Rosiglitazone Treatment and Cardiovascular Disease in the Veterans Affairs Diabetes Trial

Overview

Journal Diabetes Obes Metab

Specialty Endocrinology

Date 2015 May 13

PMID 25964070

Citations 9

Authors

H Florez

P D Reaven

G Bahn

T Moritz

S Warren

J Marks

D Reda

W Duckworth

C Abraira

R Hayward

N Emanuele

Affiliations

Soon will be listed here.

Abstract

Aims: To evaluate the relationship between patterns of rosiglitazone use and cardiovascular (CV) outcomes in the Veterans Affairs Diabetes Trial (VADT).

Methods: Time-dependent survival analyses, case-control and 1 : 1 propensity matching approaches were used to examine the relationship between patterns of rosiglitazone use and CV outcomes in the VADT, a randomized controlled study that assessed the effect of intensive glycaemic control on CV outcomes in 1791 patients with type 2 diabetes (T2D) whose mean age was 60.4 ± 9 years. Participants were recruited between 1 December 2000 and 31 May 2003, and were followed for 5-7.5 years (median 5.6) with a final visit by 31 May 2008. Rosiglitazone (4 mg and 8 mg daily) was initiated per protocol in both the intensive-therapy and standard-therapy groups. Main outcomes included a composite CV outcome, CV death and myocardial infarction (MI).

Results: Both daily doses of rosiglitazone were associated with lower risk for the primary composite CV outcome [4 mg: hazard ratio (HR) 0.63, 95% confidence interval (CI) 0.49-0.81 and 8 mg: HR 0.60, 95% CI 0.49-0.75] after adjusting for demographic and clinical covariates. A reduction in CV death was also observed (HR 0.25, p < 0.001, for both 4 and 8 mg/day rosiglitazone); however, the effect on MI was less evident for 8 mg/day and not significant for 4 mg/day.

Conclusions: In older patients with T2D the use of rosiglitazone was associated with decreased risk of the primary CV composite outcome and CV death. Rosiglitazone use did not lead to a higher risk of MI.

Citing Articles

Rosiglitazone Does Not Show Major Hidden Cardiotoxicity in Models of Ischemia/Reperfusion but Abolishes Ischemic Preconditioning-Induced Antiarrhythmic Effects in Rats In Vivo.

Weber B, Brenner G, Kiss B, Gergely T, Sayour N, Tian H Pharmaceuticals (Basel). 2022; 15(9).

PMID: 36145276 PMC: 9503202. DOI: 10.3390/ph15091055.

The forgotten type 2 diabetes mellitus medicine: rosiglitazone.

Xu B, Xing A, Li S Diabetol Int. 2022; 13(1):49-65.

PMID: 35059243 PMC: 8733070. DOI: 10.1007/s13340-021-00519-0.

Identification of potential molecular mechanisms and small molecule drugs in myocardial ischemia/reperfusion injury.

Jiang T, Liu Y, Chen B, Si L Braz J Med Biol Res. 2020; 53(9).

PMID: 32696819 PMC: 7372942. DOI: 10.1590/1414-431x20209717.

Thiazolidinediones: the Forgotten Diabetes Medications.

Lebovitz H Curr Diab Rep. 2019; 19(12):151.

PMID: 31776781 PMC: 6881429. DOI: 10.1007/s11892-019-1270-y.

Effect of rosiglitazone on inflammatory cytokines and oxidative stress after intensive insulin therapy in patients with newly diagnosed type 2 diabetes.

Li J, Shen X Diabetol Metab Syndr. 2019; 11:35.

PMID: 31073335 PMC: 6499940. DOI: 10.1186/s13098-019-0432-z.

References

Nathan D, Buse J, Davidson M, Ferrannini E, Holman R, Sherwin R . Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2008; 32(1):193-203. PMC: 2606813. DOI: 10.2337/dc08-9025. View

Baba T, Shimada K, Neugebauer S, Yamada D, Hashimoto S, Watanabe T . The oral insulin sensitizer, thiazolidinedione, increases plasma vascular endothelial growth factor in type 2 diabetic patients. Diabetes Care. 2001; 24(5):953-4. DOI: 10.2337/diacare.24.5.953. View

Bach R, Brooks M, Lombardero M, Genuth S, Donner T, Garber A . Rosiglitazone and outcomes for patients with diabetes mellitus and coronary artery disease in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial. Circulation. 2013; 128(8):785-94. PMC: 3816149. DOI: 10.1161/CIRCULATIONAHA.112.000678. View

Kahn S, Haffner S, Heise M, Herman W, Holman R, Jones N . Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med. 2006; 355(23):2427-43. DOI: 10.1056/NEJMoa066224. View

Khanderia U, Pop-Busui R, Eagle K . Thiazolidinediones in type 2 diabetes: a cardiology perspective. Ann Pharmacother. 2008; 42(10):1466-74. DOI: 10.1345/aph.1K666. View

Valencia W, Florez H . Pharmacological treatment of diabetes in older people. Diabetes Obes Metab. 2014; 16(12):1192-203. DOI: 10.1111/dom.12362. View

Saremi A, Schwenke D, Buchanan T, Hodis H, Mack W, Banerji M . Pioglitazone slows progression of atherosclerosis in prediabetes independent of changes in cardiovascular risk factors. Arterioscler Thromb Vasc Biol. 2012; 33(2):393-9. PMC: 3908828. DOI: 10.1161/ATVBAHA.112.300346. View

Simon D . Rosiglitazone. Prim Care Diabetes. 2009; 3(2):123-4. DOI: 10.1016/j.pcd.2009.05.002. View

Cheng A . Canadian Diabetes Association 2013 clinical practice guidelines for the prevention and management of diabetes in Canada. Introduction. Can J Diabetes. 2013; 37 Suppl 1:S1-3. DOI: 10.1016/j.jcjd.2013.01.009. View

10.

Home P, Pocock S, Beck-Nielsen H, Curtis P, Gomis R, Hanefeld M . Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. Lancet. 2009; 373(9681):2125-35. DOI: 10.1016/S0140-6736(09)60953-3. View

11.

Diamond G, Bax L, Kaul S . Uncertain effects of rosiglitazone on the risk for myocardial infarction and cardiovascular death. Ann Intern Med. 2007; 147(8):578-81. DOI: 10.7326/0003-4819-147-8-200710160-00182. View

12.

Koro C, Bowlin S, Weiss S . Antidiabetic therapy and the risk of heart failure in type 2 diabetic patients: an independent effect or confounding by indication. Pharmacoepidemiol Drug Saf. 2005; 14(10):697-703. DOI: 10.1002/pds.1069. View

13.

Nesto R, Bell D, Bonow R, Fonseca V, Grundy S, Horton E . Thiazolidinedione use, fluid retention, and congestive heart failure: a consensus statement from the American Heart Association and American Diabetes Association. Diabetes Care. 2003; 27(1):256-63. DOI: 10.2337/diacare.27.1.256. View

14.

Home P, Pocock S, Beck-Nielsen H, Gomis R, Hanefeld M, Jones N . Rosiglitazone evaluated for cardiovascular outcomes--an interim analysis. N Engl J Med. 2007; 357(1):28-38. DOI: 10.1056/NEJMoa073394. View

15.

Dormandy J, Charbonnel B, Eckland D, Erdmann E, Massi-Benedetti M, Moules I . Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial. Lancet. 2005; 366(9493):1279-89. DOI: 10.1016/S0140-6736(05)67528-9. View

16.

Singh S, Loke Y, Furberg C . Long-term risk of cardiovascular events with rosiglitazone: a meta-analysis. JAMA. 2007; 298(10):1189-95. DOI: 10.1001/jama.298.10.1189. View

17.

Lago R, Singh P, Nesto R . Congestive heart failure and cardiovascular death in patients with prediabetes and type 2 diabetes given thiazolidinediones: a meta-analysis of randomised clinical trials. Lancet. 2007; 370(9593):1129-36. DOI: 10.1016/S0140-6736(07)61514-1. View

18.

Gerstein H, Miller M, Byington R, Goff Jr D, Thomas Bigger J, Buse J . Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008; 358(24):2545-59. PMC: 4551392. DOI: 10.1056/NEJMoa0802743. View

19.

Nissen S, Wolski K . Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med. 2007; 356(24):2457-71. DOI: 10.1056/NEJMoa072761. View

20.

Meneghini L, Florez H, Tamariz L . The Avandia debacle: methodology and practical importance of the findings. South Med J. 2007; 100(11):1062-3. DOI: 10.1097/SMJ.0b013e3181581a24. View