. 2019 Jan 22;73(2):177-86.

In heart failure, derangements in HDL cholesterol particle (HDL-P) subfractions have prognostic implications beyond those of conventional cardiovascular risk factors, according to investigators who analyzed plasma samples from more than 6,500 patients.

The study revealed derangements that were shared and more severe in heart failure with reduced ejection fraction (HFrEF) as compared to heart failure with preserved ejection fraction (HFpEF), according to the researchers, who said their study is the largest to date of HDL-P subfractions in heart failure.

Both total HDL-P and small HDL-P had a strong inverse association with adverse outcomes, consistent with the conclusions of previous studies, they said in a report on their study in the Journal of the American College of Cardiology.

“Altogether, our findings support total and small HDL-P as important markers of residual risk in both HFrEF and HFpEF,” said the investigators, led by Wynn G. Hunter, MD, of Duke University, Durham, N.C.

Dr. Hunter and colleagues used the CATHGEN (Catheterization Genetics) biorepository to identify plasma samples obtained at catheterization for 782 patients with HFrEF, 1,004 with HFpEF, and 4,742 with no heart failure.


Lipoprotein profiling of the samples revealed that mean HDL-P size was greater in HFrEF than in HFpEF, and in both of those cases, mean HDL-P size was greater than in patients with no heart failure (P less than .0001), investigators reported.

Concentrations of small HDL-P and total HDL-P were by contrast lower in HFrEF versus HFpEF, and again, the values for both HFrEF and HFpEF were lower than in patients without heart failure (P less than .0001), they added.

Small HDL-P and total HDL-P had an inverse association with time to adverse events and all-cause mortality for both the HFrEF and HFpEF groups, according to investigators, who said those links remained robust even after multivariate adjustment for 14 cardiovascular risk factors, including diabetes, LDL particle, and GlycA, a marker of inflammation.

For example, small HDL-P and total HDL-P were inversely associated with all-cause mortality risk, with adjusted hazard ratios of 0.69-0.79 (P less than .0001), they reported. Similarly, a greater mean HDL-P size was associated with increased risk of all-cause mortality, yielding adjusted hazard ratios of 1.23-1.46 (P less than .0001).

Further studies are needed to clarify the role of HDL-P in the pathophysiology of heart failure, and to identify treatments that might increase total and small HDL-P in heart failure patients, Dr. Hunter and coauthors concluded.

Dr. Hunter reported no disclosures related to the study. Coauthors provided disclosures related to Amgen, Ostuka, Roche Diagnostics, Novartis, Trevena, Singulex, Medtronic, AstraZeneca, Bristol-Myers Squibb, Janssen, Portola, Boston Scientific, Gilead, GlaxoSmithKline, Merck, Alnylam, Ikaria Pharmaceuticals, Pfizer, Philips, LipoScience, and Pfizer, among others.

SOURCE: Hunter WG et al. J Am Coll Cardiol. 2019 Jan 22;73(2):177-86.

For the first time ever, on March 7, 2019, tens of thousands of hospitalists across the United States and around the world will celebrate their day, National Hospitalist Day.

On this day, we will honor the hard work and dedication of hospitalists in the care of millions of hospitalized patients. With more than 62,000 hospitalists across the United States, hospital medicine has been the fastest growing medical specialty and among the largest of all specialties in medicine. Hospitalists now lead clinical care in over 75% of U.S. hospitals, caring for patients in their communities. We educate the future providers of health care by serving as teachers and mentors. We push the boundaries of science in hospital care through innovative research that defines the evidence-based practices for our field. Hospitalists, proudly celebrate all that we have accomplished together on March 7, and moving forward, every first Thursday in March annually.

The Society for Hospital Medicine’s celebration of National Hospitalist Day will include spotlights on hospitalists, a social medical campaign, downloadable customizable posters, and much more. Stay tuned for details!

Attend the only meeting designed just for you

Be among the thousands of hospitalists who will celebrate hospital medicine in person at Hospital Medicine 2019 (HM19), March 24-27 in National Harbor, Md.

While at HM19, check out more than 20 educational tracks, including clinical updates, diagnostic reasoning, and health policy. New this year are two mini tracks: “Between the Guidelines” and “Clinical Mastery”. Between the Guidelines explores how we can address some of the most challenging cases we encounter in hospital medicine, where clear guidelines don’t exist. Clinical Mastery is designed to enhance our bedside diagnostic skills, from ECGs to ultrasounds.

Get ready to vote in HM19’s “The Great Debate” – pairing two talented clinicians who will debate opposing sides of challenging clinical decisions that we encounter on the front lines of health care delivery. Attendees have the opportunity to hear the two sides and then vote on who they believe has the right approach. There are six precourses planned for HM19, with a new offering in Palliative Care and Pain Management. This year, the annual conference also features additional sessions for our NP/PA attendees. They include specific workshops as well as a track that includes 4 didactic sessions. Lastly, HM19 will offer CME, MOC, AOS, AAFP, and Pharmacology credits to address the needs of our attendees.

Looking into the future

While hospitalists are a vital part of U.S. health care, our delivery systems are in transition with greater focus on value-based care. To ensure hospital medicine continues to thrive in today’s dynamic scene, SHM’s Board of Directors held a strategic meeting in October 2018 to focus on the role of hospitalists and hospital medicine in population health management.

There are many hospitalists across the nation who are currently involved in population health management. These range from medical directors to vice presidents of accountable care organizations, population health management, or value-based care. Hospitalists are seeking communities focused on population health management to share best practices and learn from each other. To address this, SHM’s Advocacy and Public Policy HMX community has served as a meeting point to discuss issues related to value-based care. To join the discussion, visit the community by logging in at hospitalmedicine.org/hmx. Furthermore, at HM19, hospitalists will have the opportunity to meet face to face regarding these issues in the Advocacy Special Interest Forum.

Key points: Population health management

• Source of truth

SHM has served as the source of reliable and trusted information about hospital medicine. We will continue to develop content and resources specific to population health management on our website so hospitalists can easily access this information. To increase our awareness about population health management, presenters at HM19 will integrate a slide about the implications of population health management on their clinical topic. These slides will illustrate the clinical and nonclinical services that are necessary to enhance the patient’s quality of care and life. In addition to best practice care, these slides will highlight topics like the role of style modification and prevention, risk stratification, chronic disease management, and care coordination throughout the continuum of care.

• Advocating for us

In addition to providing a home for hospitalists to collaborate regarding population health management, SHM will advance this agenda from a regulatory perspective. The Public Policy and Performance Measurement & Reporting Committees are actively evaluating and leading the transition from value to volume. SHM is also working with potential key partners and organizations in the areas of primary care, skilled nursing facilities, and accountable care organizations that will help improve the effectiveness of delivering population health management.

• Creating expertise

SHM will lead best practice development for tools and skills that are necessary for hospitalists to lead population health management. Telemedicine is an increasingly critical tool as we help manage our patients in other facilities, inpatient or skilled nursing facilities, as well as at home. SHM has developed a white paper about telemedicine in hospital medicine that highlights modalities, offerings, implementation of programs, and work flows necessary for success. You can find it under “Resources” at hospitalmedicine.org/telemedicine.

SHM will continue to actively develop tools that appropriately address the challenges we’re facing. From National Hospitalist Day to population health management, this is an exciting time in hospital medicine – I hope to see you at HM19 to celebrate our specialty and our bright future.

Dr. Afsar is president of the Society of Hospital Medicine, and chief ambulatory officer and chief medical officer for accountable care organizations at UC Irvine Health.

For the first time ever, on March 7, 2019, tens of thousands of hospitalists across the United States and around the world will celebrate their day, National Hospitalist Day.

On this day, we will honor the hard work and dedication of hospitalists in the care of millions of hospitalized patients. With more than 62,000 hospitalists across the United States, hospital medicine has been the fastest growing medical specialty and among the largest of all specialties in medicine. Hospitalists now lead clinical care in over 75% of U.S. hospitals, caring for patients in their communities. We educate the future providers of health care by serving as teachers and mentors. We push the boundaries of science in hospital care through innovative research that defines the evidence-based practices for our field. Hospitalists, proudly celebrate all that we have accomplished together on March 7, and moving forward, every first Thursday in March annually.

The Society for Hospital Medicine’s celebration of National Hospitalist Day will include spotlights on hospitalists, a social medical campaign, downloadable customizable posters, and much more. Stay tuned for details!

Attend the only meeting designed just for you

Be among the thousands of hospitalists who will celebrate hospital medicine in person at Hospital Medicine 2019 (HM19), March 24-27 in National Harbor, Md.

While at HM19, check out more than 20 educational tracks, including clinical updates, diagnostic reasoning, and health policy. New this year are two mini tracks: “Between the Guidelines” and “Clinical Mastery”. Between the Guidelines explores how we can address some of the most challenging cases we encounter in hospital medicine, where clear guidelines don’t exist. Clinical Mastery is designed to enhance our bedside diagnostic skills, from ECGs to ultrasounds.

Get ready to vote in HM19’s “The Great Debate” – pairing two talented clinicians who will debate opposing sides of challenging clinical decisions that we encounter on the front lines of health care delivery. Attendees have the opportunity to hear the two sides and then vote on who they believe has the right approach. There are six precourses planned for HM19, with a new offering in Palliative Care and Pain Management. This year, the annual conference also features additional sessions for our NP/PA attendees. They include specific workshops as well as a track that includes 4 didactic sessions. Lastly, HM19 will offer CME, MOC, AOS, AAFP, and Pharmacology credits to address the needs of our attendees.

Looking into the future

While hospitalists are a vital part of U.S. health care, our delivery systems are in transition with greater focus on value-based care. To ensure hospital medicine continues to thrive in today’s dynamic scene, SHM’s Board of Directors held a strategic meeting in October 2018 to focus on the role of hospitalists and hospital medicine in population health management.

There are many hospitalists across the nation who are currently involved in population health management. These range from medical directors to vice presidents of accountable care organizations, population health management, or value-based care. Hospitalists are seeking communities focused on population health management to share best practices and learn from each other. To address this, SHM’s Advocacy and Public Policy HMX community has served as a meeting point to discuss issues related to value-based care. To join the discussion, visit the community by logging in at hospitalmedicine.org/hmx. Furthermore, at HM19, hospitalists will have the opportunity to meet face to face regarding these issues in the Advocacy Special Interest Forum.

Key points: Population health management

• Source of truth

SHM has served as the source of reliable and trusted information about hospital medicine. We will continue to develop content and resources specific to population health management on our website so hospitalists can easily access this information. To increase our awareness about population health management, presenters at HM19 will integrate a slide about the implications of population health management on their clinical topic. These slides will illustrate the clinical and nonclinical services that are necessary to enhance the patient’s quality of care and life. In addition to best practice care, these slides will highlight topics like the role of style modification and prevention, risk stratification, chronic disease management, and care coordination throughout the continuum of care.

• Advocating for us

In addition to providing a home for hospitalists to collaborate regarding population health management, SHM will advance this agenda from a regulatory perspective. The Public Policy and Performance Measurement & Reporting Committees are actively evaluating and leading the transition from value to volume. SHM is also working with potential key partners and organizations in the areas of primary care, skilled nursing facilities, and accountable care organizations that will help improve the effectiveness of delivering population health management.

• Creating expertise

SHM will lead best practice development for tools and skills that are necessary for hospitalists to lead population health management. Telemedicine is an increasingly critical tool as we help manage our patients in other facilities, inpatient or skilled nursing facilities, as well as at home. SHM has developed a white paper about telemedicine in hospital medicine that highlights modalities, offerings, implementation of programs, and work flows necessary for success. You can find it under “Resources” at hospitalmedicine.org/telemedicine.

SHM will continue to actively develop tools that appropriately address the challenges we’re facing. From National Hospitalist Day to population health management, this is an exciting time in hospital medicine – I hope to see you at HM19 to celebrate our specialty and our bright future.

Dr. Afsar is president of the Society of Hospital Medicine, and chief ambulatory officer and chief medical officer for accountable care organizations at UC Irvine Health.

For the first time ever, on March 7, 2019, tens of thousands of hospitalists across the United States and around the world will celebrate their day, National Hospitalist Day.

On this day, we will honor the hard work and dedication of hospitalists in the care of millions of hospitalized patients. With more than 62,000 hospitalists across the United States, hospital medicine has been the fastest growing medical specialty and among the largest of all specialties in medicine. Hospitalists now lead clinical care in over 75% of U.S. hospitals, caring for patients in their communities. We educate the future providers of health care by serving as teachers and mentors. We push the boundaries of science in hospital care through innovative research that defines the evidence-based practices for our field. Hospitalists, proudly celebrate all that we have accomplished together on March 7, and moving forward, every first Thursday in March annually.

The Society for Hospital Medicine’s celebration of National Hospitalist Day will include spotlights on hospitalists, a social medical campaign, downloadable customizable posters, and much more. Stay tuned for details!

Attend the only meeting designed just for you

Be among the thousands of hospitalists who will celebrate hospital medicine in person at Hospital Medicine 2019 (HM19), March 24-27 in National Harbor, Md.

While at HM19, check out more than 20 educational tracks, including clinical updates, diagnostic reasoning, and health policy. New this year are two mini tracks: “Between the Guidelines” and “Clinical Mastery”. Between the Guidelines explores how we can address some of the most challenging cases we encounter in hospital medicine, where clear guidelines don’t exist. Clinical Mastery is designed to enhance our bedside diagnostic skills, from ECGs to ultrasounds.

Get ready to vote in HM19’s “The Great Debate” – pairing two talented clinicians who will debate opposing sides of challenging clinical decisions that we encounter on the front lines of health care delivery. Attendees have the opportunity to hear the two sides and then vote on who they believe has the right approach. There are six precourses planned for HM19, with a new offering in Palliative Care and Pain Management. This year, the annual conference also features additional sessions for our NP/PA attendees. They include specific workshops as well as a track that includes 4 didactic sessions. Lastly, HM19 will offer CME, MOC, AOS, AAFP, and Pharmacology credits to address the needs of our attendees.

Looking into the future

While hospitalists are a vital part of U.S. health care, our delivery systems are in transition with greater focus on value-based care. To ensure hospital medicine continues to thrive in today’s dynamic scene, SHM’s Board of Directors held a strategic meeting in October 2018 to focus on the role of hospitalists and hospital medicine in population health management.

There are many hospitalists across the nation who are currently involved in population health management. These range from medical directors to vice presidents of accountable care organizations, population health management, or value-based care. Hospitalists are seeking communities focused on population health management to share best practices and learn from each other. To address this, SHM’s Advocacy and Public Policy HMX community has served as a meeting point to discuss issues related to value-based care. To join the discussion, visit the community by logging in at hospitalmedicine.org/hmx. Furthermore, at HM19, hospitalists will have the opportunity to meet face to face regarding these issues in the Advocacy Special Interest Forum.

Key points: Population health management

• Source of truth

SHM has served as the source of reliable and trusted information about hospital medicine. We will continue to develop content and resources specific to population health management on our website so hospitalists can easily access this information. To increase our awareness about population health management, presenters at HM19 will integrate a slide about the implications of population health management on their clinical topic. These slides will illustrate the clinical and nonclinical services that are necessary to enhance the patient’s quality of care and life. In addition to best practice care, these slides will highlight topics like the role of style modification and prevention, risk stratification, chronic disease management, and care coordination throughout the continuum of care.

• Advocating for us

In addition to providing a home for hospitalists to collaborate regarding population health management, SHM will advance this agenda from a regulatory perspective. The Public Policy and Performance Measurement & Reporting Committees are actively evaluating and leading the transition from value to volume. SHM is also working with potential key partners and organizations in the areas of primary care, skilled nursing facilities, and accountable care organizations that will help improve the effectiveness of delivering population health management.

• Creating expertise

SHM will lead best practice development for tools and skills that are necessary for hospitalists to lead population health management. Telemedicine is an increasingly critical tool as we help manage our patients in other facilities, inpatient or skilled nursing facilities, as well as at home. SHM has developed a white paper about telemedicine in hospital medicine that highlights modalities, offerings, implementation of programs, and work flows necessary for success. You can find it under “Resources” at hospitalmedicine.org/telemedicine.

SHM will continue to actively develop tools that appropriately address the challenges we’re facing. From National Hospitalist Day to population health management, this is an exciting time in hospital medicine – I hope to see you at HM19 to celebrate our specialty and our bright future.

Dr. Afsar is president of the Society of Hospital Medicine, and chief ambulatory officer and chief medical officer for accountable care organizations at UC Irvine Health.

LOS ANGELES – Mounting evidence suggests that the use of sodium-glucose cotransporter 2 (SGLT-2) inhibitors helps prevent heart failure.

They also may play a role in the treatment of patients with known heart failure (HF), but further studies are required to prove definite treatment benefit.

“These trials enrolled a minority of patients with known heart failure, and, in those subgroups, the drugs seems to reduce the risk for hospitalization, opening the possibility of treatment benefit,” Javed Butler, MD, said at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease. “But there were not enough patients to conclude this. If you are treating diabetes with these agents in patients with heart failure, more power to you. But don’t think you are treating heart failure per se until the results of the dedicated heart failure trials come out.”

Good glycemic control has not been shown to affect heart failure outcomes per se, said Dr. Butler, professor and chairman of the department of medicine at the University of Mississippi Medical Center, Jackson.

“People seem to mix the concepts of prevention and treatment together,” he said. “We have now very good evidence across all trials with SGLT-2 inhibitors for prevention of heart failure. But for treatment, we need more data despite favorable early signals.

“Also, these trials include most patients with ischemic heart disease, but we don’t have data on nonischemic etiology for the development of heart failure from these trials,” Dr. Butler added.

The best available data from clinical trials suggest that patients with American College of Cardiology Foundation/American Heart Association heart failure classification stages A and B benefit the most from aggressive treatment to prevent HF.

“Either they have diseases like high blood pressure or diabetes, but their hearts are normal, or, perhaps, their hearts are abnormal, and they develop left ventricular hypertrophy or atrial fibrillation,” he said. “However, if someone is stage C – manifest heart failure – or stage D – advanced heart failure – we need further data on novel therapies to improve their outcomes.”

Dr. Butler emphasized that not all heart failure is associated with atherosclerotic vascular disease. In fact, the Health, Aging, and Body Composition Study showed that the incidence of heart failure increased progressively across age groups, both for those with and without a preceding vascular event (P = .03 and P less than .001, respectively; Eur J Heart Fail. 2014 May;16[5]:526-34). “There’s a whole other world of nonischemic heart failure that we also need to worry about,” he said. “There is a lot of microvascular endothelial dysfunction.”

The combination of heart failure and diabetes is especially lethal. “If you put them together, you’re looking at about a 10-fold higher risk of mortality, which is a horrible prognosis,” Dr. Butler said. “That means that we need to think about prevention and treatment separately.”

Data from the SAVOR-TIMI 53, EXAMINE, and TECOS trials show there is no protective effect of dipeptidyl peptidase–4 inhibitors when it comes to hospitalization for heart failure.

“The other classes of drugs either increase the risk, or we don’t have very good data,” Dr. Butler said. “So far, across the spectrum of therapies for diabetes, the effect on heart failure is neutral and perhaps confers some risk.”

SGLT-2 inhibitors convey a different story.

In the EMPA-REG OUTCOME Trial, one inclusion criterion was established cardiovascular disease (CVD) in the form of a prior MI, coronary artery disease, stroke, unstable angina, or occlusive peripheral artery disease, but not heart failure alone (N Engl J Med. 2015 Nov 26; 373[22]:2117-28). “This was not a heart failure study, so we don’t know what their New York Heart Association class was, or the details of their baseline HF treatment in the minority of patients who were enrolled who had a history of HF,” Dr. Butler cautioned.

However, the trial found that empagliflozin conferred an overall cardiovascular death risk reduction of 38%, compared with placebo. When the researchers assessed the impact of treatment on all modes of cardiovascular death, they found that death from heart failure benefited the most (hazard ratio, 0.32; P = .0008), while sudden death benefited as well. Empagliflozin also had a significant impact on reduced hospitalization for heart failure, compared with placebo (HR, 0.65).

“This is a large enough cohort that you should feel comfortable that this drug is preventing heart failure in those with HF at baseline,” said Dr. Butler, who was not involved with the study. “We can have a debate about whether this is a treatment for heart failure or not, but for prevention of heart failure, I feel comfortable that these drugs do that.”

A subsequent study of canagliflozin and cardiovascular and renal events in type 2 diabetes showed the same result (N Engl J Med. 2017 Aug 17; 377[7]:644-57). It reduced hospitalization for heart failure by 33% (HR, 0.67).

Then came the CVD-REAL study, which found low rates of hospitalization for heart failure and all-cause death in new users of SGLT-2 inhibitors. More recently, DECLARE-TIMI 58 yielded similar results.

“One of the criticisms of these findings is that heart failure characteristics were not well phenotyped in these studies,” Dr. Butler said. “I say it really does not matter. Heart failure hospitalizations are associated with a poor prognosis irrespective of whether the hospitalization occurred in patients without heart failure or in a patient with previously diagnosed heart failure, or whether the patient has reduced or preserved ejection fraction.

“Framingham and other classic studies show us that 5-year mortality for heart failure is about 50%,” he noted. “If you can prevent a disease that has a 5-year mortality of 50%, doesn’t that sound like a really good deal?”

A contemporary appraisal of the heart failure epidemic in Olmstead County, Minn., during 2000-2010 found that the mortality was 20.2% at 1 year after diagnosis, and 52.6% at 5 years after diagnosis. The data include new-onset HF in both inpatient and outpatient settings.

Specifically, new-onset HF hospitalization was associated with a 1-year post discharge mortality of 21.1% (JAMA Intern Med. 2015;175[6]:996-1004). “We cannot ignore prevention of heart failure,” Dr. Butler said. “Also, for treatment, once you get hospitalized for heart failure, the fundamental natural history of the disease changes. There is a 30% cumulative incremental death risk between the second and third hospitalizations.”

Dr. Butler concluded his presentation by noting that five randomized, controlled trials evaluating SGLT-2 inhibitors in HF have been launched, and should help elucidate any effects the drugs may have in treating the condition. They include EMPEROR-Preserved (NCT03057951), EMPEROR-Reduced (NCT03057977), Dapa-HF (NCT03036124), and SOLOIST-WHF (NCT03521934) and DELIVER (NCT03619213).

Dr. Butler disclosed that he has received research support from the National Institutes of Health, the European Union, and the Patient-Centered Outcomes Research Institute. He has also been a consultant for numerous pharmaceutical companies, including Boehringer Ingelheim, Janssen, and AstraZeneca, which sponsored the EMPA-REG, CANVAS, and DECLARE TIMI 58 trials.

[email protected]

LOS ANGELES – Mounting evidence suggests that the use of sodium-glucose cotransporter 2 (SGLT-2) inhibitors helps prevent heart failure.

They also may play a role in the treatment of patients with known heart failure (HF), but further studies are required to prove definite treatment benefit.

“These trials enrolled a minority of patients with known heart failure, and, in those subgroups, the drugs seems to reduce the risk for hospitalization, opening the possibility of treatment benefit,” Javed Butler, MD, said at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease. “But there were not enough patients to conclude this. If you are treating diabetes with these agents in patients with heart failure, more power to you. But don’t think you are treating heart failure per se until the results of the dedicated heart failure trials come out.”

Good glycemic control has not been shown to affect heart failure outcomes per se, said Dr. Butler, professor and chairman of the department of medicine at the University of Mississippi Medical Center, Jackson.

“People seem to mix the concepts of prevention and treatment together,” he said. “We have now very good evidence across all trials with SGLT-2 inhibitors for prevention of heart failure. But for treatment, we need more data despite favorable early signals.

“Also, these trials include most patients with ischemic heart disease, but we don’t have data on nonischemic etiology for the development of heart failure from these trials,” Dr. Butler added.

The best available data from clinical trials suggest that patients with American College of Cardiology Foundation/American Heart Association heart failure classification stages A and B benefit the most from aggressive treatment to prevent HF.

“Either they have diseases like high blood pressure or diabetes, but their hearts are normal, or, perhaps, their hearts are abnormal, and they develop left ventricular hypertrophy or atrial fibrillation,” he said. “However, if someone is stage C – manifest heart failure – or stage D – advanced heart failure – we need further data on novel therapies to improve their outcomes.”

Dr. Butler emphasized that not all heart failure is associated with atherosclerotic vascular disease. In fact, the Health, Aging, and Body Composition Study showed that the incidence of heart failure increased progressively across age groups, both for those with and without a preceding vascular event (P = .03 and P less than .001, respectively; Eur J Heart Fail. 2014 May;16[5]:526-34). “There’s a whole other world of nonischemic heart failure that we also need to worry about,” he said. “There is a lot of microvascular endothelial dysfunction.”

The combination of heart failure and diabetes is especially lethal. “If you put them together, you’re looking at about a 10-fold higher risk of mortality, which is a horrible prognosis,” Dr. Butler said. “That means that we need to think about prevention and treatment separately.”

Data from the SAVOR-TIMI 53, EXAMINE, and TECOS trials show there is no protective effect of dipeptidyl peptidase–4 inhibitors when it comes to hospitalization for heart failure.

“The other classes of drugs either increase the risk, or we don’t have very good data,” Dr. Butler said. “So far, across the spectrum of therapies for diabetes, the effect on heart failure is neutral and perhaps confers some risk.”

SGLT-2 inhibitors convey a different story.

In the EMPA-REG OUTCOME Trial, one inclusion criterion was established cardiovascular disease (CVD) in the form of a prior MI, coronary artery disease, stroke, unstable angina, or occlusive peripheral artery disease, but not heart failure alone (N Engl J Med. 2015 Nov 26; 373[22]:2117-28). “This was not a heart failure study, so we don’t know what their New York Heart Association class was, or the details of their baseline HF treatment in the minority of patients who were enrolled who had a history of HF,” Dr. Butler cautioned.

However, the trial found that empagliflozin conferred an overall cardiovascular death risk reduction of 38%, compared with placebo. When the researchers assessed the impact of treatment on all modes of cardiovascular death, they found that death from heart failure benefited the most (hazard ratio, 0.32; P = .0008), while sudden death benefited as well. Empagliflozin also had a significant impact on reduced hospitalization for heart failure, compared with placebo (HR, 0.65).

“This is a large enough cohort that you should feel comfortable that this drug is preventing heart failure in those with HF at baseline,” said Dr. Butler, who was not involved with the study. “We can have a debate about whether this is a treatment for heart failure or not, but for prevention of heart failure, I feel comfortable that these drugs do that.”

A subsequent study of canagliflozin and cardiovascular and renal events in type 2 diabetes showed the same result (N Engl J Med. 2017 Aug 17; 377[7]:644-57). It reduced hospitalization for heart failure by 33% (HR, 0.67).

Then came the CVD-REAL study, which found low rates of hospitalization for heart failure and all-cause death in new users of SGLT-2 inhibitors. More recently, DECLARE-TIMI 58 yielded similar results.

“One of the criticisms of these findings is that heart failure characteristics were not well phenotyped in these studies,” Dr. Butler said. “I say it really does not matter. Heart failure hospitalizations are associated with a poor prognosis irrespective of whether the hospitalization occurred in patients without heart failure or in a patient with previously diagnosed heart failure, or whether the patient has reduced or preserved ejection fraction.

“Framingham and other classic studies show us that 5-year mortality for heart failure is about 50%,” he noted. “If you can prevent a disease that has a 5-year mortality of 50%, doesn’t that sound like a really good deal?”

A contemporary appraisal of the heart failure epidemic in Olmstead County, Minn., during 2000-2010 found that the mortality was 20.2% at 1 year after diagnosis, and 52.6% at 5 years after diagnosis. The data include new-onset HF in both inpatient and outpatient settings.

Specifically, new-onset HF hospitalization was associated with a 1-year post discharge mortality of 21.1% (JAMA Intern Med. 2015;175[6]:996-1004). “We cannot ignore prevention of heart failure,” Dr. Butler said. “Also, for treatment, once you get hospitalized for heart failure, the fundamental natural history of the disease changes. There is a 30% cumulative incremental death risk between the second and third hospitalizations.”

Dr. Butler concluded his presentation by noting that five randomized, controlled trials evaluating SGLT-2 inhibitors in HF have been launched, and should help elucidate any effects the drugs may have in treating the condition. They include EMPEROR-Preserved (NCT03057951), EMPEROR-Reduced (NCT03057977), Dapa-HF (NCT03036124), and SOLOIST-WHF (NCT03521934) and DELIVER (NCT03619213).

Dr. Butler disclosed that he has received research support from the National Institutes of Health, the European Union, and the Patient-Centered Outcomes Research Institute. He has also been a consultant for numerous pharmaceutical companies, including Boehringer Ingelheim, Janssen, and AstraZeneca, which sponsored the EMPA-REG, CANVAS, and DECLARE TIMI 58 trials.

[email protected]

LOS ANGELES – Mounting evidence suggests that the use of sodium-glucose cotransporter 2 (SGLT-2) inhibitors helps prevent heart failure.

They also may play a role in the treatment of patients with known heart failure (HF), but further studies are required to prove definite treatment benefit.

“These trials enrolled a minority of patients with known heart failure, and, in those subgroups, the drugs seems to reduce the risk for hospitalization, opening the possibility of treatment benefit,” Javed Butler, MD, said at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease. “But there were not enough patients to conclude this. If you are treating diabetes with these agents in patients with heart failure, more power to you. But don’t think you are treating heart failure per se until the results of the dedicated heart failure trials come out.”

Good glycemic control has not been shown to affect heart failure outcomes per se, said Dr. Butler, professor and chairman of the department of medicine at the University of Mississippi Medical Center, Jackson.

“People seem to mix the concepts of prevention and treatment together,” he said. “We have now very good evidence across all trials with SGLT-2 inhibitors for prevention of heart failure. But for treatment, we need more data despite favorable early signals.

“Also, these trials include most patients with ischemic heart disease, but we don’t have data on nonischemic etiology for the development of heart failure from these trials,” Dr. Butler added.

The best available data from clinical trials suggest that patients with American College of Cardiology Foundation/American Heart Association heart failure classification stages A and B benefit the most from aggressive treatment to prevent HF.

“Either they have diseases like high blood pressure or diabetes, but their hearts are normal, or, perhaps, their hearts are abnormal, and they develop left ventricular hypertrophy or atrial fibrillation,” he said. “However, if someone is stage C – manifest heart failure – or stage D – advanced heart failure – we need further data on novel therapies to improve their outcomes.”

Dr. Butler emphasized that not all heart failure is associated with atherosclerotic vascular disease. In fact, the Health, Aging, and Body Composition Study showed that the incidence of heart failure increased progressively across age groups, both for those with and without a preceding vascular event (P = .03 and P less than .001, respectively; Eur J Heart Fail. 2014 May;16[5]:526-34). “There’s a whole other world of nonischemic heart failure that we also need to worry about,” he said. “There is a lot of microvascular endothelial dysfunction.”

The combination of heart failure and diabetes is especially lethal. “If you put them together, you’re looking at about a 10-fold higher risk of mortality, which is a horrible prognosis,” Dr. Butler said. “That means that we need to think about prevention and treatment separately.”

Data from the SAVOR-TIMI 53, EXAMINE, and TECOS trials show there is no protective effect of dipeptidyl peptidase–4 inhibitors when it comes to hospitalization for heart failure.

“The other classes of drugs either increase the risk, or we don’t have very good data,” Dr. Butler said. “So far, across the spectrum of therapies for diabetes, the effect on heart failure is neutral and perhaps confers some risk.”

SGLT-2 inhibitors convey a different story.

In the EMPA-REG OUTCOME Trial, one inclusion criterion was established cardiovascular disease (CVD) in the form of a prior MI, coronary artery disease, stroke, unstable angina, or occlusive peripheral artery disease, but not heart failure alone (N Engl J Med. 2015 Nov 26; 373[22]:2117-28). “This was not a heart failure study, so we don’t know what their New York Heart Association class was, or the details of their baseline HF treatment in the minority of patients who were enrolled who had a history of HF,” Dr. Butler cautioned.

However, the trial found that empagliflozin conferred an overall cardiovascular death risk reduction of 38%, compared with placebo. When the researchers assessed the impact of treatment on all modes of cardiovascular death, they found that death from heart failure benefited the most (hazard ratio, 0.32; P = .0008), while sudden death benefited as well. Empagliflozin also had a significant impact on reduced hospitalization for heart failure, compared with placebo (HR, 0.65).

“This is a large enough cohort that you should feel comfortable that this drug is preventing heart failure in those with HF at baseline,” said Dr. Butler, who was not involved with the study. “We can have a debate about whether this is a treatment for heart failure or not, but for prevention of heart failure, I feel comfortable that these drugs do that.”

A subsequent study of canagliflozin and cardiovascular and renal events in type 2 diabetes showed the same result (N Engl J Med. 2017 Aug 17; 377[7]:644-57). It reduced hospitalization for heart failure by 33% (HR, 0.67).

Then came the CVD-REAL study, which found low rates of hospitalization for heart failure and all-cause death in new users of SGLT-2 inhibitors. More recently, DECLARE-TIMI 58 yielded similar results.

“One of the criticisms of these findings is that heart failure characteristics were not well phenotyped in these studies,” Dr. Butler said. “I say it really does not matter. Heart failure hospitalizations are associated with a poor prognosis irrespective of whether the hospitalization occurred in patients without heart failure or in a patient with previously diagnosed heart failure, or whether the patient has reduced or preserved ejection fraction.

“Framingham and other classic studies show us that 5-year mortality for heart failure is about 50%,” he noted. “If you can prevent a disease that has a 5-year mortality of 50%, doesn’t that sound like a really good deal?”

A contemporary appraisal of the heart failure epidemic in Olmstead County, Minn., during 2000-2010 found that the mortality was 20.2% at 1 year after diagnosis, and 52.6% at 5 years after diagnosis. The data include new-onset HF in both inpatient and outpatient settings.

Specifically, new-onset HF hospitalization was associated with a 1-year post discharge mortality of 21.1% (JAMA Intern Med. 2015;175[6]:996-1004). “We cannot ignore prevention of heart failure,” Dr. Butler said. “Also, for treatment, once you get hospitalized for heart failure, the fundamental natural history of the disease changes. There is a 30% cumulative incremental death risk between the second and third hospitalizations.”

Dr. Butler concluded his presentation by noting that five randomized, controlled trials evaluating SGLT-2 inhibitors in HF have been launched, and should help elucidate any effects the drugs may have in treating the condition. They include EMPEROR-Preserved (NCT03057951), EMPEROR-Reduced (NCT03057977), Dapa-HF (NCT03036124), and SOLOIST-WHF (NCT03521934) and DELIVER (NCT03619213).

Dr. Butler disclosed that he has received research support from the National Institutes of Health, the European Union, and the Patient-Centered Outcomes Research Institute. He has also been a consultant for numerous pharmaceutical companies, including Boehringer Ingelheim, Janssen, and AstraZeneca, which sponsored the EMPA-REG, CANVAS, and DECLARE TIMI 58 trials.

[email protected]

Inflation in existing drugs’ prices and the debut of new drugs are both contributing to the overall rising costs of pharmaceuticals.

Kenishirotie/Thinkstock

According to new research, the costs of oral and injectable brand-name drugs increased annually during 2008-2016 by 9.2% and 15.1%, respectively, largely driven by existing drug prices.

For oral and injectable specialty drugs, costs increased 20.6% and 12.5%, respectively, with 71.1% and 52.4% attributable to new drugs. Costs of oral and injectable generic drugs grew by 4.4% and 7.3%, also driven by entrants into the market.

Researchers looked at monthly wholesale acquisition costs of 24,877 National Drug Codes for oral drugs and 3,049 injectable drugs from 2005 to 2016. They compared them with pharmacy claims from the UPMC Health Plan, which offers insurance products to more than 3.2 million members across the spectrum of private and public arenas.

“Our analyses yielded three main findings,” explained Inmaculada Hernandez, PharmD, PhD, University of Pittsburgh, and her colleagues in a report published in the January 2019 issue of Health Affairs.

“First, costs increased considerably faster than inflation across all drug classes, and increases were highest for oral specialty drugs and lowest for oral generics,” Dr. Hernandez and her colleagues wrote.

“Second, rising costs of brand-name drugs were driven by inflation in the prices of widely used existing drugs,” they added. A combination of new products and price inflation in existing drugs drove the rising costs of specialty drugs, with new drugs accounting for a larger share of the price increases.

Third, “existing generics tended to decrease the average cost of generic drugs,” Dr. Hernandez noted. However, new generic products cost more than those already on the market, which fueled the annual increases in average costs.

The authors noted that their estimates demonstrate the role of inflation on pharmaceutical cost increases and support policy efforts to control that inflation.

“In the current value-based landscape, increasing drug costs attributable to new products can sometimes be justified on the basis of improved outcomes,” Dr. Hernandez and colleagues stated. “However, rising costs due to inflation do not reflect improved value for patients.”

The researchers noted that the data are limited by the lack of rebate information, which is generally proprietary. Thus, “the contribution of existing drugs may have been lower than we estimated,” they noted. In addition, “because the magnitude of rebates has increased in the past decade, our findings likely overestimated cost increases for brand-name drugs.” The researchers also didn’t examine the effect of drugs transitioning from brand to generic offerings.

The authors provided no disclosures.
 

[email protected]

SOURCE: Hernandez I et al. Health Aff (Millwood). 2019 Jan 2019. doi: 10.1377/hlthaff.2018.05147.

Inflation in existing drugs’ prices and the debut of new drugs are both contributing to the overall rising costs of pharmaceuticals.

Kenishirotie/Thinkstock

According to new research, the costs of oral and injectable brand-name drugs increased annually during 2008-2016 by 9.2% and 15.1%, respectively, largely driven by existing drug prices.

For oral and injectable specialty drugs, costs increased 20.6% and 12.5%, respectively, with 71.1% and 52.4% attributable to new drugs. Costs of oral and injectable generic drugs grew by 4.4% and 7.3%, also driven by entrants into the market.

Researchers looked at monthly wholesale acquisition costs of 24,877 National Drug Codes for oral drugs and 3,049 injectable drugs from 2005 to 2016. They compared them with pharmacy claims from the UPMC Health Plan, which offers insurance products to more than 3.2 million members across the spectrum of private and public arenas.

“Our analyses yielded three main findings,” explained Inmaculada Hernandez, PharmD, PhD, University of Pittsburgh, and her colleagues in a report published in the January 2019 issue of Health Affairs.

“First, costs increased considerably faster than inflation across all drug classes, and increases were highest for oral specialty drugs and lowest for oral generics,” Dr. Hernandez and her colleagues wrote.

“Second, rising costs of brand-name drugs were driven by inflation in the prices of widely used existing drugs,” they added. A combination of new products and price inflation in existing drugs drove the rising costs of specialty drugs, with new drugs accounting for a larger share of the price increases.

Third, “existing generics tended to decrease the average cost of generic drugs,” Dr. Hernandez noted. However, new generic products cost more than those already on the market, which fueled the annual increases in average costs.

The authors noted that their estimates demonstrate the role of inflation on pharmaceutical cost increases and support policy efforts to control that inflation.

“In the current value-based landscape, increasing drug costs attributable to new products can sometimes be justified on the basis of improved outcomes,” Dr. Hernandez and colleagues stated. “However, rising costs due to inflation do not reflect improved value for patients.”

The researchers noted that the data are limited by the lack of rebate information, which is generally proprietary. Thus, “the contribution of existing drugs may have been lower than we estimated,” they noted. In addition, “because the magnitude of rebates has increased in the past decade, our findings likely overestimated cost increases for brand-name drugs.” The researchers also didn’t examine the effect of drugs transitioning from brand to generic offerings.

The authors provided no disclosures.
 

[email protected]

SOURCE: Hernandez I et al. Health Aff (Millwood). 2019 Jan 2019. doi: 10.1377/hlthaff.2018.05147.

Inflation in existing drugs’ prices and the debut of new drugs are both contributing to the overall rising costs of pharmaceuticals.

Kenishirotie/Thinkstock

According to new research, the costs of oral and injectable brand-name drugs increased annually during 2008-2016 by 9.2% and 15.1%, respectively, largely driven by existing drug prices.

For oral and injectable specialty drugs, costs increased 20.6% and 12.5%, respectively, with 71.1% and 52.4% attributable to new drugs. Costs of oral and injectable generic drugs grew by 4.4% and 7.3%, also driven by entrants into the market.

Researchers looked at monthly wholesale acquisition costs of 24,877 National Drug Codes for oral drugs and 3,049 injectable drugs from 2005 to 2016. They compared them with pharmacy claims from the UPMC Health Plan, which offers insurance products to more than 3.2 million members across the spectrum of private and public arenas.

“Our analyses yielded three main findings,” explained Inmaculada Hernandez, PharmD, PhD, University of Pittsburgh, and her colleagues in a report published in the January 2019 issue of Health Affairs.

“First, costs increased considerably faster than inflation across all drug classes, and increases were highest for oral specialty drugs and lowest for oral generics,” Dr. Hernandez and her colleagues wrote.

“Second, rising costs of brand-name drugs were driven by inflation in the prices of widely used existing drugs,” they added. A combination of new products and price inflation in existing drugs drove the rising costs of specialty drugs, with new drugs accounting for a larger share of the price increases.

Third, “existing generics tended to decrease the average cost of generic drugs,” Dr. Hernandez noted. However, new generic products cost more than those already on the market, which fueled the annual increases in average costs.

The authors noted that their estimates demonstrate the role of inflation on pharmaceutical cost increases and support policy efforts to control that inflation.

“In the current value-based landscape, increasing drug costs attributable to new products can sometimes be justified on the basis of improved outcomes,” Dr. Hernandez and colleagues stated. “However, rising costs due to inflation do not reflect improved value for patients.”

The researchers noted that the data are limited by the lack of rebate information, which is generally proprietary. Thus, “the contribution of existing drugs may have been lower than we estimated,” they noted. In addition, “because the magnitude of rebates has increased in the past decade, our findings likely overestimated cost increases for brand-name drugs.” The researchers also didn’t examine the effect of drugs transitioning from brand to generic offerings.

The authors provided no disclosures.
 

[email protected]

SOURCE: Hernandez I et al. Health Aff (Millwood). 2019 Jan 2019. doi: 10.1377/hlthaff.2018.05147.

The 2018-2019 flu season may have peaked as measures of influenza-like illness (ILI) activity dropped in the first week of the new year, according to the U.S. Centers for Disease Control and Prevention.

The proportion of outpatients visits for ILI dropped to 3.5% for the week ending Jan. 5, 2019, after reaching 4.0% the previous week. Outpatient ILI visits first topped the national baseline of 2.2% during the week ending Dec. 8, 2018, and have remained above that value for 5 consecutive weeks, the CDC’s influenza division said on Jan. 11.

Flu activity reported by the states reflects the national drop: 10 states came in at level 10 on the CDC’s 1-10 scale of activity for the week ending Jan. 5 – down from 12 the week before – and a total of 15 were in the high range from 8 to 10, compared with 19 the previous week, the CDC said. Two states, Mississippi and Texas, dropped from level 10 to level 7, which the CDC categorizes as moderate activity.

A total of 73 ILI-related deaths were reported during the week ending Dec. 29 (the latest with data available; reporting less than 68% complete), which already exceeds the 71 deaths reported for the week ending Dec. 22 (reporting 85% complete). Flu deaths totaled 437 through the first 13 weeks of the 2018-2019 season, compared with the 1,659 that occurred during weeks 1-13 of the very severe 2017-2018 season, CDC data show.

For the week ending Jan. 5, the CDC received reports of three flu-related pediatric deaths, all of which occurred the previous week. For the season so far, there have been 16 pediatric deaths, compared with 20 at this point in the 2017-2018 season.

Estimates released during the flu season for the first time show that between 6 and 7 million Americans have been infected since Oct. 1, 2018, and that 69,000-84,000 people have been hospitalized with the flu through Jan. 5, 2019. These cumulative totals have previously been available only at the end of the season, the CDC noted.

[email protected]

The 2018-2019 flu season may have peaked as measures of influenza-like illness (ILI) activity dropped in the first week of the new year, according to the U.S. Centers for Disease Control and Prevention.

The proportion of outpatients visits for ILI dropped to 3.5% for the week ending Jan. 5, 2019, after reaching 4.0% the previous week. Outpatient ILI visits first topped the national baseline of 2.2% during the week ending Dec. 8, 2018, and have remained above that value for 5 consecutive weeks, the CDC’s influenza division said on Jan. 11.

Flu activity reported by the states reflects the national drop: 10 states came in at level 10 on the CDC’s 1-10 scale of activity for the week ending Jan. 5 – down from 12 the week before – and a total of 15 were in the high range from 8 to 10, compared with 19 the previous week, the CDC said. Two states, Mississippi and Texas, dropped from level 10 to level 7, which the CDC categorizes as moderate activity.

A total of 73 ILI-related deaths were reported during the week ending Dec. 29 (the latest with data available; reporting less than 68% complete), which already exceeds the 71 deaths reported for the week ending Dec. 22 (reporting 85% complete). Flu deaths totaled 437 through the first 13 weeks of the 2018-2019 season, compared with the 1,659 that occurred during weeks 1-13 of the very severe 2017-2018 season, CDC data show.

For the week ending Jan. 5, the CDC received reports of three flu-related pediatric deaths, all of which occurred the previous week. For the season so far, there have been 16 pediatric deaths, compared with 20 at this point in the 2017-2018 season.

Estimates released during the flu season for the first time show that between 6 and 7 million Americans have been infected since Oct. 1, 2018, and that 69,000-84,000 people have been hospitalized with the flu through Jan. 5, 2019. These cumulative totals have previously been available only at the end of the season, the CDC noted.

[email protected]

The 2018-2019 flu season may have peaked as measures of influenza-like illness (ILI) activity dropped in the first week of the new year, according to the U.S. Centers for Disease Control and Prevention.

The proportion of outpatients visits for ILI dropped to 3.5% for the week ending Jan. 5, 2019, after reaching 4.0% the previous week. Outpatient ILI visits first topped the national baseline of 2.2% during the week ending Dec. 8, 2018, and have remained above that value for 5 consecutive weeks, the CDC’s influenza division said on Jan. 11.

Flu activity reported by the states reflects the national drop: 10 states came in at level 10 on the CDC’s 1-10 scale of activity for the week ending Jan. 5 – down from 12 the week before – and a total of 15 were in the high range from 8 to 10, compared with 19 the previous week, the CDC said. Two states, Mississippi and Texas, dropped from level 10 to level 7, which the CDC categorizes as moderate activity.

A total of 73 ILI-related deaths were reported during the week ending Dec. 29 (the latest with data available; reporting less than 68% complete), which already exceeds the 71 deaths reported for the week ending Dec. 22 (reporting 85% complete). Flu deaths totaled 437 through the first 13 weeks of the 2018-2019 season, compared with the 1,659 that occurred during weeks 1-13 of the very severe 2017-2018 season, CDC data show.

For the week ending Jan. 5, the CDC received reports of three flu-related pediatric deaths, all of which occurred the previous week. For the season so far, there have been 16 pediatric deaths, compared with 20 at this point in the 2017-2018 season.

Estimates released during the flu season for the first time show that between 6 and 7 million Americans have been infected since Oct. 1, 2018, and that 69,000-84,000 people have been hospitalized with the flu through Jan. 5, 2019. These cumulative totals have previously been available only at the end of the season, the CDC noted.

[email protected]

The Michigan chapter of the Society of Hospital Medicine has named Peter Watson, MD, SFHM, as state Hospitalist of the Year. Dr. Watson is the vice president of care management and outcomes for Health Alliance Plan (HAP) in Detroit. The Michigan chapter cited Dr. Watson’s leadership in hospital medicine and “generosity of spirit” as reasons for his selection.

Dr. Watson oversees nurses, social workers, and support staff while also serving as HAP Midwest Health Plan’s medical director. He’s a founding member of the Michigan SHM chapter, which he formerly represented as president.

Dr. Watson spent 11 years overseeing the Henry Ford Medical Group’s hospitalist program prior to joining HAP, and still works as an attending hospitalist for Henry Ford.

Hyung (Harry) Cho, MD, was named the inaugural chief value officer for NYC Health + Hospitals, which includes 11 hospitals in New York and is the largest public health system in the United States. He will oversee systemwide initiatives in value improvement and the reduction of unnecessary testing and treatment.

Prior to this appointment, Dr. Cho served as an academic hospitalist at Mount Sinai Hospital for 7 years, leading high-value care initiatives. Currently, he is a senior fellow with the Lown Institute in Brookline, Mass., and director of quality improvement implementation for the High Value Practice Academic Alliance.

Nick Fitterman, MD, SFHM, has been promoted to executive director at Huntington (N.Y.) Hospital. Dr. Fitterman has been a long-time physician and administrator at Huntington, serving previously as vice chair of medicine as well as head of hospitalists.

Dr. Fitterman has served as president of SHM’s Long Island chapter.

Previously, Dr. Fitterman was chief resident at the State University of New York at Stony Brook, and he remains an associate professor at Hofstra University, Hempstead, N.Y.

Allen Kachalia, MD, was named director of the Armstrong Institute for Patient Safety and Quality and senior vice president of patient safety and quality for Johns Hopkins Medicine in Baltimore. Dr. Kachalia is a general internist who has been an active academic hospitalist at Brigham and Women’s Hospital in Boston.

Dr. Kachalia will oversee patient safety and quality across all of Hopkins Medicine, with a focus on ending preventable harm, improving outcomes and patient experience, and reducing waste in the system’s delivery of care. He also will guide academic efforts for the Armstrong Institute, formed recently thanks to a $10 million gift.

In addition to his hospitalist work, Dr. Kachalia comes to Hopkins after serving as chief quality officer and vice president of quality and safety at Brigham Health.

Riane Dodge, PA, has been elevated to director of clinical education in physician assistant studies at Clarkson University, Potsdam, N.Y. The veteran physician assistant previously worked as a hospitalist in the Claxton Hepburn Medical Center in Ogdensburg, N.Y. There, she cared for patients in acute rehab, mental health, and on regular medical floors.

Dodge also has a background in urgent care and family medicine, and has experience as an emergency department technician.

BUSINESS MOVES

Surgical Affiliates of Sacramento, a surgical hospitalist provider with expertise in trauma, orthopedic, neurosurgery, and general surgery for hospital systems, has added partnerships with Christus Spohn Hospital South and Christus Spohn Hospital Shoreline in Corpus Christi, Texas.

Surgical Affiliates’ hospitalist system will provide round-the-clock emergency orthopedic surgery service to adult and pediatric patients in the two hospitals. With Surgical Affiliates’ help, Christus Spohn facilities will be able to cover its own patients, as well as those requiring transfer from regional hospitals.

Hospitalist surgeons will handle emergency surgeries and patient surgery consultations. Clinics will be provided at each facility to care for patients after they are discharged.

The Michigan chapter of the Society of Hospital Medicine has named Peter Watson, MD, SFHM, as state Hospitalist of the Year. Dr. Watson is the vice president of care management and outcomes for Health Alliance Plan (HAP) in Detroit. The Michigan chapter cited Dr. Watson’s leadership in hospital medicine and “generosity of spirit” as reasons for his selection.

Dr. Watson oversees nurses, social workers, and support staff while also serving as HAP Midwest Health Plan’s medical director. He’s a founding member of the Michigan SHM chapter, which he formerly represented as president.

Dr. Watson spent 11 years overseeing the Henry Ford Medical Group’s hospitalist program prior to joining HAP, and still works as an attending hospitalist for Henry Ford.

Hyung (Harry) Cho, MD, was named the inaugural chief value officer for NYC Health + Hospitals, which includes 11 hospitals in New York and is the largest public health system in the United States. He will oversee systemwide initiatives in value improvement and the reduction of unnecessary testing and treatment.

Prior to this appointment, Dr. Cho served as an academic hospitalist at Mount Sinai Hospital for 7 years, leading high-value care initiatives. Currently, he is a senior fellow with the Lown Institute in Brookline, Mass., and director of quality improvement implementation for the High Value Practice Academic Alliance.

Nick Fitterman, MD, SFHM, has been promoted to executive director at Huntington (N.Y.) Hospital. Dr. Fitterman has been a long-time physician and administrator at Huntington, serving previously as vice chair of medicine as well as head of hospitalists.

Dr. Fitterman has served as president of SHM’s Long Island chapter.

Previously, Dr. Fitterman was chief resident at the State University of New York at Stony Brook, and he remains an associate professor at Hofstra University, Hempstead, N.Y.

Allen Kachalia, MD, was named director of the Armstrong Institute for Patient Safety and Quality and senior vice president of patient safety and quality for Johns Hopkins Medicine in Baltimore. Dr. Kachalia is a general internist who has been an active academic hospitalist at Brigham and Women’s Hospital in Boston.

Dr. Kachalia will oversee patient safety and quality across all of Hopkins Medicine, with a focus on ending preventable harm, improving outcomes and patient experience, and reducing waste in the system’s delivery of care. He also will guide academic efforts for the Armstrong Institute, formed recently thanks to a $10 million gift.

In addition to his hospitalist work, Dr. Kachalia comes to Hopkins after serving as chief quality officer and vice president of quality and safety at Brigham Health.

Riane Dodge, PA, has been elevated to director of clinical education in physician assistant studies at Clarkson University, Potsdam, N.Y. The veteran physician assistant previously worked as a hospitalist in the Claxton Hepburn Medical Center in Ogdensburg, N.Y. There, she cared for patients in acute rehab, mental health, and on regular medical floors.

Dodge also has a background in urgent care and family medicine, and has experience as an emergency department technician.

BUSINESS MOVES

Surgical Affiliates of Sacramento, a surgical hospitalist provider with expertise in trauma, orthopedic, neurosurgery, and general surgery for hospital systems, has added partnerships with Christus Spohn Hospital South and Christus Spohn Hospital Shoreline in Corpus Christi, Texas.

Surgical Affiliates’ hospitalist system will provide round-the-clock emergency orthopedic surgery service to adult and pediatric patients in the two hospitals. With Surgical Affiliates’ help, Christus Spohn facilities will be able to cover its own patients, as well as those requiring transfer from regional hospitals.

Hospitalist surgeons will handle emergency surgeries and patient surgery consultations. Clinics will be provided at each facility to care for patients after they are discharged.

The Michigan chapter of the Society of Hospital Medicine has named Peter Watson, MD, SFHM, as state Hospitalist of the Year. Dr. Watson is the vice president of care management and outcomes for Health Alliance Plan (HAP) in Detroit. The Michigan chapter cited Dr. Watson’s leadership in hospital medicine and “generosity of spirit” as reasons for his selection.

Dr. Watson oversees nurses, social workers, and support staff while also serving as HAP Midwest Health Plan’s medical director. He’s a founding member of the Michigan SHM chapter, which he formerly represented as president.

Dr. Watson spent 11 years overseeing the Henry Ford Medical Group’s hospitalist program prior to joining HAP, and still works as an attending hospitalist for Henry Ford.

Hyung (Harry) Cho, MD, was named the inaugural chief value officer for NYC Health + Hospitals, which includes 11 hospitals in New York and is the largest public health system in the United States. He will oversee systemwide initiatives in value improvement and the reduction of unnecessary testing and treatment.

Prior to this appointment, Dr. Cho served as an academic hospitalist at Mount Sinai Hospital for 7 years, leading high-value care initiatives. Currently, he is a senior fellow with the Lown Institute in Brookline, Mass., and director of quality improvement implementation for the High Value Practice Academic Alliance.

Nick Fitterman, MD, SFHM, has been promoted to executive director at Huntington (N.Y.) Hospital. Dr. Fitterman has been a long-time physician and administrator at Huntington, serving previously as vice chair of medicine as well as head of hospitalists.

Dr. Fitterman has served as president of SHM’s Long Island chapter.

Previously, Dr. Fitterman was chief resident at the State University of New York at Stony Brook, and he remains an associate professor at Hofstra University, Hempstead, N.Y.

Allen Kachalia, MD, was named director of the Armstrong Institute for Patient Safety and Quality and senior vice president of patient safety and quality for Johns Hopkins Medicine in Baltimore. Dr. Kachalia is a general internist who has been an active academic hospitalist at Brigham and Women’s Hospital in Boston.

Dr. Kachalia will oversee patient safety and quality across all of Hopkins Medicine, with a focus on ending preventable harm, improving outcomes and patient experience, and reducing waste in the system’s delivery of care. He also will guide academic efforts for the Armstrong Institute, formed recently thanks to a $10 million gift.

In addition to his hospitalist work, Dr. Kachalia comes to Hopkins after serving as chief quality officer and vice president of quality and safety at Brigham Health.

Riane Dodge, PA, has been elevated to director of clinical education in physician assistant studies at Clarkson University, Potsdam, N.Y. The veteran physician assistant previously worked as a hospitalist in the Claxton Hepburn Medical Center in Ogdensburg, N.Y. There, she cared for patients in acute rehab, mental health, and on regular medical floors.

Dodge also has a background in urgent care and family medicine, and has experience as an emergency department technician.

BUSINESS MOVES

Surgical Affiliates of Sacramento, a surgical hospitalist provider with expertise in trauma, orthopedic, neurosurgery, and general surgery for hospital systems, has added partnerships with Christus Spohn Hospital South and Christus Spohn Hospital Shoreline in Corpus Christi, Texas.

Surgical Affiliates’ hospitalist system will provide round-the-clock emergency orthopedic surgery service to adult and pediatric patients in the two hospitals. With Surgical Affiliates’ help, Christus Spohn facilities will be able to cover its own patients, as well as those requiring transfer from regional hospitals.

Hospitalist surgeons will handle emergency surgeries and patient surgery consultations. Clinics will be provided at each facility to care for patients after they are discharged.

MONTREAL – For the second time in the past year, an anticoagulant failed to show superiority when it was compared with aspirin for preventing a second stroke in patients who had had an index embolic stroke of undetermined source (ESUS). But the most recent results gave a tantalizing suggestion that the anticoagulant approach might be effective for older patients, those at least 75 years old, possibly because these patients have the highest incidence of atrial fibrillation.

Mitchel L. Zoler/MDedge News

“The fact that we saw a treatment benefit in patients 75 and older [in a post hoc, subgroup analysis] means that development of atrial fibrillation (AF) is probably the most important factor,” Hans-Christoph Diener, MD, said at the World Stroke Congress. Another clue that incident AF drove a treatment benefit hidden in the new trial’s overall neutral result was that a post hoc, landmark analysis showed that, while the rate of second strokes was identical during the first year of follow-up in patients on either aspirin or the anticoagulant dabigatran (Pradaxa) after an index ESUS, patients on dabigatran had significantly fewer second strokes during subsequent follow-up.

More follow-up time was needed to see a benefit from anticoagulation because “it takes time for AF to develop, and then once a patient has AF, it takes time for a stroke to occur,” explained Dr. Diener, professor of neurology at the University of Duisburg-Essen in Essen, Germany.

The RE-SPECT ESUS (Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source) trial randomized 5,390 patients at more than 500 sites in 41 countries, including the United States, within 6 months of an index ESUS who had no history of AF and no severe renal impairment. All enrollees had to have less than 6 minutes of AF episodes during at least 20 hours of cardiac monitoring, and they had to be free of flow-limiting stenoses (50% or more) in arteries supplying their stroke region. Patients received either 150 mg or 110 mg of dabigatran twice daily depending on their age and renal function or 100 mg of aspirin daily. About a quarter of patients randomized to dabigatran received the lower dosage. The enrolled patients averaged 66 years old, almost two-thirds were men, and they started treatment a median of 44 days after their index stroke.

During a median 19 months’ follow-up, the incidence of a second stroke of any type was 4.1%/year among the patients on dabigatran and 4.8%/year among those on aspirin, a difference that was not statistically significant. However, the post hoc landmark analysis showed a significant reduction in second strokes with dabigatran treatment after the first year. In addition, a post hoc subgroup analysis showed that, among patients aged at least 75 years old, treatment with dabigatran linked with a statistically significant 37% reduction in second strokes, compared with treatment with aspirin, Dr. Diener reported.

The primary safety endpoint was major bleeds, as defined by the International Society on Thrombosis and Haemostasis, which occurred in 1.7%/year of patients on dabigatran and 1.4%/year of those on aspirin, a difference that was not statistically significant. Patients on dabigatran had a significant excess of major bleeds combined with clinically significant nonmajor bleeds: 3.3%/year versus 2.3%/year among those on aspirin.

A little over 4 months before Dr. Diener’s report, a separate research group published primary results from the NAVIGATE ESUS (Rivaroxaban Versus Aspirin in Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With Recent Embolic Stroke of Undetermined Source) trial, which compared the anticoagulant rivaroxaban (Xarelto) with aspirin for prevention of a second stroke in 7,213 ESUS patients. The results showed no significant efficacy difference between rivaroxaban and aspirin (N Engl J Med. 2018 June 7;378[23]:2191-2201).

RE-SPECT ESUS was funded by Boehringer Ingelheim, the company that markets dabigatran (Pradaxa). Dr. Diener has been a consultant to and has received research funding from Boehringer Ingelheim, as well as several other companies.

[email protected]

SOURCE: Diener H-C et al. Int J Stroke. 2018;13(2_suppl):27. Abstract 100.

MONTREAL – For the second time in the past year, an anticoagulant failed to show superiority when it was compared with aspirin for preventing a second stroke in patients who had had an index embolic stroke of undetermined source (ESUS). But the most recent results gave a tantalizing suggestion that the anticoagulant approach might be effective for older patients, those at least 75 years old, possibly because these patients have the highest incidence of atrial fibrillation.

Mitchel L. Zoler/MDedge News

“The fact that we saw a treatment benefit in patients 75 and older [in a post hoc, subgroup analysis] means that development of atrial fibrillation (AF) is probably the most important factor,” Hans-Christoph Diener, MD, said at the World Stroke Congress. Another clue that incident AF drove a treatment benefit hidden in the new trial’s overall neutral result was that a post hoc, landmark analysis showed that, while the rate of second strokes was identical during the first year of follow-up in patients on either aspirin or the anticoagulant dabigatran (Pradaxa) after an index ESUS, patients on dabigatran had significantly fewer second strokes during subsequent follow-up.

More follow-up time was needed to see a benefit from anticoagulation because “it takes time for AF to develop, and then once a patient has AF, it takes time for a stroke to occur,” explained Dr. Diener, professor of neurology at the University of Duisburg-Essen in Essen, Germany.

The RE-SPECT ESUS (Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source) trial randomized 5,390 patients at more than 500 sites in 41 countries, including the United States, within 6 months of an index ESUS who had no history of AF and no severe renal impairment. All enrollees had to have less than 6 minutes of AF episodes during at least 20 hours of cardiac monitoring, and they had to be free of flow-limiting stenoses (50% or more) in arteries supplying their stroke region. Patients received either 150 mg or 110 mg of dabigatran twice daily depending on their age and renal function or 100 mg of aspirin daily. About a quarter of patients randomized to dabigatran received the lower dosage. The enrolled patients averaged 66 years old, almost two-thirds were men, and they started treatment a median of 44 days after their index stroke.

During a median 19 months’ follow-up, the incidence of a second stroke of any type was 4.1%/year among the patients on dabigatran and 4.8%/year among those on aspirin, a difference that was not statistically significant. However, the post hoc landmark analysis showed a significant reduction in second strokes with dabigatran treatment after the first year. In addition, a post hoc subgroup analysis showed that, among patients aged at least 75 years old, treatment with dabigatran linked with a statistically significant 37% reduction in second strokes, compared with treatment with aspirin, Dr. Diener reported.

The primary safety endpoint was major bleeds, as defined by the International Society on Thrombosis and Haemostasis, which occurred in 1.7%/year of patients on dabigatran and 1.4%/year of those on aspirin, a difference that was not statistically significant. Patients on dabigatran had a significant excess of major bleeds combined with clinically significant nonmajor bleeds: 3.3%/year versus 2.3%/year among those on aspirin.

A little over 4 months before Dr. Diener’s report, a separate research group published primary results from the NAVIGATE ESUS (Rivaroxaban Versus Aspirin in Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With Recent Embolic Stroke of Undetermined Source) trial, which compared the anticoagulant rivaroxaban (Xarelto) with aspirin for prevention of a second stroke in 7,213 ESUS patients. The results showed no significant efficacy difference between rivaroxaban and aspirin (N Engl J Med. 2018 June 7;378[23]:2191-2201).

RE-SPECT ESUS was funded by Boehringer Ingelheim, the company that markets dabigatran (Pradaxa). Dr. Diener has been a consultant to and has received research funding from Boehringer Ingelheim, as well as several other companies.

[email protected]

SOURCE: Diener H-C et al. Int J Stroke. 2018;13(2_suppl):27. Abstract 100.

MONTREAL – For the second time in the past year, an anticoagulant failed to show superiority when it was compared with aspirin for preventing a second stroke in patients who had had an index embolic stroke of undetermined source (ESUS). But the most recent results gave a tantalizing suggestion that the anticoagulant approach might be effective for older patients, those at least 75 years old, possibly because these patients have the highest incidence of atrial fibrillation.

Mitchel L. Zoler/MDedge News

“The fact that we saw a treatment benefit in patients 75 and older [in a post hoc, subgroup analysis] means that development of atrial fibrillation (AF) is probably the most important factor,” Hans-Christoph Diener, MD, said at the World Stroke Congress. Another clue that incident AF drove a treatment benefit hidden in the new trial’s overall neutral result was that a post hoc, landmark analysis showed that, while the rate of second strokes was identical during the first year of follow-up in patients on either aspirin or the anticoagulant dabigatran (Pradaxa) after an index ESUS, patients on dabigatran had significantly fewer second strokes during subsequent follow-up.

More follow-up time was needed to see a benefit from anticoagulation because “it takes time for AF to develop, and then once a patient has AF, it takes time for a stroke to occur,” explained Dr. Diener, professor of neurology at the University of Duisburg-Essen in Essen, Germany.

The RE-SPECT ESUS (Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source) trial randomized 5,390 patients at more than 500 sites in 41 countries, including the United States, within 6 months of an index ESUS who had no history of AF and no severe renal impairment. All enrollees had to have less than 6 minutes of AF episodes during at least 20 hours of cardiac monitoring, and they had to be free of flow-limiting stenoses (50% or more) in arteries supplying their stroke region. Patients received either 150 mg or 110 mg of dabigatran twice daily depending on their age and renal function or 100 mg of aspirin daily. About a quarter of patients randomized to dabigatran received the lower dosage. The enrolled patients averaged 66 years old, almost two-thirds were men, and they started treatment a median of 44 days after their index stroke.

During a median 19 months’ follow-up, the incidence of a second stroke of any type was 4.1%/year among the patients on dabigatran and 4.8%/year among those on aspirin, a difference that was not statistically significant. However, the post hoc landmark analysis showed a significant reduction in second strokes with dabigatran treatment after the first year. In addition, a post hoc subgroup analysis showed that, among patients aged at least 75 years old, treatment with dabigatran linked with a statistically significant 37% reduction in second strokes, compared with treatment with aspirin, Dr. Diener reported.

The primary safety endpoint was major bleeds, as defined by the International Society on Thrombosis and Haemostasis, which occurred in 1.7%/year of patients on dabigatran and 1.4%/year of those on aspirin, a difference that was not statistically significant. Patients on dabigatran had a significant excess of major bleeds combined with clinically significant nonmajor bleeds: 3.3%/year versus 2.3%/year among those on aspirin.

A little over 4 months before Dr. Diener’s report, a separate research group published primary results from the NAVIGATE ESUS (Rivaroxaban Versus Aspirin in Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With Recent Embolic Stroke of Undetermined Source) trial, which compared the anticoagulant rivaroxaban (Xarelto) with aspirin for prevention of a second stroke in 7,213 ESUS patients. The results showed no significant efficacy difference between rivaroxaban and aspirin (N Engl J Med. 2018 June 7;378[23]:2191-2201).

RE-SPECT ESUS was funded by Boehringer Ingelheim, the company that markets dabigatran (Pradaxa). Dr. Diener has been a consultant to and has received research funding from Boehringer Ingelheim, as well as several other companies.

[email protected]

SOURCE: Diener H-C et al. Int J Stroke. 2018;13(2_suppl):27. Abstract 100.

In a position statement published online ahead of print Jan. 2 in Neurology, the American Academy of Neurology urges uniformity in the laws, policies, and practices related to brain death. Such uniformity would reduce uncertainty and improve patient care, according to the authors. The statement, which was drafted by the AAN’s Brain Death Working Group, also supports the development of uniform policies regarding brain death and its determination within American medical institutions. Finally, the document provides neurologists with guidance for responding to requests for accommodation, including objections to the determination of brain death and to the withdrawal of organ-sustaining technology.

The AAN defines brain death as death resulting from irreversible loss of function of the entire brain. The Uniform Determination of Death Act of 1981 held that brain death and circulatory death (that is, death resulting from irreversible loss of function of the circulatory system) are equivalent, and the AAN acknowledges this equivalence.

The two current medical standards for brain death are the AAN’s 2010 Evidence-Based Guideline Update: Determining Brain Death in Adults and the 2011 Guidelines for the Determination of Brain Death in Infants and Children, which was published by the pediatric section of the Society of Critical Care Medicine, the sections of neurology and critical care of the American Academy of Pediatrics, and the Child Neurology Society. “The AAN is unaware of any cases in which compliant application of the brain death guidelines led to inaccurate determination of death with return of any brain function, including consciousness, brainstem reflexes, or ventilatory effort,” according to their 2019 statement.

The only jurisdiction with laws that specifically defer to these standards, however, is Nevada. The vagueness of most states’ laws has contributed to divergent legal interpretations and idiosyncratic standards for determining brain death, according to the statement.

“The AAN believes that a specific, uniform standard for the determination of brain death is critically important to provide the highest quality patient-centered neurologic and end-of-life care,” said James Russell, DO, MS, a neurologist at Lahey Hospital and Medical Center in Burlington, Mass., and lead author of the position statement. “The AAN supports the development of legislation in every state modeled after the Nevada statute, which specifically defers to these current adult and pediatric brain death guidelines and any future updates.”

In addition to uniform institutional policies for determining brain death within U.S. medical facilities, the AAN calls for the development of training programs and credentialing mechanisms for physicians who determine brain death, regardless of their specialties. The association also supports research that enhances understanding of brain death and enhanced professional and public education.

While expressing respect and sympathy for requests for limited accommodation, the AAN asserts that these requests “must be based on the values of the patient, and not those of loved ones or other surrogate decision makers.” The association further observes that physicians have no ethical obligation to provide medical treatment to a deceased patient. New Jersey is the only state that legally obliges physicians to provide indefinite accommodation and continued application of organ-sustaining technology.

“The AAN believes that its members have both the moral authority and professional responsibility, when lawful, to perform a brain death evaluation, including apnea testing, after informing a patient’s loved ones or lawful surrogates of that intention, but without obligation to obtain informed consent,” according to the statement. “This position is analogous to the authority and responsibility historically granted to the medical profession to determine circulatory death without the requirement for additional informed consent.”

If a dispute about indefinite accommodation cannot be resolved, it is acceptable for a physician to withdraw organ-sustaining technology unilaterally over the objection of loved ones when legally permitted, according to the AAN. Such unilateral action is a measure of last resort and does not apply when the patient is a pregnant woman, said the authors. In the latter case, the ethical analysis should focus mainly on the welfare of the fetus.

The AAN provided financial support for the Brain Death Working Group’s efforts. The statement’s authors reported no relevant disclosures. The American Neurological Association and the Child Neurology Society have endorsed the AAN’s position statement.

[email protected]

SOURCE: Russell JA et al. Neurology. 2018 Jan 2. doi: 10.1212/WNL.0000000000006750.
 

In a position statement published online ahead of print Jan. 2 in Neurology, the American Academy of Neurology urges uniformity in the laws, policies, and practices related to brain death. Such uniformity would reduce uncertainty and improve patient care, according to the authors. The statement, which was drafted by the AAN’s Brain Death Working Group, also supports the development of uniform policies regarding brain death and its determination within American medical institutions. Finally, the document provides neurologists with guidance for responding to requests for accommodation, including objections to the determination of brain death and to the withdrawal of organ-sustaining technology.

The AAN defines brain death as death resulting from irreversible loss of function of the entire brain. The Uniform Determination of Death Act of 1981 held that brain death and circulatory death (that is, death resulting from irreversible loss of function of the circulatory system) are equivalent, and the AAN acknowledges this equivalence.

The two current medical standards for brain death are the AAN’s 2010 Evidence-Based Guideline Update: Determining Brain Death in Adults and the 2011 Guidelines for the Determination of Brain Death in Infants and Children, which was published by the pediatric section of the Society of Critical Care Medicine, the sections of neurology and critical care of the American Academy of Pediatrics, and the Child Neurology Society. “The AAN is unaware of any cases in which compliant application of the brain death guidelines led to inaccurate determination of death with return of any brain function, including consciousness, brainstem reflexes, or ventilatory effort,” according to their 2019 statement.

The only jurisdiction with laws that specifically defer to these standards, however, is Nevada. The vagueness of most states’ laws has contributed to divergent legal interpretations and idiosyncratic standards for determining brain death, according to the statement.

“The AAN believes that a specific, uniform standard for the determination of brain death is critically important to provide the highest quality patient-centered neurologic and end-of-life care,” said James Russell, DO, MS, a neurologist at Lahey Hospital and Medical Center in Burlington, Mass., and lead author of the position statement. “The AAN supports the development of legislation in every state modeled after the Nevada statute, which specifically defers to these current adult and pediatric brain death guidelines and any future updates.”

In addition to uniform institutional policies for determining brain death within U.S. medical facilities, the AAN calls for the development of training programs and credentialing mechanisms for physicians who determine brain death, regardless of their specialties. The association also supports research that enhances understanding of brain death and enhanced professional and public education.

While expressing respect and sympathy for requests for limited accommodation, the AAN asserts that these requests “must be based on the values of the patient, and not those of loved ones or other surrogate decision makers.” The association further observes that physicians have no ethical obligation to provide medical treatment to a deceased patient. New Jersey is the only state that legally obliges physicians to provide indefinite accommodation and continued application of organ-sustaining technology.

“The AAN believes that its members have both the moral authority and professional responsibility, when lawful, to perform a brain death evaluation, including apnea testing, after informing a patient’s loved ones or lawful surrogates of that intention, but without obligation to obtain informed consent,” according to the statement. “This position is analogous to the authority and responsibility historically granted to the medical profession to determine circulatory death without the requirement for additional informed consent.”

If a dispute about indefinite accommodation cannot be resolved, it is acceptable for a physician to withdraw organ-sustaining technology unilaterally over the objection of loved ones when legally permitted, according to the AAN. Such unilateral action is a measure of last resort and does not apply when the patient is a pregnant woman, said the authors. In the latter case, the ethical analysis should focus mainly on the welfare of the fetus.

The AAN provided financial support for the Brain Death Working Group’s efforts. The statement’s authors reported no relevant disclosures. The American Neurological Association and the Child Neurology Society have endorsed the AAN’s position statement.

[email protected]

SOURCE: Russell JA et al. Neurology. 2018 Jan 2. doi: 10.1212/WNL.0000000000006750.
 

In a position statement published online ahead of print Jan. 2 in Neurology, the American Academy of Neurology urges uniformity in the laws, policies, and practices related to brain death. Such uniformity would reduce uncertainty and improve patient care, according to the authors. The statement, which was drafted by the AAN’s Brain Death Working Group, also supports the development of uniform policies regarding brain death and its determination within American medical institutions. Finally, the document provides neurologists with guidance for responding to requests for accommodation, including objections to the determination of brain death and to the withdrawal of organ-sustaining technology.

The AAN defines brain death as death resulting from irreversible loss of function of the entire brain. The Uniform Determination of Death Act of 1981 held that brain death and circulatory death (that is, death resulting from irreversible loss of function of the circulatory system) are equivalent, and the AAN acknowledges this equivalence.

The two current medical standards for brain death are the AAN’s 2010 Evidence-Based Guideline Update: Determining Brain Death in Adults and the 2011 Guidelines for the Determination of Brain Death in Infants and Children, which was published by the pediatric section of the Society of Critical Care Medicine, the sections of neurology and critical care of the American Academy of Pediatrics, and the Child Neurology Society. “The AAN is unaware of any cases in which compliant application of the brain death guidelines led to inaccurate determination of death with return of any brain function, including consciousness, brainstem reflexes, or ventilatory effort,” according to their 2019 statement.

The only jurisdiction with laws that specifically defer to these standards, however, is Nevada. The vagueness of most states’ laws has contributed to divergent legal interpretations and idiosyncratic standards for determining brain death, according to the statement.

“The AAN believes that a specific, uniform standard for the determination of brain death is critically important to provide the highest quality patient-centered neurologic and end-of-life care,” said James Russell, DO, MS, a neurologist at Lahey Hospital and Medical Center in Burlington, Mass., and lead author of the position statement. “The AAN supports the development of legislation in every state modeled after the Nevada statute, which specifically defers to these current adult and pediatric brain death guidelines and any future updates.”

In addition to uniform institutional policies for determining brain death within U.S. medical facilities, the AAN calls for the development of training programs and credentialing mechanisms for physicians who determine brain death, regardless of their specialties. The association also supports research that enhances understanding of brain death and enhanced professional and public education.

While expressing respect and sympathy for requests for limited accommodation, the AAN asserts that these requests “must be based on the values of the patient, and not those of loved ones or other surrogate decision makers.” The association further observes that physicians have no ethical obligation to provide medical treatment to a deceased patient. New Jersey is the only state that legally obliges physicians to provide indefinite accommodation and continued application of organ-sustaining technology.

“The AAN believes that its members have both the moral authority and professional responsibility, when lawful, to perform a brain death evaluation, including apnea testing, after informing a patient’s loved ones or lawful surrogates of that intention, but without obligation to obtain informed consent,” according to the statement. “This position is analogous to the authority and responsibility historically granted to the medical profession to determine circulatory death without the requirement for additional informed consent.”

If a dispute about indefinite accommodation cannot be resolved, it is acceptable for a physician to withdraw organ-sustaining technology unilaterally over the objection of loved ones when legally permitted, according to the AAN. Such unilateral action is a measure of last resort and does not apply when the patient is a pregnant woman, said the authors. In the latter case, the ethical analysis should focus mainly on the welfare of the fetus.

The AAN provided financial support for the Brain Death Working Group’s efforts. The statement’s authors reported no relevant disclosures. The American Neurological Association and the Child Neurology Society have endorsed the AAN’s position statement.

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SOURCE: Russell JA et al. Neurology. 2018 Jan 2. doi: 10.1212/WNL.0000000000006750.