Use of Health Care Databases to Support Supplemental Indications of Approved Medications.

ABSTRACT:

Importance

Manufacturers of US Food and Drug Administration-approved prescription drugs often apply for additional indications based on randomized clinical trials. Real-world database analyses on a medication's use and outcomes in routine settings of care might help to inform decision making regarding such supplemental indications.

Objective

To examine whether longitudinal data from a health care database can support the results of a randomized clinical trial that led to a supplemental indication for telmisartan.

Design, setting, and participants

This cohort study of patients newly prescribed telmisartan or ramipril used insurance claims data from a nationwide health care database from January 1, 2003, through September 30, 2009, to compare patient outcomes. This stud

SUBMITTER: Fralick M 

PROVIDER: S-EPMC5833514 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature