L'etude clinique du mois. L'etude ADOPT: quel antidiabetique oral initier chez le patient diabetique de type 2?

ADOPT ("A Diabetes Outcome Progression Trial") is a double-blind, controlled clinical trial that aims at assessing the efficacy of rosiglitazone, as compared to metformin or glibenclamide, in maintaining long-term glycaemic control in patients with recently diagnosed type 2 diabetes. It randomized 4,360 patients who were followed for a median of 4.0 years. The cumulative incidence of monotherapy failure (defined as a confirmed level of fasting plasma glucose level of more than 180 mg/dl) averaged at 5 years 15% with rosiglitazone, 21% with metformin, and 34% with glibenclamide. This represents a risk reduction for rosiglitazone of 32% as compared to metformin and 63% as compared to glibenclamide (P < 0.001 for both comparisons). Rosiglitazone was associated with more weight gain and edema, metformin with a higher incidence of gastrointestinal events and glibenclamide with a higher risk of hypoglycaemia (P < 0.001). In conclusion, ADOPT showed better glycaemic durability with rosiglitazone monotherapy, compared to metformin or glibenclamide. The potential risks and benefits, the profile of adverse events, and the costs of the three drugs should all be considered to help inform the choice of pharmacotherapy for patients with type 2 diabetes.