A new “Comparative Effectiveness” assessment strategy using the THIN database: comparison of the cardiac complications of pioglitazone and rosiglitazone
Version of Record online: 15 OCT 2012
Copyright © 2012 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 22, Issue 1, pages 86–97, January 2013
How to Cite
Tannen, R., Xie, D., Wang, X., Yu, M. and Weiner, M. G. (2013), A new “Comparative Effectiveness” assessment strategy using the THIN database: comparison of the cardiac complications of pioglitazone and rosiglitazone. Pharmacoepidem. Drug Safe., 22: 86–97. doi: 10.1002/pds.3360
- Issue online: 7 JAN 2013
- Version of Record online: 15 OCT 2012
- Manuscript Accepted: 25 SEP 2012
- Manuscript Revised: 23 AUG 2012
- Manuscript Received: 12 JUL 2012
- myocardial infarction;
- diabetes mellitus;
- comparative effectiveness research;
- EMR database;
Examine feasibility of a new strategy to perform Electronic Medical Record database valid Comparative Effectiveness Research (CER), using determination of whether rosiglitazone (ROS) treatment increases Acute myocardial infarction (MI) in comparison to pioglitazone (PIO) as a model question.
Using the UK The Health Improvement Network Database, a retrospective cohort design replicated the proactive RCT of diabetics with ischemic cardiovascular disease (CVD). Replication studies using PIO or ROS, as well as expanded studies of subjects not requiring CVD, were performed. MI assessment used multiple analytics comparing ROS and PIO exposed patients including: unexposed subjects, the proactive RCT, and directly between ROS to PIO exposed cohorts.
PIO replication studies did not affect MI [HR 0.88 (0.49 to 1.42)], but ROS increased MI, with prior event rate ratio (PERR) adjusted HR (which overcomes unmeasured confounding) results of: [HR 1.31 (0.94 to 1.74)] versus proactive RCT [HR 0.83 (0.65 to 1.06)] (p = 0.02). Direct ROS to PIO exposed cohort comparisons yielded PERR adj HR of 1.55 (0.98 to 2.65). By contrast, expanded studies showed no differences between ROS and PIO exposure.
These results provide new insight regarding the effects of ROS and PIO on MI. In a population with established ischemic CVD, ROS increased MI in contrast to PIO; whereas in an unselected population, ROS and PIO have reasonably comparable effects. Most importantly, this study demonstrates the feasibility and advantages of a new strategy to perform reliable “CER” using an EMR database. Copyright © 2012 John Wiley & Sons, Ltd.