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Efficacy, Safety of MK-0616, an Oral PCSK9 Inhibitor

The oral PCSK9 macrocyclic peptide inhibitor MK-0616 “demonstrated statistically significant and robust, dose-dependent placebo-adjusted reductions in LDL-C at Week 8 of up to 60.9% from baseline and was well tolerated over 8 weeks of treatment and an additional 8 weeks of follow-up,” researchers report.

Adults in the dose-ranging trial had a wide range of atherosclerotic cardiovascular disease risk. Based on primary endpoints of percent change from baseline in LDL-C at week 8 and the proportion of participants with adverse events (AEs) and study intervention discontinuations due to AEs, the investigators found: “Of the 381 participants randomized, 49% were female, and median age was 62 years. Among 380 treated participants, all doses of MK-0616 demonstrated statistically significant (P <0.001) differences in LS mean % change in LDL-C from baseline to Week 8 vs. placebo: -41.2% (6 mg), -55.7% (12 mg), -59.1% (18 mg), and -60.9% (30 mg). AEs occurred in a similar proportion of participants in the MK-0616 arms (39.5% to 43.4%) as placebo (44.0%). Discontinuations due to AEs occurred in 2 or fewer participants in any treatment group.”

Source: Journal of the American College of Cardiology