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Treatment Trials to Determine Whether Statins Are the Cause of a Patient's Discomfort FREE

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The full report is titled “N-of-1 (Single-Patient) Trials for Statin-Related Myalgia.” It is in the 4 March 2014 issue of Annals of Internal Medicine (volume 160, pages 301-310). The authors are T.R. Joy, A. Monjed, G.Y. Zou, R.A. Hegele, C.G. McDonald, and J.L. Mahon.

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Ann Intern Med. 2014;160(5):I-34. doi:10.7326/P14-9007
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What is the problem and what is known about it so far?

Drugs called “statins” are recommended to many patients to reduce their risk for heart disease, stroke, and other cardiovascular problems. However, these drugs may be associated with muscle discomfort, known as myalgia, or other symptoms that lead many patients to discontinue therapy. It is sometimes difficult to judge whether statins are truly the cause of the discomfort in these patients.

Why did the researchers do this particular study?

To see whether comparing a patient's symptoms while receiving statin versus placebo pills can help determine whether prior problems that occurred with statins were caused by them.

Who was studied?

Eight patients whose pain or other symptoms had led to discontinuation of statin therapy.

How was the study done?

Each patient was given statin or placebo pills up to 3 times, each for up to 3 weeks, in random order. At the end of each week in the 3-week period, the patient completed a questionnaire to report symptoms, including the symptom that was previously attributed to statin treatment. Neither the patient nor his or her physician knew which pill was being taken during the treatment periods.

What did the researchers find?

Patients had symptoms while receiving placebo pills and statins. No statistically significant difference was found in the amount of discomfort reported by any of the patients receiving either pill. After patients were shown which pill they received during each period and reviewed their symptom reports with their physicians, most resumed using statins.

What were the limitations of the study?

Each treatment period was only 3 weeks. Although the patients’ prior symptoms had occurred within 3 weeks of starting to receive a statin, longer therapy with statins might cause problems.

What are the implications of the study?

In some patients who have had problematic symptoms while taking statins, trials such as this might be helpful to objectively determine whether the statin is truly causing the problem. These patients might then continue recommended therapy that they would otherwise discontinue.





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