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

Study Overview
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Brief Summary
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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.

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

Conditions
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Statin Myopathy

Intervention / Treatment
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* Drug: Individual-specific statin causing myopathy
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Statin<br>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). | Drug: Individual-specific statin causing myopathy<br>* Individual-specific statin causing myopathy vs. placebo<br>|
| Placebo Comparator: Placebo<br>Identical placebo to patient-specific statin | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |