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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.
Geographic Coverage
Canada
European Union
Subject of Study
Human
Subject Domain
Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects
Keywords
Muscles
Randomized Controlled Trials as Topic
Access via Zenodo

Access Restrictions
Unrestricted access
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