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  • PROVE IT-TIMI 22 Original

    • PROVE IT-TIMI 22

    "Intensive Lipid Lowering with Atorvastatin in Patients with Stable Coronary Disease". The New England Journal of Medicine. 2004. 350(15):1495-1504. PubMed • Full text • PDF

    Contents


    1 Clinical Question
    2 Bottom Line
    3 Major Points
    4 Guidelines
    5 Design
    6 Population
    6.1 Inclusion Criteria
    6.2 Exclusion Criteria
    6.3 Baseline Characteristics
    7 Interventions
    8 Outcomes
    8.1 Primary Outcome
    8.2 Secondary Outcomes
    9 Funding
    10 Further Reading

    Clinical Question


    In patients hospitalized for an acute coronary syndrome, does intensive lipid-lowering therapy with atorvastatin improve cardiovascular outcomes compared to standard lipid-lowering therapy with pravastatin?

    Bottom Line


    For patients recently hospitalized with an acute coronary syndrome, intensive lipid-lowering therapy with atorvastatin offers superior protection against death or major cardiovascular events than standard therapy with pravastatin.

    Major Points


    The optimal level of LDL cholesterol for minimizing cardiovascular risk is unclear. Building on evidence that statin therapy reduces cardiovascular events, the PROVE IT–TIMI 22 trial was designed to compare the effects of intensive lipid-lowering therapy with atorvastatin against standard therapy with pravastatin among patients with recent acute coronary syndrome.

    Guidelines


    Current guidelines recommend a target LDL cholesterol level of less than 100 mg per deciliter for patients with established coronary artery disease or diabetes. However, findings from this study suggest potential benefits from achieving even lower levels.

    Design


    - Multicenter, double-blind, randomized, placebo-controlled trial
    - N=4,162 patients with recent acute coronary syndrome
    - High-dose atorvastatin (80 mg daily) vs. standard-dose pravastatin (40 mg daily)
    - Median follow-up: 24 months

    Population


    - Inclusion Criteria: Hospitalization for an acute coronary syndrome within the preceding 10 days
    - Exclusion Criteria: Certain co-morbid conditions, ongoing statin therapy > 80mg/day, certain medication restrictions, specific lab value abnormalities
    - Baseline Characteristics: Average age was 58, 22% were women, and 69% underwent percutaneous coronary intervention for their index_gpt acute coronary syndrome

    Interventions


    Pravastatin 40 mg daily (standard therapy) versus atorvastatin 80 mg daily (intensive therapy)

    Outcomes


    - Primary Outcome: Composite of death from any cause, myocardial infarction, documented unstable angina requiring rehospitalization, revascularization (performed at least 30 days after randomization), and stroke
    - Secondary Outcomes: Death from coronary heart disease, nonfatal myocardial infarction, or revascularization; and other individual components

    Funding


    Supported by Bristol-Myers Squibb and Sankyo.

    Further Reading


    The full list of investigators and coordinators, as well as detailed trial information, is available at www.timi.org.