Simvastatin efficacy for primary prevention in people over 75 years old: a multicenter prospective, randomized, double blind, parallel-group trial

Abstract

Background: Cardiovascular diseases are the leading cause of death in Spain, however the incidence of cardiovascular disease rates are among the lowest in the world even the same cardiovascular risk factor exposure. Hypercholesterolemia is the most prevalent cardiovascular risk factor in Spain, and reducing cholesterol levels has become one of the main goals in primary prevention. When hygienic-dietetic measures are not enough statins treatment is recommended. Even when there is a high evidence of their efficacy on reducing cardiovascular events and death on people less than 75 years old at risk, there is a lack of evidence about their efficacy over that age. In a country with the highest life expectancy and a rising number of elderly, the efficacy in overall death and cardiovascular events reduction associated at statin therapy in this population must be assessed. Objectives: To evaluate the effect of statins in primary prevention compared to placebo in order to reduce mortality and cardiovascular events in people between 75 and 85 years old living in Spain. The secondary objective is to determine the incidence of adverse effects in this population. Methods: The design is a prospective, randomized, double blind, parallel-group trial that compares Simvastatin (20mg) versus placebo. 1624 patients in the intervention group and 1624 in the control group, between 75 and 85 years old, affected by hypercholesterolemia will be recruited and followed every three months for three years by their own primary care doctors and nurses, members of the AGICAP. The primary care doctors will check the new onset of cardiovascular diseases and any adverse effect