More evidence finds muscle symptoms unrelated to statins

Statins do not trigger new muscle symptoms in people who have previously experienced severe symptoms,  a series of n=1 trials in the UK has shown.

The findings from the StatinWISE study support those of the earlier SAMSON trial which was reported in the limbic last year.

The StatinWISE study, published in The BMJ, enrolled 200 patients who had stopped or were considering stopping their statins due to muscle symptoms.

Each participant was allocated to a randomised sequence of six two-month periods on either 20mg daily atorvastatin or placebo. All received one period of statins and one of placebo in their first two periods and no one received more than three consecutive periods with the same treatment.

Self-reported muscle symptoms (using a visual analogue scale from 0-10) in the last seven days of each treatment period were lower when patients were on atorvastatin than when they were on placebo (mean difference statin minus placebo −0.11 (95% confidence interval −0.36 to 0.14); P=0.40).

Secondary outcomes collected three months after the end of the final treatment period also found no evidence of an effect of statins on muscle symptoms overall (OR 1.11) or muscle symptoms that could not be attributed to another cause (OR 1.22).

General activity, mood, ability to walk, normal work, relationships with other people, sleep, and enjoyment of life were similar in both the statin and placebo periods.

Similar and low numbers of patients withdrew from the trial – 9% during a statin period and 7% during a placebo period. Adherence, as measured by returned drug packets, was more than 80%.

Most patients (88%) reported the trial was helpful for them and most (66%) said they had or intended to resume statins.

The researchers said their findings were consistent with evidence from a number of trials.

“Our findings clearly indicated that most patients taking statins did not experience symptoms causally related to their statin, highlighting the importance of blinding when assessing adverse effects,” they said.

“The availability of n-of-1 trial packs in clinical care would allow patients and clinician to replicate this study in individuals, for any statin and at any dose to suit clinical needs, in primary care or in lipid clinics,” the study concluded.

They said the nocebo effect – the expectation of adverse effects which has been perpetuated by media reports – and the general muscle aches and pains found in a similar aged cohort may explain the different findings seen in unblinded observational studies.

Disclosures: The StatinWISE trial was funded by the National Institute for Health Research-Health Technology Programme.

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