Multifactorial cardiovascular disease prevention in patients aged 75 yearsand older: A randomized controlled trial - Drugs and evidence based medicine in the elderly (DEBATE) study

Background The number of patients aged 75+ years with cardiovascular diseas es (CVD) is increasing, but few studies of secondary prevention in this age group exist. The aim of the Drug and Evidence Based Medicine in the Elderl y (DEBATE) study is to test the applicability and effectiveness of establis hed CVD treatments in elderly patients. Methods From 1998 to 2000, population-based postal surveys were performed i n Helsinki, Finland, including the age groups 75, 80, 85, 90, and 95 years (n = 4821). Of the 812 individuals reporting any atherosclerotic disease, 4 00 patients (66% of those eligible) were included in a randomized trial. In the intervention group, CVD treatments will be individualized according to current guidelines. A control group will receive the usual care. The trial period will last 2 years with a 3-year extension. The primary end point wi ll be a composite of major CVD. In addition, a number of secondary end poin ts will be recorded, including permanent institutionalization, decline in c ognitive and physical function, and quality of life. Results During 2000, 400 home-dwelling patients were randomized to the inte rvention (n = 199) and control (n = 201) groups. The mean age is 80.2 years and 65.3% are women. Of the participants, 82% have coronary heart disease (41% with history of myocardial infarction), 37% history of stroke, 19% non -insulin-dependent diabetes mellitus, and 45% hypertension, and 6% are curr ent smokers. Before randomization, 67% used aspirin, 400% beta -blockers, 1 4% angiotensin-converting enzyme inhibitors, 36% nitrates, and 20% lipid-lo wering drugs. The groups were well balanced at baseline. Conclusion We have successfully randomized elderly patients with a high deg ree of comorbidity into a multifactorial CVD prevention trial.