Inhaled corticosteroids, such as budesonide, beclomethasone or fluticasone, which have been available for many years, have proven to be an important therapy for controlling the inflammation caused by asthma. They are given usually twice daily, and are recommended therapy in international guidelines for most asthmatics. However, the currently available inhaled corticosteroids can be associated with significant side-effects, including local effects in the upper airways such as hoarseness and oral candida (thrush infection). Ciclesonide is a new steroid which is reported to make less of the active steroid available until the drug reaches the lung on inhalation, which could reduce the likelihood of throat symptoms. This findings of this review of 21 trials (7243 participants) do not allow certainty about the relative efficacy of ciclesonide compared to older inhaled corticosteroids, especially at higher doses. The results of the review to date do not indicate whether ciclesonide provides a significantly more useful safety profile that other inhaled corticosteroids at similar equivalent doses. However, the finding of lower oral candidiasis in patients treated with ciclesonide compared to fluticasone may be important for those patients who experience oral thrush with their current ICS. In addition, further studies in children are required to obtain data on the side-effect profile of ciclesonide in this population.
阅读完整摘要
Inhaled corticosteroids (ICS) are an integral part of asthma management, and act as an anti-inflammatory agent in the airways of the lung. These agents confer both significant benefit in terms of symptom management and improvement in lung function, but may also cause harm in terms of local and systemic side-effects. Ciclesonide is a novel steroid that is metabolised to its active component in the lung, making it a potentially useful for reducing local side effects.
研究目的
To assess the efficacy and adverse effects of ciclesonide relative to those of other inhaled corticosteroids in the management of chronic asthma.
检索策略
We searched the Cochrane Airways Group register of trials with pre-defined terms. Additional searches of PubMed and Clinicalstudyresults.org were undertaken. The literature searches for this review are current up to June 2007.
纳入排除标准
Randomised parallel or crossover studies were eligible for the review. We included studies comparing ciclesonide with other steroids both at nominally equivalent dose or lower doses of ciclesonide.
资料收集与分析
Two review authors independently assessed trial quality and extracted data. Study authors were contacted for additional information. Adverse effects information was collected from the trials.
主要结果
Twenty one trials involving 7243 participants were included. Equal daily doses of ciclesonide and beclomethasone (BDP) or budesonide (BUD) gave similar results for peak expiratory flow rates (PEF), although forced vital capacity (FVC) was higher with ciclesonide. Data on forced expired volume in one second (FEV1) were inconsistent. Withdrawal data and symptoms were similar between treatments. Compared with the same dose of fluticasone (FP), data on lung function parameters (FEV1, FVC and PEF) did not differ significantly. Paediatric quality of life score favoured ciclesonide. Candidiasis was less frequent with ciclesonide, although other side-effect outcomes did not give significant differences in favour of either treatment. When lower doses of ciclesonide were compared to BDP or BUD, the difference in FEV1 did not reach significance but we cannot exclude a significant effect in favour of BDP/BUD. Other lung function outcomes did not give significant differences between treatments. Paediatric quality of life scores did not differ between treatments. Adverse events occurred with similar frequency between ciclesonide and BDP/BUD. Comparison with FP at half the nominal dose was undertaken in three studies, which indicated that FEV1 was not significantly different, but was not equivalent between the treatments (per protocol: -0.05 L 95% confidence intervals -0.11 to 0.01).
作者结论
The results of this review give some support to ciclesonide as an equivalent therapy to other ICS at similar nominal doses. The studies assessed low doses of steroids, in patients whose asthma required treatment with low doses of steroids. At half the dose of FP and BDP/BUD, the effects of ciclesonide were more inconsistent The effect on candidiasis may be of importance to people who find this to be problematic. The role of ciclesonide in the management of asthma requires further study, especially in paediatric patients. Further assessment against FP at a dose ratio of 1:2 is a priority.
