Novartis announced compelling results from its Phase IV V-DIFFERENCE study, underscoring the clinical potential of Leqvio (inclisiran) in helping patients with hypercholesterolemia reach guideline-recommended cholesterol goals faster and with fewer side effects.

Presented during a Hot Line session at the European Society of Cardiology (ESC) Congress 2025 in Madrid, the trial is the largest to date evaluating Leqvio and the first to focus on patient-centered outcomes.

The study found that after just 90 days of treatment with Leqvio on top of individually optimized lipid-lowering therapy (LLT), 85 per cent of patients achieved their LDL-C targets, compared with only 31 per cent of those on placebo plus LLT (p<0.0001). Remarkably, significant benefits were evident as early as 30 days, when 81 per cent of patients treated with Leqvio achieved their cholesterol goals. The results were consistent across patient groups regardless of age, sex, or cardiovascular risk profile, reinforcing Leqvio’s broad therapeutic potential.

“V-DIFFERENCE is the most comprehensive study of Leqvio to date, and the first to highlight meaningful outcomes that directly address patient needs,” said Ulf Landmesser, M.D., Chairman of the Department of Cardiology, Angiology and Intensive Care Medicine at the German Heart Center of Charité and Charité University Medicine Berlin. “The findings demonstrate how Leqvio can support lipid management strategies and help patients overcome barriers to achieving optimal LDL-C control.”

Ruchira Glaser, M.D., Global Head of the Cardiovascular, Renal and Metabolic Development Unit at Novartis, added: “We are committed to transforming cardiovascular care by addressing the most persistent challenges in managing high cholesterol. V-DIFFERENCE confirms that early use of Leqvio allows patients to reach cholesterol goals more effectively without the need for additional therapies or higher statin doses, while also improving tolerability and overall quality of life.”