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PARAGON-HF top-line results: sacubitril/valsartan for HFpEF misses primary endpoint

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John McMurray

Novartis announced top-line results from the PARAGON-HF trial, which showed that the trial narrowly missed statistical significance for the primary endpoint in patients with HF with preserved ejection fraction who were treated with sacubitril/valsartan compared with valsartan alone.

The composite primary endpoint was reduction in CV death and total HF hospitalizations. Safety and tolerability of patients treated with sacubitril/valsartan (Entresto) were similar to other previously reported data, according to a press release from the company.

“Around half of all heart failure patients, some 13 million people worldwide, are estimated to suffer from HFpEF, and there is currently no approved treatment,” John McMurray, MD, professor of medical cardiology at the University of Glasgow in Scotland and the executive committee co-chair of the PARAGON-HF trial, said in the release. “We embarked upon the landmark phase 3 PARAGON-HF trial to determine whether sacubitril/valsartan could have a meaningful impact on the treatment of HFpEF as it does in the treatment of heart failure with reduced ejection fraction.”

The PARAGON-HF trial compared long-term safety and efficacy of sacubitril/valsartan vs. valsartan alone in 4,822 patients with HFpEF. The trial followed the phase 3 PARAMOUNT-HF trial, which found that sacubitril/valsartan reduced N-terminal pro-B-type natriuretic peptide more than valsartan alone at 12 weeks and improved NYHA class at 36 weeks, according to the release.

Full results of the PARAGON-HF trial will be presented at the European Society of Cardiology Congress in Paris.

Scott Solomon

“We look forward to presenting and discussing the data from PARAGON-HF, which should inform our understanding and treatment of HFpEF,” Scott Solomon, MD, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital and executive committee co-chair of the trial, said in the release.

Disclosures: The PARAGON-HF trial was sponsored by Novartis. Cardiology Today could not confirm relevant financial disclosures for McMurray and Solomon at the time of publication.