{"id":41978,"date":"2014-03-03T18:41:02","date_gmt":"2014-03-03T23:41:02","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=voices&p=41978"},"modified":"2014-03-03T18:41:02","modified_gmt":"2014-03-03T23:41:02","slug":"a-new-tool-for-determining-statin-tolerability","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2014\/03\/03\/a-new-tool-for-determining-statin-tolerability\/","title":{"rendered":"A New Approach for the Statin-Intolerant Patient?"},"content":{"rendered":"

We are all well familiar with the patient who reports muscle symptoms with statins.\u00a0 But just how should we deal with this?\u00a0 How do we know that symptoms are due to the statin rather than some other factor?\u00a0 The reported incidence of myalgia in clinical trials has been criticized on many fronts as inaccurate, underestimating the \u201creal world\u201d experience.<\/p>\n

Clearly, one of the challenges is determining whether a patient\u2019s symptoms are attributable to statin or some other cause. To assess this, a unique study design \u2014 an \u201cn-of-1 trial\u201d \u2014 has been purported as an effective way to limit biases in individual patients as each patient serves as his or her own control.\u00a0 N-of-1 trials are single-patient, randomized, multiple crossover, blinded comparisons of an active treatment versus placebo.<\/p>\n

In a study published today<\/a> in the Annals of Internal Medicine<\/i>, researchers at Western University in London, Ontario conducted a proof-of-concept study to assess the feasibility and potential value of n-of-1 trials in patients with statin-related myalgia.<\/p>\n

Eight 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. Treatment periods were separated by three-week washout intervals to minimize carryover effects.\u00a0\u00a0 Seven patients completed the entire trial (three treatment pairs), and one completed two treatment pairs. For each n-of-1 trial, there was no clinically significant difference in myalgia or other pain measures.\u00a0\u00a0 Five patients resumed open-label statin treatment at the end of the trial.<\/p>\n

The authors suggested that this type of trial is a potentially useful tool to examine myalgia caused by statin use in selected patients.<\/p>\n

What do you think of this type of trial design?<\/p>\n

How do you approach the statin intolerant patient now?<\/p>\n

Would the n-of-1 approach be successful in your practice?<\/p>\n","protected":false},"excerpt":{"rendered":"

Andy Kates wonders if a new type of individual patient trial can help to identify whether a patient’s myalgia is caused by statin use.<\/p>\n","protected":false},"author":202,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1,7],"tags":[2193,2194,584],"class_list":["post-41978","post","type-post","status-publish","format-standard","hentry","category-general","category-prevention","tag-myalgia","tag-n-of-1-trial","tag-statins"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/41978","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/202"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=41978"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/41978\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=41978"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=41978"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=41978"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}