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Cumulative clinical trial data on atorvastatin for reducing cardiovascular events: the clinical impact of atorvastatin.

Abstract

BACKGROUND

Since the 1990s a multitude of statin trials have definitively demonstrated the ability of statin therapy to reduce the risk of adverse coronary heart disease (CHD) events. Among these, the Atorvastatin Landmarks program - a group of 32 major atorvastatin trials - has assessed the efficacy and safety of atorvastatin across its full dose range and has helped illustrate its effectiveness in treatment of cardiovascular disease and its related disorders and also in non-cardiovascular outcomes.

SCOPE

This paper will review the major atorvastatin clinical trials and report the important findings and their clinical significance.

FINDINGS

Clinical trials with atorvastatin have established significant reductions in cardiovascular events in patients with and without CHD. Studies show that high-dose atorvastatin will reduce LDL to approximately 70 mg/dL in many patients and improve cardiac outcomes. Current evidence suggests that high-dose atorvastatin can halt and, in some cases, reverse atherosclerotic progression. A study of diabetic patients showed atorvastatin decreased the occurrence of acute CHD events, coronary revascularizations, and stroke. Atorvastatin has been found to be effective for reducing nonfatal myocardial infarctions and fatal CHD in hypertensive patients with three or more additional risk factors. High-dose atorvastatin was found to be effective in reducing risk of recurrent stroke in patients with prior cerebrovascular events, has been shown to benefit patients suffering a recent acute coronary syndrome, and to slow cognitive decline in preliminary studies of patients with Alzheimer's disease. Atorvastatin has been associated with reduced progression of mild chronic kidney disease; however, in a randomized trial of patients with end stage renal disease on hemodialysis, atorvastatin showed no statistically significant benefit. Limitations of this review include lack of generalizability of the atorvastatin trial data to other statins, lack of head to head outcome trials involving the newer more potent statins, and the relatively short study durations (none exceeded 5 years) when atherosclerosis is typically a decades-long disease.

CONCLUSION

A compelling body of evidence documents that atorvastatin reduces major cardiovascular events in both secondary and primary prevention of CHD and in a broad range of patients and disease conditions. Furthermore, throughout its dose range, atorvastatin is safe and well tolerated.

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  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City, Kansas City, MO, USA.

    ,

    Source

    Current medical research and opinion 24:4 2008 Apr pg 1217-29

    MeSH

    Acute Coronary Syndrome
    Anticholesteremic Agents
    Atorvastatin
    Cardiovascular Diseases
    Cholesterol, LDL
    Coronary Artery Disease
    Diabetes Mellitus
    Disease Progression
    Heptanoic Acids
    Humans
    Kidney Failure, Chronic
    Pyrroles
    Risk Factors
    Stroke

    Pub Type(s)

    Journal Article
    Research Support, Non-U.S. Gov't
    Review

    Language

    eng

    PubMed ID

    18358084

    Citation

    Bybee, Kevin A., et al. "Cumulative Clinical Trial Data On Atorvastatin for Reducing Cardiovascular Events: the Clinical Impact of Atorvastatin." Current Medical Research and Opinion, vol. 24, no. 4, 2008, pp. 1217-29.
    Bybee KA, Lee JH, O'Keefe JH. Cumulative clinical trial data on atorvastatin for reducing cardiovascular events: the clinical impact of atorvastatin. Curr Med Res Opin. 2008;24(4):1217-29.
    Bybee, K. A., Lee, J. H., & O'Keefe, J. H. (2008). Cumulative clinical trial data on atorvastatin for reducing cardiovascular events: the clinical impact of atorvastatin. Current Medical Research and Opinion, 24(4), pp. 1217-29. doi:10.1185/030079908X292001.
    Bybee KA, Lee JH, O'Keefe JH. Cumulative Clinical Trial Data On Atorvastatin for Reducing Cardiovascular Events: the Clinical Impact of Atorvastatin. Curr Med Res Opin. 2008;24(4):1217-29. PubMed PMID: 18358084.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Cumulative clinical trial data on atorvastatin for reducing cardiovascular events: the clinical impact of atorvastatin. AU - Bybee,Kevin A, AU - Lee,John H, AU - O'Keefe,James H, Y1 - 2008/03/20/ PY - 2008/3/25/pubmed PY - 2008/6/14/medline PY - 2008/3/25/entrez SP - 1217 EP - 29 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 24 IS - 4 N2 - BACKGROUND: Since the 1990s a multitude of statin trials have definitively demonstrated the ability of statin therapy to reduce the risk of adverse coronary heart disease (CHD) events. Among these, the Atorvastatin Landmarks program - a group of 32 major atorvastatin trials - has assessed the efficacy and safety of atorvastatin across its full dose range and has helped illustrate its effectiveness in treatment of cardiovascular disease and its related disorders and also in non-cardiovascular outcomes. SCOPE: This paper will review the major atorvastatin clinical trials and report the important findings and their clinical significance. FINDINGS: Clinical trials with atorvastatin have established significant reductions in cardiovascular events in patients with and without CHD. Studies show that high-dose atorvastatin will reduce LDL to approximately 70 mg/dL in many patients and improve cardiac outcomes. Current evidence suggests that high-dose atorvastatin can halt and, in some cases, reverse atherosclerotic progression. A study of diabetic patients showed atorvastatin decreased the occurrence of acute CHD events, coronary revascularizations, and stroke. Atorvastatin has been found to be effective for reducing nonfatal myocardial infarctions and fatal CHD in hypertensive patients with three or more additional risk factors. High-dose atorvastatin was found to be effective in reducing risk of recurrent stroke in patients with prior cerebrovascular events, has been shown to benefit patients suffering a recent acute coronary syndrome, and to slow cognitive decline in preliminary studies of patients with Alzheimer's disease. Atorvastatin has been associated with reduced progression of mild chronic kidney disease; however, in a randomized trial of patients with end stage renal disease on hemodialysis, atorvastatin showed no statistically significant benefit. Limitations of this review include lack of generalizability of the atorvastatin trial data to other statins, lack of head to head outcome trials involving the newer more potent statins, and the relatively short study durations (none exceeded 5 years) when atherosclerosis is typically a decades-long disease. CONCLUSION: A compelling body of evidence documents that atorvastatin reduces major cardiovascular events in both secondary and primary prevention of CHD and in a broad range of patients and disease conditions. Furthermore, throughout its dose range, atorvastatin is safe and well tolerated. SN - 1473-4877 UR - https://www.unboundmedicine.com/medline/citation/18358084/Cumulative_clinical_trial_data_on_atorvastatin_for_reducing_cardiovascular_events:_the_clinical_impact_of_atorvastatin_ L2 - http://www.tandfonline.com/doi/full/10.1185/030079908X292001 DB - PRIME DP - Unbound Medicine ER -