https://doi.org/10.55788/629cbf29
Prof. Christie Ballantyne (Baylor College of Medicine, TX, USA) explained that injectable treatments targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) have been shown to provide “excellent” reductions in LDL-C and the risk of atherosclerotic cardiovascular disease, but they have been poorly adopted due to access barriers and the need for multiple injections [1]. “An oral PCSK9 inhibitor may widen access and improve the attainment of guideline-recommended treatment goals.”
An oral PCSK9 inhibitor with the provisional name of MK-0616 was subjected to a phase 2b randomised controlled trial (NCT05261126) [1]. The straightforward primary objective was per cent change from baseline in LDL-C at week 8 in participants with hypercholesterolemia. A total of 381 adults were enrolled; 49% were women, and the median age was 62 years. They had a mean LDL-C of 119.5 mg/dL and 38.6% had clinical atherosclerotic cardiovascular disease; about 60% were taking a statin at study entry. Participants were randomised to placebo or one of the 4 doses of MK-0616 for 8 weeks, after which treatment was withdrawn to assess adverse events in the following 8 weeks.
All doses of MK-0616 demonstrated statistically superior and dose-dependent reductions in LDL-C versus placebo (P<0.001). Efficacy was nearly complete after 2 weeks, and a persistent effect over the 8-week treatment period was observed, as measured by the least squares mean percentage change in LDL-C. The Figure shows the primary endpoint results for the efficacy population.
Figure: LDL-C significant percent change from baseline versus placebo at week 8 for the efficacy population [1]
Apolipoprotein-B (ApoB) was also significantly lowered at week 8, with a mean difference versus placebo of 32.8% (6 mg group) to 51.8% (30 mg group). The reduction versus placebo in non-HDL-C was between 35.9% and 55.8%, in these dosage groups. The proportion of patients who attained LDL-C goals ranged from 80.5% to 90.8%, versus 9.3% in the placebo group.
MK-0616 was well tolerated; the proportion of participants with ≥1 adverse event was between 39.5% and 43.4% in the treatment arms and 44.0% in the placebo arm.
- Ballantyne CM. Efficacy and safety of the oral PCSK9 inhibitor MK-0616: a phase 2b randomized controlled trial. Session 410-16, ACC Scientific Session 2023, 4–6 March, New Orleans, USA.
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