ISRCTN30952488
Completed
Phase 4
A series of randomised controlled N-of 1 trials in patients who have discontinued or are considering discontinuing statin use due to muscle-related symptoms to assess if atorvastatin treatment causes more muscle symptoms than placebo.
ondon School of Hygiene and Tropical Medicine0 sites200 target enrollmentMay 12, 2016
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ondon School of Hygiene and Tropical Medicine
- Enrollment
- 200
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29197834 protocol 2021 Results article in https://doi.org/10.1136/bmj.n135 results (added 25/02/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33709907/ results (added 15/03/2021) 2019 Results article in https://doi.org/10.3390/healthcare7040134 (added 14/06/2023)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adults (aged 16 and over)
- •2\. Prescribed statin treatment in the last 3 years
- •3\. Stopped OR considering stopping statin treatment due to muscle symptoms
- •4\. Provided fully informed consent
Exclusion Criteria
- •1\. Any previously documented serum alanine aminotransferase (ALT) levels at or above three times the upper limit of normal
- •2\. Have persistent, generalised, unexplained muscle pain (whether associated or not with statin use) and have creatinine kinase (CK) levels greater than 5 times the upper limit of normal
- •3\. Should not be using atorvastatin 20mg daily in the opinion of the general practitioner
Outcomes
Primary Outcomes
Not specified
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