We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Active safety monitoring of newly marketed medications in a distributed data network: application of a semi-automated monitoring system.
- Authors
Gagne, J J; Glynn, R J; Rassen, J A; Walker, A M; Daniel, G W; Sridhar, G; Schneeweiss, S
- Abstract
We developed a semi-automated active monitoring system that uses sequential matched-cohort analyses to assess drug safety across a distributed network of longitudinal electronic health-care data. In a retrospective analysis, we show that the system would have identified cerivastatin-induced rhabdomyolysis. In this study, we evaluated whether the system would generate alerts for three drug-outcome pairs: rosuvastatin and rhabdomyolysis (known null association), rosuvastatin and diabetes mellitus, and telithromycin and hepatotoxicity (two examples for which alerting would be questionable). Over >5 years of monitoring, rate differences (RDs) in comparisons of rosuvastatin with atorvastatin were -0.1 cases of rhabdomyolysis per 1,000 person-years (95% confidence interval (CI): -0.4, 0.1) and -2.2 diabetes cases per 1,000 person-years (95% CI: -6.0, 1.6). The RD for hepatotoxicity comparing telithromycin with azithromycin was 0.3 cases per 1,000 person-years (95% CI: -0.5, 1.0). In a setting in which false positivity is a major concern, the system did not generate alerts for the three drug-outcome pairs.
- Publication
Clinical pharmacology and therapeutics, 2012, Vol 92, Issue 1, p80
- ISSN
1532-6535
- Publication type
Journal Article
- DOI
10.1038/clpt.2011.369