March 28, 2007 (New Orleans, LA) - The thiazolidinedione antidiabetes drug rosiglitazone (Avandia, GlaxoSmithKline) showed a trend toward a reduction in carotid intima media thickness (IMT) according to the primary end point measurement and a significant reduction according to the secondary end point measurement in the STARR study in patients with prediabetes. But the ACE inhibitor ramipril (Altace, King Pharmaceuticals) did not show any change in carotid IMT compared with placebo.
The STARR study was a substudy of the larger DREAM trial, and the results are consistent with those of the parent trial, which showed that three years of treatment with rosiglitazone reduced the incidence of type 2 diabetes in patients with prediabetes (defined as impaired fasting glucose levels, impaired glucose tolerance, or both), but treatment with ramipril did not.
Presenting the results of the STARR study at the American College of Cardiology 2007 Scientific Sessions, Dr Eva Lonn (McMaster University, Hamilton, ON) said the results backed up those of the DREAM study and supported further trials of the long-term effects of thiazolidinediones on cardiovascular disease.
Lonn commented to heart wire : "Whether or not to treat prediabetes patients with rosiglitazone is still at the discretion of individual physicians. DREAM suggests that such treatment can prevent the development of diabetes, but we still don't have any hard clinical end-point data. In the STARR substudy, we saw a trend toward stabilizing subclinical vascular disease with rosiglitazone in this population. This may be an additional reason to consider using a thiazolidinedione in prediabetes patients." She added: "There have been concerns about heart failure with these drugs. It is reassuring to see a positive effect on atherosclerosis."
In the STARR study, 1425 prediabetes patients enrolled in the DREAM trial underwent carotid ultrasound at baseline and again at the end of the trial. Patients were randomized in a 2x2 factorial design to ramipril or placebo and then to rosiglitazone or placebo. The primary end point in the STARR study was the average change in IMT per year in 12 segments of the carotid artery. This showed a positive trend toward a slower progression of atherosclerosis in the rosiglitazone group. The secondary end point was an average of two IMT measurements in the common carotid far wall. This showed a significant reduction in progression in the rosiglitazone group. There was no difference in either end point with ramipril or placebo.
STARR: Change in carotid intima media thickness (IMT) with rosiglitazone and placebo
|Change in primary IMT measurement (mm/year)||0.0069||0.0091||0.17|
|Change in secondary IMT measurement (mm/year)||0.0018||0.0060||0.017|
Lonn pointed out that unlike some carotid IMT studies, the STARR study did not select patients with increased IMT measurements at baseline. Because of this, theirs was a low-risk population in the short term, making it more difficult to show a change in subclinical vascular disease, she said.
Heartwire from Medscape © 2007 Medscape
Cite this: Sue Hughes. STARR: Rosiglitazone Shows Trend Toward Reduced Atherosclerosis Progression in Prediabetes Patients - Medscape - Mar 28, 2007.