[Info-congress. Study of the prevention of type 1 diabetes with nicotinamide: positive lessons of a negative clinical trial (ENDIT)].
ENDIT ("European Nicotinamide Diabetes Intervention Trial") is a large placebo-controlled randomised clinical trial that aimed at studying the efficacy of nicotinamide in the prevention of type 1 diabetes mellitus among first-degree relatives of type 1 diabetic patients with positive islet cell antibodies (ICA). The results presented at the last congress of the European Association for the Study of Diabetes (EASD) in Budapest do not evidence any significant difference in the risk of developing overt diabetes mellitus in the patients treated with nicotinamide (n = 274) as compared to those receiving placebo (n = 275) after 5 years of follow-up. Despite these negative results, positive lessons could be drawn from ENDIT: 1) the feasibility of a large long-standing multicentre European trial in a difficult research area; 2) the importance of large randomised controlled clinical trials to bring the evidence requested by "Evidence-Based Medicine"; 3) the predictive value of various risk markers to progress toward type 1 diabetes in first-degree relatives, especially the number of positive auto-antibodies; and 4) the urgent need to continue intensive research in this important field of preventive medicine.
Philips
J C
JC
Service de Diabétologie, Nutrition et Maladies métaboliques, Département de Médecine, CHU Sart Tilman, Liège.
Scheen
A J
AJ
D003922:Diabetes Mellitus, Type 1 / Q000517:prevention & control*; D019317:Evidence-Based Medicine; D006801:Humans; D015337:Multicenter Studies as Topic; D009536:Niacinamide / Q000494:pharmacology*; D010919:Placebos; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D012307:Risk Factors
D010919:Placebos; D009536:Niacinamide