PROVE IT研究是ACC2004最新公布一项继REVERSAL研究后的重要动脉粥样硬化循证研究。该研究及HPS、PROSPER、ALLHAT-LLT、ASCOT-LLA研究结果的结果,NCEP ATPIII指南于2004年7月做出了更新修订。
Pravastatin or Atorvastatin Evaluation and Infection Therapy (PROVE IT): Design
Cannon CP et al. N Engl J Med 2004;350:1495-1504.
4162 patients hospitalized for ACS within previous 10 days, TC ?240 mg/dL (?200 mg/dL if on lipid Rx)
Randomized to pravastatin 40 mg (standard therapy) or atorvastatin 80 mg (intensive therapy)
Primary endpoint: composite of death, MI, unstable angina requiring rehospitalization, revascularization (at least 30 days after randomization), and stroke
Follow-up: 18–36 months (mean, 24)
PROVE IT: Baseline Characteristics
Cannon CP et al. N Engl J Med 2004;350:1495-1504.
Adapted with permission. Copyright ? 2004 Massachusetts Medical Society. All rights reserved.
PROVE IT: Lipid and CRP Changes
Change from Baseline, %
Pravastatin 40 mg
Atorvastatin 80 mg
p<.001
Cannon CP et al. N Engl J Med 2004;350:1495-1504.
CRP
HDL-C
LDL-C
p<.001
p<.001
–10.4
–41.5
8.1
6.5
–82.9
–89.4
PROVE IT: LDL-C Achieved
Median LDL-C, mg/dL
106
95
62
Baseline
Cannon CP et al. N Engl J Med 2004;350:1495-1504.
Pravastatin 40 mg
Atorvastatin 80 mg
p<.001
PROVE IT: Effect on CRP
Median CRP, mg/L
12.3
2.1
1.3
Baseline
Cannon CP et al. N Engl J Med 2004;350:1495-1504.
Pravastatin 40 mg
Atorvastatin 80 mg
p<.001
PROVE IT: Primary and Secondary Endpoints
Kaplan–Meier Event Rate, %
Cannon CP et al. N Engl J Med 2004;350:1495-1504.
?14%, p=.029
?16%, p=.005
26.3
22.4
22.3
19.7
1° endpoint: death, MI, unstable angina, revascularization, stroke
2° endpoint: CHD death, MI, revascularization
Reduction in Death or Major Cardiovascular Event with Intensive Statin Therapy
Death or Major Cardiovascular Event, %
2063 2099
No. at Risk Pravastatin Atorvastatin
Months of Follow-up
1688 1736
1536 1591
1423 1485
810 842
138 133
40 mg of pravastatin
80 mg of atorvastatin
Cannon CP et al. N Engl J Med 2004;350:1495-1504.
Copyright ? 2004 Massachusetts Medical Society. All rights reserved.