Assessment on the Prevention of Progression by Rosiglitazone on Atherosclerosis in diabetes patients with Cardiovascular History (APPROACH): study design and baseline characteristics.

Abstract

BACKGROUND:

Rosiglitazone, a thiazolidinedione, has effects on insulin sensitivity and cardiovascular risk factors that may favorably impact the progression of coronary atherosclerosis.

METHODS:

APPROACH is a double-blind randomized clinical trial comparing the effects of the insulin sensitizer rosiglitazone with the insulin secretagogue glipizide on the progression of coronary atherosclerosis. Patients with type 2 diabetes and coronary artery disease undergoing clinically indicated coronary angiography or percutaneous coronary intervention are randomized to receive rosiglitazone or glipizide for 18 months using a titration algorithm designed to provide comparable glycemic control between treatment groups. The primary end point is change in percent atheroma volume from baseline to study completion in a nonintervened coronary artery, as measured by intravascular ultrasound. Cardiovascular events are adjudicated by an end point committee.

RESULTS:

A total of 672 patients were randomized. The mean age was 61 years, hemoglobin A(1c) (HbA(1c)) 7.2%, body mass index 29.5 kg/m(2), and median duration of diabetes 4.8 years. At baseline, approximately half of the participants were receiving oral antidiabetic monotherapy (53.9%) with 27.5% receiving dual combination therapy and 17.9% treated with diet and exercise alone. Approximately two thirds of the participants (68%) had dyslipidemia, 79.9% hypertension, and 24% prior myocardial infarction.

CONCLUSIONS:

APPROACH has fully enrolled a high-risk patient population and will compare the glucose-independent effects of rosiglitazone and glipizide on the progression of coronary atherosclerosis, as well as provide additional data on the cardiovascular safety of rosiglitazone in patients with type 2 diabetes and coronary artery disease.

• Authors: Robert E Ratner, Christopher P Cannon, Hertzel C Gerstein, Richard W Nesto, Patrick W Serruys, Gerrit-Anne Van Es, Nikheel S Kolatkar, Barbara G Kravitz, Andrew Zalewski, Peter J Fitzgerald, APPROACH Study Group
• Journal: American heart journal (Am Heart J) Vol. 156 Issue 6 Pg. 1074-9 (Dec 2008) ISSN: 1097-6744 [Electronic] United States
• PMID: 19033001 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Hypoglycemic Agents
• Thiazolidinediones
• Rosiglitazone
• Glipizide

Topics

• Adult
• Aged
• Coronary Artery Disease (diagnostic imaging, prevention & control)
• Diabetes Mellitus, Type 2 (diagnostic imaging, drug therapy)
• Diabetic Angiopathies (diagnostic imaging, prevention & control)
• Disease Progression
• Double-Blind Method
• Female
• Glipizide (adverse effects, therapeutic use)
• Humans
• Hypoglycemic Agents (adverse effects, therapeutic use)
• Male
• Middle Aged
• Risk Factors
• Rosiglitazone
• Thiazolidinediones (adverse effects, therapeutic use)
• Ultrasonography, Interventional