Issue: August 2016
June 28, 2016
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Analysis: Sacubitril/valsartan may prevent many deaths from HF

Issue: August 2016
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Angiotensin receptor-neprilysin inhibitor therapy may help prevent more than 28,000 deaths per year in the United States from HF with reduced ejection fraction, researchers reported in JAMA Cardiology.

“These data, given the tens of thousands of lives that can be saved, support very vigorous implementation efforts of this therapy,” Gregg C. Fonarow, MD, the Eliot Corday chair in cardiovascular medicine and science, director of the Ahmanson-UCLA Cardiomyopathy Center and co-chief of the UCLA division of cardiology, told Cardiology Today.

Gregg C. Fonarow, MD

Gregg C. Fonarow

Using the number needed to treat (NNT), standardized to 12 months, from the PARADIGM-HF trial, Fonarow and colleagues estimated the number of potential lives saved per year from angiotensin receptor-neprilysin inhibitor therapy with sacubitril/valsartan (Entresto, Novartis).

Of the 5.7 million patients with HF in the United States, 2,287,296 meet the eligibility criteria for angiotensin receptor-neprilysin inhibitor therapy. According to the results, the NNT to prevent one death, standardized to 12 months, was 80.3. The number of deaths that could be prevented each year with optimal implementation of angiotensin receptor-neprilysin inhibitor therapy would be 28,484, with the range from multiple-way sensitivity analyses being 18,230 to 41,017, according to the researchers.

“Some have advocated that a period of time should pass from when a new therapy is first approved to when it is routinely prescribed in clinical practice, allowing for potential issues regarding safety to emerge,” Fonarow told Cardiology Today. “We are highlighting here that for a therapy that has reduced mortality and whose benefits outweigh the risks, there is a substantial downside in terms of tens of thousands of deaths that could otherwise be prevented had therapy been more rapidly implemented. It quantified at the U.S. population level for HF patients how non-patient-centered and costly such an approach would be.”

According to a press release, Novartis has launched FortiHFy, a large clinical trial program to collect additional data and real-world evidence on sacubitril/valsartan. – by Tracey Romero

Disclosure: Fonarow is the associate editor for health care quality and guidelines at JAMA Cardiology and reports receiving consulting fees from Amgen, Janssen, Medtronic and Novartis. Please see full study for a list of all other researchers’ relevant financial disclosures.