Cited by 274Lipoproteins and Cardiovascular HealthStatistical Methods in Clinical TrialsPharmacovigilance and Adverse Drug Reactions

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N-of-1 Trial of a Statin, Placebo, or No Treatment to Assess Side Effects

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Wood, Frances A., Howard, James P., Finegold, Judith A., Nowbar, Alexandra N., Thompson, David M., Arnold, Ahran D., Rajkumar, Christopher A., Connolly, Susan, Cegla, Jaimini, Stride, Chris, Sever, Peter, Norton, Christine, Thom, Simon A.M., Shun-Shin, Matthew J., Francis, Darrel P.·2020·New England Journal of Medicine

DOI 10.1056/nejmc2031173

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Abstract

N-of-1 Trial of a Statin, Placebo, or No Treatment to Assess Side EffectsTo the Editor: Statins are often discontinued because of side effects, 1,2 even though some blinded trials have not shown an excess of symptoms with statins as compared with placebo.3,4 Patients who had previously discontinued statins because of side effects that occurred within 2 weeks after the initiation of treatment were enrolled in a double-blind, three-group, n-of-1 trial to test whether symptoms would be induced by a statin or placebo.Details of the trial methods are provided in Section S2 in the Supplementary Appendix (available with the full text of this letter at NEJM.org); the trial protocol and statistical analysis plan are also available at NEJM.org.The patients received four bottles containing atorvastatin at a dose of 20 mg, four bottles containing placebo, and four empty bottles; each bottle was to be used for a 1-month period according to a random sequence.The patients used a smartphone application to report symptom intensity daily.Symptom scores ranged from 0 (no symptoms) to 100 (worst imaginable symptoms).If the patients determined that their symptoms were unacceptably severe, they could discontinue the tablets for that month.The primary end point was symptom intensity as assessed with the use of the nocebo ratio (i.e., the ratio of symptom intensity induced by taking placebo to the symptom intensity induced by taking a statin).This ratio was calculated as the symptom intensity with placebo minus the symptom intensity with neither statin nor placebo, divided by the symptom intensity with a statin minus the symptom intensity with neither statin nor placebo.From June 2016 through March 2019, a total of 60 patients underwent randomization.The screening data, the baseline characteristics of the

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Statin-associated muscle symptoms: impact on statin therapy—European Atherosclerosis Society Consensus Panel Statement on Assessment, Aetiology and Management
Stroes, E. S., Thompson, P. D., Corsini, A., Vladutiu, G. D., Raal, F. J., Ray, K. K., Roden, M., Stein, E., Tokgözoğlu, L., Nordestgaard, B. G., et al. (2015) · European Heart Journal · doi:10.1093/eurheartj/ehv043 · Cited by 1,443
Adverse events associated with unblinded, but not with blinded, statin therapy in the Anglo-Scandinavian Cardiac Outcomes Trial—Lipid-Lowering Arm (ASCOT-LLA): a randomised double-blind placebo-controlled trial and its non-randomised non-blind extension phase
Gupta, A., Thompson, D., Whitehouse, A., Collier, T., Dahlof, B., Poulter, N., Collins, R., & Sever, P. (2017) · The Lancet · doi:10.1016/s0140-6736(17)31075-9 · Cited by 343
Self-citation
What proportion of symptomatic side effects in patients taking statins are genuinely caused by the drug? Systematic review of randomized placebo-controlled trials to aid individual patient choice
Finegold, J. A., Manisty, C. H., Goldacre, B., Barron, A. J., & Francis, D. P. (2014) · European Journal of Preventive Cardiology · doi:10.1177/2047487314525531 · Cited by 214
Self-citation
Statin Intolerance: the Clinician’s Perspective
Štulc, T., Češka, R., & Gotto, A. M. (2015) · Current Atherosclerosis Reports · doi:10.1007/s11883-015-0552-3 · Cited by 59

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Authors: Wood, F. A., Howard, J. P., Finegold, J. A., Nowbar, A. N., Thompson, D. M., Arnold, A. D., Rajkumar, C. A., Connolly, S., Cegla, J., Stride, C., Sever, P., Norton, C., Thom, S. A. M., Shun-Shin, M. J., & Francis, D. P.
Affiliations: Imperial College London (GB)
Imperial College Healthcare NHS Trust (GB)
University of Sheffield (GB)
King's College London (GB)
Imperial College London, London, United Kingdom
ORCID: Howard, James P.
Nowbar, Alexandra N.
Arnold, Ahran D.
Rajkumar, Christopher A.
Connolly, Susan
Cegla, Jaimini
Stride, Chris
Sever, Peter
Norton, Christine
Thom, Simon A.M.
Shun-Shin, Matthew J.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2020-11-26
Volume: 383
Issue: 22
Pages: 2182-2184
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmc2031173
OpenAlex: W3104495732
Cited by: 274
References: 4
Citations by year: 2026: 29 · 2025: 25 · 2024: 29 · 2023: 37 · 2022: 59 · 2021: 92 · 2020: 3
FWCI: 43.61
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.nejmgroup.org/legal/terms-of-use.htm (vor)
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion)
UCL Discovery (University College London) (submittedVersion)
Spiral (Imperial College London) (submittedVersion)
Funders: British Heart Foundation (PG/15/7/31235)
Topics: Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipoproteins and Cardiovascular Health
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
Keywords: statins, atorvastatin, adverse drug reactions, nocebo effect, placebo response, symptom intensity, N-of-1 trials, statin discontinuation
MeSH terms: Atorvastatin, Adult, Double-Blind Method, Humans, Placebos, Confidence Intervals, Hydroxymethylglutaryl-CoA Reductase Inhibitors

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