TY - JOUR
T1 - Thiazolidinediones and cardiovascular events in patients with type 2 diabetes mellitus
T2 - A retrospective cohort study of over 473000 patients using the national health insurance database in Taiwan
AU - Hsiao, Fei Yuan
AU - Huang, Weng Foung
AU - Wen, Yu Wen
AU - Chen, Pei Fen
AU - Kuo, Ken N.
AU - Tsai, Yi Wen
N1 - Funding Information:
This study is a component of a research grant by Taiwan’s National Science Council for which Dr W.F. Huang served as the principal investigator. The authors have no conflicts of interest to declare.
Funding Information:
We would like to thank Taiwan’s National Science Council (NSC) Grant for providing a research grant (NSC-96-N-6805). We also thank the Bureau of National Health Insurance (BNHI) and National Health Research Institutes (NHRI) for making available their databases for this study. The content of this article, however, in no way represents any official position of the BNHI or NHRI. The authors accept all responsibility for the results and their interpretation. We would like to thank Dr C. Daniel Mullins for providing consultation and assistance with the revised manuscript. We would also like to thank Mr James Steed for his assistance in editing this manuscript.
PY - 2009
Y1 - 2009
N2 - Background and objective: Concern has been expressed over the cardiovascular risks associated with rosiglitazone and pioglitazone. This study investigates the association between oral antihyperglycaemics (rosiglitazone, pioglitazone, sulfonylureas and metformin) with myocardial infarction, congestive heart failure, angina pectoris, stroke and transient ischaemic attack. Methods: We used Taiwans 20005 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.
AB - Background and objective: Concern has been expressed over the cardiovascular risks associated with rosiglitazone and pioglitazone. This study investigates the association between oral antihyperglycaemics (rosiglitazone, pioglitazone, sulfonylureas and metformin) with myocardial infarction, congestive heart failure, angina pectoris, stroke and transient ischaemic attack. Methods: We used Taiwans 20005 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.
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U2 - 10.2165/00002018-200932080-00006
DO - 10.2165/00002018-200932080-00006
M3 - Article
C2 - 19591532
AN - SCOPUS:67650465654
SN - 0114-5916
VL - 32
SP - 675
EP - 690
JO - Drug Safety
JF - Drug Safety
IS - 8
ER -
