Kaiser Permanente researcher led real-world study on sacubitril/valsartan in patients with mildly reduced and preserved ejection fraction
New research from Kaiser Permanente may help doctors better determine which patients newly diagnosed with heart failure with mildly reduced or preserved ejection fraction might benefit from a newer type of medication called sacubitril/valsartan.
The findings were presented on April 7 at the American College of Cardiology annual Scientific Sessions and published simultaneously in the European Journal of Heart Failure.
“Randomized trials have shown sacubitril/valsartan was a more effective option for patients with heart failure with a low ejection fraction and some patients with higher ejection fractions,” said co-lead author Ankeet Bhatt, MD, MBA, ScM, a research scientist at the Kaiser Permanente Division of Research and a cardiologist with The Permanente Medical Group. “But there remain concerns about how clinical trial results would translate into the real world, particularly in patients newly diagnosed with heart failure. Our study provides real-world evidence supporting the potential benefit of this therapy in patients with newly diagnosed heart failure with a higher ejection fraction.”
Ejection fraction is a measure of how much blood a person’s left ventricle pumps out with each contraction of the heart. If a heart is pumping out blood properly, normal ejection fraction will be between 55% and 70%. However, some patients may have a normal (presevered) ejection fraction but still have heart failure. In fact, people with heart failure and a mildly reduced or preserved ejection fraction are the fastest growing segment of the heart failure population.
The retrospective study included 82,664 patients who were newly diagnosed between 2016 and 2020 with heart failure with mildly reduced or preserved ejection fraction with a left ventricular ejection fraction of greater than 40%. All the patients had been seen by a provider in the US Optum database and prescribed sacubitril/valsartan or one of 2 older types of medications — angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARB).
Our study provides real-world evidence supporting the potential benefit of this therapy in patients with newly diagnosed heart failure with a higher ejection fraction.
— Ankeet Bhatt, MD, MBA, ScM
Among the 82,664 patients, 458 (0.5%) had been prescribed sacubitril/valsartan. From the remaining group, the research team identified 1,374 patients who had similar clinical characteristics who had been prescribed an ACE inhibitor or an ARB. Then they looked to see how many patients in each group had been hospitalized during the study time period.
The study found 0.79 overall hospitalizations per person year for the patients taking sacubitril/valsartan compared with 1.24 overall hospitalizations per person year for patients taking an ACE inhibitor or ARB.
When the research team looked specifically at cardiovascular-related hospitalizations, they found a rate of 0.65 hospitalization/person-year in the patients taking sacubitril/valsartan cohort compared to 1.01 hospitalizations/person-year in the group taking one of the other 2 medications.
Bhatt said these findings align with the benefits seen in the clinical trials that led to the approval of sacubitril/valsartan. Yet the study also highlighted how few patients are prescribed sacubitril/valsartan. This may be because the clinical trials found that sacubitril/valsartan could increase risk for hypotension, or low blood pressure, said Bhatt. Variations in prescription medication coverage may also make sacubitril/valsartan more expensive than an ACE inhibitor or an ARB, both of which are now available in generic versions.
“It’s not uncommon for doctors to stick with the medications they have prescribed routinely for years,” said Bhatt. “Even though sacubitril/valsartan is approved to treat patients with all types of heart failure, and there are data on its effectiveness and its ability to keep people out of the hospital and help them live longer, it’s not being used as often as the older medications. It is a potential treatment strategy that should be discussed part of the shared decision making between a patient with heart failure and their clinician as they determine which medication is the best fit.”
The study was funded by Novartis Pharma AG.
Co-authors include: Muthiah Vaduganathan, MD, MPH, of Brigham and Women’s Hospital; Barada Prasad Jena, MSc, Sylwia Suminska, MSc, Carlos Eid, MD, Rahul Khairnar, PhD, and Gabriella Farries, PhD, of Novartis; and Michele Senni, MD, of the Università Milano-Bicocca.
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About the Kaiser Permanente Division of Research
The Kaiser Permanente Division of Research conducts, publishes and disseminates epidemiologic and health services research to improve the health and medical care of Kaiser Permanente members and society at large. It seeks to understand the determinants of illness and well-being, and to improve the quality and cost-effectiveness of health care. Currently, DOR’s 600-plus staff is working on more than 450 epidemiological and health services research projects. For more information, visit divisionofresearch.kaiserpermanente.org or follow us @KPDOR.
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