Inhaled corticosteroids: Clinical relevance of safety measures

Price, John

doi:10.1002/(sici)1099-0496(199709)15+<40::aid-ppul9>3.0.co;2-v

Cited by 19 publications

(5 citation statements)

References 36 publications

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“…This conclusion is further supported by a number of studies in children with asthma of all severities, which have demonstrated only minimal or no systemic effects or HPA axis suppression with a similar dose range of inhaled corticosteroids [1,5,99], as well as a recent comprehensive clinical review of safety measures in children [100]. Further long-term, prospective dose ranging studies, with carefully standardized height measurements are necessary to define the safe and optimal use of higher doses of inhaled corticosteroids in children with asthma.…”

Section: Effect Of Corticosteroids On Knemometrymentioning

confidence: 75%

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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Section: Effect Of Corticosteroids On Knemometrymentioning

confidence: 75%

Effect of inhaled corticosteroids on bones and growth

Efthimiou¹,

Barnes²

1998

Eur Respir J

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“…Extrapolation of knemometry data to longer-term childhood growth (e.g. annualizing 1-month data) has limited value because of short-term variability in growth velocity [22,27]. Furthermore, if an inhaled corticosteroid affects growth to a certain extent during the early months of treatment, with growth velocity during later treatment approaching normal (as suggested in some studies) [16,28] annualizing short-term data would overestimate the effect of treatment on growth.…”

Section: Growth During Childhoodmentioning

confidence: 99%

Evaluating the effects of asthma therapy on childhood growth: principles of study design

Price¹,

Hindmarsh²,

Hughes³

et al. 2002

Eur Respir J

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Inhaled corticosteroids have been established as the most effective treatment for childhood asthma. However, concerns persist regarding their potential effects on growth and, most importantly, final height.To assess their effects on growth, inhaled corticosteroids can be compared with placebo (type 1 study), nonsteroidal anti-asthma therapy (type 2 study), another inhaled corticosteroid (type 3 study) or “real-life” anti-asthma therapy (type 4 study). Owing to the difficulties in obtaining final height data, several different surrogate measures have often been used: short-term lower leg growth, longer-term statural height growth velocity, childhood height and predicted final height.This paper discusses the choice of end point, key trial design issues (including selection and number of subjects in the active and control populations) duration of assessments and methods for measuring height and data analysis, in the context of the different study types.Specific study design recommendations have been developed after consideration of these factors, and these principles will be used to guide the interpretation of previously published growth studies.

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“…[18][19][20] Sorva y colaboradores 21 informaron una disminución transitoria tanto en los marcadores de formación (osteocalcina y propéptido del procolágeno tipo 1-PICP) como en los de resorción ósea (ICTP y puentes cruzados de piridinolina urinario) y sugieren que la budesonida inhalado podría disminuir ligeramente el recambio óseo, pero sin cambios en la masa ósea. Otros autores 13,[22][23][24] han observado que la osteocalcina está reducida en los pacientes con asma bronquial independientemente del uso del esteroide inhalado.…”

Section: Discussionunclassified