Evaluation of Patients With Statin Myopathy Using an N of 1 Trial Design

Completed 10 enrolled London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

RandomizedParallel-groupDouble-blindOther

Summary

This study consists of a series of prospective, randomized placebo-controlled n of 1 trials to objectively evaluate the reproducibility of subjective and objective symptoms among patients with a history of statin-related myopathy.

Timeline

Start: 2010-09
Primary completion: 2013-08
Completion: 2013-08

Outcome

Missed primary endpoint

paper For each n-of-1 trial, no statistically significant differences were seen between statin and placebo in the VAS myalgia score PMID 24737272 ↗

Publications

Joy TR, Monjed A, Zou GY, Hegele RA, McDonald CG, Mahon JL. N-of-1 (single-patient) trials for statin-related myalgia. Ann Intern Med. 2014 Mar 4;160(5):301-10. doi: 10.7326/M13-1921.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atorvastatin	Small molecule	—	—
Subject	Fluvastatin	Other / unclassified	—	—
Subject	Pravastatin	Small molecule	—	—
Subject	Rosuvastatin	Small molecule	—	—
Subject	Simvastatin	Small molecule	—	—