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

UID: 187

Author(s): Peter Doshi*, Kyungwan Hong, Sarah Tanveer, Tom Jefferson * Corresponding Author

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 of Study

Subject Domain

Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects

Keywords

Randomized Controlled Trials as Topic

Access via Zenodo
Access Restrictions: Free to All
Access Instructions: Data extractions are freely available in the Zenodo repository.
Associated Publications: Doshi, P., Hong, K., Tanveer, S., & Jefferson, T. (2022). Assessing Muscle-Related Adverse Events in Randomized Trials of Statins. Journal of general internal medicine, 37(13), 3498–3500. https://doi.org/10.1007/s11606-022-07485-6
Data Type: Administrative

Clinical Measures
Study Type: Meta-analysis

Observational
Dataset Format(s): XLSX, DOCX
Dataset Size: 3.2 MB

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