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In the Prospective Pioglitazone Clinical Trial in Macrovascular Events (PROactive) trial, the rate of primary outcome of death, myocardial infarction, stroke, acute coronary syndrome, vascular surgery, or amputation was not significantly lower among patients in the pioglitazone group than among those in the placebo group.
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Our data show that, as compared with placebo or with other antidiabetic regimens, treatment with rosiglitazone was associated with a significant increase in the risk of myocardial infarction and with an increase in the risk of death from cardiovascular causes that was of borderline significance.
Key secondary end points were changes from baseline in weight and mean daily glucose (MDG) at week 24.
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In the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial, rosiglitazone (plus metformin or a sulfonylurea) was compared with metformin plus a sulfonylurea in the combined endpoint of hospitalization or cardiovascular death.
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Pioglitazone modulates the proliferation and apoptosis of vascular smooth muscle cells via peroxisome proliferators-activated receptor-gamma.
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The prespecified secondary endpoints, in order of priority, were: time to the first event of death from any cause, myocardial infarction (excluding silent myocardial infarction), and stroke (main secondary endpoint in rest of this report); cardiovascular death; and time to individual components of the primary composite endpoint.
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It is usually mild and can be treated quickly and easily by eating or drinking a small amount of glucose-rich food.
However, a randomized, double-blind, placebo-controlled, crossover study by Rennings et al found that response to the loop diuretics furosemide and amiloride were preserved in rosiglitazone-treated subjects with insulin resistance.
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