Cited by 77Chronic Obstructive Pulmonary Disease (COPD) ResearchStatistical Methods in EpidemiologyStatistical Methods in Clinical Trials

Number needed to treat in COPD: exacerbations versus pneumonias

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Suissa, Samy·2013·Thorax

Abstract

BACKGROUND: Several recent trials in chronic obstructive pulmonary disease (COPD) have assessed the effectiveness of the fluticasone-salmeterol combination inhaler in preventing COPD exacerbations, while finding an increased risk of pneumonia. The number needed to treat (NNT) is a simple measure to perform the comparative benefit-risk impact, but its calculation involving repeated outcome events such as COPD exacerbations has been incorrect. We describe the proper methods to calculate the NNT and, using data from published trials, apply them to evaluate the relative impact of fluticasone-salmeterol treatment on exacerbations and pneumonias in patients with COPD. METHODS: We review the fundamental definition of NNT and quantify it for situations with varying follow-up times. We review the 'event-based' NNT, proposed and used for repeated event outcomes, show its inaccuracy, describe its proper use and provide an approximate formula for its application. RESULTS: We show that a 1-year trial of the fluticasone-salmeterol combination versus salmeterol used the incorrect event-based approach to calculate the NNT as two patients that need to be treated for 1 year to prevent one COPD exacerbation, when the proper calculation results in a NNT of 14. In contrast, 20 patients need to be treated to induce one pneumonia case. For the TORCH trial, the NNT is 44 patients treated for 3 years with fluticasone-salmeterol versus salmeterol to prevent one exacerbation compared with 16 patients to induce one pneumonia case. CONCLUSIONS: The NNT is a useful measure of the effect of drugs, but its proper calculation is essential to prevent misleading clinical practice guidelines.

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  1. Epidemiology on July 14, 2023 by guest. Protected by copyright. http://thorax.bmj.com/ Thorax: first published as 10.1136/thoraxjnl-2012-202709 on 2 November 2012. Downloaded from Epidemiology on July 14, 2023 by guest. Protected by copyright. http://thorax.bmj.com/ Thorax: first published as 10.1136/thoraxjnl-2012-202709 on 2 November 2012. Downloaded from REFERENCES

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Authors
Suissa, S.
Affiliations
Jewish General Hospital (CA)
Corresponding author
Suissa, Samy
Venue
Thorax
Publisher
BMJ
Published
2012-11-02
Volume
68
Issue
6
Pages
540-543
ISSN
  • 0040-6376 (ISSN-L)
  • 1468-3296
OpenAlex
W2127142891
Cited by
77
References
21
Citations by year
2025: 1 · 2024: 4 · 2021: 4 · 2020: 4 · 2019: 7 · 2018: 10 · 2017: 9 · 2016: 7 · 2015: 12 · 2014: 10 · 2013: 8 · 2012: 1
FWCI
8.00
Type
journal article
Language
en
Open access
Locations
  • Thorax (publishedVersion)
  • PubMed (publishedVersion)
  • HighWire Press Open Archive (submittedVersion)
Topics
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Chronic Obstructive Pulmonary Disease (COPD) Research
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords
number needed to treat, chronic obstructive pulmonary disease, COPD exacerbations, pneumonia, salmeterol/fluticasone, salmeterol, risk-benefit assessment, TORCH trial, inhaled corticosteroids
MeSH terms
Anti-Inflammatory Agents, Humans, Pneumonia, Global Health, Incidence, Pulmonary Disease, Chronic Obstructive

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