The challenges of comparing results between placebo controlled randomized trials and non‐experimental new user, active comparator cohort studies: the example of olmesartan
Year: 2014
Type: article
Abstract: One of the challenges of pharmacoepidemiology that is both exciting and frustrating is the replication of findings.It is often easy to frame the question as "does drug X cause side effect Y", but this ignores subtle differences in the actual contrasts that are being made.This issue is well highlighted by three recent studies of the cardiovascular safety of the medication Olmesartan published in this issue of the Journal 1-3 .These non-experimental (observational) studies were motivated by safety signals from two randomized, placebo controlled trials that suggested that Olmesartan increased all-cause mortality in patients with diabetes [4][5] .Although the absolute number of deaths observed in the randomized trials was small, the possibility of such an effect is a legitimate cause for concern [1][2][3] .The three nonexperimental studies are all well designed and placed in independent populations in two different countries (the United States of America and the United Kingdom).However, right from the beginning, there are intrinsic challenges with replicating a randomized, placebo controlled trial using a non-experimental study design.Drugs are given for specific indications and one of the primary indications of angiotensin receptor blockers (ARBs), including Olmestartan, is the treatment of hypertension.Unfortunately, hypertension itself is a risk factor for major cardiovascular events.So any analysis of the
DOI: 10.1002/pds.3602
Language: English
Subfield: Statistics and Probability
Field: Mathematics
Domain: Physical Sciences
Open Access status: green
Funders: Amgen, GlaxoSmithKline, Sanofi, Patient-Centered Outcomes Research Institute, National Institutes of Health, Agency for Healthcare Research and Quality, Genentech, University of North Carolina at Chapel Hill, UCB US, National Institute on Aging, National Heart, Lung, and Blood Institute, National Cancer Institute
Awards: G1153751621, CVD and inflammation across the lifespan in HIV infected adults and children, A retrospective cohort study of the safety of testosterone therapy in older men, PROMIS Validation in Prospective Population-based Prostate Cancer Research Study, G7616770747, G8008223734, Propensity Scores and Preventive Drug Use in the Elderly, G9000092215
OpenAlex ID: W1930097754