Determinants of elevated urinary albumin in the 4,937 type 2 diabetic subjects recruited for the DIABHYCAR Study in Western Europe and North Africa

OBJECTIVE - Whether ACE inhibition is useful for type 2 diabetic patients w ith micro- and macroalbuminuria remains unknown. The Non-Insulin-Dependent Diabetes, Hypertension, Microalbuminuria, Cardiovascular Events and Ramipri l (DIABHYCAR) Study was set up to address this issue through a multicenter double-blind parallel placebo-controlled greater than or equal to 3-year tr ial in Europe and North Africa. In this article, we report the characterist ics of the randomized patients. RESEARCH DESIGN AND METHODS - The main selection criteria were as follows: men or women aged greater than or equal to 50 years with type 2 diabetes tr eated with oral antidiabetic drugs, with or without hypertension, with a pl asma creatinine level <150 mu mol/l, and with persistent micro- or macroalb uminuria, as assessed centrally by two successive urine samples containing a urinary albumin concentration greater than or equal to 20 mg/l. Patient c haracteristics were studied by comparing patients who were randomized to th ose who were not, taking their geographical origin into account. RESULTS - There were 25,455 patients screened for urinary albumin (20,296 f rom France, 918 from Germany, 1,019 from Northwest Europe, 969 from Central Europe, 959 from Mediterranean Europe, and 1,294 from North Africa). Of th ese patients, 4,937 were randomized. Compared with the nonrandomized patien ts, the randomized patients were older, more often men, more obese, had hig her systolic/diastolic blood pressure and plasma glucose, smoked more tobac co, drank more alcohol, and had complications more frequently. Using a logi stic regression analysis, all the above-mentioned items appeared as indepen dent determinants for randomization into the study, with the exception of a lcohol intake. The contribution of each item varied slightly from one geogr aphical origin to another. CONCLUSIONS - The physical, biological, and behavioral characteristics crea te a poor renal and cardiovascular prognosis for the type 2 diabetic patien ts randomized to the DIABHYCAR Study because of micro- and macroalbuminuria . Testing the usefulness of ACE inhibition for the type 2 diabetic patients with microalbuminuria seems feasible through the DIABHYCAR Study.