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

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Statin Myopathy

Interventions

Individual-specific statin causing myopathyDRUG

Individual-specific statin causing myopathy vs. placebo

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

St. Joseph's Health Care

London, Ontario, Canada

Outcomes

Primary Outcomes

To assess the reliability and reproducibility of subjective symptoms of myalgias to active statin therapy.

Time frame: Duration of study September 2010 to August 2013

Secondary Outcomes

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.

Time frame: September 2010 to August 2013

Data from ClinicalTrials.gov

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