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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