Background: The PROspective Study of Pravastatin in the Elderly at Risk (PROSPER), a placebo-controlled trial of pravastatin, demonstrated a 19% reduction in coronary outcomes (p=0.006) after a mean of 3.2 years, with no impact on stroke outcomes or all-cause mortality. However, there was a suggestion of increased cancer risk. Our aim is to determine the long-term benefits and safety of pravastatin treatment in older people using post-trial follow-up of the PROSPER participants.
Methods: 5,804 (2,520 Scottish) men and women aged 70-82 years with either pre-existing vascular disease or increased risk of such disease because of smoking, hypertension or diabetes, were randomised to 40 mg pravastatin or matching placebo. Using record linkage to routinely collected health records, all participants (full cohort) were linked to death and cancer registries, and the Scottish cohort additionally to hospital admissions, to provide composite fatal/non-fatal cardiovascular outcomes (total mean follow-up 8.6 years).
Results: Pravastatin treatment for 3.2 years reduced CHD death in the full cohort, hazard ratio (HR) 0.80, 95% confidence interval (CI) 0.68-0.95, p=0.0091 and fatal coronary events or coronary hospitalisations in the Scottish cohort (HR 0.81, 95% CI 0.69-0.95, p=0.0081) over 8.6 years. There was no reduction in stroke or all-cause mortality. Cancer risk was not increased in the full cohort (HR 1.08, 95% CI 0.96-1.21, p=0.22).
Conclusions: Pravastatin treatment of elderly high-risk subjects for 3.2 years provided long-term protection against CHD events and CHD mortality. However, this was not associated with any increase in life expectancy, possibly due to competing mortality with deaths from other causes. There was no evidence of long-term increased risk of cancer.
Trial registration: ISRCTN40976937.