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Rosiglitazone Has Modest Effect on Vascular Measure

Drug linked to favorable effect on CIMT progression; clinical implications remain unclear

MONDAY, June 1 (HealthDay News) -- Rosiglitazone may inhibit the progression of vascular disease in individuals with pre-diabetes, according to research published in the June 2 issue of the Journal of the American College of Cardiology.

Eva M. Lonn, M.D., of McMaster University in Hamilton, Canada, and colleagues analyzed data from 1,425 subjects with impaired glucose tolerance or impaired fasting glucose who participated in the Study of Atherosclerosis with Ramipril and Rosiglitazone (STARR) trial. They were randomized to receive ramipril and rosiglitazone or their placebos, and were followed for a median of three years.

The researchers found that ramipril and placebo had similar effects on the primary and secondary outcomes, which were annualized change of aggregate maximum carotid intima-media thickness (CIMT) and annualized change of the mean far wall left and right common CIMT, respectively. Rosiglitazone did not have a significant effect on the primary outcome, but did significantly reduce the secondary outcome.

"The clinical implications of the study, however, are not extremely clear at present, particularly in view of the neutral effects of ramipril and the modest effects of rosiglitazone on CIMT in pre-diabetic patients found in the trial. Because rosiglitazone in particular is under close scrutiny after the results of the meta-analysis by Nissen and Wolski in 2007 and TZDs in general continue to be monitored in view of reports showing that these drugs can increase the risk for heart failure, the possible clinical application of the STARR findings remains uncertain," write the authors of an accompanying editorial.

The STARR trial was funded by Sanofi-Aventis, GlaxoSmithKline, and King Pharmaceuticals, which provided study medications and placebo. Several co-authors reported financial associations with two of these companies.

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