Slide Source: Lipids Online Slide Library www.lipidsonline.org Pravastatin or Atorvastatin Evaluation and Infection Therapy (PROVE IT): Design Cannon CP.

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Slide Source: Lipids Online Slide Library Pravastatin or Atorvastatin Evaluation and Infection Therapy (PROVE IT): Design Cannon CP et al. N Engl J Med 2004;350: 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)

Slide Source: Lipids Online Slide Library 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 ± ± 11.2 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: Adapted with permission. Copyright © 2004 Massachusetts Medical Society. All rights reserved.

Slide Source: Lipids Online Slide Library 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: CRPHDL-CLDL-C p<.001 p<.001 –10.4 – –82.9 –89.4

Slide Source: Lipids Online Slide Library PROVE IT: LDL-C Achieved Median LDL-C, mg/dL Baseline Cannon CP et al. N Engl J Med 2004;350: Pravastatin 40 mg Atorvastatin 80 mg p<.001

Slide Source: Lipids Online Slide Library PROVE IT: Effect on CRP Median CRP, mg/L Baseline Cannon CP et al. N Engl J Med 2004;350: Pravastatin 40 mg Atorvastatin 80 mg p<.001

Slide Source: Lipids Online Slide Library 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: 14%, p=.029 16%, p= ° endpoint: death, MI, unstable angina, revascularization, stroke 2° endpoint: CHD death, MI, revascularization

Slide Source: Lipids Online Slide Library Reduction in Death or Major Cardiovascular Event with Intensive Statin Therapy Death or Major Cardiovascular Event, % No. at Risk Pravastatin Atorvastatin Months of Follow-up mg of pravastatin 80 mg of atorvastatin Cannon CP et al. N Engl J Med 2004;350: Copyright © 2004 Massachusetts Medical Society. All rights reserved.