
Amgenâs RepathaÂŪ Cuts FirstâTime Major Cardiovascular Event Risk by 25% in VESALIUSâCV Trial
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In a landmark PhaseâŊ3 trial dubbed VESALIUSâCV, biotechnology firm Amgen found that its PCSK9 inhibitor RepathaÂŪ (evolocumab) lowered the risk of a first major adverse cardiovascular event (MACE) by 25% in highârisk adults who had no prior heart attack or stroke, when added to statin or other LDLâCâlowering therapies.
The trial enrolled more thanâŊ12,000 participants with atherosclerosis or diabetes, treated for a median of approximatelyâŊ4.6âŊyears. Among them, RepathaÂŪ also drove a 36% reduction in heartâattack risk and a 19% reduction for a broader composite endpoint including ischemiaâdriven revascularization.
Notably, the lipid subâstudy showed a median achieved LDLâC of 45âŊmg/dL in the evolving arm versus 109âŊmg/dL in placebo. No new safety signals emerged and tolerability remained consistent with existing prescribing information.
These results reinforce the importance of intensive LDLâC reduction in both primary and secondary cardiovascular prevention â even before the first heart event.
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