介绍了HPS研究（Heart Protection Study）结果。
HPS: Heart Protection Study
Purpose
To determine whether simvastatin reduces mortality and vascular events in patients with and without coronary disease, but all at high risk, and with a broad range of baseline cholesterol levels
Reference
HPS Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet 2002;360:7–22.
HPS: Heart Protection Study - TRIAL DESIGN -
Design
Multicenter, randomized, double-blind, placebo-controlled
Patients
20,536 patients aged 40–80 years, with and without coronary heart disease, but all at high risk, and with broad range of baseline total cholesterol: all >135mg/dL (>3.5mmol/L), mean 230 mg/dL (5.9 mmol/L)
Follow up and primary endpoint
Primary endpoint: all-cause mortality. Mean 5 years follow up.
Treatment
Placebo or simvastatin 40 mg daily
HPS: Heart Protection Study - TRIAL DESIGN continued-
All patients
Men
Women
History of coronary disease
Previous MI
Other
Other risk factors in absence of
coronary diseasea
Baseline characteristics
20,536
15,454
5082
8510
4876
7150
No.
75
25
41
24
35
% of total
a
Some patients had more than one of these conditions.
HPS Collaborative Group.
Lancet
2002;
360
:7
D
22.
HPS: Heart Protection Study - RESULTS -
All-cause mortality in simvastatin group significantly reduced compared with placebo (12.9 vs. 14.7%, P<0.0003); reduction was attributed largely to significant reduction in coronary death:
Other vascular death reduced but with marginal significance
Nonvascular death reduced but not significantly
First major vascular event rate significantly reduced, as were the individual event rates (fatal/nonfatal MI, fatal/nonfatal stroke, and revascularization)
No difference in new cancers (7.9 vs 7.8%, rate ratio 1.0, P=0.9) except nonmelanoma skin cancer (2.4 vs 2.0%)
No difference in withdrawal due to myopathy (0.5% in both groups)
HPS: Heart Protection Study - RESULTS continued -
Vascular causes
Coronary
Other vascular
Subtotal: any vascular
Non-vascular causes
Neoplastic
Respiratory
Other medical
Nonmedical
Subtotal: any nonvascular
ANY DEATH
587
194
781
359
90
82
16
547
1328
(5.7)
(1.9)
(7.6)
(3.5)
(0.9)
(0.8)
(0.2)
(5.3)
(12.9)
Cause of death
Death rate ratio (95% CI)
Simvastatin
(n=10,269)
No.
(%)
707
230
937
345
114
90
21
570
1507
(6.9)
(2.2)
(9.1)
(3.4)
(1.1)
(0.9)
(0.2)
(5.6)
(14.7)
RR=0.83 (0.75–0.91)
P<0.0001
RR=0.95(0.85–1.07)
P=0.4
RR=0.87(0.81–0.94)
P<0.0003
No.
(%)
Placebo
(n=10,267)
HPS Collaborative Group. Lancet 2002;360:7–22.
Dashed line indicates overall RR for a subtotal
1.0
1.2
1.4
0.8
0.6
0.4
Simvastatin better
Placebo better
Cause-specific mortality
HPS: Heart Protection Study - RESULTS continued -
P
Nonfatal MI or coronary death
0.73 (0.67–0.79)
<0.0001
First major vascular event
898
No.
(8.7)
(%)
Simvastatin
(n=10,269)
1212
No.
(11.8)
(%)
Placebo
(n=10,267)
Event rate ratio
(95% CI)
HPS Collaborative Group. Lancet 2002;360:7–22.
aData are for patients having first event of each type, hence non-additivity
HPS: Heart Protection Study - SUMMARY -
In high-risk patients with a broad range of baseline cholesterol values, simvastatin reduced:
All-cause mortality
Coronary deaths
Major vascular events