Slide Source:Lipids Online Slide Librarywww.lipidsonline.org
Prospective Study of Pravastatin in the Prospective Study of Pravastatin in the Elderly at Risk (PROSPER)Elderly at Risk (PROSPER)
5804 patients aged 70–82 years with a history of vascular disease or with cardiovascular risk factors
Randomized to pravastatin 40 mg/d or placebo
Baseline TC 155–348 mg/dL
Follow-up 3.2 years (mean)
Primary endpoint (composite): coronary death, nonfatal MI, fatal or nonfatal stroke
Shepherd J et al. Lancet 2002;360:1623–1630.
Slide Source:Lipids Online Slide Librarywww.lipidsonline.org
Kaplan–Meier Analysis of Time to Primary Kaplan–Meier Analysis of Time to Primary Endpoint: PROSPEREndpoint: PROSPER
0
5
10
15
20
Follow-up (years)0.5 1.0 3.50 1.5 4.0
Shepherd J et al. Lancet 2002;360:1623–1630.Reprinted with permission from Elsevier Science.
Pro
port
ion w
ith E
vent
(%)
2.0 2.5 3.0
Number at RiskPlaceboPravastatin
29132891
28322812
27482738
26512655
25602562
24582483
21282167
730770
4440
Placebo
Pravastatinp=0.014
Slide Source:Lipids Online Slide Librarywww.lipidsonline.org
Major Endpoints: PROSPERMajor Endpoints: PROSPER
Shepherd J et al. Lancet 2002;360:1623–1630.
EndpointEndpointPravastatin Pravastatin
(%)(%)Placebo Placebo
(%)(%)Hazard Hazard ratioratio pp
Primary endpoint:Primary endpoint:
CHD death/MI/strokeCHD death/MI/stroke 14.1 14.1 16.2 16.2 0.85 0.85 0.014 0.014
Secondary endpoints:Secondary endpoints:
CHD death/MI CHD death/MI 10.1 10.1 12.2 12.2 0.81 0.81 0.006 0.006
Fatal or nonfatal strokeFatal or nonfatal stroke 4.7 4.7 4.5 4.5 1.03 1.03 0.81 0.81
Other outcomes:Other outcomes:
Nonfatal MI Nonfatal MI 7.7 7.7 8.7 8.7 0.86 0.86 0.10 0.10
Nonfatal stroke Nonfatal stroke 4.0 4.0 4.1 4.1 0.98 0.98 0.85 0.85
Transient ischemic attack Transient ischemic attack 2.7 2.7 3.5 3.5 0.75 0.75 0.051 0.051
All CV events All CV events 15.7 15.7 18.0 18.0 0.85 0.85 0.012 0.012
Slide Source:Lipids Online Slide Librarywww.lipidsonline.org
Mortality by Cause: PROSPERMortality by Cause: PROSPER
Cause of death Cause of death Pravastatin Pravastatin
(%) (%) Placebo Placebo
(%) (%) Hazard Hazard ratio ratio pp
CHD CHD 3.33.3 4.24.2 0.76 0.76 0.043 0.043
StrokeStroke 0.80.8 0.50.5 1.571.57 0.190.19
VascularVascular 4.74.7 5.45.4 0.850.85 0.160.16
Nonvascular Nonvascular 5.6 5.6 5.1 5.1 1.11 1.11 0.380.38
Cancer Cancer 4.0 4.0 3.1 3.1 1.28 1.28 0.0820.082
Trauma/suicide Trauma/suicide 0.1 0.1 0.2 0.2 NANA NANA
All causes All causes 10.3 10.3 10.5 10.5 0.97 0.97 0.74 0.74
Shepherd J et al. Lancet 2002;360:1623–1630.
Slide Source:Lipids Online Slide Librarywww.lipidsonline.org
First New Cancer Diagnoses by Site: First New Cancer Diagnoses by Site: PROSPERPROSPER
Shepherd J et al. Lancet 2002;360:1623–1630.
Site Site Pravastatin Pravastatin
(n) (n) Placebo Placebo
(n) (n) Hazard Hazard ratio ratio
pp
BreastBreast 1818 1111 1.651.65 0.190.19
GastrointestinalGastrointestinal 6565 4545 1.461.46 0.0530.053
Renal or Renal or genitourinarygenitourinary
5858 5959 1.001.00 0.990.99
RespiratoryRespiratory 4646 4242 1.121.12 0.600.60
Other Other 5858 4242 1.411.41 0.0920.092
Total Total 245245 199199 1.25 1.25 0.0200.020