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Báo cáo y học: "Drug efficacy by direct and adjusted indirect comparison to placebo: An illustration by Mycobacterium avium complex prophylaxis in HIV"

Tuyển tập các báo cáo nghiên cứu về y học được đăng trên tạp chí y học Wertheim cung cấp cho các bạn kiến thức về ngành y đề tài: Drug efficacy by direct and adjusted indirect comparison to placebo: An illustration by Mycobacterium avium complex prophylaxis in HIV/. | Chu et al. AIDS Research and Therapy 2011 8 14 http www.aidsrestherapy.eom content 8 1 14 AIDS RESEARCH AND THERAPY SHORT REPORT Open Access Drug efficacy by direct and adjusted indirect comparison to placebo An illustration by Mycobacterium avium complex prophylaxis in HIV Jennifer Chu1 Caroline E Sloan1 Kenneth A Freedberg1 2 3 Yazdan Yazdanpanah5 Elena Losina3 4 Abstract Background Our goal was to illustrate a method for making indirect treatment comparisons in the absence of head-to-head trials by portraying the derivation of published efficacies for prophylaxis regimens of HIV-related opportunistic infections. Results We identified published results of randomized controlled trials from the United States in which HIV-infected patients received rifabutin azithromycin clarithromycin or placebo for prophylaxis against Mycobacterium avium complex MAC . We extracted the number of subjects follow-up time primary MAC events mean CD4 count and proportion of subjects on mono or dual antiretroviral therapy ART from each study. We derived the efficacy of each drug using adjusted indirect comparisons and when possible by direct comparisons. Five articles satisfied our inclusion criteria. Using direct comparison we estimated the efficacies of rifabutin clarithromycin and azithromycin compared to placebo to be 53 95 CI 48-61 66 95 CI 61-74 and 66 95 CI 60-81 respectively. Using adjusted indirect calculations the efficacy of rifabutin compared to placebo ranged from 41 to 44 . The adjusted indirect efficacies of clarithromycin and azithromycin were estimated to be 73 and 72 respectively. Conclusions Accurate estimates of specific drug dosages as compared to placebo are important for policy and implementation research. This study illustrates a simple method of adjusting for differences in study populations by using indirect comparisons in the absence of head-to-head HIV clinical trials. Background Cost-effectiveness analyses are frequently used to guide health policy decisions