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ACC 08 - Study provides patient reassurance about drug's safety according to a study being presented at the American College of Cardiology's 57th Annual Scientific Session.

According to a study being presented at the American College of Cardiology's 57th Annual Scientific Session (ACC.08), Rosiglitazone, a PPAR-gamma agonist, may prove effective in preventing the progression of blockages in coronary artery bypass grafts (CABG). ACC.08 is the premier cardiovascular medical meeting, bringing together cardiologists and cardiovascular specialists to further breakthroughs in cardiovascular medicine.

More than 500,000 patients with type 2 diabetes undergo CABG surgery each year and most will have one or more bypasses using a saphenous vein graft (a vein segment taken from the leg). However, these grafts become re-occluded in 50 percent of patients 10 years after CABG.

The number of patients with type 2 diabetes and coronary artery disease will increase dramatically over the next decade. In this study, known as the VICTORY trial, conducted at eight centers in Canada and Spain with 193 participants, researchers sought to evaluate the benefit and safety of Rosiglitazone in preventing atherosclerosis progression in patients with type 2 diabetes one to 10 years after CABG surgery. They measured atherosclerosis in one vein graft and one coronary artery using intravascular ultrasound immediately following CABG and again after 12 months. They also evaluated metabolic changes by assessing fat tissue distribution using abdominal computed tomographic (CT) scanning at baseline, six months, and 12 months.

CT scanning allows the measurement of visceral fat, (considered bad fat because it contributes to the metabolic syndrome) and sub-cutaneous fat (good fat). Body composition, or percent fat, was measured using DEXA, the same system that is used to measure bone density in menopausal women, at baseline, six months and 12 months. In addition, metabolic markers including lipids, plasma glucose-insulin homeostasis and inflammation were assessed at the same three time intervals.

"Rosiglitazone proved to be safe and was not associated with adverse effects," said Olivier F. Bertrand, M.D., Ph.D., Assistant Professor, Laval University, Quebec City, Quebec, Canada. "Other studies involving a larger number of patients are currently ongoing using Rosiglitazone and will further define the role of this agent in this important patient population with type 2 diabetes and coronary artery disease. VICTORY is only a moderate-sized trial, but our results provide reassurance about the safety of Rosiglitazone, which has been under fierce attack compared with Pioglitazone, the other glitazone compound."