Kaiser Permanente researchers lead real-world study Sacubitril/Valsartan in Patients with Mildly Reduced and Preserved Ejection Fraction

A new study from Kaiser Permanente shows doctors which newly diagnosed heart failure patients with mildly reduced or preserved ejection fraction may benefit from a new type of drug called sacubitril/valsartan. may help you make better decisions.

The findings were presented April 7 at the American College of Cardiology’s Annual Scientific Sessions and simultaneously published in the European Journal of Heart Failure.

“Randomized trials show that sacubitril/valsartan is a more effective option for heart failure patients with low ejection fraction and some patients with high ejection fraction,” said co-first author Ankeet. – said Butt, MD, MBA, MSc. Kaiser Permanente Research Division and Permanente Medical Group Cardiologist. “However, concerns remain about how clinical trial results translate to the real world, especially in patients with newly diagnosed heart failure. Our study “We provide real-world evidence supporting the potential benefits of this therapy in patients with heart failure diagnosed in the United States.”

Ejection fraction is a measure of how much blood the left ventricle pumps out with each contraction of the heart. When the heart is pumping blood properly, a normal ejection fraction is between 55% and 70%. However, some patients have heart failure even if their ejection fraction is normal (maintained). In fact, people with heart failure and mildly reduced or preserved ejection fraction are the fastest growing segment of the heart failure population.

This retrospective study included 82,664 patients with newly diagnosed heart failure with left ventricular ejection fraction >40% and mildly reduced or preserved ejection fraction between 2016 and 2020. It became. All patients were seen by a healthcare provider in the US Optum database and were prescribed either sacubitril/valsartan or two older classes of drugs: angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs). I had been prescribed one of them.

Our study provides real-world evidence supporting the potential benefits of this therapy in newly diagnosed heart failure patients with high ejection fraction.

— Ankeet Bhatt, MD, MBA, ScM

Of the 82,664 patients, 458 (0.5%) were prescribed sacubitril/valsartan. From the remaining group, the researchers identified 1,374 patients with similar clinical characteristics who were prescribed ACE inhibitors or ARBs. We then looked at how many patients were admitted to each group during the study period.

In this study, patients taking ACE inhibitors or ARBs had a total number of hospitalizations per person-year of 0.79 compared to 0.79 total hospitalizations per person-year for patients taking sacubitril/valsartan. It turned out that there were 1.24 people.

When the research team looked specifically at cardiovascular-related hospitalizations, the hospitalization rate was 0.65/person-year for patients taking the sacubitril/valsartan cohort, compared to 0.65/person-year for patients taking either of the other two drugs. The number of hospitalizations/person-year was found to be 1.01 in the group with

Bhatt said these findings are consistent with the benefits seen in the clinical trials that led to the approval of sacubitril/valsartan. However, this study also highlighted how few patients are prescribed sacubitril/valsartan. This may be because clinical trials found that sacubitril/valsartan may increase the risk of hypotension, Bhatt said. Due to differences in prescription drug coverage, sacubitril/valsartan can be more expensive than the ACE inhibitors and ARBs currently available in generic versions.

“It’s not uncommon for people to continue taking medications regularly prescribed by their doctors for years,” says Butt. “Sacubitril/valsartan is approved to treat patients with all types of heart failure, and despite data on its effectiveness and ability to keep people out of the hospital and live longer, it is not used as frequently as in older people. This is a potential treatment strategy that should be discussed as part of common decision-making as heart failure patients and their clinicians decide which drug is best.”

This study was funded by Novartis Pharma AG.

Co-authors include Muthiah Vaduganathan, MD, MPH, of Brigham and Women’s Hospital; Novartis’ Barada Prasad Jena, MS, Sylwia Suminska, MS, Carlos Eid, MD, Rahul Khairnar, PhD, and Gabriella Farries, PhD; Dr. Michele Senni from the University of Milan-Bicocca.

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About Kaiser Permanente Research Department

Kaiser Permanente’s Research Division conducts, publishes, and disseminates epidemiology and health services research to improve the health and health care of Kaiser Permanente members and society as a whole. We aim to understand the determinants of disease and health and improve the quality and cost-effectiveness of healthcare. Currently, his more than 600 staff members at DOR are working on his more than 450 epidemiology and health services research projects. For more information, visit divisionofresearch.kaiserpermanente.org or follow @KPDOR.