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

Lawson Health Research Institute

Status: Completed

Conditions: Statin Myopathy

Treatments: Drug: Placebo; Drug: Individual-specific statin causing myopathy

Study type: Interventional

Funder types: Other

Identifiers

NCT01259791

R-10-450

17352 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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10 participants in 2 patient groups, including a placebo group

Statin

Experimental group

Description:

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).

Treatment:

Drug: Individual-specific statin causing myopathy

Placebo

Placebo Comparator group

Description:

Identical placebo to patient-specific statin

Treatment:

Drug: Placebo