By Ed Susman
NEW ORLEANS -- November 12, 2008 -- Use of rosiglitazone reduced total atheroma burden in coronary arteries as measured by intravascular ultrasound, while the sulfonylurea glipizide appeared to increased plaque in the blood vessels, according to research presented here at the American Heart Association (AHA) Scientific Sessions.
However, the differences failed to reach statistical significance, said lead author Richard Nesto, MD, PhD, Department of Cardiology, Lahey Clinic, Burlington, Massachusetts.
He presented the results of the Assessment on the Prevention of Progression by Rosiglitazone in Diabetes Patients With Cardiovascular History (APPROACH) in a late-breaking session on November 12.
For their prospective, randomised, double-blind study, Dr. Nesto and colleagues enrolled 672 diabetic patients with an average age of 61, who were undergoing clinically required angiography or percutaneous coronary interventions.
All patients underwent baseline intravascular ultrasound (IVUS) evaluations of atherosclerotic plaque in arteries that were not subject to intervention. Patients were then randomised to 18 months of treatment with rosiglitazone or glipizide at dosages adjusted to achieve similar levels of glucose control.
At the end of the treatment period, IVUS was performed on the same non-intervened arteries. A total of 462 patients completed the second evaluation.
After 18 months of treatment, the change in percentage of plaque volume was a decrease of 0.21% in the patients taking rosiglitazone and an increase of 0.43% in the patients taking glipizide. The difference between the groups did not reach statistical significance (P = .12).
Neither the reduction from baseline for rosiglitazone (P = .53) nor the increase from baseline for glipizide (P = .19) achieved statistical significance, he said. The direction of the differences was similar to results of a trial of glimepiride and pioglitazone, but in that study the differences reached statistical significance, Dr. Nesto said.
Patients in both arms of the study gained weight while on treatment, he noted. The weight gain was about 2 kg among the glipizide patients and about 4.5 kg for patients on rosiglitazone.
Funding for this study was provided by GlaxoSmithKline.
[Presentation title: The APPROACH Trial: Effect of Rosiglitazone Versus Glipizide on Progression of Coronary Atherosclerosis in Patients With Type 2 Diabetes and Coronary Artery Disease. Abstract LBCT-5221]
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