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

Not Applicable

Completed

• Conditions: Statin Myopathy
• Interventions: Drug: Individual-specific statin causing myopathy; Drug: Placebo

• Registration Number: NCT01259791
• Lead Sponsor: Lawson Health Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-12-13
• Study First Submitted QC: 2010-12-13
• Study First Posted: 2010-12-14
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-13
• Last Update Posted: 2017-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• history of muscle symptoms occuring within 3 weeks of starting a statin
• need for statin therapy to achieve LDL target according to the 2009 Canadian Lipid Guidelines
• willingness to re-try statin therapy

Exclusion Criteria

• currently tolerant of statin therapy
• metabolic or inflammatory myopathy
• known neuropathy
• CK elevation >3 times upper limit of normal (ULN) previously on a statin or history of rhabdomyolysis
• pregnant, breastfeeding, or wanting to become pregnant in the near future
• participation in another clinical trial
• other medical condition associated with decreased life span
• inability to adhere to stringent regimen
• unwilling to stop consumption of grapefruit juice

Subset of 5 patients also completing neuromuscular testing:

Inclusion Criteria:

• same as above

Exclusion Criteria:

• same as above but also:
• angina III of IV
• decompensated heart failure
• history of orthopedic problems
• have any skin ulcers or other non-healed skin areas or infections in the arm or leg

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Statin	Individual-specific statin causing myopathy	Individual-specific statin causing myopathy - i.e., Patients will receive the specific statin previously associated with myopathic symptoms in them (can be any of the following statins: rosuvastatin, atorvastatin, simvastatin, fluvastatin, pravastatin in any of the doses causing symptoms previously).
Placebo	Placebo	Identical placebo to patient-specific statin

Primary Outcome Measures

Name	Time	Method
To assess the reliability and reproducibility of subjective symptoms of myalgias to active statin therapy.	Duration of study September 2010 to August 2013

Secondary Outcome Measures

Name	Time	Method
To delineate the relation of objective changes in non-invasive neuromuscular testing to subjective symptoms during the first exposure to active or placebo therapy, in subset of 5 patients with prior history of statin myopathy.	September 2010 to August 2013

Trial Locations

Locations (1)

St. Joseph's Health Care; 🇨🇦 London, Ontario, Canada