Issue: November 2016
September 27, 2016
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Sacubitril/valsartan associated with better quality-of-life metrics vs. enalapril

Issue: November 2016
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ORLANDO, Fla. The decline in health-related quality of life scores associated with HF among patients assigned sacubitril/valsartan was 50% lower than in those assigned enalapril, according to a post-hoc analysis presented at the Heart Failure Society of America Scientific Assembly.

“Patients hospitalized for HF are sicker to begin with, but after the hospitalization, they have a higher risk for increased mortality, and their quality of life typically is worse afterwards,” Eldrin F. Lewis, MD, MPH, HF and transplant cardiologist at Brigham and Women’s Hospital and associate professor of medicine at Harvard Medical School, told Cardiology Today. “As a consequence, we are very focused on things we can do to reduce that risk.”

Patients from the PARADIGM-HF trial comparing sacubitril/valsartan (Entresto, Novartis), a neprilysin inhibitor/angiotensin receptor blocker, with the ACE inhibitor enalapril completed the HF-specific Kansas City Cardiomyopathy Questionnaire (KCCQ) at randomization and at 4-month, 8-month and 1-year visits.

Eldrin F. Lewis

Of the 6,981 patients from PARADIGM-HF who completed the KCCQ at baseline and at 8 months, 4.4% (n = 305) were hospitalized for HF. Patients from both treatment groups not hospitalized for HF showed modest improvements in KCCQ scores (sacubitril/valsartan group, +1.22; enalapril group, +0.6).

Patients hospitalized for HF within 8 months of randomization had significantly decreased KCCQ scores at 8 months. When compared with the enalapril group, patients assigned sacubitril/valsartan had less pronounced decline in KCCQ overall summary scores (–5.11 vs. –11.37l; P = .003), Lewis and colleagues found.

“The proposed mechanism of action would be the neprilysin inhibitor component, which causes the body to produce its natural endogenous B-type natriuretic peptide,” Lewis told Cardiology Today. “We are trying to understand whether this is something that would be reproducible in other trials.”

Because symptoms and quality of life are important for patients with HF, and both decline after hospitalization, “we should look carefully at these patients who survive a hospitalization for HF to try to understand strategies we can use to improve their quality of life over time,” he said in an interview.

Also, he said, patients with HF whose quality of life declines outside the hospital are at increased risk for hospitalization of death, so “we should think carefully about measuring quality of life routinely in clinical practice.”

In another post-hoc analysis of PARADIGM-HF, Lewis and colleagues found that patients from either group who had a decline of at least 5% in KCCQ clinical summary score between baseline and 4 months had a 24% elevated risk for CV death (P = .009) and a 28% elevated risk for HF hospitalization (P = .004).

“These analyses suggest that sacubitril/valsartan may help mitigate the impact of HF hospitalization on a patient’s health-related quality of life and make a strong case for it as part of optimal treatment of HF with reduced ejection fraction,” Lewis said in a press release. – by Dave Quaile and Erik Swain

References:

Lewis EF, et al. Poster 064. Presented at: Heart Failure Society of America Scientific Assembly; Sept. 17-20, 2016; Orlando, Fla.

Lewis EF, et al. J Card Fail. 2016;doi:10.1016/j.cardfail.2016.06.293.

Disclosure: Lewis reports consulting for Novartis and receiving research funding from Amgen, Novartis and Sanofi.