Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial.
BACKGROUND
Although statins reduce coronary and cerebrovascular morbidity and mortality in middle-aged individuals, their efficacy and safety in elderly people is not fully established. Our aim was to test the benefits of pravastatin treatment in an elderly cohort of men and women with, or at high risk of developing, cardiovascular disease and stroke.


METHODS
We did a randomised controlled trial in which we assigned 5804 men (n=2804) and women (n=3000) aged 70-82 years with a history of, or risk factors for, vascular disease to pravastatin (40 mg per day; n=2891) or placebo (n=2913). Baseline cholesterol concentrations ranged from 4.0 mmol/L to 9.0 mmol/L. Follow-up was 3.2 years on average and our primary endpoint was a composite of coronary death, non-fatal myocardial infarction, and fatal or non-fatal stroke. Analysis was by intention-to-treat.


RESULTS
Pravastatin lowered LDL cholesterol concentrations by 34% and reduced the incidence of the primary endpoint to 408 events compared with 473 on placebo (hazard ratio 0.85, 95% CI 0.74-0.97, p=0.014). Coronary heart disease death and non-fatal myocardial infarction risk was also reduced (0.81, 0.69-0.94, p=0.006). Stroke risk was unaffected (1.03, 0.81-1.31, p=0.8), but the hazard ratio for transient ischaemic attack was 0.75 (0.55-1.00, p=0.051). New cancer diagnoses were more frequent on pravastatin than on placebo (1.25, 1.04-1.51, p=0.020). However, incorporation of this finding in a meta-analysis of all pravastatin and all statin trials showed no overall increase in risk. Mortality from coronary disease fell by 24% (p=0.043) in the pravastatin group. Pravastatin had no significant effect on cognitive function or disability.


CONCLUSIONS
Pravastatin given for 3 years reduced the risk of coronary disease in elderly individuals. PROSPER therefore extends to elderly individuals the treatment strategy currently used in middle aged people.
Shepherd
James
J
University Department of Pathological Biochemistry, University of Glasgow, Royal Infirmary, Scotland, Glasgow, UK. jshepherd@gri-biochem.org.uk
Blauw
Gerard J
GJ
Murphy
Michael B
MB
Bollen
Edward L E M
EL
Buckley
Brendan M
BM
Cobbe
Stuart M
SM
Ford
Ian
I
Gaw
Allan
A
Hyland
Michael
M
Jukema
J Wouter
JW
Kamper
Adriaan M
AM
Macfarlane
Peter W
PW
Meinders
A Edo
AE
Norrie
John
J
Packard
Chris J
CJ
Perry
Ivan J
IJ
Stott
David J
DJ
Sweeney
Brian J
BJ
Twomey
Cillian
C
Westendorp
Rudi G J
RG
D000368:Aged; D000369:Aged, 80 and over; D000924:Anticholesteremic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008078:Cholesterol, LDL / Q000097:blood; D003324:Coronary Artery Disease / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D008297:Male; D017035:Pravastatin / Q000009:adverse effects / Q000627:therapeutic use*; D012307:Risk Factors
D000924:Anticholesteremic Agents; D008078:Cholesterol, LDL; D017035:Pravastatin