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Transcript
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