Study suggests that thiazolidinediones and metformin are not associated with increased mortality and may improve outcomes in older patients with diabetes and heart failure.
Thiazolidinediones and metformin are not only not harmful, but may actually be helpful for older patients with diabetes and heart failure, according to the results of a retrospective, observational study.
"Insulin-sensitizing drugs of the thiazolidinedione class and metformin are commonly prescribed to treat diabetes in patients with heart failure despite strong warnings from the Food and Drug Administration against this practice," write Frederick A. Masoudi, MD, MSPH, from Denver Health Medical Center in Colorado, and colleagues. "Whether this results in adverse outcomes is unknown."
Using a Medicare cohort derived from the National Heart Care Project (NHC), the investigators studied the relationship between prescribing thiazolidinediones and metformin and the outcomes of death and rehospitalization among 16,417 elderly diabetic patients after hospitalization for heart failure.
Crude 1-year mortality rates were lower for the 2,226 patients treated with a thiazolidinedione (30.1%) and for the 1,861 patients treated with metformin (24.7%) than for the 12,069 patients treated with neither drug (36.0%, P < .0001 for both comparisons). Multivariate analysis suggested that risk of death was significantly lower with thiazolidinedione treatment (hazard ratio [HR] 0.87, 95% confidence interval [CI], 0.80 to 0.94) or metformin treatment (HR = .87, 95% CI 0.78 to 0.97).
Treatment with sulfonylureas or insulin did not affect mortality. Although admissions for all causes did not differ with either medication class, risk of readmission for heart failure was higher with thiazolidinedione treatment (HR 1.06, 95% CI 1.00 to 1.09) and lower with metformin treatment (HR 0.92, 95% CI 0.92 to 0.99).
"This observational study suggests that thiazolidinediones and metformin are not associated with increased mortality and may improve outcomes in older patients with diabetes and heart failure," the authors write. "These findings do not support the existing recommendations against the use of insulin sensitizers in many, if not all, patients with heart failure but emphasize the importance of close monitoring of patients treated with thiazolidinediones."
"Further clarification of the best clinical approach to the use of insulin-sensitizing drugs, optimally with randomized clinical trials, will be important in advancing the treatment of the rapidly growing population with both diabetes and heart failure," the authors conclude.
Circulation. Feb 8, 2005
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