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Prospective Study of Pravastatin in the

Elderly at Risk (PROSPER)


5804 patients aged 7082 years with a history of

vascular disease or with cardiovascular risk factors

Randomized to pravastatin 40 mg/d or placebo


Baseline TC 155348 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;360:16231630.

Slide Source:
Lipids Online Slide Library
www.lipidsonline.org

Proportion with Event


(%)

KaplanMeier Analysis of Time to Primary


Endpoint: PROSPER
20
15
10

Placebo
Pravastatin

p=0.014

5
0
0

0.5

1.0

1.5 2.0 2.5 3.0


Follow-up (years)

3.5

4.0

Number at Risk
Placebo
2913 2832 2748 2651 2560 2458 2128 730
Pravastatin
2891 2812 2738 2655 2562 2483 2167 770

44
40

Shepherd J et al. Lancet 2002;360:16231630.


Reprinted with permission from Elsevier Science.

Slide Source:
Lipids Online Slide Library
www.lipidsonline.org

Major Endpoints: PROSPER


Endpoint

Pravastatin
(%)

Placebo
(%)

Hazard
ratio

Primary endpoint:
CHD death/MI/stroke

14.1

16.2

0.85

0.014

10.1

12.2

0.81

0.006

4.7

4.5

1.03

0.81

Nonfatal MI

7.7

8.7

0.86

0.10

Nonfatal stroke

4.0

4.1

0.98

0.85

Transient ischemic attack

2.7

3.5

0.75

0.051

15.7

18.0

0.85

0.012

Secondary endpoints:
CHD death/MI
Fatal or nonfatal stroke
Other outcomes:

All CV events

Shepherd J et al. Lancet 2002;360:16231630.

Slide Source:
Lipids Online Slide Library
www.lipidsonline.org

Mortality by Cause: PROSPER


Cause of death

Pravastatin
(%)

Placebo
(%)

Hazard
ratio
0.76

CHD

3.3

4.2

0.043

Stroke

0.8

0.5

1.57

0.19

Vascular

4.7

5.4

0.85

0.16

Nonvascular

5.6

5.1

1.11

0.38

Cancer

4.0

3.1

1.28

0.082

Trauma/suicide

0.1

0.2

NA

NA

10.3

10.5

All causes

Shepherd J et al. Lancet 2002;360:16231630.

0.97

0.74
Slide Source:
Lipids Online Slide Library
www.lipidsonline.org

First New Cancer Diagnoses by Site:


PROSPER
Pravastatin
(n)

Placebo
(n)

Hazard
ratio

Breast

18

11

1.65

0.19

Gastrointestinal

65

45

1.46

0.053

Renal or
genitourinary

58

59

1.00

0.99

Respiratory

46

42

1.12

0.60

Other

58

42

1.41

0.092

245

199

1.25

0.020

Site

Total

Shepherd J et al. Lancet 2002;360:16231630.

Slide Source:
Lipids Online Slide Library
www.lipidsonline.org

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