Single-patient trials helpful in determining statin tolerability
Single-patient, or n-of-1, trials may be a useful method for determining which patients are experiencing true statin-related discomfort and which patients may be able to continue therapy, according to an article being published in Annals of Internal Medicine.
Statins are recommended to reduce risk for heart disease, stroke, and other cardiovascular problems. Myalgia (muscle pain or discomfort) is a common complaint among patients taking statins and a common reason for discontinuation of therapy. However, it can be difficult to determine whether statins are the cause of patient discomfort.
Researchers conducted a proof-of-concept study to assess the feasibility and potential value of n-of-1 trials in patients with statin-related myalgia. The investigators hypothesized that such trials would provide objective proof in some patients that their symptoms were (or were not) statin-related.
Patients who had discontinued statin use due to myalgia were randomly assigned to statin therapy or placebo, up to three times each, for up to three weeks (adequate time period for myalgia to develop). Neither the physician nor the patient knew whether the statin or placebo was taken.
Patient self-reporting revealed no clinically significant differences in myalgia or other pain measures in any of the n-of-1 trials or in the combined results across trials. Most patients resumed statin treatment after reviewing the results of their trial, which resulted in lower LDL-C levels 10 months later.