The safety of abiraterone in the treatment of prostate cancer: A meta-analysis
LI Junwei
WANG Yanhong
ZHAO Jun
SHI Lei
Abstract：Objective To provide reference for clinical rational drug use based on systematic review of safety of abiraterone in the treatment of prostate cancer. Methods PubMed, Web of Science, ClinicalTrials, Cochrane Library and CNKI databases were searched for randomized controlled trials of abiraterone versus placebo for prostate cancer up to July 2017. The quality of materials was under assessment of Cochrane system evaluation method. The interest adverse events were extracted. Then meta-analysis was accomplished by Rev Man 5.3 software and funnel analysis was used to evaluate publication bias. Results A total of 4 phase Ⅲ, multinational, double-blind, randomized placebo-controlled trials were included, with 5374 patients. The incidence of hypokalemia of all grades and severe hypokalaemia in abiraterone group was higher than the control group with statistic significance (RR = 3.00, 95％CI:1.52-5.93, P = 0.002;RR = 3.40, 95％CI: 1.16-9.95, P=0.03). The incidence of water-sodium retention of all grades in abiraterone group was higher than that of the control group with statistic significance (RR = 1.37, 95％ CI: 1.22-1.53, P＜ 0.001), but the incidence of severe water-sodium retention between the two groups had no significance (P = 0.39). The incidence of hypertension of all grades and severe hypertension in abiraterone group was higher than that of the control group with statistic significance(RR= 1.79, 95％ CI: 1.45-2.21, P＜0.00l, RR = 2.17, 95％CI:1.71-2.75, P＜0.001). The incidence of cardiovascular events of all grades and event cardiovascular events in abiraterone group was higher than that of the control group with statistic significance(RR= 1.40, 95％CI: 1.22-1.62, P＜0.001;RR = 2.04, 95％CI: 1.54-2.72, P＜0.001). The incidence of abnormal liver function of all grades and severe abnormal liver function was higher than the control (RR = 1.68, 95％ CI: 1.24-2.26, P=0.0007;RR = 3.31, 95％ CI: 1.55-7.07, P = 0.002). Funnel analysis did not show any publication bias. Conclusion As the analysis revealed a significant increase in the incidence and RR of hypokalemia and abnormal liver function in the abiraterone therapy, strict monitoring of these side effects should therefore be considered.
Keywords：Prostate cancerAbirateroneAdverse eventsSystematic reviewMeta-analysis
Publication Date：2018-03-02
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：7( 239-245 )