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

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

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.

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