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Use of health care databases to support supplemental indications of approved medications

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Researchers at Brigham and Women's Hospital and Harvard Medical School have found that, under certain circumstances, database studies may help justify requests to use an FDA-approved drug for a new purpose.

Researchers at Brigham and Women's Hospital and Harvard Medical School have found that, under certain circumstances, database studies may help justify requests to use an FDA-approved drug for a new purpose. These real-world analyses offer evidence of medication use and outcomes in patients receiving routine care, which can validate findings in clinical trial populations. To support this argument, the investigators performed a cohort study to determine if information derived from a national health care database would uphold the results of a randomized study that prompted a supplemental indication for telmisartan. Using claims data and propensity score matching, they compared cardiovascular outcomes in 4,665 patients who initiated telmisartan use and 4,655 patients who began taking ramipril. The results of the database analysis dovetailed with findings from the Ongoing Telmisartan Alone and in Combination with Ramipril Global End-point Trial (ONTARGET), which documented a like composite risk of stroke, myocardial infarction, stroke, and hospitalization for congestive heart failure with both medications. Moreover, the study tied telmisartan to a significantly lower risk of angiodema compared with ramipril.

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https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2663852

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