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Long-term efficacy and safety of proprotein convertase subtilisin/kexin 9 monoclonal antibodies: A meta-analysis of 11 randomized controlled trials.
- Source :
- Journal of Clinical Lipidology; Mar2018, Vol. 12 Issue 2, p277-291.e3, 1p
- Publication Year :
- 2018
-
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. [ABSTRACT FROM AUTHOR]
- Subjects :
- CARDIOVASCULAR disease prevention
CORONARY heart disease prevention
MYOCARDIAL infarction
PROTEOLYTIC enzymes
STROKE prevention
CONFIDENCE intervals
CORONARY artery bypass
DIET therapy for heart diseases
INFORMATION storage & retrieval systems
MEDICAL databases
MEDICAL information storage & retrieval systems
LONG-term health care
LOW density lipoproteins
MEDLINE
META-analysis
ONLINE information services
SYSTEMATIC reviews
RELATIVE medical risk
TREATMENT effectiveness
THERAPEUTICS
Subjects
Details
- Language :
- English
- ISSN :
- 19332874
- Volume :
- 12
- Issue :
- 2
- Database :
- Supplemental Index
- Journal :
- Journal of Clinical Lipidology
- Publication Type :
- Academic Journal
- Accession number :
- 128787616
- Full Text :
- https://doi.org/10.1016/j.jacl.2018.01.004