Ramipril of limited benefit in preventing diabetes

NEW YORK (Reuters Health) - Contrary to previous research suggesting that the drug ramipril (sold as Altace) may check the progression to diabetes in pre-diabetics, 3-year results of a multinational, prospective trial failed to show that ramipril is better than placebo in reducing the incidence of diabetes or death in a cohort of patients with impaired fasting glucose (sugar) levels or impaired glucose tolerance, precursors to full-blown diabetes.

However, ramipril may improve glucose metabolism by promoting regression to normal blood sugar levels or "normoglycemia," according to investigators participating in the DREAM (Diabetes Reduction Assessment with Ramipril and Rosiglitazone Medication) trial.

In their report in the New England Journal of Medicine, the trialists note that other studies evaluating the effects of ramipril were focused on patients with or at high risk for cardiovascular disease, and did not include standard assessments of glucose levels.

The ramipril arm of the DREAM trial included pre-diabetic individuals age 30 and over and were free of cardiovascular disease.

The researchers randomly assigned 2623 patients to ramipril, up to 15mg/day, and 2646 to placebo. Subjects were followed for a median of 3 years.

After a median of 3 years, there were no significant differences between groups in deaths or the development of diabetes. Similarly, fasting blood sugar levels were unaffected by group assignment.

However, significantly more patients treated with ramipril had normal fasting plasma glucose levels and normal 2-hour plasma glucose levels (42.5 percent versus 38.2 percent), compared with placebo. They also had improved glucose tolerance.

The investigators acknowledge that the trial's duration may have been too short to catch more significant differences in progression to diabetes or death.

Still, the DREAM team advises, "for now, routine use of ramipril for the express purpose of preventing diabetes is not indicated."

New England Journal of Medicine deputy editors Dr. Julie R. Ingelfinger and Dr. Caren G. Solomon concur. "Ongoing attention to diet and exercise remains our best hope for reducing the rising rate of diabetes," as they write in an accompanying editorial.

SOURCE: The New England Journal of Medicine, October 12, 2006.