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Adverse drug reactions

Patients taking placebo and statins experience similar side effects

Research published in the New England Journal of Medicine found that 90% of the symptom burden experienced by patients on statins was also present when they took placebo tablets.

atorvastatin

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One outcome of the study was that half of the patients who had stopped taking statins because of side effects were able to go back on to them

Patients experience similar side effects taking a placebo as they do taking a statin, a study in the New England Journal of Medicine has suggested (26 November 2020)[1].

The team recruited 60 patients who had previously stopped statin treatment because of side effects. They were given four bottles containing 20mg atorvastatin, four bottles of a matching placebo and four empty bottles to take in a random order for 12 months.

Patients recorded their symptoms daily via a smartphone application, scoring them from 0 (no symptoms) to 100 (worst imaginable). Of the 60 patients taking part, 49 patients completed the trial.

Across all patients, the mean symptom intensity score was 8.0 during no-tablet months (95% confidence interval [CI] 4.7–11.3), 15.4 during placebo months (95% CI 12.1–18.7) and 16.3 during statin months (95% CI 13.0–19.6); 90% of the symptom burden experienced by patients on statins was also present when they took placebo tablets.

Six months after completion of the trial, 30 of the patients had successfully restarted statins.

“Our study shows that our patients really do suffer statin side effects when they take the tablets, but they suffer similar amounts if you give them a placebo tablet,” said James Howard, a cardiologist and clinical research fellow at Imperial College London.

“This ‘nocebo’ effect is hugely important, and we found that when we showed our patients their personalised results of their side effects, half of them were able to go back on to statins and were taking them six months later.”

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2020.20208633

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