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Báo cáo y học: "Dose-associated changes in safety and efficacy parameters observed in a 24-week maintenance trial of olanzapine long-acting injection in patients with schizophrenia"

Tuyển tập báo cáo các nghiên cứu khoa học quốc tế ngành y học dành cho các bạn tham khảo đề tài: Dose-associated changes in safety and efficacy parameters observed in a 24-week maintenance trial of olanzapine long-acting injection in patients with schizophrenia | Hill et al. BMC Psychiatry 2011 11 28 http www.biomedcentral.com 1471-244X 11 28 BMC Psychiatry RESEARCH ARTICLE Open Access Dose-associated changes in safety and efficacy parameters observed in a 24-week maintenance trial of olanzapine long-acting injection in patients with schizophrenia 1 1 2 1 1 Angela L Hill Bin Sun Jamie L Karagianis Susan B Watson David P McDonnell Abstract Background In a recently published 24-week maintenance study of olanzapine long-acting injection LAI in schizophrenia Kane et al. 2010 apparent dose-associated changes were noted in both efficacy and safety parameters. To help clinicians balance safety and efficacy when choosing a dose of olanzapine LAI we further studied these changes. Methods Outpatients with schizophrenia who had maintained stability on open-label oral olanzapine for 4 to 8 weeks were randomly assigned to low 150 mg 2 weeks N 140 medium 405 mg 4 weeks N 318 or high 300 mg 2 weeks N 141 dosages of olanzapine LAI for 24 weeks. Potential relationships between dose and several safety or efficacy measures were examined via regression analysis the Jonckheere-Terpstra test continuous data or the Cochran-Armitage test categorical data . Results Safety parameters statistically significantly related to dose were mean weight change low 0.67 SD 4.38 medium 0.89 SD 3.87 high 1.70 SD 4.14 kg p .024 effect size ES 0.264 high vs. low dose mean change in prolactin low -5.61 SD 12.49 medium -2.76 SD 19.02 high 3.58 SD 33.78 gg L p .001 ES 0.410 high vs. low dose fasting triglycerides change from normal at baseline to high low 3.2 medium 6.0 high 18.9 p .001 NNT 7 high vs. low dose and fasting high-density lipoprotein cholesterol change from normal at baseline to low low 13.8 medium 19.6 high 30.7 p .019 NNT 6 high vs. low dose . Efficacy measures significantly related to dose included Positive and Negative Syndrome Scale total score mean change low 2.66 SD 14.95 medium -0.09 SD 13.47 high -2.19 SD 13.11 p .01 ES 0.356 high vs. low dose .