A new "Comparative Effectiveness" assessment strategy using the THIN database: comparison of the cardiac complications of pioglitazone and rosiglitazone

• Published in: Pharmacoepidemiology and drug safety Vol. 22; no. 1; pp. 86 - 97
• Main Authors: Tannen, Richard, Xie, Dawei, Wang, Xingmei, Yu, Menggang, Weiner, Mark G.
• Format: Journal Article
• Language: English
• Published: England Blackwell Publishing Ltd 01.01.2013; Wiley Subscription Services, Inc
• Subjects: Adult; Aged; Cardiovascular disease; Cohort Studies; comparative effectiveness research; Comparative Effectiveness Research - methods; Databases, Factual; diabetes mellitus; Diabetes Mellitus, Type 2 - drug therapy; Drug therapy; Electronic Health Records; EMR database; Feasibility Studies; Female; Heart attacks; Humans; Hypoglycemic Agents - adverse effects; Hypoglycemic Agents - therapeutic use; Male; Middle Aged; myocardial infarction; Myocardial Infarction - chemically induced; Myocardial Infarction - epidemiology; pharmacoepidemiology; Pharmacology; pioglitazone; Randomized Controlled Trials as Topic; Retrospective Studies; rosiglitazone; Side effects; Thiazolidinediones - adverse effects; Thiazolidinediones - therapeutic use
• ISSN: 1053-8569; 1099-1557; 1099-1557
• DOI: 10.1002/pds.3360

ABSTRACT Purpose 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. Methods 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. Results 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. Conclusions 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.