Early palliative care consult decreases in-hospital mortality

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Tue, 10/22/2019 - 11:36

– When initiated early, a palliative care consultation may increase the number of discharges to hospice critical care patients meeting certain end-of-life criteria, results of a recent randomized clinical trial suggest.

The rate of in-hospital mortality was lower for critical care patients receiving an early consultation, compared with those who received palliative care initiated according to usual standards in the randomized, controlled trial, described at the annual meeting of the American College of Chest Physicians.

In addition, more health care surrogates were chosen in the hospital when palliative care medicine was involved earlier, according to investigator Scott Helgeson, MD, fellow in pulmonary critical care at the Mayo Clinic in Jacksonville, Fla.

Taken together, Dr. Helgeson said, those findings suggest the importance of getting palliative care involved “very early, while the patient can still make decisions.”

“There are a lot of things that can get in the way of adequate conversations, and that’s when the palliative care team can come in,” Dr. Helgeson said in an interview.

This study is the first reported to date to look at the impact on patient care outcomes specifically within 24 hours of medical ICU admission, according to Dr. Helgeson and coinvestigators

In their randomized study, patients were eligible if they met at least one of several criteria, including advanced age (80 years or older), late-stage dementia, post–cardiac arrest, metastatic cancer, end-stage organ failure, recurrent ICU admissions, an APACHE II score of 14 or higher, a SOFA score of 9 or higher, preexisting functional dependency, or consideration for a tracheostomy or permanent feeding tube.

Of 29 patients randomized, 14 received early palliative care, and 15 received standard palliative care, which was defined as starting “whenever the treating team deems (it) is appropriate,” according to the published abstract.

Hospital mortality occurred in none of the patients in the early palliative care group, versus six in the usual care group (P = .01), Dr. Helgeson and colleagues found. Moreover, seven health care surrogates were chosen in hospital in the early palliative care group, versus none in the usual care group (P less than .01).

Length of stay in the ICU or in hospital did not vary by treatment group, according to the investigators.

About one-fifth of deaths in the United States take place in or around ICU admissions, according to the investigators, who noted that those admissions can result in changing goals from cure to comfort – though sometimes too late.

Dr. Helgeson and coauthors disclosed that they had no relationships relevant to this research presentation.

SOURCE: Helgeson S, et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.803.

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– When initiated early, a palliative care consultation may increase the number of discharges to hospice critical care patients meeting certain end-of-life criteria, results of a recent randomized clinical trial suggest.

The rate of in-hospital mortality was lower for critical care patients receiving an early consultation, compared with those who received palliative care initiated according to usual standards in the randomized, controlled trial, described at the annual meeting of the American College of Chest Physicians.

In addition, more health care surrogates were chosen in the hospital when palliative care medicine was involved earlier, according to investigator Scott Helgeson, MD, fellow in pulmonary critical care at the Mayo Clinic in Jacksonville, Fla.

Taken together, Dr. Helgeson said, those findings suggest the importance of getting palliative care involved “very early, while the patient can still make decisions.”

“There are a lot of things that can get in the way of adequate conversations, and that’s when the palliative care team can come in,” Dr. Helgeson said in an interview.

This study is the first reported to date to look at the impact on patient care outcomes specifically within 24 hours of medical ICU admission, according to Dr. Helgeson and coinvestigators

In their randomized study, patients were eligible if they met at least one of several criteria, including advanced age (80 years or older), late-stage dementia, post–cardiac arrest, metastatic cancer, end-stage organ failure, recurrent ICU admissions, an APACHE II score of 14 or higher, a SOFA score of 9 or higher, preexisting functional dependency, or consideration for a tracheostomy or permanent feeding tube.

Of 29 patients randomized, 14 received early palliative care, and 15 received standard palliative care, which was defined as starting “whenever the treating team deems (it) is appropriate,” according to the published abstract.

Hospital mortality occurred in none of the patients in the early palliative care group, versus six in the usual care group (P = .01), Dr. Helgeson and colleagues found. Moreover, seven health care surrogates were chosen in hospital in the early palliative care group, versus none in the usual care group (P less than .01).

Length of stay in the ICU or in hospital did not vary by treatment group, according to the investigators.

About one-fifth of deaths in the United States take place in or around ICU admissions, according to the investigators, who noted that those admissions can result in changing goals from cure to comfort – though sometimes too late.

Dr. Helgeson and coauthors disclosed that they had no relationships relevant to this research presentation.

SOURCE: Helgeson S, et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.803.

– When initiated early, a palliative care consultation may increase the number of discharges to hospice critical care patients meeting certain end-of-life criteria, results of a recent randomized clinical trial suggest.

The rate of in-hospital mortality was lower for critical care patients receiving an early consultation, compared with those who received palliative care initiated according to usual standards in the randomized, controlled trial, described at the annual meeting of the American College of Chest Physicians.

In addition, more health care surrogates were chosen in the hospital when palliative care medicine was involved earlier, according to investigator Scott Helgeson, MD, fellow in pulmonary critical care at the Mayo Clinic in Jacksonville, Fla.

Taken together, Dr. Helgeson said, those findings suggest the importance of getting palliative care involved “very early, while the patient can still make decisions.”

“There are a lot of things that can get in the way of adequate conversations, and that’s when the palliative care team can come in,” Dr. Helgeson said in an interview.

This study is the first reported to date to look at the impact on patient care outcomes specifically within 24 hours of medical ICU admission, according to Dr. Helgeson and coinvestigators

In their randomized study, patients were eligible if they met at least one of several criteria, including advanced age (80 years or older), late-stage dementia, post–cardiac arrest, metastatic cancer, end-stage organ failure, recurrent ICU admissions, an APACHE II score of 14 or higher, a SOFA score of 9 or higher, preexisting functional dependency, or consideration for a tracheostomy or permanent feeding tube.

Of 29 patients randomized, 14 received early palliative care, and 15 received standard palliative care, which was defined as starting “whenever the treating team deems (it) is appropriate,” according to the published abstract.

Hospital mortality occurred in none of the patients in the early palliative care group, versus six in the usual care group (P = .01), Dr. Helgeson and colleagues found. Moreover, seven health care surrogates were chosen in hospital in the early palliative care group, versus none in the usual care group (P less than .01).

Length of stay in the ICU or in hospital did not vary by treatment group, according to the investigators.

About one-fifth of deaths in the United States take place in or around ICU admissions, according to the investigators, who noted that those admissions can result in changing goals from cure to comfort – though sometimes too late.

Dr. Helgeson and coauthors disclosed that they had no relationships relevant to this research presentation.

SOURCE: Helgeson S, et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.803.

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Race mismatch may affect survival in lung transplant setting

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Wed, 10/23/2019 - 11:31

– Race compatibility is a factor that can affect survival and needs to be considered when matching lung transplant candidates to potential donors, results from a large retrospective analysis suggest.

Dr. Alexis Kofi Okoh of Rutgers Robert Wood Johnson Medical School, New Brunswick, N.J.
Andrew D. Bowser/MDedge News
Dr. Alexis Kofi Okoh

Specifically, whites had significantly worse survival when receiving lungs from African American donors in this registry analysis, according to study investigator Alexis Kofi Okoh, MD.

By contrast, donor-to-recipient race compatibility (DRRC) did not affect posttransplant survival among African American or Hispanic patients, said Dr. Okoh, who is with the lung transplant division at the Rutgers Robert Wood Johnson Medical School, New Brunswick, N.J.

While race mismatch has been shown to affect outcomes in kidney, heart, and liver transplant settings, the data for DRRC in lung transplant prior to this analysis generally has been limited to small, single-center studies, according to Dr. Okoh.

“If you do have the option, [race compatibility] should highly be considered, because it clearly has an impact on outcomes,” Dr. Okoh said in an interview here at the annual meeting of the American College of Chest Physicians.

Considering the race of both donor and recipient is especially important now that the lung transplant population is becoming more ethnically diverse, he added.

The study was based on an analysis of 19,504 lung transplant recipients in the prospectively maintained United Network for Organ Sharing (UNOS) database during 2006-2018. In that cohort, 16,485 recipients were white, 1,787 were African American, and 1,232 were Hispanic.

Race-matched donor organs were used in two-thirds (66.2%) of white recipients, about one-quarter (26.8%) of African American recipients, and one-third (33.0%) of Hispanic recipients.

Overall, survival post–lung transplant was significantly poorer among recipients who did not receive a race-matched organ in Kaplan-Meier survival estimates, Dr. Okoh said, though, that this effect was diminished after they adjusted for patient baseline characteristics (P = 0.2809).

For African American recipients, the unadjusted and adjusted survival estimates were no different regardless of donor race, and likewise, there were no apparent survival differences between Hispanic recipients who received race matched or mismatched organs.

Survival among white recipients, however, was significantly affected by race of the recipient, with decreased survival estimates noted even after adjustment for patient characteristics, according to Dr. Okoh’s presentation.

Results of regression analysis showed that white recipient/African American donor was the only race mismatch to significantly affect survival, Dr. Okoh said in the interview.

The posttransplant survival hazard ratios (and 95% confidence intervals) reported by Dr. Okoh with a no race mismatch serving as reference were 1.15 (1.08-1.23) for whites with African American donors, and 1.09 (1.01-1.18) for whites with Hispanic donors.

Dr. Okoh and coinvestigators reported no relevant conflicts in relation to their study.

SOURCE: Okoh A et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.220.

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– Race compatibility is a factor that can affect survival and needs to be considered when matching lung transplant candidates to potential donors, results from a large retrospective analysis suggest.

Dr. Alexis Kofi Okoh of Rutgers Robert Wood Johnson Medical School, New Brunswick, N.J.
Andrew D. Bowser/MDedge News
Dr. Alexis Kofi Okoh

Specifically, whites had significantly worse survival when receiving lungs from African American donors in this registry analysis, according to study investigator Alexis Kofi Okoh, MD.

By contrast, donor-to-recipient race compatibility (DRRC) did not affect posttransplant survival among African American or Hispanic patients, said Dr. Okoh, who is with the lung transplant division at the Rutgers Robert Wood Johnson Medical School, New Brunswick, N.J.

While race mismatch has been shown to affect outcomes in kidney, heart, and liver transplant settings, the data for DRRC in lung transplant prior to this analysis generally has been limited to small, single-center studies, according to Dr. Okoh.

“If you do have the option, [race compatibility] should highly be considered, because it clearly has an impact on outcomes,” Dr. Okoh said in an interview here at the annual meeting of the American College of Chest Physicians.

Considering the race of both donor and recipient is especially important now that the lung transplant population is becoming more ethnically diverse, he added.

The study was based on an analysis of 19,504 lung transplant recipients in the prospectively maintained United Network for Organ Sharing (UNOS) database during 2006-2018. In that cohort, 16,485 recipients were white, 1,787 were African American, and 1,232 were Hispanic.

Race-matched donor organs were used in two-thirds (66.2%) of white recipients, about one-quarter (26.8%) of African American recipients, and one-third (33.0%) of Hispanic recipients.

Overall, survival post–lung transplant was significantly poorer among recipients who did not receive a race-matched organ in Kaplan-Meier survival estimates, Dr. Okoh said, though, that this effect was diminished after they adjusted for patient baseline characteristics (P = 0.2809).

For African American recipients, the unadjusted and adjusted survival estimates were no different regardless of donor race, and likewise, there were no apparent survival differences between Hispanic recipients who received race matched or mismatched organs.

Survival among white recipients, however, was significantly affected by race of the recipient, with decreased survival estimates noted even after adjustment for patient characteristics, according to Dr. Okoh’s presentation.

Results of regression analysis showed that white recipient/African American donor was the only race mismatch to significantly affect survival, Dr. Okoh said in the interview.

The posttransplant survival hazard ratios (and 95% confidence intervals) reported by Dr. Okoh with a no race mismatch serving as reference were 1.15 (1.08-1.23) for whites with African American donors, and 1.09 (1.01-1.18) for whites with Hispanic donors.

Dr. Okoh and coinvestigators reported no relevant conflicts in relation to their study.

SOURCE: Okoh A et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.220.

– Race compatibility is a factor that can affect survival and needs to be considered when matching lung transplant candidates to potential donors, results from a large retrospective analysis suggest.

Dr. Alexis Kofi Okoh of Rutgers Robert Wood Johnson Medical School, New Brunswick, N.J.
Andrew D. Bowser/MDedge News
Dr. Alexis Kofi Okoh

Specifically, whites had significantly worse survival when receiving lungs from African American donors in this registry analysis, according to study investigator Alexis Kofi Okoh, MD.

By contrast, donor-to-recipient race compatibility (DRRC) did not affect posttransplant survival among African American or Hispanic patients, said Dr. Okoh, who is with the lung transplant division at the Rutgers Robert Wood Johnson Medical School, New Brunswick, N.J.

While race mismatch has been shown to affect outcomes in kidney, heart, and liver transplant settings, the data for DRRC in lung transplant prior to this analysis generally has been limited to small, single-center studies, according to Dr. Okoh.

“If you do have the option, [race compatibility] should highly be considered, because it clearly has an impact on outcomes,” Dr. Okoh said in an interview here at the annual meeting of the American College of Chest Physicians.

Considering the race of both donor and recipient is especially important now that the lung transplant population is becoming more ethnically diverse, he added.

The study was based on an analysis of 19,504 lung transplant recipients in the prospectively maintained United Network for Organ Sharing (UNOS) database during 2006-2018. In that cohort, 16,485 recipients were white, 1,787 were African American, and 1,232 were Hispanic.

Race-matched donor organs were used in two-thirds (66.2%) of white recipients, about one-quarter (26.8%) of African American recipients, and one-third (33.0%) of Hispanic recipients.

Overall, survival post–lung transplant was significantly poorer among recipients who did not receive a race-matched organ in Kaplan-Meier survival estimates, Dr. Okoh said, though, that this effect was diminished after they adjusted for patient baseline characteristics (P = 0.2809).

For African American recipients, the unadjusted and adjusted survival estimates were no different regardless of donor race, and likewise, there were no apparent survival differences between Hispanic recipients who received race matched or mismatched organs.

Survival among white recipients, however, was significantly affected by race of the recipient, with decreased survival estimates noted even after adjustment for patient characteristics, according to Dr. Okoh’s presentation.

Results of regression analysis showed that white recipient/African American donor was the only race mismatch to significantly affect survival, Dr. Okoh said in the interview.

The posttransplant survival hazard ratios (and 95% confidence intervals) reported by Dr. Okoh with a no race mismatch serving as reference were 1.15 (1.08-1.23) for whites with African American donors, and 1.09 (1.01-1.18) for whites with Hispanic donors.

Dr. Okoh and coinvestigators reported no relevant conflicts in relation to their study.

SOURCE: Okoh A et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.220.

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Patiromer allows more CKD patients to continue on spironolactone

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Tue, 10/22/2019 - 15:41

– Among patients with chronic kidney disease with resistant hypertension, coadministration of patiromer enables more patients to stay on spironolactone, Bryan Williams, MD, of University College London, said at the scientific meeting of the Heart Failure Society of America.

Dr. Bryan Williams, University College London
Andrew D. Bowser/MDedge News
Dr. Bryan Williams

Having the potassium-binding polymer on board allowed for more persistent use of spironolactone, both in the subgroup of patients with heart failure, and those without, he said in a late-breaking clinical trials session.

In the international, phase 2 AMBER (Spironolactone With Patiromer in the Treatment of Resistant Hypertension in Chronic Kidney Disease) trial, 295 patients with chronic kidney disease (estimated glomerular filtration rate from 25 to 45 mL/min per 1.73 m2) were randomly assigned to treatment with spironolactone either placebo (148) or patiromer (147).

After 12 weeks, 86% of the patiromer patients remained on spironolactone, compared with 66% of the placebo patients, for a significant between-group difference of 19.5% (P less than .0001). In addition, blood pressure lowering was significantly greater in the patiromer (–11.7 mm Hg) than in the placebo (–10.8 mm Hg) group. Results of the AMBER trial were published concurrently with Dr. Williams’ presentation (Lancet 2019 Sep 15; doi: 10.1016/S0140-6736(19)32135-X).

While spironolactone is a “highly effective” drug, studies supporting guideline recommendations for its use in resistant hypertension have largely excluded patients with advanced chronic kidney disease because of increased risk of developing spironolactone-induced hyperkalemia, Dr. Williams told attendees. It remains unclear, however, whether coadministration of patiromer will improve long-term outcomes. Also, many placebo-treated patients in AMBER were able to continue on spironolactone without the help of patiromer, prompting one attendee to question whether there was a smarter way to target the drug, rather than treating all patients up front.

“I don’t think it’s going to be easy to say, ‘this patient’s going to respond, and this patient’s not going to respond,’ ” Dr. Williams said in response, “but at least we have an opportunity to try now in a group of patients who simply may be denied treatment because of a perception that it is difficult to use spironolactone in them.”

That perception is actually not unreasonable, he added, given that 66% of patients in the placebo group in AMBER developed hyperkalemia, suggesting that spironolactone is “not an easy drug to use” in chronic kidney disease patients.

John Teerlink, MD, of the San Francisco VA Medical Center, said the AMBER study is “another building block” in a series of developments of enabling therapies.

“I think it’s a great message for all of us to begin thinking about other therapies we can use to help modify our use of these potential life-saving therapies,” he said in a panel discussion of the results.

Patiromer’s impact on longer-term outcomes is the focus of DIAMOND, a phase 3, randomized, placebo controlled trial that is currently recruiting. DIAMOND will determine whether giving patiromer to patients who developed hyperkalemia on renin-angiotensin-aldosterone system (RAAS) inhibitors decreases cardiovascular deaths and hospitalizations, by virtue of enabling continued RAAS inhibitor use.

Funding for AMBER came from Relypsa, which markets patiromer (Veltassa). Dr. Williams reported consulting for Relypsa during the conduct of the study, along with disclosures outside the scope of the AMBER study (Daiichi Sankyo, Pfizer, Novartis, Servier, Boehringer Ingelheim, and Vascular Dynamics).

SOURCE: Williams B. HFSA 2019.

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– Among patients with chronic kidney disease with resistant hypertension, coadministration of patiromer enables more patients to stay on spironolactone, Bryan Williams, MD, of University College London, said at the scientific meeting of the Heart Failure Society of America.

Dr. Bryan Williams, University College London
Andrew D. Bowser/MDedge News
Dr. Bryan Williams

Having the potassium-binding polymer on board allowed for more persistent use of spironolactone, both in the subgroup of patients with heart failure, and those without, he said in a late-breaking clinical trials session.

In the international, phase 2 AMBER (Spironolactone With Patiromer in the Treatment of Resistant Hypertension in Chronic Kidney Disease) trial, 295 patients with chronic kidney disease (estimated glomerular filtration rate from 25 to 45 mL/min per 1.73 m2) were randomly assigned to treatment with spironolactone either placebo (148) or patiromer (147).

After 12 weeks, 86% of the patiromer patients remained on spironolactone, compared with 66% of the placebo patients, for a significant between-group difference of 19.5% (P less than .0001). In addition, blood pressure lowering was significantly greater in the patiromer (–11.7 mm Hg) than in the placebo (–10.8 mm Hg) group. Results of the AMBER trial were published concurrently with Dr. Williams’ presentation (Lancet 2019 Sep 15; doi: 10.1016/S0140-6736(19)32135-X).

While spironolactone is a “highly effective” drug, studies supporting guideline recommendations for its use in resistant hypertension have largely excluded patients with advanced chronic kidney disease because of increased risk of developing spironolactone-induced hyperkalemia, Dr. Williams told attendees. It remains unclear, however, whether coadministration of patiromer will improve long-term outcomes. Also, many placebo-treated patients in AMBER were able to continue on spironolactone without the help of patiromer, prompting one attendee to question whether there was a smarter way to target the drug, rather than treating all patients up front.

“I don’t think it’s going to be easy to say, ‘this patient’s going to respond, and this patient’s not going to respond,’ ” Dr. Williams said in response, “but at least we have an opportunity to try now in a group of patients who simply may be denied treatment because of a perception that it is difficult to use spironolactone in them.”

That perception is actually not unreasonable, he added, given that 66% of patients in the placebo group in AMBER developed hyperkalemia, suggesting that spironolactone is “not an easy drug to use” in chronic kidney disease patients.

John Teerlink, MD, of the San Francisco VA Medical Center, said the AMBER study is “another building block” in a series of developments of enabling therapies.

“I think it’s a great message for all of us to begin thinking about other therapies we can use to help modify our use of these potential life-saving therapies,” he said in a panel discussion of the results.

Patiromer’s impact on longer-term outcomes is the focus of DIAMOND, a phase 3, randomized, placebo controlled trial that is currently recruiting. DIAMOND will determine whether giving patiromer to patients who developed hyperkalemia on renin-angiotensin-aldosterone system (RAAS) inhibitors decreases cardiovascular deaths and hospitalizations, by virtue of enabling continued RAAS inhibitor use.

Funding for AMBER came from Relypsa, which markets patiromer (Veltassa). Dr. Williams reported consulting for Relypsa during the conduct of the study, along with disclosures outside the scope of the AMBER study (Daiichi Sankyo, Pfizer, Novartis, Servier, Boehringer Ingelheim, and Vascular Dynamics).

SOURCE: Williams B. HFSA 2019.

– Among patients with chronic kidney disease with resistant hypertension, coadministration of patiromer enables more patients to stay on spironolactone, Bryan Williams, MD, of University College London, said at the scientific meeting of the Heart Failure Society of America.

Dr. Bryan Williams, University College London
Andrew D. Bowser/MDedge News
Dr. Bryan Williams

Having the potassium-binding polymer on board allowed for more persistent use of spironolactone, both in the subgroup of patients with heart failure, and those without, he said in a late-breaking clinical trials session.

In the international, phase 2 AMBER (Spironolactone With Patiromer in the Treatment of Resistant Hypertension in Chronic Kidney Disease) trial, 295 patients with chronic kidney disease (estimated glomerular filtration rate from 25 to 45 mL/min per 1.73 m2) were randomly assigned to treatment with spironolactone either placebo (148) or patiromer (147).

After 12 weeks, 86% of the patiromer patients remained on spironolactone, compared with 66% of the placebo patients, for a significant between-group difference of 19.5% (P less than .0001). In addition, blood pressure lowering was significantly greater in the patiromer (–11.7 mm Hg) than in the placebo (–10.8 mm Hg) group. Results of the AMBER trial were published concurrently with Dr. Williams’ presentation (Lancet 2019 Sep 15; doi: 10.1016/S0140-6736(19)32135-X).

While spironolactone is a “highly effective” drug, studies supporting guideline recommendations for its use in resistant hypertension have largely excluded patients with advanced chronic kidney disease because of increased risk of developing spironolactone-induced hyperkalemia, Dr. Williams told attendees. It remains unclear, however, whether coadministration of patiromer will improve long-term outcomes. Also, many placebo-treated patients in AMBER were able to continue on spironolactone without the help of patiromer, prompting one attendee to question whether there was a smarter way to target the drug, rather than treating all patients up front.

“I don’t think it’s going to be easy to say, ‘this patient’s going to respond, and this patient’s not going to respond,’ ” Dr. Williams said in response, “but at least we have an opportunity to try now in a group of patients who simply may be denied treatment because of a perception that it is difficult to use spironolactone in them.”

That perception is actually not unreasonable, he added, given that 66% of patients in the placebo group in AMBER developed hyperkalemia, suggesting that spironolactone is “not an easy drug to use” in chronic kidney disease patients.

John Teerlink, MD, of the San Francisco VA Medical Center, said the AMBER study is “another building block” in a series of developments of enabling therapies.

“I think it’s a great message for all of us to begin thinking about other therapies we can use to help modify our use of these potential life-saving therapies,” he said in a panel discussion of the results.

Patiromer’s impact on longer-term outcomes is the focus of DIAMOND, a phase 3, randomized, placebo controlled trial that is currently recruiting. DIAMOND will determine whether giving patiromer to patients who developed hyperkalemia on renin-angiotensin-aldosterone system (RAAS) inhibitors decreases cardiovascular deaths and hospitalizations, by virtue of enabling continued RAAS inhibitor use.

Funding for AMBER came from Relypsa, which markets patiromer (Veltassa). Dr. Williams reported consulting for Relypsa during the conduct of the study, along with disclosures outside the scope of the AMBER study (Daiichi Sankyo, Pfizer, Novartis, Servier, Boehringer Ingelheim, and Vascular Dynamics).

SOURCE: Williams B. HFSA 2019.

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Checklist may improve quality measures in the surgical ICU

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Mon, 10/21/2019 - 12:49

 

– A standardized checklist may help reduce errors and improve common quality measures in critically ill patients, results of a recent retrospective analysis of 200 consecutive patients suggest.

Use of the checklist was linked to significantly shorter hospital length of stay and ICU length of stay as well as fewer days on a ventilator in the analysis, which was presented here at the annual meeting of the American College of Chest Physicians. The 10-item standardized checklist covered a variety topics ranging from comfort, prophylaxis, and sedation to infection control and prevention, nutrition, and medication management review.

Although health economics weren’t evaluated in this analysis, changes in those quality measures might also impact the bottom line, according to study coauthor Priscilla Chow, DO, a resident at Suburban Community Hospital in East Norriton, Pa.

“Obviously, if the patient is spending less time in the hospital and fewer days on the ventilator and in the ICU, then we can potentially also be more cost effective in our care,” Dr. Chow said in a podium presentation at the meeting.

The use of checklists to standardize processes and reduce errors is a “relatively simple approach” that was adopted from the airline industry and now has been evaluated in a variety of medical care settings, according to Dr. Chow.

Previous studies have demonstrated that checklist-driven care may reduce the incidence of postoperative complications, central line–associated bloodstream infection, ventilator-associated pneumonia, and catheter associated–urinary tract infection.

The present retrospective data analysis by Dr. Chow and colleagues included 200 consecutive patients admitted to the surgical ICU at an urban level 1 trauma center, including 100 patients managed according to the checklist and 100 managed according to standard processes.

Though survival to discharge was comparable between the groups, use of the checklist was associated with a significantly shorter hospital length of stay versus standard care (23.9 vs. 9.5 days). Likewise, the ICU length of stay was shorter in the checklist group (13.0 vs. 6.5 days), and the checklist group had fewer ventilator days (7.7 to 2.8).

Injury Severity Score did not differ between groups, though overall, use of the checklist resulted in more of the underlying topics being addressed in clinical documentation (5.0 vs. 8.7 items).

Dr. Chow and colleagues disclosed that they had no relationships relevant to their study.

SOURCE: Akella K et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.201.

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– A standardized checklist may help reduce errors and improve common quality measures in critically ill patients, results of a recent retrospective analysis of 200 consecutive patients suggest.

Use of the checklist was linked to significantly shorter hospital length of stay and ICU length of stay as well as fewer days on a ventilator in the analysis, which was presented here at the annual meeting of the American College of Chest Physicians. The 10-item standardized checklist covered a variety topics ranging from comfort, prophylaxis, and sedation to infection control and prevention, nutrition, and medication management review.

Although health economics weren’t evaluated in this analysis, changes in those quality measures might also impact the bottom line, according to study coauthor Priscilla Chow, DO, a resident at Suburban Community Hospital in East Norriton, Pa.

“Obviously, if the patient is spending less time in the hospital and fewer days on the ventilator and in the ICU, then we can potentially also be more cost effective in our care,” Dr. Chow said in a podium presentation at the meeting.

The use of checklists to standardize processes and reduce errors is a “relatively simple approach” that was adopted from the airline industry and now has been evaluated in a variety of medical care settings, according to Dr. Chow.

Previous studies have demonstrated that checklist-driven care may reduce the incidence of postoperative complications, central line–associated bloodstream infection, ventilator-associated pneumonia, and catheter associated–urinary tract infection.

The present retrospective data analysis by Dr. Chow and colleagues included 200 consecutive patients admitted to the surgical ICU at an urban level 1 trauma center, including 100 patients managed according to the checklist and 100 managed according to standard processes.

Though survival to discharge was comparable between the groups, use of the checklist was associated with a significantly shorter hospital length of stay versus standard care (23.9 vs. 9.5 days). Likewise, the ICU length of stay was shorter in the checklist group (13.0 vs. 6.5 days), and the checklist group had fewer ventilator days (7.7 to 2.8).

Injury Severity Score did not differ between groups, though overall, use of the checklist resulted in more of the underlying topics being addressed in clinical documentation (5.0 vs. 8.7 items).

Dr. Chow and colleagues disclosed that they had no relationships relevant to their study.

SOURCE: Akella K et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.201.

 

– A standardized checklist may help reduce errors and improve common quality measures in critically ill patients, results of a recent retrospective analysis of 200 consecutive patients suggest.

Use of the checklist was linked to significantly shorter hospital length of stay and ICU length of stay as well as fewer days on a ventilator in the analysis, which was presented here at the annual meeting of the American College of Chest Physicians. The 10-item standardized checklist covered a variety topics ranging from comfort, prophylaxis, and sedation to infection control and prevention, nutrition, and medication management review.

Although health economics weren’t evaluated in this analysis, changes in those quality measures might also impact the bottom line, according to study coauthor Priscilla Chow, DO, a resident at Suburban Community Hospital in East Norriton, Pa.

“Obviously, if the patient is spending less time in the hospital and fewer days on the ventilator and in the ICU, then we can potentially also be more cost effective in our care,” Dr. Chow said in a podium presentation at the meeting.

The use of checklists to standardize processes and reduce errors is a “relatively simple approach” that was adopted from the airline industry and now has been evaluated in a variety of medical care settings, according to Dr. Chow.

Previous studies have demonstrated that checklist-driven care may reduce the incidence of postoperative complications, central line–associated bloodstream infection, ventilator-associated pneumonia, and catheter associated–urinary tract infection.

The present retrospective data analysis by Dr. Chow and colleagues included 200 consecutive patients admitted to the surgical ICU at an urban level 1 trauma center, including 100 patients managed according to the checklist and 100 managed according to standard processes.

Though survival to discharge was comparable between the groups, use of the checklist was associated with a significantly shorter hospital length of stay versus standard care (23.9 vs. 9.5 days). Likewise, the ICU length of stay was shorter in the checklist group (13.0 vs. 6.5 days), and the checklist group had fewer ventilator days (7.7 to 2.8).

Injury Severity Score did not differ between groups, though overall, use of the checklist resulted in more of the underlying topics being addressed in clinical documentation (5.0 vs. 8.7 items).

Dr. Chow and colleagues disclosed that they had no relationships relevant to their study.

SOURCE: Akella K et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.201.

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Low disease activity a valid target in early SLE, investigators say

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Thu, 10/17/2019 - 16:25

 

While remission is typically recommended as the main goal of treatment in patients with newly diagnosed systemic lupus erythematosus (SLE), achieving low disease activity is a “valid alternative” that may also prevent accrual of damage, investigators in a small retrospective study have concluded.

Both complete remission (CR) and achievement of a lupus low disease activity state (LLDAS) were independently associated with lower accrual of early damage after 6 months of treatment, according to results of the study, reported in Arthritis Care & Research.

Patients maintaining LLDAS over the next 12 months developed considerably less damage than did those who never achieved LLDAS or who did not maintain LLDAS over time, according to the investigators, led by Alberto Floris, MD, and Matteo Piga, MD, of the AOU University Clinic of Cagliari (Italy).

Based on these findings, maintenance of both CR and LLDAS should be targeted for damage prevention, according to the authors. “Significant differences did not emerge between persistent LLDAS and CR over 12 months in preventing early damage,” they said in their report.

Their retrospective, single-center analysis included 116 adult patients with newly diagnosed SLE who had an SLE Disease Activity Index 2000 (SLEDAI-2K) score of at least 6 at baseline and started treatment at enrollment. The mean age of this patient cohort was approximately 35 years, and about 90% were female.

After 6 months of follow-up, 42% of the cohort achieved LLDAS, defined in part as a SLEDAI-2K of 4 or less with no major organ activity or new disease activity, while 21.6% met CR criteria, which included a SLEDAI-2K of 0.

Achieving LLDAS at that 6-month time point was independently associated with lower damage accrual at 18 months (odds ratio, 0.25; 95% confidence interval, 0.06-0.99; P = .049); likewise, a 6-month CR translated into less damage at 18 months, according to multivariate analysis (OR, 0.07; 95% CI, 0.01-0.59; P = .015).

Those patients in LLDAS at 6 months who maintained that target for another 12 months had significantly less damage when compared with those who lost response or never achieved it, the investigators added.

“Losing the early attained LLDAS and CR may frustrate prevention of damage, and therefore, LLDAS and CR maintenance should be targeted since the first stage of SLE management,” the investigators said in their report.

About 54% of the patients in LLDAS at 6 months achieved CR at an 18-month follow-up time point, while about 21% remained in LLDAS and 25% went on to develop active disease, the investigators said. Among those in CR at 6 months, 60% maintained it at 18 months, while 40% worsened to either LLDAS or active disease.

Dr. Floris, Dr. Piga, and coauthors reported no funding or competing interests related to their research.
 

SOURCE: Floris A et al. Arthritis Care Res. 2019 Oct 10. doi: 10.1002/acr.24086.

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While remission is typically recommended as the main goal of treatment in patients with newly diagnosed systemic lupus erythematosus (SLE), achieving low disease activity is a “valid alternative” that may also prevent accrual of damage, investigators in a small retrospective study have concluded.

Both complete remission (CR) and achievement of a lupus low disease activity state (LLDAS) were independently associated with lower accrual of early damage after 6 months of treatment, according to results of the study, reported in Arthritis Care & Research.

Patients maintaining LLDAS over the next 12 months developed considerably less damage than did those who never achieved LLDAS or who did not maintain LLDAS over time, according to the investigators, led by Alberto Floris, MD, and Matteo Piga, MD, of the AOU University Clinic of Cagliari (Italy).

Based on these findings, maintenance of both CR and LLDAS should be targeted for damage prevention, according to the authors. “Significant differences did not emerge between persistent LLDAS and CR over 12 months in preventing early damage,” they said in their report.

Their retrospective, single-center analysis included 116 adult patients with newly diagnosed SLE who had an SLE Disease Activity Index 2000 (SLEDAI-2K) score of at least 6 at baseline and started treatment at enrollment. The mean age of this patient cohort was approximately 35 years, and about 90% were female.

After 6 months of follow-up, 42% of the cohort achieved LLDAS, defined in part as a SLEDAI-2K of 4 or less with no major organ activity or new disease activity, while 21.6% met CR criteria, which included a SLEDAI-2K of 0.

Achieving LLDAS at that 6-month time point was independently associated with lower damage accrual at 18 months (odds ratio, 0.25; 95% confidence interval, 0.06-0.99; P = .049); likewise, a 6-month CR translated into less damage at 18 months, according to multivariate analysis (OR, 0.07; 95% CI, 0.01-0.59; P = .015).

Those patients in LLDAS at 6 months who maintained that target for another 12 months had significantly less damage when compared with those who lost response or never achieved it, the investigators added.

“Losing the early attained LLDAS and CR may frustrate prevention of damage, and therefore, LLDAS and CR maintenance should be targeted since the first stage of SLE management,” the investigators said in their report.

About 54% of the patients in LLDAS at 6 months achieved CR at an 18-month follow-up time point, while about 21% remained in LLDAS and 25% went on to develop active disease, the investigators said. Among those in CR at 6 months, 60% maintained it at 18 months, while 40% worsened to either LLDAS or active disease.

Dr. Floris, Dr. Piga, and coauthors reported no funding or competing interests related to their research.
 

SOURCE: Floris A et al. Arthritis Care Res. 2019 Oct 10. doi: 10.1002/acr.24086.

 

While remission is typically recommended as the main goal of treatment in patients with newly diagnosed systemic lupus erythematosus (SLE), achieving low disease activity is a “valid alternative” that may also prevent accrual of damage, investigators in a small retrospective study have concluded.

Both complete remission (CR) and achievement of a lupus low disease activity state (LLDAS) were independently associated with lower accrual of early damage after 6 months of treatment, according to results of the study, reported in Arthritis Care & Research.

Patients maintaining LLDAS over the next 12 months developed considerably less damage than did those who never achieved LLDAS or who did not maintain LLDAS over time, according to the investigators, led by Alberto Floris, MD, and Matteo Piga, MD, of the AOU University Clinic of Cagliari (Italy).

Based on these findings, maintenance of both CR and LLDAS should be targeted for damage prevention, according to the authors. “Significant differences did not emerge between persistent LLDAS and CR over 12 months in preventing early damage,” they said in their report.

Their retrospective, single-center analysis included 116 adult patients with newly diagnosed SLE who had an SLE Disease Activity Index 2000 (SLEDAI-2K) score of at least 6 at baseline and started treatment at enrollment. The mean age of this patient cohort was approximately 35 years, and about 90% were female.

After 6 months of follow-up, 42% of the cohort achieved LLDAS, defined in part as a SLEDAI-2K of 4 or less with no major organ activity or new disease activity, while 21.6% met CR criteria, which included a SLEDAI-2K of 0.

Achieving LLDAS at that 6-month time point was independently associated with lower damage accrual at 18 months (odds ratio, 0.25; 95% confidence interval, 0.06-0.99; P = .049); likewise, a 6-month CR translated into less damage at 18 months, according to multivariate analysis (OR, 0.07; 95% CI, 0.01-0.59; P = .015).

Those patients in LLDAS at 6 months who maintained that target for another 12 months had significantly less damage when compared with those who lost response or never achieved it, the investigators added.

“Losing the early attained LLDAS and CR may frustrate prevention of damage, and therefore, LLDAS and CR maintenance should be targeted since the first stage of SLE management,” the investigators said in their report.

About 54% of the patients in LLDAS at 6 months achieved CR at an 18-month follow-up time point, while about 21% remained in LLDAS and 25% went on to develop active disease, the investigators said. Among those in CR at 6 months, 60% maintained it at 18 months, while 40% worsened to either LLDAS or active disease.

Dr. Floris, Dr. Piga, and coauthors reported no funding or competing interests related to their research.
 

SOURCE: Floris A et al. Arthritis Care Res. 2019 Oct 10. doi: 10.1002/acr.24086.

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Dupilumab may reduce dysphagia in adults with eosinophilic esophagitis

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Sun, 10/27/2019 - 13:24

 

Dupilumab (Dupixent) significantly reduced patient-reported dysphagia among adults with eosinophilic esophagitis enrolled in a randomized trial, investigators reported.

Treatment with this monoclonal antibody also improved histologic disease features and abnormal endoscopic features, compared with placebo, according to investigators in the phase 2 trial, which included 47 patients enrolled at 14 U.S. study sites.

Injection-site erythema and nasopharyngitis were more common among dupilumab-treated versus placebo-treated patients, and there were no serious adverse events or deaths observed, according to cofirst authors Ikuo Hirano, MD, of Northwestern University, Chicago, and Evan S. Dellon, MD, MPH, of the University of North Carolina at Chapel Hill.

“Dupilumab is the first targeted biologic agent to improve dysphagia, histologic and endoscopic measures of disease, as well as esophageal function, and have an acceptable safety profile in adult patients with active eosinophilic esophagitis,” said Dr. Hirano and Dr. Dellon and associates in the journal Gastroenterology.

The report on the phase 2 trial included 47 adults with active eosinophilic esophagitis randomized to weekly subcutaneous injections of dupilumab at a dose of 300 mg or placebo. All participants had a score of 5 or higher on the Straumann Dysphagia Instrument (SDI), a patient-reported outcome measure.

Change in SDI score from baseline to week 10, the study primary endpoint, was significantly improved for dupilumab, according to investigators, who reported a least-squares mean change of –3.0 from baseline, versus –1.3 for placebo (P = .0304).

The original plan was to measure dupilumab’s effect on SDI out to week 12 of treatment, but because of technical problems with an electronic diary system used in the trial, there was significant data loss, and this primary endpoint was instead evaluated at week 10, investigators said in their report.

Improvements in SDI scores were apparent as early as week 1 after dupilumab treatment started, they added, noting that 39% of dupilumab-treated patients had an improvement in SDI score of at least 3, compared with just 13% of placebo-treated patients (P = .490).

Dupilumab also improved outcomes measured by the eosinophilic esophagitis histology scoring system (EoE-HSS), including a 68.3% improvement in severity and 54.6% in extent of disease from baseline to week 12, investigators said.

Likewise, dupilumab improved endoscopic outcomes at week 12 as measured by the eosinophilic esophagitis Endoscopic Reference Score (EREFS), and improved esophageal distensibility plateau, a measure of esophageal function, by 18%, compared with placebo, according to the report.

The Food and Drug Administration has approved dupilumab for use in atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis, and has granted orphan drug designation for its use in the treatment of eosinophilic esophagitis, according to Sanofi and Regeneron Pharmaceuticals.

Dupilumab antagonizes the interleukin (IL)–4 receptor-alpha component of the type 2 receptor, thereby inhibiting signaling of IL-4 and IL-13, the investigators noted in their report.

“These results demonstrate that interleukin-4 and interleukin-13 are central pathological mediators of esophageal inflammation and dysfunction in adult patients with active eosinophilic esophagitis,” said investigators in their report.

The anti-IgE monoclonal antibody omalizumab (Xolair) failed to improve dysphagia and histologic features of eosinophilic esophagitis, suggesting the pathogenesis of this disease is not mediated by IgE, they added.

A number of other targeted biologic agents, including the anti–IL-5 agents mepolizumab and reslizumab, have failed to significantly improve dysphagia versus placebo in patients with eosinophilic esophagitis, they added.

The research was sponsored by Sanofi and Regeneron. Several study coauthors indicated that they were current or former employees of those companies. Other study authors provided disclosures related to Adare, Allakos, Banner, Calypso, Enumeral, EsoCap, GlaxoSmithKline, Meritage, Regeneron, Robarts, and Shire, and among others.

SOURCE: Hirano I et al. Gastroenterology. 2019 Oct 5. doi: 10.1053/j.gastro.2019.09.042.

AGA patient education on eosinophilic esophagitis can help your patients better understand the condition. Visit https://www.gastro.org/practice-guidance/gi-patient-center/topic/eosinophilic-esophagitis-eoe.

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Dupilumab (Dupixent) significantly reduced patient-reported dysphagia among adults with eosinophilic esophagitis enrolled in a randomized trial, investigators reported.

Treatment with this monoclonal antibody also improved histologic disease features and abnormal endoscopic features, compared with placebo, according to investigators in the phase 2 trial, which included 47 patients enrolled at 14 U.S. study sites.

Injection-site erythema and nasopharyngitis were more common among dupilumab-treated versus placebo-treated patients, and there were no serious adverse events or deaths observed, according to cofirst authors Ikuo Hirano, MD, of Northwestern University, Chicago, and Evan S. Dellon, MD, MPH, of the University of North Carolina at Chapel Hill.

“Dupilumab is the first targeted biologic agent to improve dysphagia, histologic and endoscopic measures of disease, as well as esophageal function, and have an acceptable safety profile in adult patients with active eosinophilic esophagitis,” said Dr. Hirano and Dr. Dellon and associates in the journal Gastroenterology.

The report on the phase 2 trial included 47 adults with active eosinophilic esophagitis randomized to weekly subcutaneous injections of dupilumab at a dose of 300 mg or placebo. All participants had a score of 5 or higher on the Straumann Dysphagia Instrument (SDI), a patient-reported outcome measure.

Change in SDI score from baseline to week 10, the study primary endpoint, was significantly improved for dupilumab, according to investigators, who reported a least-squares mean change of –3.0 from baseline, versus –1.3 for placebo (P = .0304).

The original plan was to measure dupilumab’s effect on SDI out to week 12 of treatment, but because of technical problems with an electronic diary system used in the trial, there was significant data loss, and this primary endpoint was instead evaluated at week 10, investigators said in their report.

Improvements in SDI scores were apparent as early as week 1 after dupilumab treatment started, they added, noting that 39% of dupilumab-treated patients had an improvement in SDI score of at least 3, compared with just 13% of placebo-treated patients (P = .490).

Dupilumab also improved outcomes measured by the eosinophilic esophagitis histology scoring system (EoE-HSS), including a 68.3% improvement in severity and 54.6% in extent of disease from baseline to week 12, investigators said.

Likewise, dupilumab improved endoscopic outcomes at week 12 as measured by the eosinophilic esophagitis Endoscopic Reference Score (EREFS), and improved esophageal distensibility plateau, a measure of esophageal function, by 18%, compared with placebo, according to the report.

The Food and Drug Administration has approved dupilumab for use in atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis, and has granted orphan drug designation for its use in the treatment of eosinophilic esophagitis, according to Sanofi and Regeneron Pharmaceuticals.

Dupilumab antagonizes the interleukin (IL)–4 receptor-alpha component of the type 2 receptor, thereby inhibiting signaling of IL-4 and IL-13, the investigators noted in their report.

“These results demonstrate that interleukin-4 and interleukin-13 are central pathological mediators of esophageal inflammation and dysfunction in adult patients with active eosinophilic esophagitis,” said investigators in their report.

The anti-IgE monoclonal antibody omalizumab (Xolair) failed to improve dysphagia and histologic features of eosinophilic esophagitis, suggesting the pathogenesis of this disease is not mediated by IgE, they added.

A number of other targeted biologic agents, including the anti–IL-5 agents mepolizumab and reslizumab, have failed to significantly improve dysphagia versus placebo in patients with eosinophilic esophagitis, they added.

The research was sponsored by Sanofi and Regeneron. Several study coauthors indicated that they were current or former employees of those companies. Other study authors provided disclosures related to Adare, Allakos, Banner, Calypso, Enumeral, EsoCap, GlaxoSmithKline, Meritage, Regeneron, Robarts, and Shire, and among others.

SOURCE: Hirano I et al. Gastroenterology. 2019 Oct 5. doi: 10.1053/j.gastro.2019.09.042.

AGA patient education on eosinophilic esophagitis can help your patients better understand the condition. Visit https://www.gastro.org/practice-guidance/gi-patient-center/topic/eosinophilic-esophagitis-eoe.

 

Dupilumab (Dupixent) significantly reduced patient-reported dysphagia among adults with eosinophilic esophagitis enrolled in a randomized trial, investigators reported.

Treatment with this monoclonal antibody also improved histologic disease features and abnormal endoscopic features, compared with placebo, according to investigators in the phase 2 trial, which included 47 patients enrolled at 14 U.S. study sites.

Injection-site erythema and nasopharyngitis were more common among dupilumab-treated versus placebo-treated patients, and there were no serious adverse events or deaths observed, according to cofirst authors Ikuo Hirano, MD, of Northwestern University, Chicago, and Evan S. Dellon, MD, MPH, of the University of North Carolina at Chapel Hill.

“Dupilumab is the first targeted biologic agent to improve dysphagia, histologic and endoscopic measures of disease, as well as esophageal function, and have an acceptable safety profile in adult patients with active eosinophilic esophagitis,” said Dr. Hirano and Dr. Dellon and associates in the journal Gastroenterology.

The report on the phase 2 trial included 47 adults with active eosinophilic esophagitis randomized to weekly subcutaneous injections of dupilumab at a dose of 300 mg or placebo. All participants had a score of 5 or higher on the Straumann Dysphagia Instrument (SDI), a patient-reported outcome measure.

Change in SDI score from baseline to week 10, the study primary endpoint, was significantly improved for dupilumab, according to investigators, who reported a least-squares mean change of –3.0 from baseline, versus –1.3 for placebo (P = .0304).

The original plan was to measure dupilumab’s effect on SDI out to week 12 of treatment, but because of technical problems with an electronic diary system used in the trial, there was significant data loss, and this primary endpoint was instead evaluated at week 10, investigators said in their report.

Improvements in SDI scores were apparent as early as week 1 after dupilumab treatment started, they added, noting that 39% of dupilumab-treated patients had an improvement in SDI score of at least 3, compared with just 13% of placebo-treated patients (P = .490).

Dupilumab also improved outcomes measured by the eosinophilic esophagitis histology scoring system (EoE-HSS), including a 68.3% improvement in severity and 54.6% in extent of disease from baseline to week 12, investigators said.

Likewise, dupilumab improved endoscopic outcomes at week 12 as measured by the eosinophilic esophagitis Endoscopic Reference Score (EREFS), and improved esophageal distensibility plateau, a measure of esophageal function, by 18%, compared with placebo, according to the report.

The Food and Drug Administration has approved dupilumab for use in atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis, and has granted orphan drug designation for its use in the treatment of eosinophilic esophagitis, according to Sanofi and Regeneron Pharmaceuticals.

Dupilumab antagonizes the interleukin (IL)–4 receptor-alpha component of the type 2 receptor, thereby inhibiting signaling of IL-4 and IL-13, the investigators noted in their report.

“These results demonstrate that interleukin-4 and interleukin-13 are central pathological mediators of esophageal inflammation and dysfunction in adult patients with active eosinophilic esophagitis,” said investigators in their report.

The anti-IgE monoclonal antibody omalizumab (Xolair) failed to improve dysphagia and histologic features of eosinophilic esophagitis, suggesting the pathogenesis of this disease is not mediated by IgE, they added.

A number of other targeted biologic agents, including the anti–IL-5 agents mepolizumab and reslizumab, have failed to significantly improve dysphagia versus placebo in patients with eosinophilic esophagitis, they added.

The research was sponsored by Sanofi and Regeneron. Several study coauthors indicated that they were current or former employees of those companies. Other study authors provided disclosures related to Adare, Allakos, Banner, Calypso, Enumeral, EsoCap, GlaxoSmithKline, Meritage, Regeneron, Robarts, and Shire, and among others.

SOURCE: Hirano I et al. Gastroenterology. 2019 Oct 5. doi: 10.1053/j.gastro.2019.09.042.

AGA patient education on eosinophilic esophagitis can help your patients better understand the condition. Visit https://www.gastro.org/practice-guidance/gi-patient-center/topic/eosinophilic-esophagitis-eoe.

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Key clinical point: Dupilumab (Dupixent) significantly reduced patient-reported dysphagia among adults with eosinophilic esophagitis.

Major finding: Change in the Straumann Dysphagia Instrument (SDI) score from baseline to week 10, the study primary endpoint, was significantly improved for dupilumab (least squares mean change of –3.0 from baseline, versus –1.3 for placebo; P = .0304).

Study details: A phase 2 trial including 47 adults with EoE randomized to dupilumab or placebo.

Disclosures: The research was sponsored by Sanofi and Regeneron Pharmaceuticals. Several study coauthors indicated that they were current or former employees of those companies. Other study authors provided disclosures related to Regeneron, Adare, Allakos, Receptos/Celgene, Meritage, Shire, Alivio, Banner, Calypso, Enumeral, EsoCap, Glax-oSmithKline, and Robarts, among others.

Source: Hirano I et al. Gastroenterology. 2019 Oct 5. doi: 10.1053/j.gastro.2019.09.042.

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In older patients with immune-mediated TTP, atypical features may delay diagnosis

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Wed, 10/09/2019 - 10:59

 

Older patients with immune thrombotic thrombocytopenic purpura (iTTP) more often have an atypical neurological presentation, which could result in a delayed diagnosis, according to authors of a recent retrospective analysis.

“Practitioners should be aware of this in order to shorten the time to treatment, which could improve the prognosis in older iTTP patients,” Paul Coppo, MD, PhD, of Hôpital Saint-Antoine, Paris, and coauthors wrote in Blood.

The older patients also had increased 1-month and 1-year mortality compared with younger patients, and had more than a threefold risk of long-term mortality compared with elderly patients without iTTP, according to the study report.

The analysis included 411 patients with iTTP entered into a national registry in France between 2000 and 2016. Seventy-one patients were 60 years of age or older.

Time from hospital admission to diagnosis was 3 days for those older patients, versus just 1 day for patients under 60 years of age (P = .0001), Dr. Coppo and colleagues reported.

Clinical records were available for 67 of the older iTTP patients, of whom 17 had no evidence of delayed diagnosis. The remainder had a “possible diagnostic delay,” according to the report; among those, the iTTP diagnosis was preceded by neurological manifestations in 26 cases, and transient ischemic stroke that usually led to focal deficiency or aphasia in 14 cases. Other features preceding the diagnosis included malaise, behavioral abnormalities, seizure, and dizziness.

Many of these findings are “not specific to a disease, and they are less alarming than in young patients,” the researchers wrote. “In this context, the presence of a thrombocytopenia with anemia should alert physicians to this possible rare diagnosis.”

Older patients also presented with less pronounced cytopenias compared with younger patients, which could have contributed to a late diagnosis, they added.

Older age is a known risk factor for mortality related to iTTP. In the present study, rates of 1-month mortality were 37% for patients aged 60 years and older, and 9% for those younger than age 60 (P less than .0001). The 1-year mortality rates were 49% and 11% for older and younger patients, respectively (P less than .0001).

Compared with older individuals without iTTP from a different study, older iTTP patients had a lower long-term survival rate. iTTP remained an independent risk factor for death even after adjustment for age, sex, and some comorbidities (hazard ratio, 3.44; 95% confidence interval, 2.02-5.87).

The study was partly funded by a grant from the French Ministry of Health. Dr. Coppo reported that he is a clinical advisory board member for Alexion, Ablynx (now part of Sanofi), Shire, and Octapharma. Two other co-authors reported participating in advisory boards for Ablynx.

SOURCE: Prevel R et al. Blood. 2019 Sep 17. doi: 10.1182/blood.2019000748.

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Older patients with immune thrombotic thrombocytopenic purpura (iTTP) more often have an atypical neurological presentation, which could result in a delayed diagnosis, according to authors of a recent retrospective analysis.

“Practitioners should be aware of this in order to shorten the time to treatment, which could improve the prognosis in older iTTP patients,” Paul Coppo, MD, PhD, of Hôpital Saint-Antoine, Paris, and coauthors wrote in Blood.

The older patients also had increased 1-month and 1-year mortality compared with younger patients, and had more than a threefold risk of long-term mortality compared with elderly patients without iTTP, according to the study report.

The analysis included 411 patients with iTTP entered into a national registry in France between 2000 and 2016. Seventy-one patients were 60 years of age or older.

Time from hospital admission to diagnosis was 3 days for those older patients, versus just 1 day for patients under 60 years of age (P = .0001), Dr. Coppo and colleagues reported.

Clinical records were available for 67 of the older iTTP patients, of whom 17 had no evidence of delayed diagnosis. The remainder had a “possible diagnostic delay,” according to the report; among those, the iTTP diagnosis was preceded by neurological manifestations in 26 cases, and transient ischemic stroke that usually led to focal deficiency or aphasia in 14 cases. Other features preceding the diagnosis included malaise, behavioral abnormalities, seizure, and dizziness.

Many of these findings are “not specific to a disease, and they are less alarming than in young patients,” the researchers wrote. “In this context, the presence of a thrombocytopenia with anemia should alert physicians to this possible rare diagnosis.”

Older patients also presented with less pronounced cytopenias compared with younger patients, which could have contributed to a late diagnosis, they added.

Older age is a known risk factor for mortality related to iTTP. In the present study, rates of 1-month mortality were 37% for patients aged 60 years and older, and 9% for those younger than age 60 (P less than .0001). The 1-year mortality rates were 49% and 11% for older and younger patients, respectively (P less than .0001).

Compared with older individuals without iTTP from a different study, older iTTP patients had a lower long-term survival rate. iTTP remained an independent risk factor for death even after adjustment for age, sex, and some comorbidities (hazard ratio, 3.44; 95% confidence interval, 2.02-5.87).

The study was partly funded by a grant from the French Ministry of Health. Dr. Coppo reported that he is a clinical advisory board member for Alexion, Ablynx (now part of Sanofi), Shire, and Octapharma. Two other co-authors reported participating in advisory boards for Ablynx.

SOURCE: Prevel R et al. Blood. 2019 Sep 17. doi: 10.1182/blood.2019000748.

 

Older patients with immune thrombotic thrombocytopenic purpura (iTTP) more often have an atypical neurological presentation, which could result in a delayed diagnosis, according to authors of a recent retrospective analysis.

“Practitioners should be aware of this in order to shorten the time to treatment, which could improve the prognosis in older iTTP patients,” Paul Coppo, MD, PhD, of Hôpital Saint-Antoine, Paris, and coauthors wrote in Blood.

The older patients also had increased 1-month and 1-year mortality compared with younger patients, and had more than a threefold risk of long-term mortality compared with elderly patients without iTTP, according to the study report.

The analysis included 411 patients with iTTP entered into a national registry in France between 2000 and 2016. Seventy-one patients were 60 years of age or older.

Time from hospital admission to diagnosis was 3 days for those older patients, versus just 1 day for patients under 60 years of age (P = .0001), Dr. Coppo and colleagues reported.

Clinical records were available for 67 of the older iTTP patients, of whom 17 had no evidence of delayed diagnosis. The remainder had a “possible diagnostic delay,” according to the report; among those, the iTTP diagnosis was preceded by neurological manifestations in 26 cases, and transient ischemic stroke that usually led to focal deficiency or aphasia in 14 cases. Other features preceding the diagnosis included malaise, behavioral abnormalities, seizure, and dizziness.

Many of these findings are “not specific to a disease, and they are less alarming than in young patients,” the researchers wrote. “In this context, the presence of a thrombocytopenia with anemia should alert physicians to this possible rare diagnosis.”

Older patients also presented with less pronounced cytopenias compared with younger patients, which could have contributed to a late diagnosis, they added.

Older age is a known risk factor for mortality related to iTTP. In the present study, rates of 1-month mortality were 37% for patients aged 60 years and older, and 9% for those younger than age 60 (P less than .0001). The 1-year mortality rates were 49% and 11% for older and younger patients, respectively (P less than .0001).

Compared with older individuals without iTTP from a different study, older iTTP patients had a lower long-term survival rate. iTTP remained an independent risk factor for death even after adjustment for age, sex, and some comorbidities (hazard ratio, 3.44; 95% confidence interval, 2.02-5.87).

The study was partly funded by a grant from the French Ministry of Health. Dr. Coppo reported that he is a clinical advisory board member for Alexion, Ablynx (now part of Sanofi), Shire, and Octapharma. Two other co-authors reported participating in advisory boards for Ablynx.

SOURCE: Prevel R et al. Blood. 2019 Sep 17. doi: 10.1182/blood.2019000748.

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Treatment guided by remote readings works when used as intended

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Thu, 10/10/2019 - 07:36

 

– A heart failure management strategy guided by home lung fluid measurements from the remote dielectric sensing (ReDS) system can significantly reduce recurrent hospitalizations, as long as the technology is used as intended.

Dr. William T. Abraham, The Ohio State University
Andrew D. Bowser/MDedge News
Dr. William T. Abraham

A ReDS-directed management strategy did not significantly reduce recurrent hospitalizations for acute decompensated heart failure (ADHF) in the traditional intent-to-treat analysis of the randomized, controlled SMILE trial, William T. Abraham, MD, of the Ohio State University, Columbus, said at the annual scientific meeting of the Heart Failure Society of America.

However, use of the Food and Drug Administration–cleared thoracic fluid status monitoring system to guide treatment changes did cut such hospitalizations by 58% in a modified intent-to-treat population that excluded patients who failed to take daily measurements at home and who didn’t receive modified treatment despite actionable readings, Dr. Abraham reported in an oral presentation.

“These observations may support an adherence-based approach to the utilization and reimbursement of ReDS-guided management in recently discharged ADHF patients,” he said.

The ReDS system consists of a device that, within about 90 seconds, provides a measurement of lung fluid via a focused electromagnetic radar beam that passes through the right lung, Dr. Abraham said. Clinicians access data from measurements patients initiate at home through a secure, cloud-based system, and then initiate changes to heart failure management as warranted based on a ReDS-specific treatment algorithm, Dr. Abraham said.



The postmarketing SMILE study of the ReDS system was stopped early because of an administrative decision by the sponsor, according to Dr. Abraham. However, 268 patients enrolled at 43 U.S. sites continued to the end of the study, with an average follow-up of about 6 months, while readmissions were collected and adjudicated by an independent clinical events committee.

A total of 135 patients were randomized to a ReDS-based management strategy, while 133 were randomized to standard of care, the investigator said.

Most of the medication changes made in response to ReDS measurements were increased diuretics because of high lung fluid volume measurements, or decreased diuretics in response to low measurements, though some changes in vasodilator medications were also made, Dr. Abraham said.

The ReDS-directed management approach yielded a “highly nonsignificant” 19% reduction in recurrent or cumulative heart failure readmissions (P = .36); by contrast, after removing nonadherent, noncompliant cases, there were 11 hospitalizations in 91 treatment patients, compared with 43 hospitalizations in 133 control patients, yielding a hazard ratio of 0.42 (95% CI, 0.22-0.82; P = .01).

“This comes back to the adage that, if you don’t use it, you can’t improve clinical outcomes,” he said, explaining that this study’s modified intent-to-treat population was defined by excluding patients who took no ReDS measurements for more than 20 consecutive days; or by clinicians who received at least eight notifications of out-of-range ReDS values yet didn’t implement the ReDS treatment algorithm.

There were no adverse events reported as being definitely related to the use of the device, and five adverse events reported as possibly related to the device, Dr. Abraham said.

SMILE was sponsored by Sensible Medical Innovations. Dr. Abraham reported disclosures (consultant/advisory board) related to Sensible Medical Innovations, Abbott, Boehringer Ingelheim, Victorious Medical, V-Wave Medical, and others.

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– A heart failure management strategy guided by home lung fluid measurements from the remote dielectric sensing (ReDS) system can significantly reduce recurrent hospitalizations, as long as the technology is used as intended.

Dr. William T. Abraham, The Ohio State University
Andrew D. Bowser/MDedge News
Dr. William T. Abraham

A ReDS-directed management strategy did not significantly reduce recurrent hospitalizations for acute decompensated heart failure (ADHF) in the traditional intent-to-treat analysis of the randomized, controlled SMILE trial, William T. Abraham, MD, of the Ohio State University, Columbus, said at the annual scientific meeting of the Heart Failure Society of America.

However, use of the Food and Drug Administration–cleared thoracic fluid status monitoring system to guide treatment changes did cut such hospitalizations by 58% in a modified intent-to-treat population that excluded patients who failed to take daily measurements at home and who didn’t receive modified treatment despite actionable readings, Dr. Abraham reported in an oral presentation.

“These observations may support an adherence-based approach to the utilization and reimbursement of ReDS-guided management in recently discharged ADHF patients,” he said.

The ReDS system consists of a device that, within about 90 seconds, provides a measurement of lung fluid via a focused electromagnetic radar beam that passes through the right lung, Dr. Abraham said. Clinicians access data from measurements patients initiate at home through a secure, cloud-based system, and then initiate changes to heart failure management as warranted based on a ReDS-specific treatment algorithm, Dr. Abraham said.



The postmarketing SMILE study of the ReDS system was stopped early because of an administrative decision by the sponsor, according to Dr. Abraham. However, 268 patients enrolled at 43 U.S. sites continued to the end of the study, with an average follow-up of about 6 months, while readmissions were collected and adjudicated by an independent clinical events committee.

A total of 135 patients were randomized to a ReDS-based management strategy, while 133 were randomized to standard of care, the investigator said.

Most of the medication changes made in response to ReDS measurements were increased diuretics because of high lung fluid volume measurements, or decreased diuretics in response to low measurements, though some changes in vasodilator medications were also made, Dr. Abraham said.

The ReDS-directed management approach yielded a “highly nonsignificant” 19% reduction in recurrent or cumulative heart failure readmissions (P = .36); by contrast, after removing nonadherent, noncompliant cases, there were 11 hospitalizations in 91 treatment patients, compared with 43 hospitalizations in 133 control patients, yielding a hazard ratio of 0.42 (95% CI, 0.22-0.82; P = .01).

“This comes back to the adage that, if you don’t use it, you can’t improve clinical outcomes,” he said, explaining that this study’s modified intent-to-treat population was defined by excluding patients who took no ReDS measurements for more than 20 consecutive days; or by clinicians who received at least eight notifications of out-of-range ReDS values yet didn’t implement the ReDS treatment algorithm.

There were no adverse events reported as being definitely related to the use of the device, and five adverse events reported as possibly related to the device, Dr. Abraham said.

SMILE was sponsored by Sensible Medical Innovations. Dr. Abraham reported disclosures (consultant/advisory board) related to Sensible Medical Innovations, Abbott, Boehringer Ingelheim, Victorious Medical, V-Wave Medical, and others.

 

– A heart failure management strategy guided by home lung fluid measurements from the remote dielectric sensing (ReDS) system can significantly reduce recurrent hospitalizations, as long as the technology is used as intended.

Dr. William T. Abraham, The Ohio State University
Andrew D. Bowser/MDedge News
Dr. William T. Abraham

A ReDS-directed management strategy did not significantly reduce recurrent hospitalizations for acute decompensated heart failure (ADHF) in the traditional intent-to-treat analysis of the randomized, controlled SMILE trial, William T. Abraham, MD, of the Ohio State University, Columbus, said at the annual scientific meeting of the Heart Failure Society of America.

However, use of the Food and Drug Administration–cleared thoracic fluid status monitoring system to guide treatment changes did cut such hospitalizations by 58% in a modified intent-to-treat population that excluded patients who failed to take daily measurements at home and who didn’t receive modified treatment despite actionable readings, Dr. Abraham reported in an oral presentation.

“These observations may support an adherence-based approach to the utilization and reimbursement of ReDS-guided management in recently discharged ADHF patients,” he said.

The ReDS system consists of a device that, within about 90 seconds, provides a measurement of lung fluid via a focused electromagnetic radar beam that passes through the right lung, Dr. Abraham said. Clinicians access data from measurements patients initiate at home through a secure, cloud-based system, and then initiate changes to heart failure management as warranted based on a ReDS-specific treatment algorithm, Dr. Abraham said.



The postmarketing SMILE study of the ReDS system was stopped early because of an administrative decision by the sponsor, according to Dr. Abraham. However, 268 patients enrolled at 43 U.S. sites continued to the end of the study, with an average follow-up of about 6 months, while readmissions were collected and adjudicated by an independent clinical events committee.

A total of 135 patients were randomized to a ReDS-based management strategy, while 133 were randomized to standard of care, the investigator said.

Most of the medication changes made in response to ReDS measurements were increased diuretics because of high lung fluid volume measurements, or decreased diuretics in response to low measurements, though some changes in vasodilator medications were also made, Dr. Abraham said.

The ReDS-directed management approach yielded a “highly nonsignificant” 19% reduction in recurrent or cumulative heart failure readmissions (P = .36); by contrast, after removing nonadherent, noncompliant cases, there were 11 hospitalizations in 91 treatment patients, compared with 43 hospitalizations in 133 control patients, yielding a hazard ratio of 0.42 (95% CI, 0.22-0.82; P = .01).

“This comes back to the adage that, if you don’t use it, you can’t improve clinical outcomes,” he said, explaining that this study’s modified intent-to-treat population was defined by excluding patients who took no ReDS measurements for more than 20 consecutive days; or by clinicians who received at least eight notifications of out-of-range ReDS values yet didn’t implement the ReDS treatment algorithm.

There were no adverse events reported as being definitely related to the use of the device, and five adverse events reported as possibly related to the device, Dr. Abraham said.

SMILE was sponsored by Sensible Medical Innovations. Dr. Abraham reported disclosures (consultant/advisory board) related to Sensible Medical Innovations, Abbott, Boehringer Ingelheim, Victorious Medical, V-Wave Medical, and others.

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Cardiotoxicity after checkpoint inhibitor treatment seen early, linked to elevated biomarkers

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Thu, 10/10/2019 - 07:29

 

While immune checkpoint inhibitors were not significantly more cardiotoxic than other lung cancer treatments, major adverse cardiac events (MACE) did occur earlier, and occurred more frequently in patients with elevated biomarkers, in a retrospective cohort study reported at the annual scientific meeting of the Heart Failure Society of America.

Dr. Kalyan R. Chitturi, DeBakey Heart and Vascular Center, Houston Methodist Hospital
Andrew D. Bowser/MDedge News
Dr. Kalyan R. Chitturi

The findings support monitoring of cardiac biomarkers in the initial phase of checkpoint inhibitor treatment to identify patient at high cardiac risk, according to Kalyan R. Chitturi, DO, a resident physician with the DeBakey Heart and Vascular Center, Houston Methodist Hospital, who presented the results.

“It’s the early period that warrants the closest monitoring, as within the first 30-40 days, there’s higher risk,” Dr. Chitturi said in an interview. “When there was a biomarker elevation, it markedly increased the risk of MACE, warranting a closer vigilance during that time period.”

The retrospective study conducted by Dr. Chitturi and colleagues included a total of 252 patients with lung cancer who had been treated at one of seven different sites in Houston Methodist Cancer Center between Aug. 1, 2015, and Aug. 1, 2018.

Immune checkpoint inhibitors did not significantly increase the risk of MACE, compared with other lung cancer therapies, with incidences of 13.3% and 10.3%, respectively (P = .632), the investigators found.

However, MACE did occur earlier in the checkpoint inhibitor group, at a median time to event of 40 days, compared with 118 days in the patients not treated with checkpoint inhibitors, they found.

Risk of MACE with checkpoint inhibitor treatment was increased in patients with elevated troponin (hazard ratio, 2.48; 95% confidence interval, 1.18-5.21; P = .017) or elevated brain natriuretic peptide (HR, 5.77; 95% CI, 2.70-12.35; P less than .001), according to multivariate logistic regression analysis results.

These results suggest biomarkers such as cardiac troponin and brain natriuretic peptide are warranted to monitor patients in the early phase of checkpoint inhibitor treatment, according to Dr. Chitturi. “In the cost-benefit ratio of often-lethal MACE, it’s well worth it to collect these,” he said in the interview.

The results corroborate findings from some other recent studies, he noted. These include a recent study that linked elevated serum troponin to myocarditis in patients treated with immune checkpoint inhibitors (J Am Coll Cardiol. 2018 Apr 24;71[16]:1755-64).

Dr. Chitturi and coauthors reported no disclosures related to their presentation at the HFSA meeting.

SOURCE: Chitturi KR et al. HFSA 2019, Abstract 127.

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While immune checkpoint inhibitors were not significantly more cardiotoxic than other lung cancer treatments, major adverse cardiac events (MACE) did occur earlier, and occurred more frequently in patients with elevated biomarkers, in a retrospective cohort study reported at the annual scientific meeting of the Heart Failure Society of America.

Dr. Kalyan R. Chitturi, DeBakey Heart and Vascular Center, Houston Methodist Hospital
Andrew D. Bowser/MDedge News
Dr. Kalyan R. Chitturi

The findings support monitoring of cardiac biomarkers in the initial phase of checkpoint inhibitor treatment to identify patient at high cardiac risk, according to Kalyan R. Chitturi, DO, a resident physician with the DeBakey Heart and Vascular Center, Houston Methodist Hospital, who presented the results.

“It’s the early period that warrants the closest monitoring, as within the first 30-40 days, there’s higher risk,” Dr. Chitturi said in an interview. “When there was a biomarker elevation, it markedly increased the risk of MACE, warranting a closer vigilance during that time period.”

The retrospective study conducted by Dr. Chitturi and colleagues included a total of 252 patients with lung cancer who had been treated at one of seven different sites in Houston Methodist Cancer Center between Aug. 1, 2015, and Aug. 1, 2018.

Immune checkpoint inhibitors did not significantly increase the risk of MACE, compared with other lung cancer therapies, with incidences of 13.3% and 10.3%, respectively (P = .632), the investigators found.

However, MACE did occur earlier in the checkpoint inhibitor group, at a median time to event of 40 days, compared with 118 days in the patients not treated with checkpoint inhibitors, they found.

Risk of MACE with checkpoint inhibitor treatment was increased in patients with elevated troponin (hazard ratio, 2.48; 95% confidence interval, 1.18-5.21; P = .017) or elevated brain natriuretic peptide (HR, 5.77; 95% CI, 2.70-12.35; P less than .001), according to multivariate logistic regression analysis results.

These results suggest biomarkers such as cardiac troponin and brain natriuretic peptide are warranted to monitor patients in the early phase of checkpoint inhibitor treatment, according to Dr. Chitturi. “In the cost-benefit ratio of often-lethal MACE, it’s well worth it to collect these,” he said in the interview.

The results corroborate findings from some other recent studies, he noted. These include a recent study that linked elevated serum troponin to myocarditis in patients treated with immune checkpoint inhibitors (J Am Coll Cardiol. 2018 Apr 24;71[16]:1755-64).

Dr. Chitturi and coauthors reported no disclosures related to their presentation at the HFSA meeting.

SOURCE: Chitturi KR et al. HFSA 2019, Abstract 127.

 

While immune checkpoint inhibitors were not significantly more cardiotoxic than other lung cancer treatments, major adverse cardiac events (MACE) did occur earlier, and occurred more frequently in patients with elevated biomarkers, in a retrospective cohort study reported at the annual scientific meeting of the Heart Failure Society of America.

Dr. Kalyan R. Chitturi, DeBakey Heart and Vascular Center, Houston Methodist Hospital
Andrew D. Bowser/MDedge News
Dr. Kalyan R. Chitturi

The findings support monitoring of cardiac biomarkers in the initial phase of checkpoint inhibitor treatment to identify patient at high cardiac risk, according to Kalyan R. Chitturi, DO, a resident physician with the DeBakey Heart and Vascular Center, Houston Methodist Hospital, who presented the results.

“It’s the early period that warrants the closest monitoring, as within the first 30-40 days, there’s higher risk,” Dr. Chitturi said in an interview. “When there was a biomarker elevation, it markedly increased the risk of MACE, warranting a closer vigilance during that time period.”

The retrospective study conducted by Dr. Chitturi and colleagues included a total of 252 patients with lung cancer who had been treated at one of seven different sites in Houston Methodist Cancer Center between Aug. 1, 2015, and Aug. 1, 2018.

Immune checkpoint inhibitors did not significantly increase the risk of MACE, compared with other lung cancer therapies, with incidences of 13.3% and 10.3%, respectively (P = .632), the investigators found.

However, MACE did occur earlier in the checkpoint inhibitor group, at a median time to event of 40 days, compared with 118 days in the patients not treated with checkpoint inhibitors, they found.

Risk of MACE with checkpoint inhibitor treatment was increased in patients with elevated troponin (hazard ratio, 2.48; 95% confidence interval, 1.18-5.21; P = .017) or elevated brain natriuretic peptide (HR, 5.77; 95% CI, 2.70-12.35; P less than .001), according to multivariate logistic regression analysis results.

These results suggest biomarkers such as cardiac troponin and brain natriuretic peptide are warranted to monitor patients in the early phase of checkpoint inhibitor treatment, according to Dr. Chitturi. “In the cost-benefit ratio of often-lethal MACE, it’s well worth it to collect these,” he said in the interview.

The results corroborate findings from some other recent studies, he noted. These include a recent study that linked elevated serum troponin to myocarditis in patients treated with immune checkpoint inhibitors (J Am Coll Cardiol. 2018 Apr 24;71[16]:1755-64).

Dr. Chitturi and coauthors reported no disclosures related to their presentation at the HFSA meeting.

SOURCE: Chitturi KR et al. HFSA 2019, Abstract 127.

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Machine learning–derived risk score predicts heart failure risk in diabetes patients

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Tue, 05/03/2022 - 15:13

 

– For patients with high-risk diabetes, a novel, machine learning–derived risk score based on 10 common clinical variables can identify those facing a heart failure risk of up to nearly 20% over the ensuing 5 years, an investigator said at the annual meeting of the Heart Failure Society of America.

The risk score, dubbed WATCH-DM, has greater accuracy in predicting incident heart failure than traditional risk-based models, and requires no specific cardiovascular biomarkers or imaging, according to Muthiah Vaduganathan, MD, MPH, a cardiologist at Brigham and Women’s Hospital and faculty at Harvard Medical School in Boston.

The tool may help inform risk-based monitoring and introduction of sodium-glucose transporter 2 (SGLT2) inhibitors, which have been shown in multiple clinical trials to prevent heart failure in at-risk patients with type 2 diabetes mellitus (T2DM), Dr. Vaduganathan said.

“Patients identified at high risk based on WATCH-DM should be strongly considered for initiation of SGLT2 inhibitors in clinical practice,” Dr. Vaduganathan said in an interview.

WATCH-DM is available online at cvriskscores.com. Work is underway to integrate the tool into electronic health record systems at Brigham and Women’s Hospital and at the University of Texas Southwestern Medical Center in Dallas. “I expect that to be launched in the next year,” he said.

The WATCH-DM score was developed based on data from the ACCORD (Action to Control Cardiovascular Risk in Diabetes) trial, including 8,756 T2DM patients with inadequate glycemic control at high cardiovascular risk and no heart failure at baseline.

Starting with 147 variables, the investigators used a decision-tree machine learning approach to identify predictors of heart failure.

“What machine learning does is automate the variable selection process, as a form of artificial intelligence,” Dr. Vaduganathan said.

The WATCH-DM risk score was based on the 10 best-performing predictors as selected by machine learning, including body mass index, age, systolic blood pressure, diastolic blood pressure, fasting plasma glucose, serum creatinine, high-density lipoprotein cholesterol, QRS duration, prior myocardial infarction, and prior coronary artery bypass grafting.

The 5-year risk of heart failure was just 1.1% for patients with WATCH-DM scores in the lowest quintile, increasing in a graded fashion to nearly 20% (17.4%) in the highest quintile, study results show.

Findings of the study were simultaneously published in the journal Diabetes Care.

Dr. Vaduganathan said he is supported by an award from Harvard Catalyst. He provided disclosures related to Amgen, AstraZeneca, Baxter Healthcare, Bayer AG, Boehringer Ingelheim (advisory boards), and with Novartis and the National Institutes of Health (participation on clinical endpoint committees).

SOURCE: HFSA 2019; Segar MW, Vaduganathan M et al. Diabetes Care. doi: 10.2337/dc19-0587.

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– For patients with high-risk diabetes, a novel, machine learning–derived risk score based on 10 common clinical variables can identify those facing a heart failure risk of up to nearly 20% over the ensuing 5 years, an investigator said at the annual meeting of the Heart Failure Society of America.

The risk score, dubbed WATCH-DM, has greater accuracy in predicting incident heart failure than traditional risk-based models, and requires no specific cardiovascular biomarkers or imaging, according to Muthiah Vaduganathan, MD, MPH, a cardiologist at Brigham and Women’s Hospital and faculty at Harvard Medical School in Boston.

The tool may help inform risk-based monitoring and introduction of sodium-glucose transporter 2 (SGLT2) inhibitors, which have been shown in multiple clinical trials to prevent heart failure in at-risk patients with type 2 diabetes mellitus (T2DM), Dr. Vaduganathan said.

“Patients identified at high risk based on WATCH-DM should be strongly considered for initiation of SGLT2 inhibitors in clinical practice,” Dr. Vaduganathan said in an interview.

WATCH-DM is available online at cvriskscores.com. Work is underway to integrate the tool into electronic health record systems at Brigham and Women’s Hospital and at the University of Texas Southwestern Medical Center in Dallas. “I expect that to be launched in the next year,” he said.

The WATCH-DM score was developed based on data from the ACCORD (Action to Control Cardiovascular Risk in Diabetes) trial, including 8,756 T2DM patients with inadequate glycemic control at high cardiovascular risk and no heart failure at baseline.

Starting with 147 variables, the investigators used a decision-tree machine learning approach to identify predictors of heart failure.

“What machine learning does is automate the variable selection process, as a form of artificial intelligence,” Dr. Vaduganathan said.

The WATCH-DM risk score was based on the 10 best-performing predictors as selected by machine learning, including body mass index, age, systolic blood pressure, diastolic blood pressure, fasting plasma glucose, serum creatinine, high-density lipoprotein cholesterol, QRS duration, prior myocardial infarction, and prior coronary artery bypass grafting.

The 5-year risk of heart failure was just 1.1% for patients with WATCH-DM scores in the lowest quintile, increasing in a graded fashion to nearly 20% (17.4%) in the highest quintile, study results show.

Findings of the study were simultaneously published in the journal Diabetes Care.

Dr. Vaduganathan said he is supported by an award from Harvard Catalyst. He provided disclosures related to Amgen, AstraZeneca, Baxter Healthcare, Bayer AG, Boehringer Ingelheim (advisory boards), and with Novartis and the National Institutes of Health (participation on clinical endpoint committees).

SOURCE: HFSA 2019; Segar MW, Vaduganathan M et al. Diabetes Care. doi: 10.2337/dc19-0587.

 

– For patients with high-risk diabetes, a novel, machine learning–derived risk score based on 10 common clinical variables can identify those facing a heart failure risk of up to nearly 20% over the ensuing 5 years, an investigator said at the annual meeting of the Heart Failure Society of America.

The risk score, dubbed WATCH-DM, has greater accuracy in predicting incident heart failure than traditional risk-based models, and requires no specific cardiovascular biomarkers or imaging, according to Muthiah Vaduganathan, MD, MPH, a cardiologist at Brigham and Women’s Hospital and faculty at Harvard Medical School in Boston.

The tool may help inform risk-based monitoring and introduction of sodium-glucose transporter 2 (SGLT2) inhibitors, which have been shown in multiple clinical trials to prevent heart failure in at-risk patients with type 2 diabetes mellitus (T2DM), Dr. Vaduganathan said.

“Patients identified at high risk based on WATCH-DM should be strongly considered for initiation of SGLT2 inhibitors in clinical practice,” Dr. Vaduganathan said in an interview.

WATCH-DM is available online at cvriskscores.com. Work is underway to integrate the tool into electronic health record systems at Brigham and Women’s Hospital and at the University of Texas Southwestern Medical Center in Dallas. “I expect that to be launched in the next year,” he said.

The WATCH-DM score was developed based on data from the ACCORD (Action to Control Cardiovascular Risk in Diabetes) trial, including 8,756 T2DM patients with inadequate glycemic control at high cardiovascular risk and no heart failure at baseline.

Starting with 147 variables, the investigators used a decision-tree machine learning approach to identify predictors of heart failure.

“What machine learning does is automate the variable selection process, as a form of artificial intelligence,” Dr. Vaduganathan said.

The WATCH-DM risk score was based on the 10 best-performing predictors as selected by machine learning, including body mass index, age, systolic blood pressure, diastolic blood pressure, fasting plasma glucose, serum creatinine, high-density lipoprotein cholesterol, QRS duration, prior myocardial infarction, and prior coronary artery bypass grafting.

The 5-year risk of heart failure was just 1.1% for patients with WATCH-DM scores in the lowest quintile, increasing in a graded fashion to nearly 20% (17.4%) in the highest quintile, study results show.

Findings of the study were simultaneously published in the journal Diabetes Care.

Dr. Vaduganathan said he is supported by an award from Harvard Catalyst. He provided disclosures related to Amgen, AstraZeneca, Baxter Healthcare, Bayer AG, Boehringer Ingelheim (advisory boards), and with Novartis and the National Institutes of Health (participation on clinical endpoint committees).

SOURCE: HFSA 2019; Segar MW, Vaduganathan M et al. Diabetes Care. doi: 10.2337/dc19-0587.

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