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PRavastatin Or atorVastatin Evaluation and Infection Therapy (TIMI 22)
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Background
  • Statin therapy is highly effective vs. placebo in long-term treatment of CHD
    • Are statins effective in reducing events in patients with an acute coronary syndrome (ACS)?
    • Does “intensive” LDL-C lowering to an average of 65 mg/dL achieve a greater reduction in clinical events than “standard” LDL-C lowering to an average of 95 mg/dL?
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PROVE IT - TIMI 22:
Study Design
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Patient Population
  • Inclusion Criteria:
    • Hospitalization for acute MI or high-risk unstable angina < 10 d
    • Total cholesterol < 240 mg/dL (< 200 mg/dL if on Lipid ¯ Rx)
    • Stabilized (i.e., without ischemia, CHF, post PCI if performed)
  • Major Exclusion Criteria:
    • Co-morbidity: patient survival < 2 years
    • Current therapy with simvastatin or atorvastatin 80 mg
    • Need for, or anticipated use of fibrates or niacin
    • CABG for treatment of qualifying ACS
    • Liver disease or unexplained CK elevations
    • Strong inhibitors of CYP450 3A4 (2o atorvastatin metabolism)


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Patient Enrollment by Country
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Top Ten Enrolling Clinical Centers
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Trial Organization
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Primary Endpoint Over Time
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Summary
  • In patients recently hospitalized within 10 days for an acute coronary syndrome:
    • “Intensive” high-dose LDL-C lowering (median LDL-C 62 mg/dL) compared to “moderate” standard-dose lipid-lowering therapy (median LDL-C 95 mg/dL) reduced the risk of all cause mortality or major cardiac events by 16% (p=0.005)
    • Benefits emerged within 30 days post ACS with continued benefit observed throughout the 2.5 years of follow-up
    • Benefits were consistent across all cardiovascular endpoints, except stroke, and most clinical subgroups
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PROVE-IT Conclusion
  • Our findings indicate that patients recently hospitalized for an acute coronary syndrome benefit from early and continued lowering of LDL-C  to levels substantially below current target levels.