Ciclesonide | place in therapy review measurements, or HPA suppression occurred in any of the patients (Agertoft & Pedersen 2005). Growth velocity was unaffected by 1 year of treatment with ciclesonide in 661 children aged 5–8.5 years (Skoner et al. 2006). During treatment, mean linear growth velocity was 5.73 cm/year with ciclesonide 40 mcg/day, 5.6 cm/year with ciclesonide 160 mcg/day, and 5.75 cm/year with placebo. In the same patient cohort, ciclesonide also had no effect on skeletal maturity, as measured by chronologic to bone age ratio (Neffen et al. 2006). A shift from normal to high ratio was seen in 17 patients, although a treatment-related effect seems unlikely since fewer of those taking higher-dose ciclesonide were affected (1.1%), and the incidence with low-dose ciclesonide was similar to that with placebo (4.3 and 4%). Drug interaction potential The pharmacokinetic properties of ciclesonide are such that significant drug–drug interactions are not expected with its use. Ciclesonide is activated in airways at the desired site of action and very little of the drug is available to the systemic circulation. A single pharmacokinetic study evaluating ciclesonide and erythromycin coadministration demonstrated a lack of interaction between these medications (Nave et al. 2005b). As with other inhaled corticosteroids, drug–drug interactions are not considered to be a clinical concern. Resource utilization At present, economic evidence comparing the use of ciclesonide with other inhaled corticosteroids is not available. Ciclesonide, from a clinical standpoint, appears comparable to budesonide and fluticasone propionate, but with less propensity for systemic adverse effects. It is possible that the once-daily administration of ciclesonide coupled with its low adverse event profile will give ciclesonide an advantage over other inhaled corticosteroids. Use of ciclesonide over one of the other inhaled corticosteroids will ultimately depend on additional long-term data as they become available, including its long-term adverse effect profile and impact on HRQOL. Economic data, including the effect of ciclesonide treatment on both direct and indirect medical costs, will need to be factored into the decision-making process to determine its place in therapy with regard to the other inhaled corticosteroids. In general, inhaled corticosteroids are considered the most effective therapy for reducing asthma exacerbations and studies have reported that the use of these agents reduce medical costs and decrease the use of healthcare resources (Halpern 2003). A recent meta analysis examined the long-term effects of inhaled corticosteroids, long-acting beta2 agonists, leukotriene pathway modifiers/receptor antagonists, and antiimmunoglobulin E antibody therapies. Of these agents, inhaled corticosteroids were found to have the greatest impact on the reduction of asthma exacerbations (55% vs placebo; relative risk 0.46, 95% confidence intervals 0.34, 0.62; P<0.001) (Sin et al. 2004). These reductions in exacerbations translate to economic savings from decreased hospitalizations, decreased emergency room 246 visits, and a decrease in physician visits and use of rescue medications. In order for an inhaled corticosteroid to produce its positive effects, it must be used continuously to keep the inflammatory process in check. Patient group/population Asthma affects all age groups, from pediatric patients to the elderly. Available evidence for ciclesonide demonstrates efficacy in patients with persistent asthma that is similar to other currently available inhaled corticosteroids. Inhaled corticosteroids are the mainstay of treatment for patients with persistent asthma. Any patient with symptom frequency that suggests persistent disease would benefit from maintenance treatment with an agent such as ciclesonide. The evidence for a lack of effect on growth rate and skeletal maturation in children in the long term (1 year) indicates that ciclesonide is suitable for pediatric use. Dosage, administration, and formulations Ciclesonide (Alvesco®) is available in a 80 mcg and 160 mcg metered-dose inhaler, with hydrofluoroalkane propellant. Approved dosages and indications vary between different countries, and readers are advised to consult their local prescribing information (Anon. 2006). The recommended starting dose is usually 160 mcg once daily, preferably in the evening. Maintenance on 80 mcg once daily may be effective in some patients. No dosage adjustment is necessary in the elderly or in patients with hepatic or renal impairment. Place in therapy The unique pharmacokinetic profile of ciclesonide confers a potential advantage in that there is minimal systemic absorption of active drug, which appears to be sustained as shown by a lack of HPA axis suppression after 1 year of treatment. Further evidence will confirm if efficacy is sustained in the longer term with approved doses, and if the decrease in systemic exposure is linked to an overall increased safety profile. The decrease in adverse effects that have been observed in short-term trials may be beneficial in some patients for whom the local effects are bothersome and may lead to disruptions in therapy. In addition, patients with more severe disease who are being treated with higher doses of inhaled corticosteroids may also benefit because of the apparent decrease in systemic exposure associated with ciclesonide use. The drug appears to have a role in the management of pediatric patients with asthma, and is not associated with growth retardation in long-term use. The available evidence indicates that ciclesonide is as effective as fluticasone and budesonide for the management of persistent asthma, as shown by improvements in lung function parameters, symptom scores, and use of rescue medications. Inhaled corticosteroids are considered to be the foundation of asthma management in patients with persistent disease (Table 2). It is expected that ciclesonide will be included in updated guidelines as a primary therapy along with other inhaled corticosteroids. Currently, the use of combination inhalers © 2006 Core Medical Publishing Limited