Abstract | BACKGROUND AND OBJECTIVE: METHODS: We used Taiwan's 2000-5 National Health Insurance database to conduct a population-based, retrospective cohort study of 473 483 newly diagnosed patients with type 2 diabetes mellitus. We classified study patients into five basic groups based on the agents they were prescribed during the study period: (i) rosiglitazone monotherapy; (ii) pioglitazone monotherapy; (iii) sulfonylurea-based therapy; (iv) metformin-based therapy; and (v) sulfonylurea and metformin-based therapy. Cox proportional hazards models were used to evaluate the association between the use of rosiglitazone or pioglitazone and the occurrence of cardiovascular events. RESULTS: Patients receiving rosiglitazone monotherapy were at higher risk for any cardiovascular event (hazard ratio [HR] 1.89; 95% CI 1.57, 2.28), myocardial infarction (HR 2.09; 95% CI 1.36, 3.24), angina pectoris (HR 1.79; 95% CI 1.39, 2.30) and transient ischaemic attack (HR 2.57; 95% CI 1.33, 4.96) than those receiving metformin monotherapy. Overall, add-on rosiglitazone and pioglitazone were associated with comparable cardiovascular risk. Based on our point estimates, pioglitazone as an add-on therapy was found to have a favourable, but nonsignificant, effect on outcome. CONCLUSIONS: Our findings extend the evidence from current literature to a real-world setting and support data from clinical trials that the disadvantages or harm caused by thiazolidinediones, especially rosiglitazone, may outweigh their benefits in patients with type 2 diabetes.
|
Authors | Fei-Yuan Hsiao, Weng-Foung Huang, Yu-Wen Wen, Pei-Fen Chen, Ken N Kuo, Yi-Wen Tsai |
Journal | Drug safety
(Drug Saf)
Vol. 32
Issue 8
Pg. 675-90
( 2009)
ISSN: 1179-1942 [Electronic] New Zealand |
PMID | 19591532
(Publication Type: Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Hypoglycemic Agents
- Sulfonylurea Compounds
- Thiazolidinediones
- Rosiglitazone
- Metformin
- Pioglitazone
|
Topics |
- Aged
- Cardiovascular Diseases
(chemically induced, epidemiology)
- Cohort Studies
- Databases, Factual
- Diabetes Mellitus, Type 2
(drug therapy)
- Female
- Humans
- Hypoglycemic Agents
(adverse effects, therapeutic use)
- Male
- Metformin
(adverse effects, therapeutic use)
- Middle Aged
- Pioglitazone
- Proportional Hazards Models
- Retrospective Studies
- Rosiglitazone
- Sulfonylurea Compounds
(adverse effects, therapeutic use)
- Taiwan
(epidemiology)
- Thiazolidinediones
(adverse effects, therapeutic use)
|