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An Analysis of the Candesartan in Heart Failure: Assessment of Reduction in Mortality and Morbidity (CHARM) Program

Hertzel C. Gerstein, MD, MSc; Karl Swedberg, MD, PhD; Jonas Carlsson, MSc; John J. V. McMurray, MD; Eric L. Michelson, MD; Bertil Olofsson, PhD; Marc A. Pfeffer, MD, PhD; Salim Yusuf, DPhil; for the CHARM Program Investigators

Arch Intern Med. 2008;168(15):1699-1704.

Background  A progressive relationship between hemoglobin A_1c (HbA_1c) levels and cardiovascular (CV) events has been observed in persons with and without diabetes. To our knowledge, the nature of such a relationship in patients with symptomatic chronic heart failure (HF) has not been studied.

Methods  A total of 2412 participants (907 with prior diabetes) in the Candesartan in Heart failure: Assessment of Reduction in Mortality and Morbidity (CHARM) program with at least 1 HbA_1c level were followed up for a median of 34 months. The incidence of the primary outcome (CV death or HF hospitalization), CV death, and total mortality was calculated according to eighths of the usual HbA_1c level ranging from 5.8% or less to greater than 8.6%. Adjusted and unadjusted hazard ratios per 1% rise in HbA_1c levels were also calculated.

Results  A total of 99.6% of eligible participants were followed up until they developed an outcome or the study finished. The risk of the primary composite outcome, CV death, hospitalization for worsening HF, and total mortality rose progressively with higher levels of usual HbA_1c (P for trend <.001). After age and sex were adjusted for, hazards of these outcomes per 1% higher HbA_1c level were 1.25 (95% confidence interval [CI ],1.20-1.31), 1.24 (95% CI, 1.17-1.31), 1.25 (95% CI, 1.19-1.31), and 1.22 (95% CI, 1.16-1.29), respectively. This relationship was evident in patients with and without diabetes and with reduced or preserved ejection fraction and persisted after adjustment for diabetes, other risk factors, and allocation to candesartan.

Conclusion  In diabetic and nondiabetic patients with symptomatic chronic HF, the HbA_1c level is an independent progressive risk factor for CV death, hospitalization for HF, and total mortality.

Author Affiliations: Department of Medicine and the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada (Drs Gerstein and Yusuf); Sahlgrenska University Hospital/Östra, Göteborg, Sweden (Dr Swedberg); AstraZeneca R&D, Mölndal, Sweden (Drs Carlsson and Olofsson); University of Glasgow, Glasgow, Scotland (Dr McMurray); AstraZeneca LP, Wilmington, Delaware (Dr Michelson); and Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts (Dr Pfeffer).
Group Information: A list of the CHARM Program Investigators was published in Lancet. 2003;362(9386):759-766.

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