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Diabetes Care 28:20-26, 2005
© 2005 by the American Diabetes Association, Inc.

Clinical Care/Education/Nutrition
Original Article

Antidiabetic Drugs and Heart Failure Risk in Patients With Type 2 Diabetes in the U.K. Primary Care Setting

Shoko Maru, DSC1, Gary G. Koch, PHD2, Monika Stender, DRSCHUM3, Douglas Clark, MBA3, Laura Gibowski, MPH4, Hans Petri, MD, PHD3, Alice D. White, PHD3 and Ross J. Simpson, Jr., MD, PHD5

1 Department of Epidemiology, School of Public Health, University of North Carolina, Chapel Hill, North Carolina
2 Department of Biostatistics, School of Public Health, University of North Carolina, Chapel Hill, North Carolina
3 Worldwide Epidemiology, GlaxoSmithKline R&D, Greenford, U.K.
4 Alphametrics, Durham, North Carolina
5 Division of Cardiology, School of Medicine, University of North Carolina, Chapel Hill, North Carolina

Address correspondence and reprint requests to Ross J. Simpson, Jr., MD, PhD, Division of Cardiology, University of North Carolina at Chapel Hill, CB no. 7075, 130 Mason Farm Rd., Suite 4128, Chapel Hill, NC 27599-7075. E-mail: rsimpson{at}med.unc.edu

OBJECTIVE—To assess the effects of antidiabetic drugs on the risk of heart failure in patients with type 2 diabetes.

RESEARCH DESIGN AND METHODS—We conducted a retrospective cohort study with a newly diagnosed diabetes cohort of 25,690 patients registered in the U.K. General Practice Research Database, 1988–1999. We categorized person-time drug exposures to monotherapies in insulin, sulfonylureas (SUs), metformins, and other oral hypoglycemic agents (i.e., acarbose, guar gum) and combination therapy including insulin, combination therapy without insulin, and triple combination therapy with or without insulin. A drug-free time interval served as a reference category. Cox interval-wise (piece-wise) regression analyses were used. The main outcome was incident heart failure.

RESULTS—Among 43,390 drug exposure intervals for 25,690 patients who had a mean follow-up period of 2.5 years, 1,409 patients developed heart failure. Heart failure occurred most frequently in SU monotherapy exposure. After adjusting for duration of diabetes, the timing and order of treatments received, and known risk factors for heart failure, we found no differential effects among type-specific therapies. Patients with any drug use within the first year after diabetes diagnosis had a 4.75-fold higher risk (hazard ratio) for heart failure than those with drug-free status but had no increased risk during subsequent years.

CONCLUSIONS—In conclusion, the use of any pharmacological therapy for type 2 diabetes appears to be associated with an increased risk of heart failure. This risk does not persist beyond the first year after diagnosis of diabetes and does not appear to differ among the types of drug therapy examined. This observation suggests that the severity of diabetes or the preclinical duration of diabetes and the need for drug therapy, and not the therapy itself, is an explanation for heart failure in patients with type 2 diabetes.

Abbreviations: GPRD, General Practice Research Database • OHA, oral hypoglycemic agent • OXMIS, Oxford Medical Information System • SU, sulfonylurea


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