Ciclesonide (Nycomed, Inc) is a new ICS which seems to have no significant effect on growth and hypothalamic-pituitary-adrenal axis.
In 2008, the FDA approved ciclesonide inhalation aerosol (Alvesco, 80 and 160 µg/actuation BID) for prophylactic therapy of asthma in patients aged 12 years and older.
In studies, the incidence of oral adverse events (e.g., oral candidiasis, pharyngitis, cough, and hoarseness) was similar to placebo (9.4% vs 8%). Ciclesonide appears as effective as other ICS but reportedly has a better safety profile.
In a study of 661 prepubertal children (aged (5 to 8.5 years), inhaled ciclesonide at 40-160 μg QD for 1 year had no detectable effect on linear growth. Use of inhaled ciclesonide at 40-160 μg QD for 1 year was not associated with increased adverse events, with no cases of oral candidiasis, and there are no significant changes in cortisol levels.
Patients who previously received bronchodilators alone or inhaled corticosteroids (ICS) should initially receive 80 µg BID, and those who received oral corticosteroids should be given 320 µg BID (maximum dose is 320 µg BID).
References:
FDA Approvals: Alvesco and Tysabri. Medscape, 01/2008.
Ciclesonide May Not Affect Growth Velocity in Children With Asthma. Medscape.
Ciclesonide: An Expert Interview With David I. Bernstein, MD, Medscape Pulmonary Medicine, 2005.
Inhaled steroids can suppress growth of children who are 2 years of age weighing less than 15 kg (high dose per kg). AAAAI, 2011.
No significant effect of daily inhaled steroid for 2 years on linear growth in preschool children with wheezing http://goo.gl/ySAlk
Why ciclesonide has no significant effect on hypothalamic-pituitary-adrenal axis?
The medication is "activated" locally in the lungs. Carboxylesterases in bronchial epithelial cells convert ciclesonide to des-CIC in the lungs. Low systemic levels of des-CIC are a result of the high metabolic clearance by the liver following CIC inhalation.
In studies, the incidence of oral adverse events (e.g., oral candidiasis, pharyngitis, cough, and hoarseness) was similar to placebo (9.4% vs 8%). Ciclesonide appears as effective as other ICS but reportedly has a better safety profile.
In a study of 661 prepubertal children (aged (5 to 8.5 years), inhaled ciclesonide at 40-160 μg QD for 1 year had no detectable effect on linear growth. Use of inhaled ciclesonide at 40-160 μg QD for 1 year was not associated with increased adverse events, with no cases of oral candidiasis, and there are no significant changes in cortisol levels.
Patients who previously received bronchodilators alone or inhaled corticosteroids (ICS) should initially receive 80 µg BID, and those who received oral corticosteroids should be given 320 µg BID (maximum dose is 320 µg BID).
Ciclesonide mnemonic
C
Ciclesonide
Converted to active form (des-CIC)
Carboxyl-esterases in bronchial epithelial cells
Clearance by liver
References:
FDA Approvals: Alvesco and Tysabri. Medscape, 01/2008.
Ciclesonide May Not Affect Growth Velocity in Children With Asthma. Medscape.
Ciclesonide: An Expert Interview With David I. Bernstein, MD, Medscape Pulmonary Medicine, 2005.
Inhaled steroids can suppress growth of children who are 2 years of age weighing less than 15 kg (high dose per kg). AAAAI, 2011.
No significant effect of daily inhaled steroid for 2 years on linear growth in preschool children with wheezing http://goo.gl/ySAlk
Growth and bone maturation unaffected by 1 year of therapy with inhaled flunisolide in prepubescent children with asthma http://goo.gl/G4HMC
Images source: Wikipedia, a free GNU license and public domain.
Images source: Wikipedia, a free GNU license and public domain.