Short-term knemometry and urine cortisol excretion in children treated with fluticasone propionate and budesonide: a dose response study

Agertoft, Lone; Pedersen, Søren

doi:10.1183/09031936.97.10071507

Cited by 115 publications

(83 citation statements)

References 26 publications

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“…8 The potential adverse effects of long-term corticosteroid treatment have been a concern. In school children, ICSs have been reported to affect shortterm growth (2 weeks), 9 intermediate-term growth (3-12 months), 10 -14 and long-term growth (4 -6 years), 15 although final adult height was not affected in 1 long-term observational study. 16 In children aged 2 to 8 years, intermediate-term growth of 12 months was reduced during daily treatment with 1 mg of nebulized budesonide (BUD).…”

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confidence: 81%

Twelve-Month Safety and Efficacy of Inhaled Fluticasone Propionate in Children Aged 1 to 3 Years With Recurrent Wheezing

Bisgaard

Allen²,

Milanowski³

et al. 2004

Pediatrics

141

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ABSTRACT. Objective. Our aim was to compare the 12-month safety and efficacy of fluticasone propionate (FP) and sodium cromoglycate (SCG) in children aged 1 to 3 years with mild to moderate recurrent wheeze.Methods. The study was a randomized, parallelgroup, open-label multicenter study of 625 children, aged 1 to 3 years, with recurrent wheeze randomized in a 3:1 ratio to treatment for 52 weeks with FP (100 g twice daily) via metered-dose inhaler and Babyhaler spacer device or SCG (5 mg 4 times daily) via metered-dose inhaler and Nebuhaler spacer device, respectively.Results. There was no significant difference in mean adjusted growth rates between the 2 groups: 84.0 mm/ year in the FP group versus 86.4 mm/year in the SCG group (difference FP-SCG: ؊2.4 mm/year; 95% confidence interval: ؊6.6 to 1.8). Growth comparisons were independent of age, gender, previous use of steroid, or whether measured as length and/or height. Serum and urinary cortisol concentrations showed a statistically significant suppression of 10% and 14%, respectively, but the number of patients with serum cortisol levels below the lower normal limit was reduced during the trial. Both treatments were well tolerated. The most common drugrelated adverse events were cough (2% FP vs 1% SCG) and hoarseness (1% FP vs 0% SCG). One incident of cataract was observed at baseline and 1 after FP treatment; the latter had resolved after 12 months. The efficacy of FP was superior to SCG with fewer cases of symptom worsening, exacerbations, and requirements for oral steroid treatment and more symptom-free days and days without use of rescue treatment.Conclusions. Twelve months of treatment with inhaled FP (100 g twice daily) in preschool children aged 1 to 3 years with recurrent wheeze has no effect on growth and no other clinically important side effects but is more efficacious than SCG. Pediatrics 2004;113:e87-e94. URL: http://www.pediatrics.org/cgi/content/full/113/2/e87; fluticasone propionate, sodium cromoglycate, asthma, wheeze, preschool children, growth velocity, cortisol.

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confidence: 81%

Twelve-Month Safety and Efficacy of Inhaled Fluticasone Propionate in Children Aged 1 to 3 Years With Recurrent Wheezing

Bisgaard

Allen²,

Milanowski³

et al. 2004

Pediatrics

141

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“…Todavia, tem sido detectada supressão do eixo HHA (sem qualquer expressão clínica) ao se empregar dispositivos de inalação de pó, que aumentam a quantidade de droga que atinge o pulmão, mesmo nessas doses mais baixas 32 .…”

Section: Supressão Do Eixo Hipotálamo-hipófise-adrenalunclassified

Inhaled corticosteroids in the treatment of respiratory allergy: safety vs. efficacy

Rizzo

Solé

2006

J Pediatr (Rio J)

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Objective: Review the molecular mechanisms of action, efficacy, and potential side effects associated with inhaled corticosteroids (ICS) in children with persistent asthma.Sources: Articles in English from MEDLINE. The following terms were used: corticosteroids, inhaled corticosteroids, asthma, children, beclomethasone, fluticasone, budesonide, ciclesonide, growth, adrenal insufficiency, bone mineral density, and oral candidiasis. Treatment guidelines, review articles, controlled trials, meta-analyses, and systematic reviews evaluating the efficacy and the adverse events of treatment with ICS were selected.Summary of the findings: In vivo and in vitro studies show that t h e a v a i l a b l e I C S h a v e d i f f e r e n t p h a r m a c o k i n e t i c a n d pharmacodynamic properties that result in different action potentials. ICS also differ as to the systemic and local side effects. The bioavailability of these products is essential in order to determine the incidence of side effects. In general, ICS are capable of controlling asthma, reducing the number of exacerbations, medical consultations, hospitalizations, and the need of oral corticosteroid (applications) bursts. Improvement can also be seen in pulmonary function, especially in patients with recent onset asthma. The most documented adverse effect is transitory decrease of growth rate.Conclusions: ICS are the main anti-inflammatory agent used to treat persistent asthma. When administered in low doses, they seem to be safe and effective. Patient monitoring allows for early detection of possible side effects associated with ICS.J Pediatr (Rio J). 2006;82(5 Suppl):S198-205: Children, asthma, inhaled corticosteroids, budesonide, beclomethasone, fluticasone, ciclesonide. ResumoObjetivo: Revisar os mecanismos moleculares de ação, eficácia e potenciais efeitos adversos relacionados aos corticosteróides inalados (CEI) em crianças com asma persistente.Fontes dos dados: Artigos de língua inglesa da base de dados MEDLINE. Foram empregados os termos: corticosteroids, inhaled corticosteroids, asthma, children, beclomethasone, fluticasone, budesonide, ciclesonide, growth, adrenal insufficiency, bone mineral density, oral candidiasis. Foram selecionados guias de tratamento, artigos de revisão, estudos controlados, meta-análises e revisões sistemáticas que avaliaram a eficácia e os eventos adversos do tratamento com CEI. Síntese dos dados:Estudos in vivo e in vitro mostram que os CEI disponíveis apresentam diferentes características farmacociné-ticas e farmacodinâmicas que lhes conferem diferentes potenciais de ação. Os CEI também diferem quanto aos efeitos adversos sistêmicos e locais. Salienta-se a biodisponibilidade desses produtos como essencial para determinar a incidência de efeitos colaterais. Em linhas gerais, os CEI são capazes de controlar a asma, reduzindo o número de exacerbações, atendimentos médicos, hospitalizações e a necessidade de pulsos de corticosteróides orais. Também se observa melhora da função pulmonar, sobretudo nos pacientes com asma ...

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“…One of the most carefully designed knemometry studies investigated the effect of FP 200 µg·day -1 and 400 µg·day -1 and budesonide 200 µg·day -1 and 400 µg·day -1 , as dry powders, and placebo on lower leg growth rate [95]. This was a single centre, randomized, double-blind, double dummy, three way crossover study with each treatment lasting 15 days, carried out in 48 children aged 6-12 yrs with mild asthma.…”

Section: Effect Of Corticosteroids On Knemometrymentioning

confidence: 99%

Effect of inhaled corticosteroids on bones and growth

Efthimiou¹,

Barnes²

1998

Eur Respir J

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Asthma is a chronic inflammatory disease of the airways and current national and international asthma management guidelines advocate the early introduction of inhaled corticosteroids as the most effective anti-inflammatory therapy available [1][2][3][4]. However, inhaled corticosteroids are not entirely devoid of risk and their use in clinical practice entails a judgement that weighs the potential benefits against the risks of treatment [5][6]. The potential for systemic effects of inhaled corticosteroids is considered to be reflected in their activity of suppressing the hypothalamic-pituitary-adrenal (HPA) axis [7]. However, the clinical relevance of such suppression has been questioned [8] and concerns have been raised concerning the possible effects of inhaled corticosteroids on bones [9] and growth [10]. This review examines the effects of inhaled corticosteroids on bone metabolism, bone density and growth in adults and children with asthma, in view of the recent availability of a substantial amount of new information from clinical trials. Effect of corticosteroids on bone metabolismCorticosteroids may lead to a reduction in bone mass and osteopenia via several different mechanisms, including direct effects on bone formation and bone resorption and indirect effects via actions on the pituitary-gonadal and pituitary-adrenal axes, intestinal calcium absorption, renal tubular calcium reabsorption and secondary hyperparathyroidism ( fig. 1) [11]. A number of biochemical markers have been used to assess the short-term effects of inhaled corticosteroids on bone turnover [12] (table 1). Bone formation has been evaluated by measuring blood concentrations of bone-specific alkaline phosphatase, osteocalcin and procollagen type-1 carboxy-terminal and amino-terminal propeptides (P1CP and P1NP, respectively). Bone resorption has been evaluated by measuring urinary excretion of hydroxyproline, calcium and pyridinium cross-links and by serum levels of type-1 carboxy-terminal telopeptide (1CTP) and tartrate-resistant acid phosphatase. Examination of relevant retrospective and prospective data, involving 11 studies (1,240 patients) on biochemical bone markers and 14 studies (373 patients) on bone density over a wide dose range, have largely indicated no significant or clinically important effect on these measurements in adults or children with asthma. Markers of bone formation and resorption need to be measured concurrently for a reliable assessment of bone turnover to be made.Knemometry, measuring lower leg growth rate, is a sensitive technique for comparing the systemic activity of different inhaled corticosteroids, but does not relate to long-term growth. The majority of approximately 40 studies on inhaled corticosteroids and statural growth in children, over a wide recommended dose range, including a number of recent long-term, prospective studies, demonstrate little or no effect. Children taking above recommended doses of inhaled corticosteroids should have their growth monitored using stadiometry at least every 6 month...

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Short-term knemometry and urine cortisol excretion in children treated with fluticasone propionate and budesonide: a dose response study

Abstract: It is concluded that, dose-for-dose, budesonide Turbuhaler and fluticasone propionate Diskhaler have similar systemic effects.

Cited by 115 publications

References 26 publications

Twelve-Month Safety and Efficacy of Inhaled Fluticasone Propionate in Children Aged 1 to 3 Years With Recurrent Wheezing

Twelve-Month Safety and Efficacy of Inhaled Fluticasone Propionate in Children Aged 1 to 3 Years With Recurrent Wheezing

Inhaled corticosteroids in the treatment of respiratory allergy: safety vs. efficacy

Effect of inhaled corticosteroids on bones and growth

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