The design of a Prospective Study of Pravastatin in the Elderly at Risk (PROSPER)

The PROspective Study of Pravastatin in the Elderly at Risk (PROSPER) is a randomized, double-blind, placebo-controlled trial designed to test the hyp othesis that treatment with pravastatin will diminish risk of: subsequent m ajor vascular events in a cohort of men and women (70 to 82 years old) with preexisting vascular disease or significant risk of developing this condit ion. Five thousand eight hundred four men and women in addition to receivin g advice on diet and smoking, have been randomized equally to treatment wit h 40 mg pravastatin/day or matching placebo in 3 centers (Cork, Ireland, Gl asgow, Scotland, and Leiden, The Netherlands). Following an average 3.5-yea r intervention period, a primary assessment will be made of the influence o f this therapy on major vascular events (a combination of coronary heart di sease, death, nonfatal myocardial infarction, and fatal and nonfatal stroke ). A number of additional analyses will also be conducted on the individual components of the primary end point, on men, on women, and on subjects wit h and without previous evidence of vascular disease. Finally, an assessment will be made of the effects of treatment on cognitive function, disability , hospitalization or institutionalization, vascular mortality, and all-caus e mortality. (C) 1999 by Excerpta Medica, inc.