Browse > Article
http://dx.doi.org/10.3345/kjp.2015.58.9.347

The efficacy and safety of Montelukast sodium in the prevention of bronchopulmonary dysplasia  

Kim, Sang Bum (Department of Pediatrics, Ajou University School of Medicine)
Lee, Jang Hoon (Department of Pediatrics, Ajou University School of Medicine)
Lee, Juyoung (Department of Pediatrics, Seoul National University College of Medicine)
Shin, Seung Han (Department of Pediatrics, Seoul National University College of Medicine)
Eun, Ho Sun (Department of Pediatrics, Yonsei University College of Medicine)
Lee, Soon Min (Department of Pediatrics, Yonsei University College of Medicine)
Sohn, Jin A (Department of Pediatrics, Seoul National University College of Medicine)
Kim, Han Suk (Department of Pediatrics, Seoul National University College of Medicine)
Choi, Byung Min (Department of Pediatrics, Korea University Ansan Hospital)
Park, Min Soo (Department of Pediatrics, Yonsei University College of Medicine)
Park, Kook In (Department of Pediatrics, Yonsei University College of Medicine)
Namgung, Ran (Department of Pediatrics, Yonsei University College of Medicine)
Park, Moon Sung (Department of Pediatrics, Ajou University School of Medicine)
Publication Information
Clinical and Experimental Pediatrics / v.58, no.9, 2015 , pp. 347-353 More about this Journal
Abstract
Purpose: The purpose of this study was to evaluate the efficacy and safety of Montelukast sodium in the prevention of bronchopulmonarydysplasia (BPD). Methods: The Interventional study was designed as a multicenter, prospective, and randomized trial, with open labeled and parallel-experimental groups, 66 infants were enrolled and allocated to either the case group (n=30) or the control group (n=36) based on gestational age (GA). Infants in the case group were given Montelukast sodium (Singulair) based on their body weight (BW). Zero week was defined as the start time of the study. Results: The incidence of moderate to severe BPD was not different between the groups (case group: 13 of 30 [43.3%] vs. control group: 19 of 36 [52.8%], P=0.912). Additionally, secondary outcomes such as ventilation index, mean airway pressure and resort to systemic steroids were not significantly different. There were no serious adverse drug reactions in either group, and furthermore the rate of occurrence of mild drug related-events were not significantly different (case group: 10 of 42 [23.8%] vs. control group: 6 of 48 (15.8%), P=0.414). Conclusion: Montelukast was not effective in reducing moderate or severe BPD. There were no significant adverse drug events associated with Montelukast treatment.
Keywords
Broncopulmonary dysplasia; Leukotriene antagonists; Montelukast; Pharmacokinetics; Premature infant;
Citations & Related Records
Times Cited By KSCI : 2  (Citation Analysis)
연도 인용수 순위
1 Laughon M, Allred EN, Bose C, O'Shea TM, Van Marter LJ, Ehrenkranz RA, et al. Patterns of respiratory disease during the first 2 postnatal weeks in extremely premature infants. Pediatrics 2009; 123:1124-31.   DOI
2 Wright CJ, Kirpalani H. Targeting inflammation to prevent bronchopulmonary dysplasia: can new insights be translated into therapies? Pediatrics 2011;128:111-26.   DOI
3 Zeitlin J, Draper ES, Kollee L, Milligan D, Boerch K, Agostino R, et al. Differences in rates and short-term outcome of live births before 32 weeks of gestation in Europe in 2003: results from the MOSAIC cohort. Pediatrics 2008;121:e936-44.   DOI
4 Storms W, Michele TM, Knorr B, Noonan G, Shapiro G, Zhang J, et al. Clinical safety and tolerability of montelukast, a leukotriene receptor antagonist, in controlled clinical trials in patients aged > or = 6 years. Clin Exp Allergy 2001;31:77-87.   DOI
5 Philip AG. Oxygen plus pressure plus time: the etiology of bronchopulmonary dysplasia. Pediatrics 1975;55:44-50.
6 Baveja R, Christou H. Pharmacological strategies in the prevention and management of bronchopulmonary dysplasia. Semin Perinatol 2006;30:209-18.   DOI
7 Jobe AH, Ikegami M. Prevention of bronchopulmonary dysplasia. Curr Opin Pediatr 2001;13:124-9.   DOI
8 Choi CW, Kim BI, Kim EK, Song ES, Lee JJ. Incidence of bronchopulmonary dysplasia in Korea. J Korean Med Sci 2012;27:914-21.   DOI
9 Payne NR, LaCorte M, Karna P, Chen S, Finkelstein M, Goldsmith JP, et al. Reduction of bronchopulmonary dysplasia after participation in the Breathsavers Group of the Vermont Oxford Network Neonatal Intensive Care Quality Improvement Collaborative. Pediatrics 2006;118 Suppl 2:S73-7.   DOI
10 Stoll BJ, Hansen NI, Bell EF, Shankaran S, Laptook AR, Walsh MC, et al. Neonatal outcomes of extremely preterm infants from the NICHD Neonatal Research Network. Pediatrics 2010;126:443-56.   DOI
11 Speer CP. New insights into the pathogenesis of pulmonary inflammation in preterm infants. Biol Neonate 2001;79:205-9.   DOI
12 Jobe AH. What is BPD in 2012 and what will BPD become? Early Hum Dev 2012;88 Suppl 2:S27-8.   DOI
13 Martin RJ, Fanaroff AA. The preterm lung and airway: past, present, and future. Pediatr Neonatol 2013;54:228-34.   DOI
14 Beller TC, Friend DS, Maekawa A, Lam BK, Austen KF, Kanaoka Y. Cysteinyl leukotriene 1 receptor controls the severity of chronic pulmonary inflammation and fibrosis. Proc Natl Acad Sci U S A 2004;101:3047-52.   DOI
15 Phillips GJ, Mohammed W, Kelly FJ. Oxygen-induced lung injury in the pre-term guinea pig: the role of leukotriene B4. Respir Med 1995;89:607-13.   DOI
16 Sheikh S, Null D, Gentile D, Bimle C, Skoner D, McCoy K, et al. Urinary leukotriene E(4) excretion during the first month of life and subsequent bronchopulmonary dysplasia in premature infants. Chest 2001;119:1749-54.   DOI
17 Kim HM, Song JE, Lee SM, Park MS, Park KI, Namgung R, et al. Montelukast as an add-on therapy in bronchopulmonary dysplasia. Korean J Pediatr 2009;52:181-6.   DOI
18 Joung KE, Kim HS, Lee J, Shim GH, Choi CW, Kim EK, et al. Correlation of urinary inflammatory and oxidative stress markers in very low birth weight infants with subsequent development of bronchopulmonary dysplasia. Free Radic Res 2011;45:1024-32.   DOI
19 Knorr B, Maganti L, Ramakrishnan R, Tozzi CA, Migoya E, Kearns G. Pharmacokinetics and safety of montelukast in children aged 3 to 6 months. J Clin Pharmacol 2006;46:620-7.   DOI
20 Kearns GL, Lu S, Maganti L, Li XS, Migoya E, Ahmed T, et al. Pharmacokinetics and safety of montelukast oral granules in children 1 to 3 months of age with bronchiolitis. J Clin Pharmacol 2008;48:502-11.   DOI
21 Ambalavanan N, Wu TJ, Tyson JE, Kennedy KA, Roane C, Carlo WA. A comparison of three vitamin A dosing regimens in extremely-low-birth-weight infants. J Pediatr 2003;142:656-61.   DOI
22 Dani C, Bertini G, Pezzati M, Filippi L, Cecchi A, Rubaltelli FF. Inhaled nitric oxide in very preterm infants with severe respiratory distress syndrome. Acta Paediatr 2006;95:1116-23.   DOI
23 Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med 2001;163:1723-9.   DOI
24 Northway WH Jr, Rosan RC, Porter DY. Pulmonary disease following respirator therapy of hyaline-membrane disease. Bronchopulmonary dysplasia. N Engl J Med 1967;276:357-68.   DOI
25 Bonikos DS, Bensch KG, Northway WH Jr, Edwards DK. Bronchopulmonary dysplasia: the pulmonary pathologic sequel of necrotizing bronchiolitis and pulmonary fibrosis. Hum Pathol 1976;7:643-66.   DOI
26 Charafeddine L, D'Angio CT, Phelps DL. Atypical chronic lung disease patterns in neonates. Pediatrics 1999;103(4 Pt 1):759-65.   DOI
27 Park MS, Sohn MH, Kim KE, Park MS, Namgung R, Lee C. 5-Lipoxygenase-activating protein (FLAP) inhibitor MK-0591 prevents aberrant alveolarization in newborn mice exposed to 85% oxygen in a dose- and time-dependent manner. Lung 2011;189: 43-50.   DOI
28 Manji JS, O'Kelly CJ, Leung WI, Olson DM. Timing of hyperoxic exposure during alveolarization influences damage mediated by leukotrienes. Am J Physiol Lung Cell Mol Physiol 2001;281:L799-806.   DOI
29 Rogers LK, Tipple TE, Nelin LD, Welty SE. Differential responses in the lungs of newborn mouse pups exposed to 85% or >95% oxygen. Pediatr Res 2009;65:33-8.   DOI
30 Bjermer L. Montelukast in the treatment of asthma as a systemic disease. Expert Rev Clin Immunol 2005;1:325-36.   DOI
31 Nayak A, Langdon RB. Montelukast in the treatment of allergic rhinitis: an evidence-based review. Drugs 2007;67:887-901.   DOI
32 Bisgaard H, Skoner D, Boza ML, Tozzi CA, Newcomb K, Reiss TF, et al. Safety and tolerability of montelukast in placebo-controlled pediatric studies and their open-label extensions. Pediatr Pulmonol 2009;44:568-79.   DOI
33 Sarkar M, Koren G, Kalra S, Ying A, Smorlesi C, De Santis M, et al. Montelukast use during pregnancy: a multicentre, prospective, comparative study of infant outcomes. Eur J Clin Pharmacol 2009; 65:1259-64.   DOI