Heart failure events with rosiglitazone in type 2 diabetes: data from the RECORD clinical trial

Komajda, M., McMurray, J. J. V. , Beck-Nielsen, H., Gomis, R., Hanefeld, M., Pocock, S. J., Curtis, P. S., Jones, N. P. and Home, P. D. (2010) Heart failure events with rosiglitazone in type 2 diabetes: data from the RECORD clinical trial. European Heart Journal, 31(7), pp. 824-831. (doi:10.1093/eurheartj/ehp604)

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Abstract

Aims Thiazolidinediones are insulin sensitizers, and are associated with fluid retention and increased risk of heart failure (HF) in people with type 2 diabetes. We assessed fatal and non-fatal HF events and their outcome, and identified HF predictors in the RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of glycaemia in Diabetes) trial population. Methods and results In a multicentre, open-label study, we randomized 4447 people with type 2 diabetes on metformin or sulfonylurea monotherapy with a mean HbA(1c) of 7.9% to add-on rosiglitazone (n = 2220) or to a combination of metformin and sulfonylurea (n = 2227) and followed them over 5.5 years on average. Heart failure hospitalizations and deaths were adjudicated by a Clinical Endpoint Committee using pre-specified criteria. Independent predictors of HF events were identified out of a group of 30 pre-specified clinical, demographic, and biological variables. In the rosiglitazone group, the risk of HF death or hospitalization was doubled: HR = 2.10 (95% CI, 1.35-3.27): the excess HF event rate was 2.6 (1.1-4.1) per 1000 person-years. An excess in HF deaths was observed (10 vs. two), including four HF deaths as first HF events. By contrast, there was no increase in cardiovascular mortality or hospitalization (HR = 0.99, 95% Cl, 0.85-1.16) or in cardiovascular deaths (60 vs. 71). Independent predictors of HF were rosiglitazone assignment, age, urinary albumin : creatinine ratio, body mass index, and systolic blood pressure at baseline. A history of previous cardiovascular disease was not predictive of HF. Duration of HF hospitalization and rate of HF re-hospitalization were similar in the two groups. Conclusion These findings confirm the increased risk of HF events in people treated with rosiglitazone and support the recommendation that this agent should not continue to be used in people developing symptomatic HF while using the medication. Close follow-up for the risk of HF should be offered to elderly people, people with markedly increased body mass index, people with microalbuminuria/proteinuria, and people with increased systolic blood pressure

Item Type:Articles
Keywords:AGE ASSOCIATION BLOOD blood pressure BLOOD-PRESSURE body mass index BODY-MASS-INDEX cardiovascular disease CARDIOVASCULAR MORTALITY CARDIOVASCULAR-DISEASE CARE clinical trials CREATININE RATIO DEATH DEATHS diabetes DISEASE DURATION elderly ENGLAND EVENTS FAILURE FLUID FLUID RETENTION FOLLOW-UP GLUCOSE HEART Heart failure HEART-FAILURE INCREASE INCREASED RISK INDEX insulin MASS Medication METFORMIN MORTALITY outcome OUTCOMES PEOPLE POPULATION predictors RANDOMIZED CONTROLLED-TRIAL RISK SYSTEM THIAZOLIDINEDIONES TRIAL Type 2 diabetes TYPE-2 VARIABLES
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:McMurray, Professor John
Authors: Komajda, M., McMurray, J. J. V., Beck-Nielsen, H., Gomis, R., Hanefeld, M., Pocock, S. J., Curtis, P. S., Jones, N. P., and Home, P. D.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cardiovascular and Medical Sciences
College of Medical Veterinary and Life Sciences
Journal Name:European Heart Journal
ISSN:0195-668X

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