Therapeutic efficacy and safety of PCSK9-monoclonal antibodies on familial hypercholesterolemia and statin-intolerant patients: A meta-analysis of 15 randomized controlled trials.
Proprotein convertase subtilisin/kexin9 monoclonal antibodies (PCSK9-mAb) have been studied intensively to identify their effect in lowering levels of low density lipoprotein cholesterol (LDL-C). However, the applicable target of PCSK9-mAbs remains inconclusive so far. Therefore, this first meta-analysis was carried out to clarify the therapeutic efficacy and safety of PCSK9-mAbs on the potential patients: familial hypercholesterolemia and statin-intolerant patients. All randomized controlled trials that met the search terms were retrieved in multiple databases. Efficacy outcomes included parameter changes from baseline in LDL-C and other lipid levels. Therapeutic safety were evaluated by rates of common adverse events. A total of 15 studies encompassing 4,288 patients with at least 8 weeks duration were selected. Overall, the therapeutic efficacy was achieved with significant reduction in LDL-C, TC, TG, Lp(a), Apo-B versus placebo. The decline in familial hypercholesterolemia patients (-53.28%, 95% CI: -59.88 to -46.68%) was even more obvious than that in statin-intolerant patients (-34.95%, 95% CI: -41.46 to -28.45%). No obvious safety difference was found out in the rates of common and serious adverse events. To conclude, PCSK9-mAb contributes to the decreased level of LDL-C and other lipids in familial hypercholesterolemia and statin-intolerant patients with satisfactory safety and tolerability.
Department of Geriatrics, First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China.
Li Jun
0000-0002-8773-2065
LJ
Qian
Department of Geriatrics, First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China.
Yao
Y
Gao
Department of Geriatrics, First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China.
Yan Mei
YM
Zhang
Department of Geriatrics, First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China.
Ming
M
Chu
Department of Cardiology, First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China.
Jing
J
Yao
Department of Geriatrics, First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China. xudi1964@gmail.com.
Di
D
Xu
D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D008078:Cholesterol, LDL / Q000097:blood; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects*; D006938:Hyperlipoproteinemia Type II / Q000188:drug therapy*; D007155:Immunologic Factors / Q000008:administration & dosage* / Q000009:adverse effects; D000091362:PCSK9 Inhibitors; D010919:Placebos / Q000008:administration & dosage; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome; D000071449:Proprotein Convertase 9
D000911:Antibodies, Monoclonal; D008078:Cholesterol, LDL; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D007155:Immunologic Factors; D000091362:PCSK9 Inhibitors; D010919:Placebos; C472125:PCSK9 protein, human; D000071449:Proprotein Convertase 9