Keywords :
Advisory Committees; Clinical Trials as Topic; Diabetes Mellitus, Type 2/drug therapy; Heart Diseases/chemically induced; Humans; Hypoglycemic Agents/adverse effects/therapeutic use; Risk Assessment; Thiazolidinediones/adverse effects/therapeutic use; United States; United States Food and Drug Administration
Abstract :
[en] The present article aims at summarizing the recent controversy about rosiglitazone (Avandia), an insulin sensitizer used as oral antidiabetic agent in the treatment of type 2 diabetes. We will present and briefly discuss 1) the results of the meta-analysis that raised suspicion about a possible excess of coronary complications with rosiglitazone; 2) the more favourable results of the large prospective clinical trial RECORD, but which are currently limited to an interim analysis; and 3) the reassuring data from several large US databases comparing the cardiovascular prognosis of type 2 diabetic patients treated with different antidiabetic drugs. We will conclude, referring to the recent position statement of the Advisory Committee of the Food and Drug Administration, by providing some practical recommendations.
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