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Báo cáo y học: "Onset of efficacy and tolerability following the initiation dosing of long-acting paliperidone palmitate: post-hoc analyses of a randomized, double-blind clinical trial"

Tuyển tập báo cáo các nghiên cứu khoa học quốc tế ngành y học dành cho các bạn tham khảo đề tài: Onset of efficacy and tolerability following the initiation dosing of long-acting paliperidone palmitate: post-hoc analyses of a randomized, double-blind clinical trial | Bossie et al. BMC Psychiatry 2011 11 79 http www.biomedcentral.com 1471-244X 11 79 BMC Psychiatry RESEARCH ARTICLE Open Access Onset of efficacy and tolerability following the initiation dosing of long-acting paliperidone palmitate post-hoc analyses of a randomized double-blind clinical trial 1 Ỷ 1Ỷ 2Ỷ 1Ỷ 1Ỷ Cynthia A Bossie Jennifer K Sliwa Yi-Wen Ma Dong-Jing Fu 1 and Larry Alphs 1 Abstract Background Paliperidone palmitate is a long-acting injectable atypical antipsychotic for the acute and maintenance treatment of adults with schizophrenia. The recommended initiation dosing regimen is 234 mg on Day 1 and 156 mg on Day 8 via intramuscular deltoid injection followed by 39 to 234 mg once-monthly thereafter deltoid or gluteal . These post-hoc analyses addressed two commonly encountered clinical issues regarding the initiation dosing the time to onset of efficacy and the associated tolerability. Methods In a 13-week double-blind trial 652 subjects with schizophrenia were randomized to paliperidone palmitate 39 156 or 234 mg corresponding to 25 100 or 150 mg equivalents of paliperidone respectively or placebo NCT 00590577 . Subjects randomized to paliperidone palmitate received 234 mg on Day 1 followed by their randomized fixed dose on Day 8 and monthly thereafter with no oral antipsychotic supplementation. The onset of efficacy was defined as the first timepoint where the paliperidone palmitate group showed significant improvement in the Positive and Negative Syndrome Scale PANSS score compared to placebo Analysis of Covariance ANCOVA models and Last Observation Carried Forward LOCF methodology without adjusting for multiplicity using data from the Days 4 8 22 and 36 assessments. Adverse event AE rates and relative risks RR with 95 confidence intervals CI versus placebo were determined. Results Paliperidone palmitate 234 mg on Day 1 was associated with greater improvement than placebo on Least Squares LS mean PANSS total score at Day 8 p 0.037 . After the Day 8 .