India Pharma Outlook Team | Tuesday, 02 September 2025
Novartis reported encouraging findings from V-DIFFERENCE, a phase IV study comparing Leqvio (inclisiran) to a placebo, both of which were given in addition to individually tailored lipid-lowering therapy (LLT), in patients with hypercholesterolemia high cholesterol who have not met the LDL-C targets recommended by guidelines. The information was provided during a Hot Line session of the 2025 European Society of Cardiology (ESC) Congress, which took place from August 29 to September 1, 2025, in Madrid, Spain.
In comparison to 31% of patients who received a placebo on top of LLT, 85% of patients who received Leqvio on top of LLT after 90 days reached their LDL-C target as advised by guidelines (p<0.0001). As early as 30 days, there were noticeable improvements, with 81% of patients reaching their LDL-C goals.
Regardless of the study participants' age, sex, or cardiovascular risk, the results were consistent.The V-DIFFERENCE study's findings support the increasing amount of data supporting Leqvio in the VictORION clinical programmes, which includes over 60,000 patients from 50 countries throughout the globe.
Also Read: Sensorion and Institut Pasteur Team up to Advance Gene Theraphy Program
“V-DIFFERENCE is the largest LDL-C lowering study with Leqvio to read out to date, and the first to focus on patient-centered outcomes," said Ulf Landmesser, M.D., chairman of the Department of Cardiology, Angiology and Intensive Care Medicine at German Heart Center of Charité and Charité University Medicine Berlin. "These findings are significant as they demonstrate effective options for lipid management improvement in patients at risk, a majority of whom continue to remain above recommended LDL-C levels."
