Imperial College London
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DrJamesHoward

Faculty of Medicine, National Heart & Lung Institute

Clinical Senior Lecturer in Cardiology (Cardiac MR and AI)
 
 
 
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james.howard1 Website CV

 
 
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Location

 

Block B Hammersmith HospitalHammersmith Campus

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Summary

 

Publications

Citation

BibTex format

@article{Howard:2021:10.1016/j.jacc.2021.07.022,
author = {Howard, J and Wood, F and Finegold, J and Nowbar, A and Thompson, DM and Arnold, A and Rajkumar, C and Connolly, S and Cegla, J and Stride, C and Sever, P and Northon, C and Thom, S and Shun-Shin, M and Francis, D},
doi = {10.1016/j.jacc.2021.07.022},
journal = {Journal of the American College of Cardiology},
pages = {1210--1222},
title = {Side effect patterns in a crossover trial of statin, placebo and no treatment},
url = {http://dx.doi.org/10.1016/j.jacc.2021.07.022},
volume = {78},
year = {2021}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - BackgroundMost people who begin statins abandon them, most commonly because of side-effects. ObjectivesAssess daily symptom scores on statin, placebo and no treatment in participants who had abandoned statins.MethodsParticipants received 12 one-month medication bottles, 4 containing atorvastatin 20mg, 4 placebo and 4 empty. We measured daily symptom intensity for each using an app (scale 1-100). We also measured the nocebo ratio: the ratio of symptoms induced by taking statin that was also induced by taking placebo. Results60 participants were randomized and 49 completed the 12-month protocol. Mean symptom score was 8.0 (95% confidence interval 4.7 to 11.3) in no-tablet months. It was higher in statin months (16.3, 13.0 to 19.6, p<0.001), but also in placebo months (15.4, 12.1 to 18.7, p<0.001), with no difference between the two (p=0.388). The corresponding nocebo ratio was 0.90.In the individual-patient daily data, neither symptom intensity on starting (odds ratio 1.02, 95% CI 0.98 to 1.06, p=0.28) nor extent of symptom relief on stopping (1.01, 95% CI 0.98 to 1.05, p=0.48) distinguished between statin and placebo.Stopping was no more frequent for statin than placebo (p=0.173), and subsequent symptom relief was similar between statin and placebo.6 months after the trial, 30/60 (50%) of participants were back taking statins. ConclusionsThe majority of symptoms caused by statin tablets were nocebo. Clinicians should not interpret symptom intensity or timing of symptom onset or offset (on starting or stopping statin tablets) as indicating pharmacological causation, because the pattern is identical for placebo.
AU  - Howard,J
AU  - Wood,F
AU  - Finegold,J
AU  - Nowbar,A
AU  - Thompson,DM
AU  - Arnold,A
AU  - Rajkumar,C
AU  - Connolly,S
AU  - Cegla,J
AU  - Stride,C
AU  - Sever,P
AU  - Northon,C
AU  - Thom,S
AU  - Shun-Shin,M
AU  - Francis,D
DO  - 10.1016/j.jacc.2021.07.022
EP  - 1222
PY  - 2021///
SN  - 0735-1097
SP  - 1210
TI  - Side effect patterns in a crossover trial of statin, placebo and no treatment
T2  - Journal of the American College of Cardiology
UR  - http://dx.doi.org/10.1016/j.jacc.2021.07.022
UR  - https://www.sciencedirect.com/science/article/pii/S0735109721057016?via%3Dihub
UR  - http://hdl.handle.net/10044/1/90664
VL  - 78
ER  -
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