Long-term efficacy and safety of proprotein convertase subtilisin/kexin 9 monoclonal antibodies: A meta-analysis of 11 randomized controlled trials.

BACKGROUND: Monoclonal antibodies targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) have been shown to significantly reduce low-density lipoprotein cholesterol (LDL-C) levels.

OBJECTIVE: The purpose of this study was to assess the long-term efficacy and safety of PCSK9 antibodies.

METHODS: PubMed, EMBASE, the Cochrane Library, and ClinicalTrials.gov were searched for relevant studies.

RESULTS: A total of 11 studies including 38,235 participants who were treated for at least 48 weeks were included in this meta-analysis. The results suggested that PCSK9 antibody treatment significantly decreased LDL-C levels (mean difference, -50.23% [95% confidence interval {CI}, -56.65% to -43.82%]) compared with no PCSK9 antibody treatment and also decreased other atherogenic lipid fractions. PCSK9 antibody treatment also elicited a significant reduction in cardiovascular event rates compared with no antibody treatment (relative risk [RR], 0.86 [95% CI, 0.81-0.92]). This reduction consisted of separate significant reductions in the rates of myocardial infarction (RR, 0.73 [95% CI, 0.65-0.82]), coronary revascularization (RR, 0.79 [95% CI, 0.73-0.87]), and stroke (RR, 0.81 [95% CI, 0.68-0.96]). There were no clear differences in the incidences of treatment-emergent adverse events (TEAEs), serious TEAEs, or TEAEs of interest between the 2 groups; moreover, no differences between the 2 groups were found for other laboratory parameters.

CONCLUSION: PCSK9 antibodies have significant effects on reducing LDL-C levels and improve cardiovascular outcomes. These antibodies have a satisfactory safety profile, which suggests that they are suitable for use as a long-term treatment.