A Comparison of the Effects of Rosiglitazone and Glyburide on Cardiovascular Function and Glycemic Control in Patients With Type 2 Diabetes

A Comparison of the Effects of Rosiglitazone and Glyburide on Cardiovascular Function and Glycemic Control in Patients With Type 2 Diabetes Martin St. John Sutton , FRCP 1 , Marc Rendell , MD 2 , Paresh Dandona , MD 3 , Jo F. Dole , PHD 4 , Karen Murphy , MT (ASCP) 4 , Rita Patwardhan , PHD 4 , Jai Patel , MD 4 , Martin Freed , MD 4 and For the Rosiglitazone Clinical Trials Study Group 1 University of Pennsylvania Medical Center, Philadelphia, Pennsylvania 2 Creighton University, Omaha, Nebraska 3 State University of New York School of Medicine at Buffalo, Buffalo, New York 4 GlaxoSmithKline, Collegeville, Pennsylvania Abstract OBJECTIVE —This open-label, active-controlled study investigated the cardiac safety and antihyperglycemic effect of rosiglitazone (RSG) in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS —Of the 203 patients randomly assigned to RSG (4 mg b.i.d.) or glyburide (GLB) (titrated to achieve optimal glycemic control for the first 8 weeks only to limit the risk of hypoglycemia; mean 10.5 mg/day), 118 had an echocardiogram performed at week 52. Left ventricular (LV) mass index, ejection fraction, and left ventricular end-diastolic volume were assessed by M-mode echocardiography at baseline and weeks 12, 28, and 52; 24-h ambulatory blood pressure was assessed at baseline and at weeks 28 and 52. Glycemic control was assessed by measuring fasting plasma glucose (FPG) and HbA 1c . RESULTS —Neither treatment produced an increase in LV mass index that exceeded 1 SD. Ejection fraction did not change in either group. Both groups had clinically insignificant increases in LV end-diastolic volume. RSG, but not GLB, caused a statistically significant reduction in ambulatory diastolic blood pressure. Both treatments reduced HbA 1c and FPG. CONCLUSIONS —A total of 52 weeks of therapy with RSG (4 mg b.i.d.) did not adversely affect cardiac structure or function in patients with type 2 diabetes and produced significant and sustained reductions in hyperglycemia. Decreases in ambulatory diastolic blood pressure with RSG were superior to those with GLB. ACEI, ACE inhibitor AE, adverse event BP, blood pressure ECG, electrocardiogram EF, ejection fraction FPG, fasting plasma glucose GLB, glyburide ITT, intent to treat LOCF, last observation carried forward LV, left ventricular LVEDV, LV end-diastolic volume LVM, LV mass LVMI, LV mass index MR, mitral regurgitation RSG, rosiglitazone Footnotes Address correspondence and reprint requests to Martin St.