Novartis PARAGON-HF trial suggests Entresto benefit in HFpEF patients but narrowly misses primary endpoint

- Entresto (sacubitril/valsartan) reduced the composite of total (first and recurrent) heart failure hospitalizations and cardiovascular death although narrowly missed statistical?significance?(p = 0.059)[1]
- Totality of evidence, including improvement in various measures of symptoms, quality of life, and renal function, suggests clinically important benefits in HFpEF[1]
- Entresto was well tolerated and the overall safety profile was comparable to previous findings in HFrEF patients[1]
The digital press release with multimedia content can be accessed here:
- Entresto was safe and well tolerated in HFpEF patients, largely as observed in HFrEF patients in PARADIGM-HF.
- Hypotension occurred more frequently with Entresto (23.2%) than with valsartan (17%), but rates of discontinuation due to hypotension were similar (2.4% and 2.3%, respectively).
- Overall incidence of confirmed angioedema events was low in the two treatment arms, with 15 events in the Entresto arm (0.58%) and 4 events in the valsartan arm (0.17%); no angioedema events resulted in airway compromise or death.
- Entresto resulted in lower rates of renal dysfunction and hyperkalemia compared to valsartan, as well as lower rates of discontinuation of study medication due to these events[1].