Why the study?
Does pioglitazone improve 6-minute walk test distance in patients with type 2 diabetes and mild cardiac disease compared to glyburide?
Does pioglitazone improve 6-minute walk test distance in patients with type 2 diabetes and mild cardiac disease compared to glyburide?
In patients with type 2 diabetes and NYHA class I heart failure, pioglitazone did not significantly affect 6-minute walk distance compared to glyburide over 1 year, but was associated with more edema and weight gain.
Pioglitazone does not improve functional capacity in T2DM with NYHA I HF; cautions against use given edema and weight gain.
Pioglitazone may cause fluid retention, a well-known side effect of thiazolidinediones, and may exacerbate heart failure. Patients with type 2 diabetes and mild cardiac disease (New York Heart Association functional class I) received pioglitazone (n=151) or glyburide (n=149) for 1 year. The primary endpoint was change in distance covered in the 6-minute walk test. Main secondary endpoints included comparison of cardiovascular mortality and morbidity, analysis of changes from baseline in cardiac structure and function by echocardiogram, and lipid panel. There was no significant treatment difference in the mean change from baseline in the 6-minute walk test (-11.7 m [95% confidence interval, -29.79 to 6.42]). Cardiovascular mortality and morbidity were not significantly different between the treatment groups. Echocardiographic data suggested no significant deterioration in cardiac function with pioglitazone, although more heart failure (10 vs 7 patients), edema (21.2% vs 12.8%), and weight gain (2.56+/-4.62 kg vs 0.86+/-3.85 kg) were observed than with glyburide.
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Giles et al. (2010) studied this question.
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