Novartis Korea unveiled the results of the PARADE-HF study on Monday, showcasing the effectiveness of its heart failure treatment, Entresto, in a real-world Korean context. The data revealed a significant reduction in both all-cause mortality and hospitalization risks for patients with chronic heart failure.

Entresto, a combination of sacubitril and valsartan, is approved to reduce the risk of cardiovascular death and hospitalization for adult patients with chronic heart failure.

The PARADE-HF study, published in ESC Heart Failure in October, analyzed data from a nationwide cohort of patients with heart failure with reduced ejection fraction (HFrEF), using information from Korea’s National Health Insurance database (2017-2021). The study compared outcomes between 13,483 heart failure patients treated with Entresto and an equal number who received traditional renin-angiotensin system (RAS) inhibitors, such as angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs).

The study aimed to assess the impact of medication adherence on treatment outcomes by comparing death and hospitalization rates between patients using Entresto and those on traditional RAS inhibitors. 

This large-scale, retrospective study, which assessed mortality and hospitalization rates over one year, revealed that patients on Entresto had significantly better outcomes. The primary endpoint, a composite of all-cause mortality and hospitalization, showed that 49.1 percent of patients in the Entresto group experienced adverse outcomes, compared to 64.1 percent in the RAS inhibitor group—representing a 22 percent reduction in risk. Secondary outcomes also favored Entresto, with a 14 percent lower risk of death and a 23 percent reduction in hospitalizations.

The benefits of Entresto were particularly evident in men over 50 and women over 60, with the most dramatic improvements seen in those over 80, regardless of gender. These findings support previous results from the PARADIGM-HF trial, which showed that Entresto outperformed the RAS inhibitor enalapril in reducing cardiovascular death and heart failure hospitalizations by more than 20 percent.

The PARADE-HF study also highlighted the importance of medication adherence. Patients who adhered to their Entresto regimen (with over 80 percent adherence) experienced a 25 percent greater reduction in both mortality and hospitalization risk compared to those on RAS inhibitors. In contrast, no significant benefits were observed among patients with lower adherence.

“The study’s large sample size and its recent analysis of real-world impact on HFrEF patients underscore its significance,” said Professor Yoo Byung-su, a cardiologist at Yonsei University’s Wonju College of Medicine and the corresponding author of the PARADE-HF study. “With Entresto’s effectiveness confirmed for Korean HFrEF patients, proactive efforts to improve medication adherence are essential.”

Cho Yeon-jin, head of CVD and NGTx at Novartis Korea, added that data from Korean patients will help address the heart failure treatment landscape in Korea, where the disease’s prevalence and socioeconomic burden are rising due to an aging population.