Possibilities of multifactorial cardiovascular disease prevention in patients aged 75 and older: a randomized controlled trial Drugs and Evidence Based Medicine in the Elderly (DEBATE) Study

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. CONCLUSIONS: 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.