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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 Age 70–82 years Pre-existing vascular disease (coronary, cerebral, or peripheral)

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Pravastatin in Elderly Individuals at Risk of Vascular Disease

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

  2. PROSPER • 5,804 high-risk elderly patients • 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

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

  4. 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

  5. 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

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