Novartis Leqvio® shows statistically significant and clinically meaningful early LDL-C goal achievement with less muscle pain

Core Insights - Novartis announced positive results from the V-DIFFERENCE Phase IV study, demonstrating the efficacy of Leqvio (inclisiran) in lowering LDL-C levels in patients with high cholesterol who did not meet guideline-recommended targets [1][2][4] Group 1: Study Results - After 90 days of treatment, 85% of patients on Leqvio achieved their LDL-C targets compared to 31% on placebo, with statistical significance (p<0.0001) [2][3] - Significant benefits were observed as early as 30 days, with 81% of patients achieving LDL-C targets [2] - Leqvio reduced LDL-C levels by an average of 59% after 360 days, outperforming placebo by 35% (p<0.0001) [3][9] Group 2: Patient Outcomes - The study showed that patients receiving Leqvio were 43% less likely to experience muscle-related adverse events compared to those on placebo (p<0.0001) [3][7] - Improvements in pain-related quality-of-life scores were also reported among patients treated with Leqvio [3] Group 3: Clinical Significance - V-DIFFERENCE is the largest LDL-C lowering study with Leqvio to date, focusing on patient-centered outcomes [3][10] - The study included 1,770 individuals, randomized to receive either Leqvio plus LLT or placebo plus LLT [8][9] Group 4: Broader Context - Leqvio is the first and only small interfering RNA therapy approved in over 100 countries, including the US, EU, Japan, and China [5][6] - The VictORION clinical program, which includes V-DIFFERENCE, encompasses over 60,000 patients across more than 30 trials, aiming to expand evidence for LDL-C reduction [10]