PROSPER Trial: Pravastatin Benefit in Elderly Vascular Disease Patients
"The PROSPER trial demonstrated the benefits of pravastatin in high-risk elderly patients with vascular disease, showing significant reductions in cardiovascular events. Safety concerns regarding cancer risk were addressed through a meta-analysis. Explore the trial results and implications."
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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) 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 www. Clinical trial results.org Lancet 2002; 360: 1623 30
PROSPER: Clinical Events* CV Death / MI CV Death / MI / Stroke CV Death Stroke P=0.047 P=0.006 P=0.014 P=0.043 6% 20% 15% 6% 12.2% 16.2% 4.7% 4.5% 15% 14.1% 4.2% 10.1% 4% 10% 4% 3.3% 10% 2% 5% 2% 5% 0% 0% 0% 0% Pravastatin Placebo Pravastatin Placebo Pravastatin Placebo Pravastatin Placebo www. Clinical trial results.org Lancet 2002; 360: 1623 30 * Mean follow-up = 3.2 years
PROSPER: Safety Events Any New Cancer The major safety concern was the increased rate of any new cancer in the pravastatin arm P = 0.02 10% 8.5% 8% However, in a meta-analysis of statin randomized 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 6.8% placebo- 6% 4% 2% 0% Pravastatin Placebo www. Clinical trial results.org 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 www. Clinical trial results.org
