Novartis announced the global phase III PARAGON-HF study results; examining the safety and efficacy of sacubitril/valsartan versus the active comparator valsartan in HFpEF patients. The trial merely missed statistical significance for its composite primary endpoint for death reduction due to cardiovascular (CV) issues and total heart failure hospitalizations. Safety and tolerability were constant with earlier reported sacubitril/valsartan data.
The phase III study was randomized, double-blinded, parallel group, active-controlled, 2-arm, event-driven trial which compared the long-term efficacy and safety of sacubitril/valsartan versus valsartan in 4,822 patients with HFpEF. The participants in the study represented ambulatory patients with settled HFpEF being treated for symptoms in which approximately half of whom had a history of heart failure hospitalizations. The primary endpoint of the trial was the cumulative of total (first and recurrent) heart failure hospitalizations and cardiovascular death.
Heart failure (HF) is a gradual and acute condition in which the heart is unavailable to pump enough blood for the body. There are two distinct heart failure types : preserved ejection fraction (HFpEF) and reduced ejection fraction (HfrEF).
Sacubitril/valsartan is a primary-choice of treatment in heart failure with reduced ejection fraction (HFrEF), based on its superiority to the angiotensin-converting enzyme (ACE) inhibitor enalapril and its capability of significantly reducing CV death and HFrEF hospitalizations.
Clinical Research Newsletter
Mr Vinod Arora, Principal Advisor, IGMPI
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