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  • Assessing Muscle-Related Adverse Events in Randomized Trials of Statins
    UMB Dataset

    Authors
    Peter Doshi
    Kyungwan Hong
    Sarah Tanveer
    Tom Jefferson
    Description

    This study examined randomized trials of statins to investigate the reporting of muscle-related adverse events (MRAEs). The study highlights the importance of critical appraisal of trial design and data collection methods from clinical study reports. Internal company trial documents were requested from the European Medicines Agency and Health Canada for all clinical trials of atorvastatin, rosuvastatin, fluvastatin, and simvastatin. 25 of the 85 trails obtained and screened for documents met the inclusion criteria for assessment.

    Subject
    Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects
    Geographic Coverage
    Canada
    European Union
    Access Rights
    Unrestricted access

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