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

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute
• Treatments: Hydroxymethylglutaryl-CoA Reductase Inhibitors

Criteria

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