ARTICLE | Clinical News

Researchers use RWE to reproduce trial results

November 22, 2017 9:20 PM UTC

In an article published in the Journal of the American Medical Association, a team of Harvard researchers used real-world evidence from a U.S. health insurance database to replicate the results of a randomized clinical trial that supported a supplemental indication of cardiovascular risk reduction for hypertension drug telmisartan, which is now available as a generic.

To replicate the pivotal Phase IV ONTARGET trial, the RWE study used insurance claims data from 9,330 propensity score-matched patients who received telmisartan or comparator ramipril. The claims data were available at the time FDA approved telmisartan's sNDA for the CV risk indication. The RWE study produced almost an identical hazard ratio (HR=0.99) as ONTARGET (HR=1.01) on the primary endpoint, which compared telmisartan to ramipril on the composite outcome of myocardial infarction (MI), stroke or hospitalization for congestive heart failure...