"In patients who had discontinued statin therapy because of side effects, 90% of the symptom burden elicited by a statin challenge was also elicited by placebo," said researchers presenting findings from the SAMSON trial Nov. 15 during AHA 2020. The trial, which was also published in the New England Journal of Medicine, also found that half of trial participants were able to restart statins.

The small, randomized, n-of-1 trial enrolled 60 patients who had previously discontinued statins within two weeks of starting treatment due to side effects. Patients were given four bottles containing atorvastatin (20 mg), four bottles containing placebo, and four empty bottles. Each bottle was to be used for a one-month period according to a random sequence and patients used a smartphone application to report their symptom intensity each day (0/no symptoms; 100/worst imaginable symptoms). Patients could discontinue the tablets for the month if they believed the symptoms to be too severe. The primary end point was symptom intensity calculated with the nocebo ratio.

Results for all 60 patients showed the mean symptom intensity was 8.0 during no-tablet months (95% CI, 4.7 to 11.3), 15.4 during placebo months (95% CI, 12.1 to 18.7) and 16.3 during statin months (95% CI, 13.0 to 19.6). Six months after completion of the trial, 50% of patients had successfully restarted statins. A total of 25 patients were not receiving statins, nor planning to restart, at the end of six months.

"Patients really do get side effects from statin tablets," said James Howard, PhD, of Imperial College, London, who presented the findings. However, he noted these side effects appear to be mainly caused by the act of taking tablets, not what is in them. He stressed the importance of taking patients seriously and exploring the reported side effects with them.

Clinical Topics: Diabetes and Cardiometabolic Disease, Dyslipidemia, Prevention

Keywords: AHA Annual Scientific Sessions, AHA20, Primary Prevention, Dyslipidemias

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