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American Journal of Respiratory and Critical Care Medicine Vol 175. pp. 1347b-1348, (2007)
© 2007 American Thoracic Society


Correspondence

Avoiding Mistakes in Calculating the Number Needed to Treat in Severe COPD

From the Authors:

We thank Dr. Aaron for the comments on our recent article (1), and for giving us the opportunity to clarify the issue of the number needed to treat (NNT) for exacerbations of chronic obstructive pulmonary disease (COPD). The NNT has been introduced for binary outcome variables as the reciprocal of the absolute risk reduction (2). However, our primary outcome (number of moderate and severe exacerbations) is not binary, since our patients with severe COPD had at least two (mean 2.87–2.91) exacerbations in the year preceding the inclusion into the study. From a clinically realistic point of view, we focused just on reducing the number of exacerbations (that is from three per year to two or one), even if they could not have been completely abolished.

The NNT of 12.3 computed by Dr. Aaron says one has to treat on average 12.3 patients for 44 weeks to have 1 additional patient without any COPD exacerbation within 44 weeks. We, however, looked for the NNT to prevent one single exacerbation, since the NNT concept is not restricted to binary outcomes. There are extensions for other types of variables. A rather simple extension is possible for count variables—for example, number of COPD exacerbations within a given time period.

Halpin defines "event-based NNTs," that is, the NNTs to avoid (or achieve) a particular outcome, as "the reciprocal of the difference between the treatment and the control groups in the rate of a particular outcome per patient within a given time frame" (3). For the event exacerbation one has to estimate the rate of exacerbations per patient and year in each treatment group and calculate the reciprocal of the difference. With the data from our study, this gives 1/(1.4 – 0.92) = 2.08. Avoiding one exacerbation, however, does not mean that the patient must have no exacerbation. This definition for an event-based NNT has been used by several authors (46).

Peter Kardos

Maingau Hospital, Frankfurt am Main, Germany

Marion Wencker*

Frankfurt am Main, Germany

Thomas Glaab*

Hannover, Germany

Claus Vogelmeier

Philipps University, Marburg, Germany

FOOTNOTES

* M.W. and T.G. were employees of GlaxoSmithKline Germany at the time of the study. Back

Conflict of Interest Statement: P.K. has been reimbursed by Altana, AstraZeneca (AZ), Cefalon, GlaxoSmithKline (GSK), Novartis, and Viatris for attending several conferences; he has participated as a speaker in scientific meetings and courses organized and financed by various pharmaceutical companies (Altana, AZ, Berlin-Chemic, Boehringer Ingelheim [BI], Cefalon, GSK, Novartis, and Pfizer) and served on advisory boards for the following companies: AZ, BI, GSK, Novartis, and Pfizer; he has received aggregated honoraria of $12,000 in 2005 from GSK and $11,000 from Novartis; and his group has received $14,000, $18,000, and $15,000 in 2003, 2004, and 2005, respectively, from Altana, AZ, GSK, and Novartis as research grants for participating in several multicenter clinical trials. M.W. was an employee of GlaxoSmithKline Germany at the time of the study. T.G. was an employee of GlaxoSmithKline Germany at the time of the study. C.V. has given presentations in the last three years at industry symposia sponsored by Altana, AstraZeneca (AZ), Bayer, Boehringer Ingelheim, GSK, Merck Darmstadt, Novartis, Pfizer, Sanofi Aventis, and Talecris; he also served on advisory boards for Altana, AZ, Bayer, Boehringer Ingelheim, GSK, Pfizer, and Sanofi Aventis; in addition, his institution took part in clinical studies sponsored by AZ, GSK, and Intermune; in 2005, aggregated honoraria and industry sponsored grants comprised $22,000 from Altana, $50,000 from AZ, and $30,000 from GSK.

REFERENCES

  1. Kardos P, Wencker M, Glaab T, Vogelmeier C. Impact of salmeterol/fluticasone propionate versus salmeterol on exacerbations in severe chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2007;175:144–149.[Abstract/Free Full Text]
  2. Laupacis A, Sackett DL, Roberts RS. An assessment of clinically useful measures of the consequences of treatment. N Engl J Med 1988;318:1728–1733.[Medline]
  3. Halpin DM. Evaluating the effectiveness of combination therapy to prevent COPD exacerbations: the value of NNT analysis. Int J Clin Pract 2005;59:1187–1194.[CrossRef][Medline]
  4. Calverley PM, Boonsawat W, Cseke Z, Zhong N, Peterson S, Olsson H. Maintenance therapy with budesonide and formoterol in chronic obstructive pulmonary disease. Eur Respir J 2003;22:912–919.[Abstract/Free Full Text]
  5. Szafranski W, Cukier A, Ramirez A, Menga G, Sansores R, Nahabedian S. Peterson S, Olsson H. Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease. Eur Respir J 2003;21:74–81.[Abstract/Free Full Text]
  6. Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW, Yates JC, Vestbo J. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med 2007;356:775–789.[Abstract/Free Full Text]




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HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
Proc. Am. Thorac. Soc. Am. J. Respir. Cell Mol. Biol.
Copyright © 2007 American Thoracic Society