PROSPER: PROspective Study of Pravastatin in the Elderly at Risk
Purpose
To determine whether pravastatin reduces morbidity and mortality in elderly men and women at risk of vascular disease
Reference
Shepherd J, Blauw GJ, Murphy MB et al. on behalf of the PROSPER study group. Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial. Lancet 2002;360:1623–30.
PROSPER: PROspective Study of Pravastatin in the Elderly at Risk - TRIAL DESIGN -
Design
Multicenter, multinational, randomized, double-blind, placebo-controlled
Patients
5804 patients (2804 men, 3000 women) aged 70–82 years with pre-existing or raised risk of vascular disease (coronary, cerebral or peripheral), baseline cholesterol 155–348 mg/dL (4–9mmol/L) and triglycerides <530 mg/dL (<6 mmol/L)
Follow up and primary endpoint
Primary endpoint: coronary heart disease death, nonfatal MI or fatal/nonfatal stroke. Mean 3.2 years follow up.
Treatment
Placebo or pravastatin 40 mg daily
PROSPER: PROspective Study of Pravastatin in the Elderly at Risk - TRIAL DESIGN continued-
Mean age (years)
Male (%)
History
Mean BP (mmHg)
Hypertension (%)
Angina (%)
MI (%)
Systolic
Diastolic
Baseline characteristics
Shepherd et al. Lancet 2002; 360:1623–30.
PROSPER: PROspective Study of Pravastatin in the Elderly at Risk - RESULTS -
Compared with placebo, pravastatin significantly reduced:
Primary endpoint of coronary heart disease death, nonfatal MI or fatal/nonfatal stroke (14.1 vs. 16.2%, P=0.014)
Secondary endpoint of coronary heart disease death or nonfatal MI (10.1 vs. 12.2%, P=0.006)
Coronary heart disease death (3.3 vs. 4.2%, P=0.043)
Stroke not significantly different in the two groups (4.7 vs. 4.5%, P=0.81)
Nonfatal MI was reduced, but not significantly (7.7 vs. 8.7%, hazard ratio 0.86, 95% CI 0.72–1.03, P=0.10)
New cancer diagnoses increased (hazard ratio 1.25, 95% CI 1.04–1.51, P=0.02); nonsignificant trend towards increased cancer death
PROSPER: PROspective Study of Pravastatin in the Elderly at Risk - RESULTS continued -
Years after randomization
Proportion
with event
(%)
0
0
1
2
3
4
5
10
15
20
Primary and secondary outcomes
Shepherd et al. Lancet 2002; 360:1623–30.
Coronary heart disease death, nonfatal MI or fatal/nonfatal stroke
P = 0.014
P = 0.006
PROSPER: PROspective Study of Pravastatin in the Elderly at Risk - RESULTS continued -
P
Primary endpoint
Coronary heart disease death
or nonfatal MI or
fatal/nonfatal stroke
Secondary endpoints
Coronary heart disease death
or nonfatal MI
Fatal/nonfatal stroke
Deaths
Coronary heart disease
Cancer
0.85 (0.74–0.97)
0.81 (0.69–0.94)
1.03 (0.81–1.31)
0.76 (0.58–0.99)
1.28 (0.97–1.68)
0.014
0.006
0.81
0.043
0.082
Major outcomes and death due to coronary heart disease or cancer
408
292
135
94
115
No.
(14.1)
(10.1)
(4.7)
(3.3)
(4.0)
(%)
Pravastatin
(n=2891)
473
356
131
122
91
No.
(16.2)
(12.2)
(4.5)
(4.2)
(3.1)
(%)
Placebo
(n=2913)
Hazard ratio
(95% CI)
Shepherd et al. Lancet 2002; 360:1623–30.
PROSPER: PROspective Study of Pravastatin in the Elderly at Risk - SUMMARY -
In elderly patients with pre-existing or raised risk of vascular disease, pravastatin:
Reduced primary endpoint of coronary heart disease death, nonfatal MI or fatal/nonfatal stroke
Reduced coronary heart disease death, but favorable trend in nonfatal MI was not significant and there was no difference in stroke
Increased new diagnoses of cancer