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Báo cáo y học: " Paliperidone ER and oral risperidone in patients with schizophrenia: a comparative database analysis"

Tuyển tập báo cáo các nghiên cứu khoa học quốc tế ngành y học dành cho các bạn tham khảo đề tài: Paliperidone ER and oral risperidone in patients with schizophrenia: a comparative database analysis | Turkoz et al. BMC Psychiatry 2011 11 21 http www.biomedcentral.com 1471-244X 11 21 BMC Psychiatry 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 2-4 mg day n 113 or risperidone 4-6 mg day n 129 were 64.8 54.0 and 66.7 respectively placebo-adjusted rates paliperidone ER vs risperidone 2-4 mg day p 0.005 paliperidone ER vs risperidone 4-6 mg day p 0.159 . PANSS total score improvement with paliperidone ER was greater than with .