Pravastatin in Elderly Individuals at Risk of Vascular Disease
Presented at Late Breaking Clinical Trials
AHA 2002
PROSPER
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
Endpoints:
Primary – composite of coronary death, non-fatal myocardial infarction, and fatal or non-fatal stroke
Lancet 2002; 360: 1623–30
Average follow-up = 3.2 years
P=0.014
PROSPER: Clinical Events*
Stroke
P=0.006
Pravastatin
Placebo
P=0.047
P=0.043
CV Death / MI / Stroke
CV Death / MI
* Mean follow-up = 3.2 years
Lancet 2002; 360: 1623–30
CV Death
Pravastatin
Placebo
Pravastatin
Placebo
Pravastatin
Placebo
P = 0.02
Any New Cancer
PROSPER: Safety Events
Lancet 2002; 360: 1623–30
Pravastatin
Placebo
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
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