Novartis International AG, a Swiss-based pharmaceutical company recently announced results from Phase 3 PARAGON-HF trial in HFpEF (heart failure patients with preserved ejection fraction), investigating the efficacy & safety of sacubitril/ valsartan versus the active comparator valsartan.

The trial closely missed statistical importance for its composite primary endpoint of decreasing total heart failure hospitalizations and cardiovascular death. As per the sacubitril/valsartan data, safety & tolerability were consistent.

For the record, there is no approved treatment for heart failure patients with preserved ejection fraction at present. Sacubitril/valsartan is proven to treat HFrEF (heart failure with reduced ejection fraction) due to its ACE (angiotensin-converting enzyme) inhibitor enalapril along with the ability to reduce HFrEF hospitalizations & cardiovascular deaths.

John McMurray, M.D., PARAGON-HF Executive Committee Co-Chairperson and Professor of Medical Cardiology at University of Glasgow was reportedly quoted saying that around 13 million people globally are estimated to suffer from heart failure, and presently, there is no approved treatment available.

He added saying that phase 3 PARAGON-HF trial of sacubitril/valsartan was undertaken to determine its impact on treatment of HFpEF, as it does in the treatment of HFrEF (heart failure with reduced ejection fraction).

John Tsai, M.D., Global Drug Development & CMO of Novartis was reported to state that the trial indicates that the treatment with sacubitril/valsartan has a potential to get positive results in HFpEF. The firm is planning to discuss with clinical experts to take the trials forward and meanwhile is preparing to present the full results at the European Society of Cardiology Congress 2019.

As per credible sources, Novartis is presently studying sacubitril/valsartan to treat HFrEF, with new data on cardiac remodeling being presented at the European Society of Cardiology Congress 2019. PARAGON-HF results will also be reported in detail at that time. Further studies examining sacubitril/valsartan on other relevant endpoints for treating HFpEF are ongoing.

Source credits: https://www.novartis.com/news/media-releases/novartis-provides-update-phase-iii-paragon-hf-trial-heart-failure-patients-preserved-ejection-fraction-hfpef