Statin Side Effects, Examined in an N-of-1 Trial

To examine the extent to which patient-reported statin side effects are “real,” U.K. researchers performed an n-of-1 randomized trial. This 1-year study included 60 patients (mean age, 66) who reported side effects within 2 weeks of starting statin therapy. Participants received month-long courses of either atorvastatin (20 mg/day), a placebo tablet, or no treatment, sequenced in random order; at the end of 1 year, each person had spent 4 months in each treatment group. Symptom scores were recorded daily and ranged from 0 (no symptoms) to 100 (worst imaginable).

Mean symptom intensity was 8, 15, and 16 points during the no-treatment, placebo, and atorvastatin months, respectively. Participants stopped treatment due to intolerable side effect…