[DREAM study: prevention of type 2 diabetes with ramipril and/or rosiglitazone in persons with dysglycaemia but no cardiovascular desease].

DREAM ("Diabetes Reduction Assessment with ramipril and rosiglitazone Medication") is a double-blind randomised placebo-controlled clinical trial with a 2-by-2 factorial design aiming to study the effects of an ACE inhibitor (ramipril 15 mg/day) and/or a thiazolidinedione (rosiglitazone 8 mg/day) on the development of diabetes or death (primary outcome) and on the regression to normoglycaemia (secondary outcome) in 5269 adults aged 30 years or more with impaired fasting glucose and/or impaired glucose tolerance, and no previous cardiovascular disease. There was no statistical evidence of an interaction between the ramipril and the rosiglitazone arms. After a mean follow up of 3 years, the use of ramipril does not significantly reduce the incidence of diabetes or death but does significantly increase regression to normoglycaemia. In contrast, the treatment with rosiglitazone reduces by almost 60% the incidence of type 2 diabetes and increases the likelihood (+70%) of regression to normoglycaemia. Whether it is a true prevention effect or simply a treatment effect remains to be determined when participants will be retested after a washout period. Cardiovascular event rates were rather low and much the same in all treatment groups, except a higher rate of heart failure in the rosiglitazone group. These results suggest that the routine inhibition of the renin-angiotensin system for the express purpose of preventing diabetes is not indicated in individuals not at high risk for cardiovascular disease and appear to confirm the promises of the glitazone use in the very early stage of the natural history of type 2 diabetes.