Jie Bai1, Li-Lin Gong1, Qi-Fu Li1, Zhi-Hong Wang2. 1. Department of Endocrinology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China. 2. Department of Endocrinology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China. Electronic address: towzh713@126.com.
Abstract
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.
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.
Authors: Gabriella di Mauro; Alessia Zinzi; Cristina Scavone; Francesco Rossi; Annalisa Capuano; Annamaria Mascolo; Mario Gaio; Liberata Sportiello; Carmen Ferrajolo; Concetta Rafaniello Journal: Drug Saf Date: 2020-12-22 Impact factor: 5.606
Authors: Marcin Basiak; Michał Kosowski; Marcin Cyrnek; Łukasz Bułdak; Mateusz Maligłówka; Grzegorz Machnik; Bogusław Okopień Journal: Int J Mol Sci Date: 2021-03-19 Impact factor: 5.923