Paliperidone extended-release tablets in Chinese patients with schizophrenia: meta-analysis of randomized controlled trials

Abstract

Shangli Cai,1,2 Huafei Lu,2 Zhihua Bai,2 Renrong Wu,1 Jingping Zhao1 1Mental Health Institute of the Second Xiangya Hospital, National Technology Institute of Psychiatry, Key Laboratory of Psychiatry and Mental Health of Hunan Province, Central South University, Hunan, 2Janssen Research and Development, Beijing, People’s Republic of China Background: Previous meta-analyses have compared paliperidone extended-release (ER) tablets with other antipsychotics, but none have involved Chinese patients or studies from People’s Republic of China. Further, the results of these meta-analyses may not be applicable to Chinese patients. In the present study, we evaluated the efficacy, safety, and acceptability of paliperidone ER compared with other second-generation antipsychotics (SGAs) for Chinese patients with schizophrenia.Methods: Randomized controlled studies of paliperidone ER and other SGAs as oral monotherapy in the acute phase treatment of schizophrenia were retrieved from Medline, Embase, and the Cochrane Library (CENTRAL), as well as from Chinese databases including the China National Knowledge Infrastructure, Wanfang, and VIP Information/Chinese Scientific Journals Database. We pooled data on response rates, chance of withdrawal due to adverse events, probability of adverse events, and odds of withdrawal for any reason.Results: Fifty randomized controlled trials were identified. The response rate for paliperidone ER was significantly higher than that of other pooled SGAs (risk ratio [RR] 0.83, 95% confidence interval [CI] 0.72–0.96) and ziprasidone (RR 0.57, 95% CI 0.39–0.82). Paliperidone ER significantly reduced the chance of withdrawal due to adverse events and the chance of any adverse events compared with other pooled SGAs (RR 0.32, 95% CI 0.17–0.58 and RR 0.88, 95% CI 0.79–0.97) and risperidone (RR 0.31, 95% CI 0.14–0.67 and RR 0.70, 95% CI 0.57–0.86). The incidence of extrapyramidal symptoms on paliperidone ER was comparable with other pooled SGAs (RR 0.94, 95% CI 0.66–1.35) and significantly lower than that of risperidone (RR 0.56, 0.41–0.77) but higher than that of olanzapine (RR 1.88, 95% CI 1.05–3.36). Paliperidone ER was superior to other pooled SGAs (RR 0.32, 95% CI 0.21–0.49 and RR 0.50, 95% CI 0.35–0.72) and olanzapine (RR 0.23, 95% CI 0.15–0.33 and RR 0.33, 95% CI 0.23–0.47) as far as weight gain and somnolence were concerned. Further, prolactin-related adverse events caused by paliperidone ER were comparable with other pooled SGAs (RR 1.30, 95% CI 0.73–2.33), but outnumbered those caused by olanzapine (RR 7.53, 95% CI 2.05–27.71).Conclusion: Paliperidone ER is efficacious, safe, and well accepted when compared with other pooled SGAs for the treatment of Chinese patients with schizophrenia. Keywords: paliperidone extended-release, second-generation antipsychotics, schizophrenia, meta-analysis