1. 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

2. 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

3. 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

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