THOUSAND OAKS (dpa-AFX) - Amgen (AMGN) announced detailed findings from its Phase 3 VESALIUS-CV clinical trial, revealing that Repatha (evolocumab) significantly reduces major adverse cardiovascular events (MACE) in high-risk adults who have not previously experienced a heart attack or stroke. When added to statins or other LDL-C-lowering therapies, Repatha achieved both statistically significant and clinically meaningful outcomes.
Repatha is now the first and only PCSK9 inhibitor to demonstrate a substantial reduction in cardiovascular events for both high-risk primary and secondary prevention. This milestone positions the drug as a potential game-changer in the management of cardiovascular risk.
The trial enrolled over 12,000 patients with atherosclerosis or diabetes, all of whom had no prior history of heart attack or stroke. Repatha led to a 25% relative reduction in the risk of a composite outcome of coronary heart disease (CHD) death, heart attack, or ischemic stroke (3-point MACE). It also achieved a 19% reduction in a broader composite that included ischemia-driven arterial revascularization (4-point MACE). Notably, the risk of heart attack alone was reduced by 36%. In a lipid sub-study, patients on Repatha reached a median LDL-C of 45 mg/dL, compared to 109 mg/dL in the placebo group.
The drug also showed significant benefit across multiple secondary endpoints. These included reductions in combinations of heart attack, ischemic stroke, and revascularization procedures, as well as CHD death and cardiovascular death. Trends toward lower mortality were observed, with a 21% relative risk reduction in cardiovascular death, 11% in CHD death, and 20% in all-cause mortality. A 21% reduction in ischemic stroke was also noted.
Importantly, nearly 60% of trial participants had diabetes-a population often undertreated for LDL-C. Repatha's effectiveness in this group reinforces the urgent need for aggressive lipid management in diabetic patients to prevent cardiovascular complications.
Safety outcomes were reassuring, with no new safety signals identified. The treatment was well tolerated, and only serious adverse events or those leading to discontinuation were recorded, consistent with Repatha's current U.S. prescribing information.
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