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Assessing Muscle-Related Adverse Events in Randomized Trials of Statins
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UID: 187

Author(s): Peter Doshi*, Kyungwan Hong, Sarah Tanveer, Tom Jefferson * Corresponding Author
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.
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Data extractions are freely available in the Zenodo repository.
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3.2 MB