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Trials That Matter: Rosiglitazone, Ramipril, and the Prevention of Type 2 Diabetes
- David M. Nathan, MD; and
- Michael Berkwits, MSCE, Deputy Editor
- From the Massachusetts General Hospital Diabetes Unit, Boston, MA 02114, and American College of Physicians, Philadelphia, PA 19106.
Despite the growing number of options for treating type 2 diabetes, clinicians wanting to prevent the disease in high-risk patients have few good choices. Lifestyle changes that lead to weight loss can prevent diabetes (1, 2) but are difficult to adopt and maintain (3). Drugs used to treat diabetes are often expensive, and testing has only recently begun on their efficacy as primary preventive agents. Two large trials in 2002 showed that metformin (1) and acarbose (4) effectively prevent diabetes in participants with impaired glucose tolerance, but neither drug has been approved by the U.S. Food and Drug Administration (FDA) for prevention and their use has not become part of routine practice.
Thiazolidinediones and angiotensin-converting enzyme inhibitors are also potential candidates for primary diabetes prevention. Troglitazone showed early promise in clinical trials (5, 6), but further testing was preempted by the drug's withdrawal from the market. Secondary analyses of large trials of angiotensin-converting enzyme inhibitors and angiotensin-receptor blockers for treating cardiovascular disease raised the possibility that the effects of these drugs might protect against diabetes (7–9). The DREAM (Diabetes Reduction Assessment with Ramipril and Rosiglitazone Medication) trial was designed to determine if ramipril and rosiglitazone could fulfill the promise of type 2 diabetes prevention suggested by the earlier studies (10, 11).
What Did this Landmark Trial Show?
The trial investigators randomly assigned 5269 patients with impaired fasting glucose (plasma glucose level >6.1 mmol/L [>110 mg/dL] but <7.0 mmol/L [<126 mg/dL]), impaired glucose tolerance (plasma glucose level ≥7.8 mmol/L [≥140 mg/dL] but <11.1 mmol/L [<200 mg/dL] 2 hours after an oral glucose load), or both to receive ramipril (5 mg daily increased to 10 mg after 2 months and to 15 mg after 1 year), rosiglitazone (4 mg daily increased to 8 mg after 2 months), both, or placebo. The participants were evaluated …
