Atorvastatin effects on muscle symptoms similar to placebo
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Atorvastatin demonstrated no overall effect on the frequency or severity of muscle symptoms among individuals who previously reported severe muscle symptoms while on statins, compared with placebo, according to data published in The BMJ.
In the StatinWISE n-of-1 series of trials, patients who had taken statins previously but reported severe muscle symptoms when on them were given atorvastatin and placebo at separate times and asked to report severe muscle symptoms. The design and findings were similar to the SAMSON trial, which Healio previously reported on.
“A causal link between statins and rare but severe muscle adverse effects is well characterized, but the causal effect of statins on less severe muscle symptoms, such as stiffness, pain and weakness, is uncertain,” Emily Herrett, PhD, assistant professor in the department of noncommunicable disease epidemiology at the London School of Hygiene and Tropical Medicine, and colleagues wrote.
The series of randomized, placebo-controlled trials included 200 participants (mean age, 69 years; 43% women) who recently stopped or were considering stopping statin treatment due to muscle symptoms. Participants were randomly assigned to six double-blind treatment periods lasting 2 months each of 20 mg daily atorvastatin or placebo.
These n-of-1 trials were conducted in primary care across 50 sites in the U.K. from December 2016 to April 2018. After each treatment period, participants rated their muscle symptoms on a visual analog scale of 0 to 10 and scores were compared between statin and placebo treatments.
Symptom scores for at least one statin treatment period and at least one placebo treatment period were obtained from 151 participants and included in the analysis.
Researchers observed no differences in muscle symptom scores between the statin treatment and placebo treatment periods (mean difference, –0.11; 95% CI, –0.36 to 0.14; P = .4).
Of those who completed the trial, two-thirds reported restarting long-term statin treatment.
Withdrawal due to intolerable muscle symptoms occurred in 9% of patients during the statin period and 7% of patients during the placebo period.
According to the researchers, statin treatment for high-risk individuals has potential benefits that are lost if patients stop treatment, and n-of-1 trials allow patients and clinicians to replicate the findings of this study for any statin at any dose.
“Our results suggest that most patients would restart treatment after such a trial,” the researchers wrote. “Future work could focus on conducting n-of-1 trials for other types of statins and higher doses and for other drugs which are associated with transient adverse effects.”
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