[Clinical study of the month. Premature interruption of ASCOT and CARDS clinical trials of cardiovascular prevention with atorvastatin in patients with arterial hypertension or diabetes mellitus: compromise between ethics and statistics in evidence-based medicine ].
The Anglo-Scandinavian Cardiac Outcomes Trial--Lipid Lowering Arm (ASCOT-LLA), performed in hypertensive patients with coronary risk and the Collaborative AtoRvastatin Diabetes Study (CARDS), performed in diabetic patients, also at coronary risk, were prematurely stopped, at the special request of the Data Safety Monitoring Board. Indeed, an interim analysis demonstrated the efficacy of atorvastatin, at a daily dosage of 10 mg as compared to placebo, in the prevention of major cardiovascular events, so that it appeared unethical to continue the study until the end. At the glance of these observations, the ethical and statistical aspects of such prevention clinical trials are discussed, in particular when the premature interruption of the ongoing study appears mandatory, with respect of the main rules of evidence-based medicine.
Scheen
A J
AJ
Service de Diabétologie, Nutrition et Maladies métaboliques et de Médecine interne générale, Département de Médecine, CHU Sart Tilman, Liège.
D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D000069059:Atorvastatin; D002318:Cardiovascular Diseases / Q000209:etiology / Q000517:prevention & control*; D026661:Clinical Trials Data Monitoring Committees; D002986:Clinical Trials as Topic; D048909:Diabetes Complications; D032984:Ethics, Research; D006538:Heptanoic Acids / Q000627:therapeutic use*; D006801:Humans; D006949:Hyperlipidemias / Q000150:complications / Q000188:drug therapy; D006973:Hypertension / Q000150:complications* / Q000188:drug therapy; D007494:Ireland; D011758:Pyrroles / Q000627:therapeutic use*; D012307:Risk Factors; D012537:Scandinavian and Nordic Countries; D006113:United Kingdom
D000924:Anticholesteremic Agents; D006538:Heptanoic Acids; D011758:Pyrroles; D000069059:Atorvastatin