Lower leg growth suppression caused by inhaled glucocorticoids is not accompanied by reduced thickness of the cutis or subcutis

Schou, Anders; Plomgaard, Anne Mette; Thomsen, Kristine Rømer; Wolthers, Ole D.

doi:10.1111/j.1651-2227.2004.tb02986.x

Cited by 14 publications

(19 citation statements)

References 23 publications

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“…The lower leg growth rates were almost identical to the data in trials finding short‐term and 1‐yr height growth to be unaffected by montelukast 5 mg daily (24, 25). The 2‐ and 4‐wks short‐term budesonide lower leg growth rates of 0.17 and 0.20 mm/wk, which were approximately 50% of mean lower leg growth rates in populations of pre‐pubertal asthmatic children not on inhaled corticosteroids, and the suppressed height growth rate of 1 cm/yr was very similar to recent double‐blind trials of budesonide Turbuhaler ® 400 μg daily (18, 19, 26). Therefore, it can be firmly concluded that budesonide 200 μg from the Pulairmax ® inhaler once daily in the morning significantly suppress short‐term and 1‐yr height growth.…”

Section: Discussionsupporting

confidence: 89%

“…Short‐term knemometry is a robust measure and the reproducibility of short‐term growth rates in children treated with inhaled corticosteroids does not exclusively rely on whether double‐blinding is applied or not. Studies of dry powder inhaled budesonide delivered from the Turbuhaler ® using open‐label designs have been found to be as sensitive as double‐blind designs as long as the recommended standard measurement conditions for knemometry are followed and, especially, as the measurements are performed without reference to previous recordings (19). The present study conditions all complied with these recommendations.…”

Section: Discussionmentioning

confidence: 99%

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A randomized trial of lower leg and height growth in children with asthma treated with inhaled budesonide from a new dry powder inhaler

Gradman

Wolthers

2010

Pediatric Allergy Immunology

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Short-term knemometry is a highly sensitive and accurate method for non-invasive assessment of systemic activity of inhaled corticosteroids in children with asthma. However, there are no randomized data available to elucidate the relation between inhaled corticosteroid suppressed short-term lower leg and height growth. The aim of the present study was to assess the relation between short-term lower leg and 1-yr height growth in children with asthma treated with inhaled budesonide from the new Pulairmax inhaler 200 μg once daily in the morning or montelukast 5 mg once daily. A total of 52 pre-pubertal children with asthma were included in a randomized open-label parallel group study. Length of the lower leg and height were measured by knemometry and stadiometry, respectively, at study entry and after 2, 4, 12, 20, 28, 36, 44 and 52 wks. Lower leg and height growth rates were significantly lower in the budesonide than in the montelukast group (p < 0.0001). Mean 2-wks lower leg growth rate was 0.17 mm/wk in the budesonide and 0.39 mm/wk in the montelukast treated children (p = 0.02). Mean 1-yr height growth rate was 5.51 cm/yr in the budesonide and 6.51 cm/yr in the montelukast group [95% CI: (0.20; 1.79)]. There was a strong linear correlation between lower leg and height growth in both groups, rho = 0.96 (budesonide) and 0.98 (montelukast). In conclusion, 1-yr height growth suppression of budesonide 200 μg administered via the Pulairmax inhaler once daily in the morning was indicated from suppressed short-term lower leg growth providing evidence that short-term knemometry is able to predict 1-yr height growth suppression of inhaled corticosteroids. Short-term knemometry should be performed as part of the safety assessments of new inhaled corticosteroids and inhalation devices in children with asthma before long-term height growth evaluations are initiated.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 99%

A randomized trial of lower leg and height growth in children with asthma treated with inhaled budesonide from a new dry powder inhaler

Gradman

Wolthers

2010

Pediatric Allergy Immunology

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“… Results of 13 randomized, double‐blind short‐term knemometry studies of inhaled glucocorticoids and of oral prednisolene expressed as percentages of placebo lower leg growth rate (LLGR) (3, 4, 7, 9, 12–18, 20, 31). The right hand y ‐axis is generated from the 1‐yr randomized, double‐blind height growth rate trials listed in Table 1.…”

Section: Short‐term Knemometry Implications For Intermediate‐term Heightmentioning

confidence: 99%

Methodology and implications of knemometry in growth assessment of inhaled glucocorticoids

Wolthers¹

2010

Pediatric Allergy Immunology

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When validated recommendations for standardization and measurement procedures are used short-term assessment of lower leg growth by knemometry is a highly accurate and reproducible method for assessment of systemic activity of inhaled glucocorticoids. Crossover and parallel designs applying consistent measurement intervals can be used. Crossover designs with a single-blind run in and washout and double-blind active periods are as sensitive as designs using randomized placebo periods. In populations of children, short-term knemometry appears to be capable of defining specific glucocorticoids, application devices and doses that do not suppress long-term height growth. Although no specific cut-off level can be identified in individuals from the available randomized, double-blind short-term knemometry and intermediate-term height growth rate studies, good evidence have been provided that if the short-term lower leg growth suppression in populations of children is higher than approximately 25%, the risk of intermediate-term growth suppression becomes significant with a mean height growth rate retardation in the range of approximately 0.5-1.5 cm during the first year of treatment. Short-term knemometry should be performed as an integral part of the safety assessments of new inhaled glucocorticoids and inhalation devices in children with asthma, before intermediate-term height growth evaluations are initiated.

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“…This notion has been supported by the finding of reduced serum markers of bone turnover accompanying short term growth suppression during glucocorticoid treatment [27;29-31;36;37;56;57]. Furthermore, recent studies indicate that reduced subcutaneous thickness may cause some of the growth suppression during prednisolone treatment [25], however, moderate doses (400 µg daily from a dry powder inhaler) of inhaled budesonide do not effect the subcutaneous thickness [32]. Further studies are needed to fully elucidate the contribution of glucocorticoid effects in the bones, cartilage, growth plates, cutis and subcutis, etc.…”

Section: Resultsmentioning

confidence: 90%

“…However, the changes in subcutaneous thickness could only explain a part of the reduced lower leg growth rate, indicating that other factors as reduced linear bone growth must also play a role [25]. No changes in the thickness of cutis and subcutis were found in a parallel study examining the effects of inhaled budesonide 400 µg daily [32]. There are no available studies of the potential effects of higher doses of inhaled glucocorticoids on the thickness of cutis and subcutis in children.…”

Section: Cutis and Subcutismentioning

confidence: 93%

Knemometry for Assessment of Growth Suppressive Effects of Exogenous Glucocorticoids

Schou¹

2006

CPR

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Exogenous glucocorticoids are commonly used in the treatment of various conditions including asthma, rhinitis, and a range of renal, gastrointestinal and malignant diseases in children. Glucocorticoid treatment has numerous systemic side effects beside the beneficial effects. An important and well described side effect is growth suppression. Knemometry, i.e. measurement of the lower leg length, is a well established method for assessment of short term growth. The present article reviews the role of knemometry in the assessment of growth suppressive effects of glucocorticoid treatment, and the present data on lower leg growth during glucocorticoid treatment are summarized. Our knowledge on the effects of exogenous glucocorticoids in the different components (bones, cartilage, cutis and subcutis, etc.) of the lower leg is reviewed, and integrated with recent studies assessing such effects by new methods.

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Lower leg growth suppression caused by inhaled glucocorticoids is not accompanied by reduced thickness of the cutis or subcutis

Cited by 14 publications

References 23 publications

A randomized trial of lower leg and height growth in children with asthma treated with inhaled budesonide from a new dry powder inhaler

A randomized trial of lower leg and height growth in children with asthma treated with inhaled budesonide from a new dry powder inhaler

Methodology and implications of knemometry in growth assessment of inhaled glucocorticoids

Knemometry for Assessment of Growth Suppressive Effects of Exogenous Glucocorticoids

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