paliperidone er and oral risperidone in patients with schizophrenia a comparative database analysispaliperidone er和口服利培酮对精神分裂症患者比较数据库分析.pdf

Turkoz et al. BMC Psychiatry 2011, 11:21 /1471-244X/11/21 RESEARCH ARTICLE Open Access Paliperidone ER and oral risperidone in patients with schizophrenia: a comparative database analysis 1* 2 3 4 1 Ibrahim Turkoz , Cynthia A Bossie , Jean-Pierre Lindenmayer , Nina Schooler , Carla M Canuso Abstract Background: To compare the efficacy and tolerability of paliperidone extended-release (ER) with risperidone immediate-release using propensity score methodology. Methods: Six double-blind, randomized, placebo-controlled, short-term clinical trials for acute schizophrenia with availability of individual patient-level data were identified (3 per compound). Propensity score pairwise matching was used to balance observed covariates between the paliperidone ER and risperidone patient populations. Scores were generated using logistic regression models, with age, body mass index, race, sex, baseline Positive and Negative Syndrome Scale (PANSS) total score and baseline Clinical Global Impressions–Severity (CGI-S) score as factors. The dosage range of paliperidone ER (6-12 mg/day) was compared with 2 risperidone dosage ranges: 2-4 and 4-6 mg/day. The primary efficacy measure was change in PANSS total score at week 6 end point. Tolerability end points included adverse event (AE) reports and weight. AEs with rates ≥5% and with a ≥2% difference between paliperidone ER and risperidone were identified. Results: Completion rates for placebo-treated subjects in paliperidone ER trials (n = 95) and risperidone trials (n = 122) groups were 36.8% and 51.6%, respectively; end point changes on PANSS total scores were similar (p = 0.768). Completion rates for subjects receiving paliperidone ER 6-12 mg/day (n = 179), risperidone 2