A COMPARISON OF CLINICAL EFFICACY AND SAFETY OF CICLESONIDE WITH FLUTICASONE IN 1-1 AND 1-2 DOSE RATIOS IN THE TREATEMENT OF BRONCHIAL ASTHMA

Author(s)

Wojciechowski P, Stozek A, Rogoz A, Rys P, Wladysiuk M, Plisko RHTA Consulting, Krakow, Poland

OBJECTIVES: This study compared efficacy and safety of ciclesonide (CIC) with fluticasone (FP) in the treatment of bronchial asthma. METHODS: Comparison was based on randomized controlled trials (RCTs) identified by means of systematic review, carried out according to the Cochrane Collaboration guidelines. The most important medical databases (EMBASE, MEDLINE, CENTRAL) were searched. Two reviewers independently selected trials, assessed their quality and extracted data. Meta-analysis of head-to-head trials was performed. RESULTS:  Ten RCTs directly comparing CIC vs FP were identified and included in the analysis. Comparisons of both interventions in 1:1 and 1:2 dose ratios were assessed in 8 and 5 trials, respectively. Efficacy of CIC was comparable to FP in both, 1:1 and 1:2 dose ratios with respect to reduction in risk of asthma exacerbations, improvement in proportion of symptom-free days, rescue medication-free days and improvement in asthma symptoms. Moreover, CIC and FP showed similar improvement in spirometric parameters. Comparison between CIC and FP in 1:1 dose ratio revealed that treatment with CIC was associated with statistically significant risk reduction of adverse events possibly related to study medication (RR = 0.57 [0.39; 0.83]; NNT = 16.89 [10.24; 48.18]) and candidosis (RR = 0.31 [0.17; 0.56], NNT = 32.74 [22.23; 61.99]), while the differences between groups were not significant for 1:2 dose ratio. There were no statistically significant differences between CIC and FP in either dose ratio with respect to the risk of any adverse events, upper respiratory tract infections, pharyngitis and dysphonia. CONCLUSIONS: Ciclesonide is a therapeutic option for patients with bronchial asthma showing comparable efficacy to fluticasone in both 1:1 and 1:2 dose ratios and provides concomitant risk reduction of candidosis and adverse events related to study medication.

Conference/Value in Health Info

2010-11, ISPOR Europe 2010, Prague, Czech Republic

Value in Health, Vol. 13, No. 7 (November 2010)

Code

PRS7

Topic

Clinical Outcomes, Epidemiology & Public Health

Topic Subcategory

Comparative Effectiveness or Efficacy, Safety & Pharmacoepidemiology

Disease

Respiratory-Related Disorders

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