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The PCSK9 inhibitor evolocumab (Repatha) reduces atherosclerosis volume as measured by intravascular ultrasound (IVUS) compared with placebo atop statin therapy, .
Along with that positive finding for the primary endpoint at 78 weeks, the trial also met the secondary endpoints of percent and total atheroma volume regression from baseline.
The findings were encouraging, , a lipid specialist at the Instituto de Clinica Medica in Buenos Aires, and , of Massachusetts General Hospital in Boston, agreed in a conversation on Twitter.
It might make positive findings more likely from the pending large cardiovascular outcomes trial, due out early in 2017, suggested , of the University of California San Francisco, in the same . "Anecdotally, IVUS correctly predicted torcetrapib results," whereas carotid intima-media thickness did not, Weiss added.
However, "I wouldn't declare victory too early," responded , of Yale University in New Haven, Conn., noting that the outcomes trials haven't been stopped prematurely for efficacy.
The included 968 patients getting cardiac catheterization, who were on optimized background statin therapy and randomized to double-blind treatment with evolocumab (420 mg monthly) or placebo subcutaneous injections.
Amgen said no new safety concerns emerged in the trial nor was there a difference in treatment-emergent adverse events between groups.
Detailed results are slated for presentation at themeeting in November.