Pravastatin in Elderly Individuals at Risk of Vascular Disease PROSPER Pravastatin in Elderly Individuals at Risk of Vascular Disease Presented at Late Breaking Clinical Trials AHA 2002

PROSPER 5,804 high-risk elderly patients Pravastatin 40 mg per day Age 70–82 years Pre-existing vascular disease (coronary, cerebral, or peripheral) High-risk for vascular disease (smoking, hypertension, or diabetes) Total cholesterol 4.0–9.0 mmol/L Triglyceride < 6.0 mmol/L Pravastatin 40 mg per day n = 2,891 Placebo n = 2,913 Average follow-up = 3.2 years Endpoints: Primary – composite of coronary death, non-fatal myocardial infarction, and fatal or non-fatal stroke Lancet 2002; 360: 1623–30

PROSPER: Clinical Events* CV Death / MI / Stroke CV Death / MI CV Death Stroke P=0.014 P=0.006 P=0.043 P=0.047 Pravastatin Placebo Pravastatin Placebo Pravastatin Placebo Pravastatin Placebo * Mean follow-up = 3.2 years Lancet 2002; 360: 1623–30

PROSPER: Safety Events Any New Cancer The major safety concern was the increased rate of any new cancer in the pravastatin arm However, in a meta-analysis of statin randomized placebo-controlled trials, treatment with either pravastatin (hazard ratio 1.06, p=0.20) or any statin (HR 1.02, p=0.32) was not associated with an excess risk of cancer P = 0.02 Pravastatin Placebo Lancet 2002; 360: 1623–30

PROSPER : Summary The PROSPER trial was the first major study to show a benefit with a lipid-lowering agent specifically in high-risk elderly patients The primary endpoint of CV Death / MI / stroke was reduced significantly in the pravastatin arm All components of the endpoint except stroke showed a benefit with pravastatin The major safety concern was the increased rate of any cancer in the pravastatin arm, which was not confirmed in a meta-analysis