Evaluation of Patients With Statin Myopathy Using an N of 1 Trial Design
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- To assess the reliability and reproducibility of subjective symptoms of myalgias to active statin therapy.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Statin
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).
Intervention: Individual-specific statin causing myopathy (Drug)
Placebo
Identical placebo to patient-specific statin
Intervention: Placebo (Drug)
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.(September 2010 to August 2013)
Investigators
Tisha Joy
Assistant Professor, Division of Endocrinology
Lawson Health Research Institute