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Novartis: Phase III PARAGON-HF Trial Narrowly Misses Statistical Significance

Swiss drug major Novartis AG (NVS) announced Monday that the global Phase III PARAGON-HF study in heart failure patients with preserved ejection fraction or HFpEF narrowly missed statistical significance for its composite primary endpoint. Meanwhile, overall safety profile confirmed.

The trial investigated the safety and efficacy of sacubitril/valsartan versus the active comparator valsartan in HFpEF patients. The primary endpoint was reducing cardiovascular death and total heart failure hospitalizations. Safety and tolerability were consistent with previously reported sacubitril/valsartan data.

According to the company, the totality of evidence from the trial suggests that treatment with sacubitril/valsartan may result in clinically important benefits in HFpEF.

Novartis said it will discuss potential next steps with clinical experts and regulators while preparing to present the full results at the ESC Congress 2019 in September.

There is currently no approved treatment for HFpEF. Novartis continues to study sacubitril/valsartan in HfrEF.

Additional studies investigating sacubitril/valsartan on other relevant endpoints in HFpEF are ongoing.

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