Thiazolidinediones and cardiovascular events in high-risk patients with type-2 diabetes mellitus: a comparison with other oral antidiabetic agents.

CONTEXT.: The use of thiazolidinediones (TZDs) in patients with type-2 diabetes mellitus appears to be associated with an increased risk of myocardial infarction (MI) compared with placebo or other oral antidiabetic drug regimens. OBJECTIVE.: We conducted a study to investigate whether there was a difference in the risk of acute MI and hemorrhagic and non-hemorrhagic stroke between specific TZDs, namely rosiglitazone maleate (Avandia) and pioglitazone (Actos), and other oral antidiabetic agents in a high-risk, largely underrepresented and largely minority Medicaid population. STUDY DESIGN, SETTING, AND PATIENTS.: We analyzed patient encounter data using propensity-scoring methods and logistic regression to compare the risk of cardiovascular (CV) events in patients with type-2 diabetes in a high-risk population. MAIN OUTCOME MEASURES.: Outcomes were identified through International Classification of Disease (ICD-9) codes 410-411 for acute MI; 430-438 for stroke; and revenue (emergency department) codes 450-459 in the case of MI. RESULTS.: Using retrospective medical encounter and prescription data analyses, we found that rosiglitazone, compared with other oral antidiabetic agents, was associated with an increased rate of CV events by 20% in a high-risk cohort of diabetic patients. Neither pioglitazone nor the TZD drug class as a whole was associated with an increased CV risk. CONCLUSION.: Rosiglitazone was associated with a significant increase in CV events (MI and stroke) among high-risk patients with type-2 diabetes, whereas pioglitazone was not. We recommend further research to capture risk factors that were not observed in our encounter data.