Acetaminophen versus Ibuprofen in young children with Mild Persistent Asthma

W. J. Sheehan, David Mauger, Ian Paul, J. N. Moy, S. J. Boehmer, S. J. Szefler, A. M. Fitzpatrick, D. J. Jackson, L. B. Bacharier, M. D. Cabana, R. Covar, F. Holguin, R. F. Lemanske, F. D. Martinez, J. A. Pongracic, A. Beigelman, S. N. Baxi, M. Benson, K. Blake, J. F. Chmiel & 23 others C. L. Daines, M. O. Daines, J. M. Gaffin, D. A. Gentile, W. A. Gower, E. Israel, H. V. Kumar, J. E. Lang, S. C. Lazarus, J. J. Lima, N. Ly, J. Marbin, W. J. Morgan, R. E. Myers, J. T. Olin, S. P. Peters, H. H. Raissy, R. G. Robison, K. Ross, C. A. Sorkness, S. M. Thyne, M. E. Wechsler, W. Phipatanakul

Research output: Contribution to journalArticle

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Abstract

BACKGROUND Studies have suggested an association between frequent acetaminophen use and asthma-related complications among children, leading some physicians to recommend that acetaminophen be avoided in children with asthma; however, appropriately designed trials evaluating this association in children are lacking. METHODS In a multicenter, prospective, randomized, double-blind, parallel-group trial, we enrolled 300 children (age range, 12 to 59 months) with mild persistent asthma and assigned them to receive either acetaminophen or ibuprofen when needed for the alleviation of fever or pain over the course of 48 weeks. The primary outcome was the number of asthma exacerbations that led to treatment with systemic glucocorticoids. Children in both treatment groups received standardized asthma-controller therapies that were used in a simultaneous, factorially linked trial. RESULTS Participants received a median of 5.5 doses (interquartile range, 1.0 to 15.0) of trial medication; there was no significant between-group difference in the median number of doses received (P = 0.47). The number of asthma exacerbations did not differ significantly between the two groups, with a mean of 0.81 per participant with acetaminophen and 0.87 per participant with ibuprofen over 46 weeks of follow-up (relative rate of asthma exacerbations in the acetaminophen group vs. the ibuprofen group, 0.94; 95% confidence interval, 0.69 to 1.28; P = 0.67). In the acetaminophen group, 49% of participants had at least one asthma exacerbation and 21% had at least two, as compared with 47% and 24%, respectively, in the ibuprofen group. Similarly, no significant differences were detected between acetaminophen and ibuprofen with respect to the percentage of asthma-control days (85.8% and 86.8%, respectively; P = 0.50), use of an albuterol rescue inhaler (2.8 and 3.0 inhalations per week, respectively; P = 0.69), unscheduled health care utilization for asthma (0.75 and 0.76 episodes per participant, respectively; P = 0.94), or adverse events. CONCLUSIONS Among young children with mild persistent asthma, as-needed use of acetaminophen was not shown to be associated with a higher incidence of asthma exacerbations or worse asthma control than was as-needed use of ibuprofen.

Original languageEnglish (US)
Pages (from-to)619-630
Number of pages12
JournalNew England Journal of Medicine
Volume375
Issue number7
DOIs
StatePublished - Aug 18 2016

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Ibuprofen
Acetaminophen
Asthma
Patient Acceptance of Health Care
Albuterol
Nebulizers and Vaporizers
Inhalation
Glucocorticoids
Fever
Therapeutics

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Sheehan, W. J. ; Mauger, David ; Paul, Ian ; Moy, J. N. ; Boehmer, S. J. ; Szefler, S. J. ; Fitzpatrick, A. M. ; Jackson, D. J. ; Bacharier, L. B. ; Cabana, M. D. ; Covar, R. ; Holguin, F. ; Lemanske, R. F. ; Martinez, F. D. ; Pongracic, J. A. ; Beigelman, A. ; Baxi, S. N. ; Benson, M. ; Blake, K. ; Chmiel, J. F. ; Daines, C. L. ; Daines, M. O. ; Gaffin, J. M. ; Gentile, D. A. ; Gower, W. A. ; Israel, E. ; Kumar, H. V. ; Lang, J. E. ; Lazarus, S. C. ; Lima, J. J. ; Ly, N. ; Marbin, J. ; Morgan, W. J. ; Myers, R. E. ; Olin, J. T. ; Peters, S. P. ; Raissy, H. H. ; Robison, R. G. ; Ross, K. ; Sorkness, C. A. ; Thyne, S. M. ; Wechsler, M. E. ; Phipatanakul, W. / Acetaminophen versus Ibuprofen in young children with Mild Persistent Asthma. In: New England Journal of Medicine. 2016 ; Vol. 375, No. 7. pp. 619-630.
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title = "Acetaminophen versus Ibuprofen in young children with Mild Persistent Asthma",
abstract = "BACKGROUND Studies have suggested an association between frequent acetaminophen use and asthma-related complications among children, leading some physicians to recommend that acetaminophen be avoided in children with asthma; however, appropriately designed trials evaluating this association in children are lacking. METHODS In a multicenter, prospective, randomized, double-blind, parallel-group trial, we enrolled 300 children (age range, 12 to 59 months) with mild persistent asthma and assigned them to receive either acetaminophen or ibuprofen when needed for the alleviation of fever or pain over the course of 48 weeks. The primary outcome was the number of asthma exacerbations that led to treatment with systemic glucocorticoids. Children in both treatment groups received standardized asthma-controller therapies that were used in a simultaneous, factorially linked trial. RESULTS Participants received a median of 5.5 doses (interquartile range, 1.0 to 15.0) of trial medication; there was no significant between-group difference in the median number of doses received (P = 0.47). The number of asthma exacerbations did not differ significantly between the two groups, with a mean of 0.81 per participant with acetaminophen and 0.87 per participant with ibuprofen over 46 weeks of follow-up (relative rate of asthma exacerbations in the acetaminophen group vs. the ibuprofen group, 0.94; 95{\%} confidence interval, 0.69 to 1.28; P = 0.67). In the acetaminophen group, 49{\%} of participants had at least one asthma exacerbation and 21{\%} had at least two, as compared with 47{\%} and 24{\%}, respectively, in the ibuprofen group. Similarly, no significant differences were detected between acetaminophen and ibuprofen with respect to the percentage of asthma-control days (85.8{\%} and 86.8{\%}, respectively; P = 0.50), use of an albuterol rescue inhaler (2.8 and 3.0 inhalations per week, respectively; P = 0.69), unscheduled health care utilization for asthma (0.75 and 0.76 episodes per participant, respectively; P = 0.94), or adverse events. CONCLUSIONS Among young children with mild persistent asthma, as-needed use of acetaminophen was not shown to be associated with a higher incidence of asthma exacerbations or worse asthma control than was as-needed use of ibuprofen.",
author = "Sheehan, {W. J.} and David Mauger and Ian Paul and Moy, {J. N.} and Boehmer, {S. J.} and Szefler, {S. J.} and Fitzpatrick, {A. M.} and Jackson, {D. J.} and Bacharier, {L. B.} and Cabana, {M. D.} and R. Covar and F. Holguin and Lemanske, {R. F.} and Martinez, {F. D.} and Pongracic, {J. A.} and A. Beigelman and Baxi, {S. N.} and M. Benson and K. Blake and Chmiel, {J. F.} and Daines, {C. L.} and Daines, {M. O.} and Gaffin, {J. M.} and Gentile, {D. A.} and Gower, {W. A.} and E. Israel and Kumar, {H. V.} and Lang, {J. E.} and Lazarus, {S. C.} and Lima, {J. J.} and N. Ly and J. Marbin and Morgan, {W. J.} and Myers, {R. E.} and Olin, {J. T.} and Peters, {S. P.} and Raissy, {H. H.} and Robison, {R. G.} and K. Ross and Sorkness, {C. A.} and Thyne, {S. M.} and Wechsler, {M. E.} and W. Phipatanakul",
year = "2016",
month = "8",
day = "18",
doi = "10.1056/NEJMoa1515990",
language = "English (US)",
volume = "375",
pages = "619--630",
journal = "New England Journal of Medicine",
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Sheehan, WJ, Mauger, D, Paul, I, Moy, JN, Boehmer, SJ, Szefler, SJ, Fitzpatrick, AM, Jackson, DJ, Bacharier, LB, Cabana, MD, Covar, R, Holguin, F, Lemanske, RF, Martinez, FD, Pongracic, JA, Beigelman, A, Baxi, SN, Benson, M, Blake, K, Chmiel, JF, Daines, CL, Daines, MO, Gaffin, JM, Gentile, DA, Gower, WA, Israel, E, Kumar, HV, Lang, JE, Lazarus, SC, Lima, JJ, Ly, N, Marbin, J, Morgan, WJ, Myers, RE, Olin, JT, Peters, SP, Raissy, HH, Robison, RG, Ross, K, Sorkness, CA, Thyne, SM, Wechsler, ME & Phipatanakul, W 2016, 'Acetaminophen versus Ibuprofen in young children with Mild Persistent Asthma', New England Journal of Medicine, vol. 375, no. 7, pp. 619-630. https://doi.org/10.1056/NEJMoa1515990

Acetaminophen versus Ibuprofen in young children with Mild Persistent Asthma. / Sheehan, W. J.; Mauger, David; Paul, Ian; Moy, J. N.; Boehmer, S. J.; Szefler, S. J.; Fitzpatrick, A. M.; Jackson, D. J.; Bacharier, L. B.; Cabana, M. D.; Covar, R.; Holguin, F.; Lemanske, R. F.; Martinez, F. D.; Pongracic, J. A.; Beigelman, A.; Baxi, S. N.; Benson, M.; Blake, K.; Chmiel, J. F.; Daines, C. L.; Daines, M. O.; Gaffin, J. M.; Gentile, D. A.; Gower, W. A.; Israel, E.; Kumar, H. V.; Lang, J. E.; Lazarus, S. C.; Lima, J. J.; Ly, N.; Marbin, J.; Morgan, W. J.; Myers, R. E.; Olin, J. T.; Peters, S. P.; Raissy, H. H.; Robison, R. G.; Ross, K.; Sorkness, C. A.; Thyne, S. M.; Wechsler, M. E.; Phipatanakul, W.

In: New England Journal of Medicine, Vol. 375, No. 7, 18.08.2016, p. 619-630.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Acetaminophen versus Ibuprofen in young children with Mild Persistent Asthma

AU - Sheehan, W. J.

AU - Mauger, David

AU - Paul, Ian

AU - Moy, J. N.

AU - Boehmer, S. J.

AU - Szefler, S. J.

AU - Fitzpatrick, A. M.

AU - Jackson, D. J.

AU - Bacharier, L. B.

AU - Cabana, M. D.

AU - Covar, R.

AU - Holguin, F.

AU - Lemanske, R. F.

AU - Martinez, F. D.

AU - Pongracic, J. A.

AU - Beigelman, A.

AU - Baxi, S. N.

AU - Benson, M.

AU - Blake, K.

AU - Chmiel, J. F.

AU - Daines, C. L.

AU - Daines, M. O.

AU - Gaffin, J. M.

AU - Gentile, D. A.

AU - Gower, W. A.

AU - Israel, E.

AU - Kumar, H. V.

AU - Lang, J. E.

AU - Lazarus, S. C.

AU - Lima, J. J.

AU - Ly, N.

AU - Marbin, J.

AU - Morgan, W. J.

AU - Myers, R. E.

AU - Olin, J. T.

AU - Peters, S. P.

AU - Raissy, H. H.

AU - Robison, R. G.

AU - Ross, K.

AU - Sorkness, C. A.

AU - Thyne, S. M.

AU - Wechsler, M. E.

AU - Phipatanakul, W.

PY - 2016/8/18

Y1 - 2016/8/18

N2 - BACKGROUND Studies have suggested an association between frequent acetaminophen use and asthma-related complications among children, leading some physicians to recommend that acetaminophen be avoided in children with asthma; however, appropriately designed trials evaluating this association in children are lacking. METHODS In a multicenter, prospective, randomized, double-blind, parallel-group trial, we enrolled 300 children (age range, 12 to 59 months) with mild persistent asthma and assigned them to receive either acetaminophen or ibuprofen when needed for the alleviation of fever or pain over the course of 48 weeks. The primary outcome was the number of asthma exacerbations that led to treatment with systemic glucocorticoids. Children in both treatment groups received standardized asthma-controller therapies that were used in a simultaneous, factorially linked trial. RESULTS Participants received a median of 5.5 doses (interquartile range, 1.0 to 15.0) of trial medication; there was no significant between-group difference in the median number of doses received (P = 0.47). The number of asthma exacerbations did not differ significantly between the two groups, with a mean of 0.81 per participant with acetaminophen and 0.87 per participant with ibuprofen over 46 weeks of follow-up (relative rate of asthma exacerbations in the acetaminophen group vs. the ibuprofen group, 0.94; 95% confidence interval, 0.69 to 1.28; P = 0.67). In the acetaminophen group, 49% of participants had at least one asthma exacerbation and 21% had at least two, as compared with 47% and 24%, respectively, in the ibuprofen group. Similarly, no significant differences were detected between acetaminophen and ibuprofen with respect to the percentage of asthma-control days (85.8% and 86.8%, respectively; P = 0.50), use of an albuterol rescue inhaler (2.8 and 3.0 inhalations per week, respectively; P = 0.69), unscheduled health care utilization for asthma (0.75 and 0.76 episodes per participant, respectively; P = 0.94), or adverse events. CONCLUSIONS Among young children with mild persistent asthma, as-needed use of acetaminophen was not shown to be associated with a higher incidence of asthma exacerbations or worse asthma control than was as-needed use of ibuprofen.

AB - BACKGROUND Studies have suggested an association between frequent acetaminophen use and asthma-related complications among children, leading some physicians to recommend that acetaminophen be avoided in children with asthma; however, appropriately designed trials evaluating this association in children are lacking. METHODS In a multicenter, prospective, randomized, double-blind, parallel-group trial, we enrolled 300 children (age range, 12 to 59 months) with mild persistent asthma and assigned them to receive either acetaminophen or ibuprofen when needed for the alleviation of fever or pain over the course of 48 weeks. The primary outcome was the number of asthma exacerbations that led to treatment with systemic glucocorticoids. Children in both treatment groups received standardized asthma-controller therapies that were used in a simultaneous, factorially linked trial. RESULTS Participants received a median of 5.5 doses (interquartile range, 1.0 to 15.0) of trial medication; there was no significant between-group difference in the median number of doses received (P = 0.47). The number of asthma exacerbations did not differ significantly between the two groups, with a mean of 0.81 per participant with acetaminophen and 0.87 per participant with ibuprofen over 46 weeks of follow-up (relative rate of asthma exacerbations in the acetaminophen group vs. the ibuprofen group, 0.94; 95% confidence interval, 0.69 to 1.28; P = 0.67). In the acetaminophen group, 49% of participants had at least one asthma exacerbation and 21% had at least two, as compared with 47% and 24%, respectively, in the ibuprofen group. Similarly, no significant differences were detected between acetaminophen and ibuprofen with respect to the percentage of asthma-control days (85.8% and 86.8%, respectively; P = 0.50), use of an albuterol rescue inhaler (2.8 and 3.0 inhalations per week, respectively; P = 0.69), unscheduled health care utilization for asthma (0.75 and 0.76 episodes per participant, respectively; P = 0.94), or adverse events. CONCLUSIONS Among young children with mild persistent asthma, as-needed use of acetaminophen was not shown to be associated with a higher incidence of asthma exacerbations or worse asthma control than was as-needed use of ibuprofen.

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U2 - 10.1056/NEJMoa1515990

DO - 10.1056/NEJMoa1515990

M3 - Article

VL - 375

SP - 619

EP - 630

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 7

ER -