A study to determine whether myalgia is due to statin use

Category Primary study
Registry of TrialsANZCTR
Year 2016
INTERVENTION: Rosuvastatin 5mg once daily for 3 weeks followed by a “wash‐out period” with a matching placebo for 3 weeks, and followed by matching placebo 3 weeks. Oral capsules CONDITION: Statin‐induced myalgia PRIMARY OUTCOME: To evaluate the value of N‐of‐1 trials in determining statin induced myalgia by comparing measures of myalgia (through the Myalgia Score questionnaire, and CK levels in serum assay) in treatment versus control periods. ; SECONDARY OUTCOME: The percentage of participants that are given a final diagnosis of statin‐related myalgia at the conclusion of their participation in the N‐of‐1 service ; To evaluate resume rate to statin therapy after completion of N‐of‐1 trials ; the number of participants that will continue statin therapy after completion of the study ; To evaluate the trial drop out rate and reasons for drop out ; ; To record the number of eligible patients screened and number of those consent to participate ; INCLUSION CRITERIA: Has indication for statin therapy; History of intolerance of both atorvastatin 10 mg AND rosuvastatin 5 mg monotherapy; History of statin‐related myalgia occuring within three weeks of starting statin therapy and consequently discontinued statin use; Without clinically significant CK elevations, <3x the upper limit of normal or <3x times the baseline value Willing to restart statin therapy.
Epistemonikos ID: 144ca1350879d7789fc5cd4dfdb2b6b2eb053f3f
First added on: Aug 25, 2024