Montelukast — evaluation in 6 to 14 years old children with persistent asthma — pediatric montelukast study group

Kukreja, Sham; Saran, Sonal; Ghosh, Gautam; Aggarwal, Kshitij; Moharana, Ashok K

doi:10.1007/bf02730720

Cited by 3 publications

(1 citation statement)

References 20 publications

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“…Table 3 provides a breakdown of the frequencies of the ADRs by class organ system reported in the prospective studies and RCT. [26][27][28][29] Following SmPC guidelines, a standardised frequency term was generated (very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10 000 to <1/1000); very rare (<1/10 000)). 25 The total number of patients who were administered with an LTRA across the four prospective studies/RCT (1050 patients) was used as the denominator.…”

Section: Attribution Of Frequency Terms-prospective Studies and Rctmentioning

confidence: 99%

Adverse drug reactions of leukotriene receptor antagonists in children with asthma: a systematic review

Dixon

Rugg-Gunn

Sellick³

et al. 2021

bmjpo

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BackgroundAsthma is the most common chronic condition of childhood. Leukotriene receptor antagonists (LTRAs) are included in international guidelines for children and young people (CYP), but there have been highly publicised concerns about potential adverse effects. The aim was to identify and understand the reported frequency of adverse drug reactions (ADRs) attributed to LTRAs in CYP with asthma.MethodsEmbase, MEDLINE, PubMed and CINAHL were searched up to October 2020. Reference lists of eligible papers were manually screened. Eligible studies identified adverse events attributed to an LTRA in individuals aged between 0 and 18 years diagnosed with asthma. Four different tools were used to assess risk of bias or quality of data to accommodate the papers assessed.ResultsThe search identified 427 papers after deduplication; 15 were included (7 case reports, 7 case–controlled or cohort studies and 1 randomised control trial (RCT)). 7012 patients were recorded, of which 6853 received an LTRA. 13 papers examined the ADRs attributed to montelukast, one to pranlukast and one to unspecified LTRAs. After language standardisation, 48 ADRs were found, 20 of which were psychiatric disorders. Across all studies, the most commonly reported ADRs were ‘anxiety’, ‘sleep disorders’ and ‘mood disorders’. The frequency of ADRs could be calculated in seven of the eight studies. Applying standardised frequency terms to the prospective studies and RCT, there were 14 ‘common’ and ‘uncommon’ ADRs. ‘Common’ ADRs included ‘agitation/hyperactivity/irritability/nervousness’, ‘aggression’ and ‘headache’. The case reports showed a similar pattern, describing 46 different ADRs experienced by a total of eight patients.ConclusionsLTRAs have a wide range of suspected ADRs in CYP, predominantly gastrointestinal and neuropsychiatric disorders. Careful monitoring of CYP with asthma is required, both to assess and manage ADRs and to step treatment down when clinically stable.PROSPERO registration numberCRD42020209627.

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Section: Attribution Of Frequency Terms-prospective Studies and Rctmentioning

confidence: 99%

Adverse drug reactions of leukotriene receptor antagonists in children with asthma: a systematic review

Dixon

Rugg-Gunn

Sellick³

et al. 2021

bmjpo

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Montelukast administered in the morning or evening to prevent exercise‐induced bronchoconstriction in children

Pajaron-Fernandez

Garcia-Rubia²,

Sánchez-Solís

et al. 2006

Pediatric Pulmonology

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Montelukast is recommended to be taken in the evening. The effectiveness of this drug to prevent exercise-induced bronchoconstriction (EIB) in children was already evaluated. However, there is no information to determine if this effectiveness could vary depending on dosage time. Children (n = 24) with a documented history of EIB performed an exercise challenge test before starting montelukast treatment. Twelve children were randomly allocated to receive the drug in the morning for 2 weeks, and another 12 to receive it in the evening. After this treatment period and after a week of washout, the children were crossed over. An exercise test was repeated after the first and second periods of treatment. Values obtained after morning or evening dosage were compared with pretreatment values for the whole group of children. There was a significant effect of montelukast for protecting against EIB, measured both as percent of maximum fall in forced expired volume in 1 sec (FEV1) (18.9 +/- 9.7, morning, 18.7 +/- 11.3, evening, vs. 27.5 +/- 9.8, pretreatment; P < 0.05) or as area under the curve (156.4 +/- 102.0, morning, 145.4 +/- 130.6, evening, vs. 294.3 +/- 156.5, pretreatment; P < 0.005). There were no statistical differences between taking the drug in the morning or evening. In conclusion, montelukast, taken for 2 weeks, is equally effective in exercise-induced bronchoconstriction when dosing either in the morning or in the evening.

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Montelukast versus Budesonide as a First Line Preventive Therapy in Mild Persistent Asthma in 2 to 18 y

et al. 2014

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The present study suggests that oral Montelukast is not inferior to Budesonide in treatment of mild persistent asthma in 2 to 18 y children in terms of control of symptoms and improvement in pulmonary function tests over a 12 wk period. However, there was more significant improvement in day time symptoms, more significant increase in FEV1/FVC ratio and less exacerbation in patients receiving Budesonide compared to those receiving Montelukast. However, side effects due to long term use of steroids such as growth stunting and bone osteopenia should also be considered before recommending. Trial registered at CTRI no. REF/2012/09/004035.

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Montelukast — evaluation in 6 to 14 years old children with persistent asthma — pediatric montelukast study group

Abstract: Montelukast administered once daily improved efficacy end-points and was well tolerated in pediatric patients with chronic persistent asthma establishing itself as a valuable treatment option to current asthma therapies in 6 to 14 years old patients.

Cited by 3 publications

References 20 publications

Adverse drug reactions of leukotriene receptor antagonists in children with asthma: a systematic review

Adverse drug reactions of leukotriene receptor antagonists in children with asthma: a systematic review

Montelukast administered in the morning or evening to prevent exercise‐induced bronchoconstriction in children

Montelukast versus Budesonide as a First Line Preventive Therapy in Mild Persistent Asthma in 2 to 18 y

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