1.
Clinical efficacy of montelukast sodium in treating infantile wheezing.
Zou, YX, Zhang, J, Ma, C, Li, J, Zai, J, Guo, YS
European review for medical and pharmacological sciences. 2014;(6):775-80
Abstract
OBJECTIVES The efficacy and safety of a single-dose of Montelukast sodium for treating virus-related infantile wheezing are investigated in this study. PATIENTS AND METHODS A prospective, open, randomized, controlled study was carried out on 595 cases of infants who exhibited wheezing after a respiratory syncytial virus infection. Treatment with Montelukast sodium was provided over the course of 12 weeks. The clinical efficacy of Montelukast sodium was determined based on the clinical symptom score, tidal breathing lung function, and short-acting bronchodilator usage, as well as infantile asthma diagnosis rate change at the 4th and 12th week after the administration of the treatment. The adverse reactions were also observed, and a control group was set. The mean age of the 595 patients with infantile wheezing was 10.82 months ± 4.22 months. Among these patients, 45.9% (273 out of 595) had a family history of asthma, 30.6% (182 out of 595) had allergic rhinitis, 23.9% (142 out of 595) increased peripheral blood eosinophilia, 6.1% (36 out of 595) exhibited total IgE increase, 40.0% (238 out of 595) had a recurrent history of wheezing, and 64.0% (381 out of 595) had a family history of eczema. RESULTS After 12 weeks of treatment, the clinical symptom scores significantly improved. Significant differences in the cough, wheezing, and motility scores were observed before and after the treatment (p < 0.05). TPTEF/TE and VPEF/VE significantly improved (p < 0.05) after the treatment. The asthma diagnosis rate was 9.6% (57 out of 595). At four weeks after treatment, various indicators correspondingly improved. Twenty-nine (4.9%) patients exhibited adverse reactions, 55.2% exhibited excitation, 20.7% suffered from insomnia, 10.3% had headaches, 3.4% had erythra, 3.4% suffered from abdominal pain, and 3.4% exhibited an increased glutamic-pyruvate transaminase level. The symptoms of eczema were relieved to some extent, and the symptoms of rhinitis became less serious. Significant differences were observed in the number of wheezing attacks, annual number of days hospitalized, annual number of days when β2AG was utilized, and lung function improvement (p < 0.05). CONCLUSIONS Montelukast sodium is clinically effective in treating virus-related wheezing, and clinical application for 4 weeks to 12 weeks can effectively relieve the symptoms of wheezing, improve lung function, and reduce the incidence rate of infantile asthma. Montelukast sodium also causes few adverse reactions.
2.
Effect of montelukast, a once-daily leukotriene receptor antagonist, on peak expiratory flow variability.
Zhang, J, Yu, C, Noonan, G, Reiss, TF
Clinical therapeutics. 2002;(4):574-82
Abstract
BACKGROUND Peak expiratory flow (PEF) is an important measure of airway functin in asthma. PEF variability (PEFvar) assessment is described in asthma treatment guidelines as another means of evaluating patient status and response to therapy. OBJECTIVE The goal of this study was to determine the clinical effect of oral montelukast, a leukotriene receptor antagonist, on PEFvar in asthmatic patients and to assess the relationship of PEFvar with other clinical measures. METHODS This was a retrospective analysis of data from a multicenter, randomized, double-blind, placebo-controlled, parallel-group study, details of which have been published previously. Eligible patients had chronic stable asthma, had a forced expiratory volume in 1 second (FEV1) that was 50% to 85% of the predicted value, used inhaled beta-agonists, had at least 15% improvement in absolute FEV1 after inhaled beta-agonist administration, and showed a minimal predefined level of daytime asthma symptoms. Treatment consisted of a 2-week, single-blind, placebo run-in period followed by a 12-week, double-blind treatment period (montelukast 10 mg or matching placebo once daily at bedtime). RESULTS Six hundred eighty-one patients (age range, 15-79 years) were randomized to treatment at 50 centers. Baseline PEFvar was 11.44% +/- 6.55% and 10.62% +/- 6.48% in the montelukast and placebo groups, respectively. PEFvar decreased 20.1% and 7.5% from baseline in the montelukast and placebo groups, respectively. The between-group difference was significant (P < 0.001). PEFvar had low correlation with other clinical measures. CONCLUSIONS Over 12 weeks of treatment, montelukast significantly reduced PEFvar compared with placebo, indicating improved asthma control. The relative reduction in PEFvar was similar in patients with different degrees of variability at baseline. PEFvar did not correlate highly with other outcome variables and may measure different aspects of the disease.
3.
Clinical safety and tolerability of montelukast, a leukotriene receptor antagonist, in controlled clinical trials in patients aged > or = 6 years.
Storms, W, Michele, TM, Knorr, B, Noonan, G, Shapiro, G, Zhang, J, Shingo, S, Reiss, TF
Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology. 2001;(1):77-87
Abstract
OBJECTIVE Montelukast is a leukotriene receptor antagonist administered orally once daily for treatment of chronic asthma in adults and children. A comprehensive analysis of safety data from double-blind, randomized, placebo-controlled trials with montelukast has not been previously reported. PATIENTS AND METHODS A pooled analysis of safety data from 11 multicentre, randomized, controlled montelukast Phase IIb and III trials and five long-term extension studies was performed. A total of 3386 adult patients (aged 15-85 years) and 336 paediatric patients (aged 6-14 years) were enrolled in the trials; 2031 adults received montelukast for up to 4.1 years, and 257 children received montelukast for up to 1.8 years. Summary statistics comparing incidences of adverse events among treatment groups were calculated. RESULTS The overall incidence of clinical and laboratory adverse events among montelukast-treated patients, both adult and paediatric, was similar to that among patients receiving placebo. There were no clinically relevant differences in individual adverse events, including infectious upper respiratory conditions and transaminase elevations, between montelukast and placebo groups. Discontinuations due to adverse events occurred with similar frequencies during placebo, montelukast and inhaled beclomethasone therapy. No dose-related adverse effects of montelukast were observed in adults treated with dosages as high as 200 mg per day (20 times the recommended dose) for 5 months. This tolerability profile montelukast observed in clinical trials has been generally reflected in the post-marketing safety experience seen to date. CONCLUSIONS These data indicate a tolerability profile for montelukast similar to placebo during both short-term and long-term administration, even at doses substantially higher than the recommended clinical dose of 10 mg once daily for adults and 5 mg once daily for children aged 6-14 years.