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APPROACH: Rosiglitazone not significantly better than glipizide at reducing atherosclerosis
IVUS study shows insignificant reduction in percent atheroma volume with rosiglitazone vs. an increase with glipizide.
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Rosiglitazone treatment failed to reduce percent atheroma volume compared with glipizide treatment, according to results of the APPROACH study.
APPROACH, a prospective, randomized, double-blind, active-controlled trial, compared the effect of rosiglitazone vs glipizide therapy on the progression of atherosclerosis in 672 patients with diabetes. Patients underwent coronary angiography or PCI; during the procedures, investigators used IVUS to measure plaque burden in a non-intervened artery with at least one stenosis and 10% to 50% luminal narrowing. Patients were then treated with the study drugs and measured again at 18 months follow up.
Patients who had received rosiglitazone had a 0.21% reduction from baseline in percent atheroma volume (P=.53), compared with a 0.43% increase among patients assigned glipizide (P=.19; treatment difference between groups, P=.12).
Secondary endpoints of the study included normalized total atheroma volume and atheroma volume in the most diseased 10 mm. Rosiglitazone produced significantly better results that glipizide in normalized total atheroma volume; normalized total atheroma volume in the rosiglitazone group was reduced by 3.9 mm3 compared with an increase in the glipizide group of 1.2 mm3 (5.12 mm3 difference between groups; P=.04). Atheroma volume in the most diseased 10 mm was not significantly lower in the rosiglitazone group (5.3 mm3 vs. 3.6 mm3; P=.13).
APPROACH was presented as a late-breaking trial at the American Heart Association's Scientific Sessions by Richard W. Nesto, MD, PhD, chair of the division of internal medicine at Brigham and Women's Hospital. In October, the American Diabetes Association and the European Association for the Study of Diabetes issued updated treatment recommendations for the management of hyperglycemia in patients with type 2 diabetes; rosiglitazone was eliminated from their list of recommended medications.