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Side effect patterns in a crossover trial of statin, placebo, and no treatment

Journal of the American College of Cardiology Oct 14, 2021

Howard JP, Wood FA, Finegold JA, et al. - In this study of people who had abandoned statins, most of the symptoms induced by statin tablets were nocebo. Clinicians are recommended not to interpret symptom intensity or timing of symptom onset or offset (on commencing or stopping statin tablets) as indicating pharmacological causation, since the pattern is the same for placebo.

  • Majority of persons who commence statins abandon them, most often due to side effects.

  • People who had abandoned statins were included, and participants consumed 12 1-month medication bottles, 4 consisting of atorvastatin 20 mg, 4 placebo, and 4 empty.

  • Overall 60 participants were randomly assigned and 49 completed the 12-month protocol.

  • In no-tablet months, mean symptom score was 8.0, and it was higher in statin months (16.3), but also in placebo months (15.4), with no difference between the 2; corresponding nocebo ratio was 0.90.

  • According to individual-patient daily data, neither symptom intensity on commencing (OR: 1.02) nor extent of symptom amelioration on cessation (OR: 1.01) distinguished between statin and placebo.

  • Discontinuation was no more frequent for statin relative to placebo, and a similar subsequent symptom relief was observed between statin and placebo.

  • At 6 months post-trial, statin use in 30 of 60 (50%) participants was evident.

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