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Slide Source: Lipids Online Slide Library www.lipidsonline.org 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)
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Slide Source: Lipids Online Slide Library www.lipidsonline.org PROVE IT: Baseline Characteristics Mean ± SD, n (%), or median (interquartile range) Pravastatin 40 mg (n=2063) Atorvastatin 80 mg (n=2099) Age, yr 58.3 ± 11.358.1 ± 11.2 Male sex1617 (78.4)1634 (77.8) White race1865 (90.4)1911 (91.0) Diabetes361 (17.5)373 (17.8) Hypertension1014 (49.2)1077 (51.3) Current smoker766 (37.1)763 (36.4) Peripheral arterial disease [p=.03]136 (6.6)105 (5.0) Total cholesterol, mg/dL180 (158–202)181 (160–205) LDL-C, mg/dL106 (87–127)106 (89–128) HDL-C, mg/dL39 (33–46)38 (32–46) Triglycerides, mg/dL154 (115–207)158 (119–214) Prior statin therapy514 (24.9)535 (25.5) Cannon CP et al. N Engl J Med 2004;350:1495-1504. Adapted with permission. Copyright © 2004 Massachusetts Medical Society. All rights reserved.
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Slide Source: Lipids Online Slide Library www.lipidsonline.org 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. CRPHDL-CLDL-C p<.001 p<.001 –10.4 –41.5 8.1 6.5 –82.9 –89.4
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Slide Source: Lipids Online Slide Library www.lipidsonline.org 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
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Slide Source: Lipids Online Slide Library www.lipidsonline.org 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
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Slide Source: Lipids Online Slide Library www.lipidsonline.org Pravastatin 40 mg Atorvastatin 80 mg 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
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Slide Source: Lipids Online Slide Library www.lipidsonline.org Reduction in Death or Major Cardiovascular Event with Intensive Statin Therapy Death or Major Cardiovascular Event, % 2063 2099 No. at Risk Pravastatin Atorvastatin 036912151821242730 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.
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