Aims The effectiveness of multifactorial cardiovascular disease prevention in patients aged 75 years or older is uncertain, because these patients have often been excluded from trials. The aim of this pre-planned, first-year analysis of the Drugs and Evidence-Based Medicine in the Elderly (DEBATE) Study was to determine the feasibility of prevention efforts in elderly cardiovascular patients. Methods and results For DEBATE, home-dwelling individuals aged 75 years and over with cardiovascular diseases (n=400, mean age 80 years, 65% women) were recruited from the community. These high-risk participants were randomly assigned to the intervention group (n=199) where both lifestyle modification and pharmacological cardiovascular treatments are individualized by a geriatrician according to current European guidelines. The control group (n=201) receives the usual care. Interim analysis of the study groups at one year shows that intervention has succeeded in increasing the use of statins, aspirin, beta-blockers, and ACE inhibitors, and decreasing serum cholesterol (p<0.0001), LDL-cholesterol (p<0.0001), and hsCRP (p=0.04). Body mass index, blood pressure, and blood glucose were similar at one year in both groups. No safety problems or adverse effects on health-related quality of life were observed and compliance was good. Conclusion It is possible and safe to institute evidence-based cardiovascular treatments in the 75+ cardiovascular patients in a real life setting, but only serum cholesterol and hsCRP are significantly decreased. (C) 2003 The European Society of Cardiology. Published by Elsevier Ltd. All rights reserved.