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Ciclesonide vs. Fluticasone Removal/Replacement to the List Peer Feedback: “similar cost to Avamys and not as effective or well tolerated” Note: Avamys is a fluticasone furoate nasal spray. Fluticasone was included on the list. At the time of this write-up Ciclesonide was not indicated on the list for rhinitis which was the intention of the research team. Literature Review Question: Is Fluticasone (Avamys) more efficacious and better tolerated then Ciclesonide for the treatment of asthma? Literature Search: Medline search of ‘fluticasone AND ciclesonide AND efficacy AND asthma restricted to reviews and meta-analysis’ 2013 Cochrane Review and 2007 review from Abdullah and Khan eCPS - Respiratory Disorders: Asthma in Adults Cochrane Review 2013: Ciclesonide compared to fluticasone (dose ratio 1:1): no significant differences were found for the outcome asthma symptoms. Pooled results showed no significant differences in number of patients with exacerbations (RR 1.37, 95% CI 0.58 to 3.21) and data from a study that could not be pooled in the meta-analysis reported similar numbers of patients with exacerbations in both groups. None of the studies found a difference in adverse effects. No significant difference was found for 24-hour urine cortisol levels between the groups (mean difference 0.54 nmol/mmol, 95% CI -5.92 to 7.00). Ciclesonide versus fluticasone (dose ratio 1:2) was assessed in one study and showed similar results between the two corticosteroids for asthma symptoms. The number of children with exacerbations was significantly higher in the ciclesonide group (RR 3.57, 95% CI 1.35 to 9.47). No significant differences were found in adverse effects (RR 0.98, 95% CI 0.81 to 1.14) and 24hour urine cortisol levels (mean difference 1.15 nmol/mmol, 95% CI 0.07 to 2.23). The quality of evidence was judged ’low’ for the outcomes asthma symptoms and adverse events and ’very low’ for the outcome exacerbations for ciclesonide versus budesonide (dose ratio 1:1). The quality of evidence was graded ’moderate’ for the outcome asthma symptoms, ’very low’ for the outcome exacerbations and ’low’ for the outcome adverse events for ciclesonide versus fluticasone (dose ratio 1:1). For ciclesonide versus fluticasone (dose ratio 1:2) the quality was rated ’low’ for the outcome asthma symptoms and ’very low’ for exacerbations and adverse events (dose ratio 1:2). An improvement in asthma symptoms, exacerbations and side effects of ciclesonide versus budesonide and fluticasone could be neither demonstrated nor refuted and the trade-off between benefits and harms of using ciclesonide instead of budesonide or fluticasone is unclear. The resource use or costs of different ICS should therefore also be considered in final decision making. Longer-term superiority trials are needed to identify the usefulness and safety of ciclesonide compared to other ICS. Additionally these studies should be powered for patient relevant outcomes (exacerbations, asthma symptoms, quality of life and side effects). There is a need for studies comparing ciclesonide once daily with other ICS twice daily to assess the advantages of ciclesonide being a pro-drug that can be administered once daily with possibly increased adherence leading to increased control of asthma and fewer side effects. Kramer, Sharon, et al. "Ciclesonide versus other inhaled corticosteroids for chronic asthma in children." The Cochrane Library (2013). Abdullah and Khan (2007): Fluticasone (FP) compared to Ciclesonide (CIC) Efficacy Equal Quality of life Equal Local Side effects Worse Adrenal suppression Worse Growth retardation Worse Pregnancy Category C / n/a Fluticasone advantages FP is in clinical use for over 10 years while CIC is not yet available in US Fluticasone disadvantages FP must be given BID to be as effective as CIC once daily, and it has more side effects than CIC. Overall CIC may be preferred over FP if it fulfills its early promises of efficacy and safety on further clinical experience Abdullah, Anwar K., and Salman Khan. "Evidence-based selection of inhaled corticosteroid for treatment of chronic asthma." Journal of Asthma 44.1 (2007): 1-12. eCPS (2015) Class Drug Corticosteroids, ciclesonide inhaled Alvesco Dose Adverse Effects pMDI: 100–800 µg daily; usual starting dose200 µg/day b At 800 µg/day, divide dose BID Sore mouth, sore throat, dysphonia, oral thrush (can be reduced by rinsing mouth or using spacer). Corticosteroids, fluticasone pMDI/DPI: 200– Sore mouth, inhaled Flovent 1000 sore throat, HFA,Flovent µg/daydivided dysphonia, oral Comments Bone densitometry is suggested in patients who require high doses or have risk factors for osteoporosis. Costa $$ Patients with personal or family history of glaucoma (and need high-dose inhaled corticosteroids) should have IOP checked soon after starting therapy and periodically thereafter. Bone densitometry is suggested in patients who require high doses or have risk factors for osteoporosis. $$ Class Drug Diskus Adverse Effects Dose BID; may increase to 1000 µg BID if very severe; usual starting dose 200 or250 µg/day b thrush (can be reduced by rinsing mouth or using spacer). Comments Costa Patients with personal or family history of glaucoma (and need high-dose inhaled corticosteroids) should have IOP checked soon after starting therapy and periodically thereafter. Respiratory Disorders: Asthma in Adults, David G. McCormack, MD, FRCPC, FCCP; Date of revision: April 2015 Medication Uses Contraindications (CI), drug interactions (DI) or cautions Adverse Effects (common and severe) Initial dose; typical dose ciclesonide asthma chronic DI: aerosol solution deactivated by CYP3A4 oral thrush, dysphonia Aerosol Soln: 100, 200mcg ; 100, 200 or 400 mcg every 12 hours fluticasone asthma chronic DI: itraconazole oral thrush, dysphonia MDI: 50, 125, 250mcg; 2 puffs every 12 hours Diskus: 250, 500mcg; 12 every 12 hours Monitoring RFTs in elderly and renal impairment