<i>N</i>-of-1 (Single-Patient) Trials for Statin-Related Myalgia
Authors: Tisha R. Joy, Guang Yong Zou, Jeffrey L. Mahon
Journal: Annals of Internal Medicine (2014)

Letters7 October 2014N-of-1 (Single-Patient) Trials for Statin-Related MyalgiaTisha R. Joy, MD, Guang Yong Zou, PhD, and Jeffrey L. Mahon, MD, MScTisha R. Joy, MDFrom Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada; Robarts Research Institute, Western University, London, Ontario, Canada; and Schulich School of Medicine and Dentistry and Robarts Research Institute, Western University, London, Ontario, Canada., Guang Yong Zou, PhDFrom Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada; Robarts Research Institute, Western University, London, Ontario, Canada; and Schulich School of Medicine and Dentistry and Robarts Research Institute, Western University, London, Ontario, Canada., and Jeffrey L. Mahon, MD, MScFrom Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada; Robarts Research Institute, Western University, London, Ontario, Canada; and Schulich School of Medicine and Dentistry and Robarts Research Institute, Western University, London, Ontario, Canada.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/L14-5019-2 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail IN RESPONSE:The decision to restrict each treatment exposure and washout phase to 3 weeks did indeed mean that our N-of-1 trials could not reliably detect statin-related muscle symptoms that took more than 3 weeks to develop and/or resolve. To minimize this circumstance, we chose patients who previously developed myalgia within 3 weeks of starting therapy with a statin and received the same statin in the N-of-1 trial that they associated with myalgia during open-label treatment. We provided our rationale for choosing a 3-week washout period in the article.In Hansen and associates' review (1), we note that one third ...References1. Hansen KE, Hildebrand JP, Ferguson EE, Stein JH. Outcomes in 45 patients with statin-associated myopathy. Arch Intern Med. 2005;165:2671-6. [PMID: 16344427] CrossrefMedlineGoogle Scholar2. Cham S, Evans MA, Denenberg JO, Golomb BA. Statin-associated muscle-related adverse effects: a case series of 354 patients. Pharmacotherapy. 2010;30:541-53. [PMID: 20500044] doi:10.1592/phco.30.6.541 CrossrefMedlineGoogle Scholar3. Guyatt G, Sackett D, Adachi J, Roberts R, Chong J, Rosenbloom D, et al. A clinician's guide for conducting randomized trials in individual patients. CMAJ. 1988;139:497-503. [PMID: 3409138] MedlineGoogle Scholar4. Heeren T, D'Agostino R. Robustness of the two independent samples t-test when applied to ordinal scaled data. Stat Med. 1987;6:79-90. [PMID: 3576020] CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAuthors: Tisha R. Joy, MD; Guang Yong Zou, PhD; Jeffrey L. Mahon, MD, MScAffiliations: From Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada; Robarts Research Institute, Western University, London, Ontario, Canada; and Schulich School of Medicine and Dentistry and Robarts Research Institute, Western University, London, Ontario, Canada.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M13-1921. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoN-of-1 (Single-Patient) Trials for Statin-Related Myalgia Tisha R. Joy , Alaa Monjed , Guang Yong Zou , Robert A. Hegele , Charlotte G. McDonald , and Jeffrey L. Mahon N-of-1 (Single-Patient) Trials for Statin-Related Myalgia Oladimeji Akinboro , Linda Williams , and Daniel Pomerantz N-of-1 (Single-Patient) Trials for Statin-Related Myalgia Oladimeji Akinboro , Linda Williams , and Daniel Pomerantz Metrics Cited bySeries of virtual light therapy interventions for fatigue: a feasibility pilot study protocol for a series of personalised (N-of-1) trialsSAMSON and the Nocebo Effect: Management of Statin IntoleranceUnblinded and Blinded N-of-1 Trials Versus Usual Care: A Randomized Controlled Trial to Increase Statin Uptake in Primary CareN-of-1 Trials in NeurologyNovel Research DesignsThe history and development of N-of-1 trialsEBM has not only called out the problems but offered solutionsStatin intolerance – a question of definitionN of 1 randomized trials: a commentaryIdentification and management of patients with statin-associated symptoms in clinical practice: A clinician survey 7 October 2014Volume 161, Issue 7Page: 531-532KeywordsCohort studiesDisclosureMusclesMyalgiaStatins ePublished: 7 October 2014 Issue Published: 7 October 2014 Copyright & PermissionsCopyright © 2014 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...