title: Database evaluation of the effects of long-term rosiglitazone treatment on cardiovascular outcomes in patients with type 2 diabetes.
abstract: Recent meta-analyses suggest an increased risk of acute myocardial infarction (AMI) in patients with type 2 diabetes mellitus (T2DM) treated with rosiglitazone. These meta-analyses have drawn considerable criticisms. Retrospective observational studies do not consistently support this association. The objective of this study was to compare rates of adverse cardiovascular outcomes in T2DM patients treated with rosiglitazone alone or combined with metformin or metformin alone. This retrospective study, using the health maintenance organization database, included patients who were dispensed rosiglitazone (alone or with metformin) for at least 6 months as follows: rosiglitazone alone (n = 745), rosiglitazone and metformin (n = 2753), and metformin alone (n = 11 938). Adverse cardiovascular outcomes were new diagnosis of AMI, acute coronary syndrome (ACS), coronary revascularization (CRV), congestive heart failure (CHF), and all-cause mortality. Mean on-treatment follow-up was 30 months. After adjustment for covariates found to be significant in univariate analyses, rosiglitazone was associated only with CHF (hazard ratio [HR] = 2.23; 95% confidence interval [CI]: 1.41-1.95) with no increase of risk for AMI (HR = 1.13; 95%CI: 0.60-2.12), ACS (HR = 0.85; 95% CI: 0.57-1.26), coronary revascularization (HR = 1.22; 95% CI:0.82-1.54), or all-cause mortality (HR = 1.15; 95% CI: 0.85-1.56). In this community-based cohort, 30 months of therapy with rosiglitazone treatment was associated with increased risk of CHF but was not associated with increased risk of AMI, ACS, coronary revascularization, or all-cause mortality.
authors.affiliation: Department of Pharmaceutics and Clinical Pharmacology, Maccabi Healthcare Services, 27, Hamered St, Tel Aviv, Israel. loebst_r@mac.org.il
authors.forename: Ronen
authors.initials: R
authors.lastname: Loebstein
authors.forename: Marina
authors.initials: M
authors.lastname: Dushinat
authors.forename: Janet
authors.initials: J
authors.lastname: Vesterman-Landes
authors.forename: Barbara
authors.initials: B
authors.lastname: Silverman
authors.forename: Nurit
authors.initials: N
authors.lastname: Friedman
authors.forename: Itzhak
authors.initials: I
authors.lastname: Katzir
authors.forename: Daniel
authors.initials: D
authors.lastname: Kurnik
authors.forename: Yossef
authors.initials: Y
authors.lastname: Lomnicky
authors.forename: Ehud
authors.initials: E
authors.lastname: Kokia
authors.forename: Hillel
authors.initials: H
authors.lastname: Halkin
mesh_terms: D000368:Aged; D002318:Cardiovascular Diseases / Q000453:epidemiology / Q000209:etiology; D016208:Databases, Factual; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000453:epidemiology / Q000209:etiology; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D008687:Metformin / Q000009:adverse effects* / Q000627:therapeutic use; D008875:Middle Aged; D012189:Retrospective Studies; D000077154:Rosiglitazone; D045162:Thiazolidinediones / Q000009:adverse effects* / Q000627:therapeutic use
chemical_list: D007004:Hypoglycemic Agents; D045162:Thiazolidinediones; D000077154:Rosiglitazone; D008687:Metformin