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Implications of Recent Clinical Trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines.

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Implications of Recent Clinical Trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines

Scott M. Grundy; James I. Cleeman; C. Noel Bairey Merz; H. Bryan Brewer, Jr.; Luther T. Clark; Donald B. Hunninghake; Richard C. Pasternak; Sidney C. Smith, Jr.; Neil J. Stone; for the Coordinating Committee of the National Cholesterol Education Program

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Implications of Recent Clinical Trials for the NCEP ATP III Guidelines

Background

  • The Adult Treatment Panel (ATP III) of theNational Cholesterol Education Program issued an evidence-based set of guidelines on cholesterol management in 2001

Grundy, S. et al., Circulation 2004;110:227-39.

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Implications of Recent Clinical Trials for the NCEP ATP III Guidelines

Background

  • Since the publication of ATP III, 5 major clinical trials of statin therapy with clinical end points have been published
  • These trials addressed issues that were not examined in previous clinical trials of cholesterol-lowering therapy

Grundy, S. et al., Circulation 2004;110:227-39.

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Implications of Recent Clinical Trials for the NCEP ATP III Guidelines

Objective

  • To review the results of these recent trials and assess their implications for cholesterol management

Grundy, S. et al., Circulation 2004;110:227-39.

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Log-Linear Relationship Between LDL-C Levels and Relative Risk for CHD

3.7

2.9

2.2

1.7

1.3

1.0

Relative Risk for Coronary Heart Disease (Log Scale)

40 70 100 130 160 190

LDL-Cholesterol (mg/dL)

Grundy, S. et al., Circulation 2004;110:227-39.

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Doses of Currently Available Statins Required to Attain an Approximate 30% to 40% Reduction of LDL-C Levels (Standard Doses)

† All of these are available at doses up to 80 mg. For every doubling of the dose above the standard dose, an approximate 6% decrease in LDL-C level can be obtained.

‡ For rosuvastatin, doses available up to 40 mg; the efficacy for 5 mg is estimated by subtracting 6% from the FDA reported efficacy at 10 mg

Grundy, S. et al., Circulation 2004;110:227-39.

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ATP III LDL-C Goals and Cutpoints for TLC and Drug Therapy in Different Risk Categories and Proposed Modifications Based on Recent Clinical Trial Evidence

Grundy, S. et al., Circulation 2004;110:227-39.

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Recommendations for Modifications to Footnotethe ATP III Treatment Algorithm for LDL-C

Overview of Recommendations

  • Therapeutic lifestyle changes (TLC) remain an essential modality in clinical management
  • TLC have the potential to reduce CV risk through several mechanisms beyond LDL lowering

Grundy, S. et al., Circulation 2004;110:227-39.

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Recommendations for Modifications to Footnotethe ATP III Treatment Algorithm for LDL-C

High-Risk Persons

  • Recommended LDL-C goal is <100 mg/dL
    • An LDL-C goal of <70 mg/dL is a therapeutic option on the basis of available clinical trial evidence, especially for patients at very high risk
    • If LDL-C is 100 mg/dL, an LDL-lowering drug is indicated simultaneously withlifestyle changes

Grundy, S. et al., Circulation 2004;110:227-39.

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Recommendations for Modifications to Footnotethe ATP III Treatment Algorithm for LDL-C

High-Risk Persons

  • Recommended LDL-C goal is <100 mg/dL
    • If baseline LDL-C is <100 mg/dL, institution of an LDL-lowering drug to achieve an LDL-C level <70 mg/dL is a therapeutic option on the basis of available clinical trial evidence

Grundy, S. et al., Circulation 2004;110:227-39.

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Recommendations for Modifications to Footnotethe ATP III Treatment Algorithm for LDL-C

High-Risk Persons

  • Recommended LDL-C goal is <100 mg/dL
    • If a high-risk person has high triglycerides or low HDL-C, consideration can be given to combining a fibrate or nicotinic acid with an LDL-lowering drug
    • When triglycerides are 200 mg/dL, non-HDL-C is a secondary target of therapy, with a goal 30 mg/dL higher than the identified LDL-C goal

Grundy, S. et al., Circulation 2004;110:227-39.

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Recommendations for Modifications to Footnotethe ATP III Treatment Algorithm for LDL-C

Moderately High-Risk Persons

  • Recommended LDL-C goal is <130 mg/dL
    • An LDL-C goal <100 mg/dL is a therapeutic option on the basis of available clinical trial evidence

Grundy, S. et al., Circulation 2004;110:227-39.

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Recommendations for Modifications to Footnotethe ATP III Treatment Algorithm for LDL-C

Moderately High-Risk Persons

  • Recommended LDL-C goal is <100 mg/dL
    • When LDL-C level is 100 to 129 mg/dL, at baseline or on lifestyle therapy, initiation of an LDL-lowering drug to achieve an LDL-C level <100 mg/dL is a therapeutic option on the basis of available clinical trial evidence

Grundy, S. et al., Circulation 2004;110:227-39.

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Recommendations for Modifications to Footnotethe ATP III Treatment Algorithm for LDL-C

High Risk/Moderately High-Risk Persons

  • Any person at high risk or moderately high risk who has lifestyle-related risk factors (e.g., obesity, physical inactivity, elevated triglyceride, low HDL-C, or metabolic syndrome) is a candidate for TLC to modify these risk factors regardless of LDL-C level

Grundy, S. et al., Circulation 2004;110:227-39.

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Recommendations for Modifications to Footnotethe ATP III Treatment Algorithm for LDL-C

High Risk/Moderately High-Risk Persons

  • When LDL-lowering drug therapy is employed in high-risk or moderately high-risk persons, it is advised that intensity of therapy be sufficient to achieve at least a 30% to 40% reduction in LDL-C levels

Grundy, S. et al., Circulation 2004;110:227-39.

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Recommendations for Modifications to Footnotethe ATP III Treatment Algorithm for LDL-C

Lower-Risk Persons

  • For people in lower-risk categories, recent clinical trials do not modify the goals and cutpoints of therapy

Grundy, S. et al., Circulation 2004;110:227-39.