Management of the Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) study after the Scandinavian Simvastatin Survival Study (4S).

Abstract

The Long-term Intervention with Pravastatin in Ischaemic Disease (LIPID) study was designed when considerable disagreement existed as to relative benefits and risks of cholesterol reduction. Between June 1990 and December 1992, 9,014 patients aged 31-75 years were randomized to receive either pravastatin 40 mg once daily or placebo. These patients had experienced either acute myocardial infarction or unstable angina within the preceding 3 months to 3 years and had total cholesterol levels of 155-271 mg/dl (4.0-7.0 mmol/liter). All patients received dietary advice. The LIPID study is projected for conclusion in 1997, after a follow-up period of at least 5 years. The primary study endpoint is mortality due to coronary artery disease (CAD). The Scandinavian Simvastatin Survival Study (4S) is the first secondary prevention trial to show a reduction in total mortality with lipid-lowering therapy. However, the LIPID study should continue for the following reasons: (1) important differences exist between the LIPID study and 4S cohorts. Overall, > 80% of the LIPID patients could not have been included in 4S on the basis of their cholesterol level, age, or history of CAD; (2) the LIPID study will also provide important information on noncoronary mortality and on other groups, such as women and diabetic patients, who have been underrepresented in previous trials; (3) the LIPID study design allows for clinical management, including lipid-lowering therapy, to be at the discretion of the physician managing a trial patient. The 4S results have been brought to the attention of all LIPID investigators, Institutional Ethics Committees, the physicians of the individual patients, and the patients themselves.(ABSTRACT TRUNCATED AT 250 WORDS)