PMID- 20484611 OWN - NLM STAT- MEDLINE DCOM- 20110421 LR - 20220409 IS - 1552-4604 (Electronic) IS - 0091-2700 (Linking) VI - 51 IP - 2 DP - 2011 Feb TI - Database evaluation of the effects of long-term rosiglitazone treatment on cardiovascular outcomes in patients with type 2 diabetes. PG - 173-80 LID - 10.1177/0091270010368281 [doi] AB - 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. FAU - Loebstein, Ronen AU - Loebstein R AD - Department of Pharmaceutics and Clinical Pharmacology, Maccabi Healthcare Services, 27, Hamered St, Tel Aviv, Israel. loebst_r@mac.org.il FAU - Dushinat, Marina AU - Dushinat M FAU - Vesterman-Landes, Janet AU - Vesterman-Landes J FAU - Silverman, Barbara AU - Silverman B FAU - Friedman, Nurit AU - Friedman N FAU - Katzir, Itzhak AU - Katzir I FAU - Kurnik, Daniel AU - Kurnik D FAU - Lomnicky, Yossef AU - Lomnicky Y FAU - Kokia, Ehud AU - Kokia E FAU - Halkin, Hillel AU - Halkin H LA - eng PT - Comparative Study PT - Journal Article DEP - 20100519 PL - England TA - J Clin Pharmacol JT - Journal of clinical pharmacology JID - 0366372 RN - 0 (Hypoglycemic Agents) RN - 0 (Thiazolidinediones) RN - 05V02F2KDG (Rosiglitazone) RN - 9100L32L2N (Metformin) SB - IM MH - Aged MH - Cardiovascular Diseases/epidemiology/etiology MH - Databases, Factual MH - Diabetes Mellitus, Type 2/*drug therapy MH - Female MH - Follow-Up Studies MH - Heart Failure/epidemiology/etiology MH - Humans MH - Hypoglycemic Agents/*adverse effects/therapeutic use MH - Male MH - Metformin/*adverse effects/therapeutic use MH - Middle Aged MH - Retrospective Studies MH - Rosiglitazone MH - Thiazolidinediones/*adverse effects/therapeutic use EDAT- 2010/05/21 06:00 MHDA- 2011/04/22 06:00 CRDT- 2010/05/21 06:00 PHST- 2010/05/21 06:00 [entrez] PHST- 2010/05/21 06:00 [pubmed] PHST- 2011/04/22 06:00 [medline] AID - 0091270010368281 [pii] AID - 10.1177/0091270010368281 [doi] PST - ppublish SO - J Clin Pharmacol. 2011 Feb;51(2):173-80. doi: 10.1177/0091270010368281. Epub 2010 May 19.