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    Liver function testing in patients on HMG-CoA reductase inhibitors

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    Authors
    Andrade, Susan E.
    Donahue, James G.
    Chan, K. Arnold
    Watson, Douglas J.
    Platt, Richard
    UMass Chan Affiliations
    Meyers Primary Care Institute
    Document Type
    Journal Article
    Publication Date
    2003-06-19
    Keywords
    Aged
    Drug Labeling
    Drug-Induced Liver Injury
    Female
    Humans
    Hydroxymethylglutaryl-CoA Reductase Inhibitors
    Liver Function Tests
    Male
    Middle Aged
    Retrospective Studies
    United States
    United States Food and Drug Administration
    Health Services Research
    Primary Care
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    Link to Full Text
    http://dx.doi.org/10.1002/pds.832
    Abstract
    PURPOSE: The Food and Drug Administration currently requires the labeling of HMG-CoA reductase inhibitors to recommend liver function tests (LFTs) before the start of therapy and at various intervals during therapy, depending on the specific agent. We sought to determine the frequency and patterns of LFT screening in patients receiving HMG-CoA reductase inhibitors. METHODS: A retrospective study was conducted at a staff-model health maintenance organization among 4178 new users of HMG-CoA reductase inhibitors during the period 1 January 1991 through 31 December 1996. The number and proportions of HMG-CoA reductase inhibitor therapy courses with baseline LFTs (within 180 days prior to dispensing), follow-up LFTs and LFT abnormalities were calculated. RESULTS: For the initial HMG-CoA reductase inhibitor dispensed, 1947 patients (47%) had at least one screening LFT at baseline and 3063 (73%) had at least one follow-up LFT. Twenty-seven (0.9%) patients with at least one follow-up LFT performed had a level greater than 3 times the upper limit of normal. In a random sample of 100 discontinued patients, none discontinued due to elevated LFTs or liver disease. CONCLUSIONS: A large proportion of patients dispensed HMG-CoA reductase inhibitors in this managed care setting did not have baseline and follow-up LFTs performed. Modest LFT abnormalities were common among users of HMG-CoA reductase inhibitors; however, in this population, serious abnormalities were rare.
    Source
    Pharmacoepidemiol Drug Saf. 2003 Jun;12(4):307-13. Link to article on publisher's site
    DOI
    10.1002/pds.832
    Permanent Link to this Item
    http://hdl.handle.net/20.500.14038/36930
    PubMed ID
    12812011
    Related Resources
    Link to Article in PubMed
    ae974a485f413a2113503eed53cd6c53
    10.1002/pds.832
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