Pravastatin in Elderly Individuals at Risk of Vascular Disease (PROSPER)

The PROSPER (Prospective Study of Pravastatin in the Elderly at Risk) trial randomized 5,804 adults aged 70–82 years with established vascular disease or cardiovascular risk factors to pravastatin 40 mg daily or placebo, with a mean follow-up of 3.2 years.

Pravastatin reduced LDL-C by 34% and significantly reduced the composite of coronary death and nonfatal MI by 19% (HR 0.81, p=0.006). Coronary revascularization was reduced. However, stroke was not significantly reduced, and new cancer diagnoses were slightly more frequent in the pravastatin group — a finding that was not replicated in subsequent statin trials and is generally attributed to chance given the large number of prior statin trials showing no cancer risk.

The clinical significance of PROSPER is that it established statin benefit in elderly patients — a population historically underrepresented in cardiovascular trials. The “fit-elderly” aged 70–82 with established or high-risk cardiovascular disease derive meaningful coronary event reduction from pravastatin, with an acceptable safety profile. Age alone is not a contraindication to statin therapy.

The lack of stroke benefit in PROSPER is not characteristic of the broader statin literature, where stroke reduction has been consistently demonstrated. The PROSPER population’s shorter follow-up (3.2 years) and the predominance of secondary prevention patients (who may have had established cerebrovascular disease) may explain the null stroke finding.

We rate the evidence strong. A landmark RCT establishing statin benefit in elderly patients with established vascular disease — defining the evidence basis for statin prescribing in older adults.