THE DIAB-HYCAR STUDY

Microalbuminuria and proteinuria are strong independent predictors for increased cardiovascular mortality in non-insulin-dependent diabetic (NIDDM) patients. In such patients, angiotensin converting enzyme (ACE ) inhibition improves the evolution of diabetic nephropathy; however, no data are currently available on the effects of such intervention on cardiovascular morbidity and mortality. The aim of the Diab-Hycar stu dy is to test the hypothesis that ACE inhibition with a low daily dose of 1.25 mg ramipril, which has no significant effect on blood pressur e, may reduce cardiovascular morbidity and/or mortality in normotensiv e or hypertensive NIDDM patients with persistent albuminuria. Selected and followed by general practitioners, 4000 patients will receive the ir usual oral antidiabetic treatment and if necessary antihypertensive treatment (ACE inhibitors excluded). In addition in a randomized, dou ble-blind trial they will be given either a placebo or 1.25 mg ramipri l daily. The follow-up is currently scheduled to last 3 years. The eff icacy of ACE-inhibition will be assessed by the following major end-po ints: cardiovascular death, sudden death, myocardial infarction, strok e, renal replacement therapy. The Diab-Hycar study started on 3 Februa ry 1995. By 1 September 1995, 11 000 urine samples were tested. The pr evalence of persistent albuminuria was 23 %, 964 patients were initial ly included in the study, with 619 eligible patients included soon aft er. Different strategies have been developed to record cardiovascular events correctly and to minimize the number of patients lost to follow -up.