Acetaminophen versus Ibuprofen in Young Children with Mild Persistent Asthma
William J Sheehan, David T Mauger, Ian M Paul, James N Moy, Susan J Boehmer, Stanley J Szefler, Anne M Fitzpatrick, Daniel J Jackson, Leonard B Bacharier, Michael D Cabana, Ronina Covar, Fernando Holguin, Robert F Lemanske Jr, Fernando D Martinez, Jacqueline A Pongracic, Avraham Beigelman, Sachin N Baxi, Mindy Benson, Kathryn Blake, James F Chmiel, Cori L Daines, Michael O Daines, Jonathan M Gaffin, Deborah A Gentile, W Adam Gower, Elliot Israel, Harsha V Kumar, Jason E Lang, Stephen C Lazarus, John J Lima, Ngoc Ly, Jyothi Marbin, Wayne J Morgan, Ross E Myers, J Tod Olin, Stephen P Peters, Hengameh H Raissy, Rachel G Robison, Kristie Ross, Christine A Sorkness, Shannon M Thyne, Michael E Wechsler, Wanda Phipatanakul, NIH/NHLBI AsthmaNet, David T Mauger, Elliot Israel, Wanda Phipatanakul, Lewis Smith, Julian Solway, Jerry Krishnan, Jacqueline Pongracic, Michael Wechsler, Stanley Szefler, Christine Sorkness, Robert Lemanske, Sally Wenzel, Fernando Holguin, Stephen Lazarus, Michael Cabana, Mario Castro, Leonard Bacharier, Monica Kraft, Fernando Martinez, Stephen Peters, Anne Fitzpatrick, William W Busse, Erica Butler, Jennifer Maiolo, Sara Misplay, David Skoner, Glennys Smith, Iliana Flexas, Rajesh Kumar, Melanie Makhija, Nashmia Qamar, Christine Szychlinski, Valerie Bloss, Mark Brown, Katherine Chee, Sarah David, Clara S Ehrman, Dima Ezmigna, Jamie Goodwin, Roni Grad, Anunya Hiranratta, Silvia Lopez, Andrea Paco, Janette Priefert, Natalie S Provencio, Elizabeth Ryan, Monica Varela, Monica Vasquez, Rosemary Weese, Jesus Wences, Jason Decker, Keonna Harrison, Dayna Long, Kelley Meade, Robert Mok, Cindy Nelson-Purdy, Dennis Ren, Hollie Stessel, Lisa Bartnikas, Alisha Bouzaher, Christopher Burke, Matthew Cavanaugh, Julia Chen, Elizabeth Cunningham, Amparito Cunningham, James Friedlander, Enal Hindi, David Kantor, Lianne Kopel, Perdita Permaul, Deviko Rao, Melinda Rossi, Doris Schierembergg, Lynda Schneider, Jennifer Troung, Dale Umetsu, Joseph Zhou, Shean Aujla, John Broyles, Hey Chong, Patricia Dubin, Jonathan Finder, Todd D Green, Lori Holt, Adam Kufen, Geoffrey Kurland, Rose Lanzo, David Nash, Julianne Parente, Catherine Smith, Jonathan Spahr, Daniel J Weiner, Timothy Beaty, Shanae Wakefield Brown, Alice C Bruce, Jennifer C Dodds, Shaneka Douglas, Karen Freedle, Dawn M Simon, Dawn M Whitlock, Melanie Gleason, Gayle Spears, D A Sundstrom, Michael White, Jenny Batalla, Michelle Littlefield, Burnese Rutledge, Deanna Seymour, Shanae Brown, Omar OquendoFlores, Loretta Doty, Beth Gern, Aimee Merchlinski, Jonathan Nelson, James Schmidt, Lindsay Texter, Angela Updegrave, Jennifer Zeller, Ronald Zimmerman Jr, Daniel Craven, Amy DiMarino, Meeghan Hart, Leigh A Kerns, Laurie Logan, Laura Veri, Christopher Codispoti, Jun Fu, Grace Li, Diana Munoz-Mendoza, Shannon Stevens, Benjamin Thompson, Samantha Zitzer, Jessica Bowman, Vicky Bowyer, Judy Gonzales-Vargas, Michelle McKean, Nancy Tran, Christina Batson, Lea Davies, Franceska Kelly, Esmeralda Morales, Abby Redway, Mary Spicher, Lauren Kaminski, Megan R Knutson, Shelly Olson, Sheila Turcsanyi, Tanya Watson, Cheryl Wilmoth, Wanda Caldwell, Courtney Dula, Alysa Ellis, Caroline Horner, Lila Kertz, Tina Norris, Katherine Rivera-Spoljaric, Oscar Rodriguez, Robert Strunk, William J Sheehan, David T Mauger, Ian M Paul, James N Moy, Susan J Boehmer, Stanley J Szefler, Anne M Fitzpatrick, Daniel J Jackson, Leonard B Bacharier, Michael D Cabana, Ronina Covar, Fernando Holguin, Robert F Lemanske Jr, Fernando D Martinez, Jacqueline A Pongracic, Avraham Beigelman, Sachin N Baxi, Mindy Benson, Kathryn Blake, James F Chmiel, Cori L Daines, Michael O Daines, Jonathan M Gaffin, Deborah A Gentile, W Adam Gower, Elliot Israel, Harsha V Kumar, Jason E Lang, Stephen C Lazarus, John J Lima, Ngoc Ly, Jyothi Marbin, Wayne J Morgan, Ross E Myers, J Tod Olin, Stephen P Peters, Hengameh H Raissy, Rachel G Robison, Kristie Ross, Christine A Sorkness, Shannon M Thyne, Michael E Wechsler, Wanda Phipatanakul, NIH/NHLBI AsthmaNet, David T Mauger, Elliot Israel, Wanda Phipatanakul, Lewis Smith, Julian Solway, Jerry Krishnan, Jacqueline Pongracic, Michael Wechsler, Stanley Szefler, Christine Sorkness, Robert Lemanske, Sally Wenzel, Fernando Holguin, Stephen Lazarus, Michael Cabana, Mario Castro, Leonard Bacharier, Monica Kraft, Fernando Martinez, Stephen Peters, Anne Fitzpatrick, William W Busse, Erica Butler, Jennifer Maiolo, Sara Misplay, David Skoner, Glennys Smith, Iliana Flexas, Rajesh Kumar, Melanie Makhija, Nashmia Qamar, Christine Szychlinski, Valerie Bloss, Mark Brown, Katherine Chee, Sarah David, Clara S Ehrman, Dima Ezmigna, Jamie Goodwin, Roni Grad, Anunya Hiranratta, Silvia Lopez, Andrea Paco, Janette Priefert, Natalie S Provencio, Elizabeth Ryan, Monica Varela, Monica Vasquez, Rosemary Weese, Jesus Wences, Jason Decker, Keonna Harrison, Dayna Long, Kelley Meade, Robert Mok, Cindy Nelson-Purdy, Dennis Ren, Hollie Stessel, Lisa Bartnikas, Alisha Bouzaher, Christopher Burke, Matthew Cavanaugh, Julia Chen, Elizabeth Cunningham, Amparito Cunningham, James Friedlander, Enal Hindi, David Kantor, Lianne Kopel, Perdita Permaul, Deviko Rao, Melinda Rossi, Doris Schierembergg, Lynda Schneider, Jennifer Troung, Dale Umetsu, Joseph Zhou, Shean Aujla, John Broyles, Hey Chong, Patricia Dubin, Jonathan Finder, Todd D Green, Lori Holt, Adam Kufen, Geoffrey Kurland, Rose Lanzo, David Nash, Julianne Parente, Catherine Smith, Jonathan Spahr, Daniel J Weiner, Timothy Beaty, Shanae Wakefield Brown, Alice C Bruce, Jennifer C Dodds, Shaneka Douglas, Karen Freedle, Dawn M Simon, Dawn M Whitlock, Melanie Gleason, Gayle Spears, D A Sundstrom, Michael White, Jenny Batalla, Michelle Littlefield, Burnese Rutledge, Deanna Seymour, Shanae Brown, Omar OquendoFlores, Loretta Doty, Beth Gern, Aimee Merchlinski, Jonathan Nelson, James Schmidt, Lindsay Texter, Angela Updegrave, Jennifer Zeller, Ronald Zimmerman Jr, Daniel Craven, Amy DiMarino, Meeghan Hart, Leigh A Kerns, Laurie Logan, Laura Veri, Christopher Codispoti, Jun Fu, Grace Li, Diana Munoz-Mendoza, Shannon Stevens, Benjamin Thompson, Samantha Zitzer, Jessica Bowman, Vicky Bowyer, Judy Gonzales-Vargas, Michelle McKean, Nancy Tran, Christina Batson, Lea Davies, Franceska Kelly, Esmeralda Morales, Abby Redway, Mary Spicher, Lauren Kaminski, Megan R Knutson, Shelly Olson, Sheila Turcsanyi, Tanya Watson, Cheryl Wilmoth, Wanda Caldwell, Courtney Dula, Alysa Ellis, Caroline Horner, Lila Kertz, Tina Norris, Katherine Rivera-Spoljaric, Oscar Rodriguez, Robert Strunk
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 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. (Funded by the National Institutes of Health; AVICA ClinicalTrials.gov number, NCT01606319.).
Figures
Source: PubMed