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Author Bisgaard, H.; Skoner, D.; Boza, M.L.; Tozzi, C.A.; Newcomb, K.; Reiss, T.F.; Knorr, B.; Noonan, G. url  doi
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  Title Safety and tolerability of montelukast in placebo-controlled pediatric studies and their open-label extensions Type Journal Article
  Year (down) 2009 Publication Pediatric Pulmonology Abbreviated Journal Pediatr Pulmonol  
  Volume 44 Issue 6 Pages 568-579  
  Keywords Acetates/*adverse effects; Adolescent; Anti-Asthmatic Agents/*adverse effects; Asthma/*drug therapy; Child; Child, Preschool; Humans; Infant; Quinolines/*adverse effects; Rhinitis, Allergic, Perennial/*drug therapy  
  Abstract BACKGROUND: Montelukast is a potent leukotriene-receptor antagonist administered once daily that provides clinical benefit in the treatment of asthma and allergic rhinitis in children and adults. Because of its wide use as a pediatric controller, there is a need for a further review of the safety and tolerability of montelukast in children. OBJECTIVE: To summarize safety and tolerability data for montelukast from previously reported as well as from unpublished placebo-controlled, double-blind, pediatric studies and their active-controlled open-label extension/extended studies. METHODS: These studies evaluated 2,751 pediatric patients 6 months to 14 years of age with persistent asthma, intermittent asthma associated with upper respiratory infection, or allergic rhinitis. These patients were enrolled in seven randomized, placebo-controlled, double-blind registration and post-registration studies and three active-controlled open-label extension/extended studies conducted by Merck Research Laboratories between 1995 and 2004. RESULTS: Montelukast was well tolerated in all studies. Clinical and laboratory adverse experiences for patients treated with montelukast were generally mild and transient. The most frequent clinical adverse events for all treatments (placebo, montelukast, active control/usual care) in virtually all studies were upper respiratory infection, worsening asthma, pharyngitis, and fever. CONCLUSION: The clinical and laboratory safety profile for montelukast was similar to that observed for placebo or active control/usual care therapies. The safety profile of montelukast did not change with long-term use.  
  Address Danish Pediatric Asthma Center, Copenhagen University Hospital, Gentofte, Copenhagen, Denmark. bisgaard@copsac.dk  
  Corporate Author Thesis  
  Impact Factor 02,704 First Author Bisgaard, H. Editor  
  Language English Summary Language Original Title  
  Series Editor Series Title Abbreviated Series Title  
  Series Volume Series Issue Senior Author Noonan, G.  
  ISSN 1099-0496 ISBN Medium  
  Area Expedition Conference  
  Notes PMID:19449366 Approved no  
  Call Number Serial 135  
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