Use of n-of-1 trials to determine statin tolerability

Reactions 1495, p4 - 5 Apr 2014

Use of n-of-1 trials to determinestatin tolerability

Statin-related muscle symptoms occur in 15 to 20 %of patients receiving statins, but for some patients it islikely that the cause of these symptoms is falselyattributed to the drug. A recent study confirmed thefeasibility and potential value of n-of-1 trials in providinga reliable means of assessing whether such symptomsare in fact attributable to the statin.

The study included eight adult patients who metCanadian Dyslipidemia Guidelines criteria for requiringstatin therapy and who had statin-related myalgiaaccording to American College of Cardiology criteria.Patients were recruited from endocrinology clinics at atertiary referral centre; those with a history ofrhabdomyolysis, metabolic or inflammatory myopathy,or neuropathy were excluded. The n-of-1 trialsconducted included three randomized, double-blind,cross-over comparisons (statin versus placebo), withtreatments separated by three 3-week washout periods.One patient completed two treatment pairs, while sevenpatients completed all three treatment pairs. Across alleight trials, there were no statistically significantdifferences between statin and placebo treatment pairsin measures of myalgia or pain. Five patients resumedstatin therapy following review of the results of their n-of-1 trial, with an associated improvement in mean low-density lipoprotein cholesterol level after a medianfollow-up of 10 months.Joy TR, et al. N-of-1 (Single-Patient) Trials for Statin-Related Myalgia. Annals ofInternal Medicine 160: 301-310, No. 5, 11 Mar 2014. Available from: URL: http://doi.org/10.7326/M13-1921 803100606

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Reactions 5 Apr 2014 No. 14950114-9954/14/1495-0001/$14.95 Adis © 2014 Springer International Publishing AG. All rights reserved