Database studies may be reliable and robust enough to establish supplemental indications and applications for US Food and Drug Administration-approved medications, according to a study published in JAMA Internal Medicine.

Investigators of this study used data from insurance claims of patients prescribed either ramipril (n=4665) or telmisartan (n=4665) to determine whether a healthcare database can support the results of a randomized clinical trial that led to a supplemental indication. The study replicated the Ongoing Telmisartan Alone and in Combination with Ramipril Global End-point Trial (ONTARGET) and included propensity score matching as a means to balance various baseline patient characteristics.

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There was no difference between the 2 arms with regard to composite risk for myocardial infarction, stroke, and congestive heart failure hospitalization (hazard ratio [HR], 1.0; 95% CI, 0.9-1.1). Participants taking telmisartan had a lower risk for angioedema compared with those taking ramipril (HR, 0.1; 95% CI, 0.03-0.56). These findings reflected those presented in the Ongoing ONTARGET, demonstrating the utility of database research for determining patient outcomes and additional supplemental applications associated with approved and marketed medications.

Because the investigators of this study used propensity score matching prior to data assessment, it is possible that unmeasured confounders influenced the findings. Additionally, the researchers of this cohort study indicate that they were unable to determine patients’ adherence to medication following filling of prescriptions.

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Using nonrandomized, real-world health database studies to support the supplemental use of approved medications can be useful because these studies “represent outcomes in settings of typical care, rather than the highly controlled research environments of randomized controlled trials, and can be accomplished quickly and inexpensively.”


Fralick M, Kesselheim AS, Avorn J, Schneeweiss S. Use of health care databases to support supplemental indications of approved medications [published online November 20, 2017]. JAMA Intern Med.doi:10.1001/jamainternmed.2017.3919