Efficacy and safety of high-dose ciclesonide for the treatment of severe asthma

Bateman, Eric D.

doi:10.1586/17476348.2013.814385

Cited by 7 publications

(5 citation statements)

References 71 publications

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“…[8,9] The side effects of normal ICS use are modest, including hoarseness and oral ulcers, [10,11] whereas high-dose and sustained use of ICS is associated with more serious adverse effects. [12–15] However, many studies have found heterogeneity in the therapeutic responses to ICS among asthma patients who show poor improvements in the forced expiratory volume at one second (FEV 1 ), even though they are highly compliant with medication use. [4,16] Thus, identifying those patients who do not benefit from ICS and modifying their treatment regimens to improve health outcomes would be meaningful.…”

Section: Introductionmentioning

confidence: 99%

GLCCI1 rs37973

et al. 2017

Medicine

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Glucocorticoids are the primary anti-inflammatory therapy for asthma, but their effects are characterized by some interindividual variability that might have a genetic basis.We aimed to determine the relationship between pulmonary function change and the variant of the glucocorticoid-induced transcript 1 (GLCCI1) gene in patients with asthma receiving long-term ICS treatment, the association of GLCCI1 genotypes and the level of GLCCI1 expression and cytokines production.A total of 418 patients with asthma, including 25 individuals from 11 families with a history of asthma, were enrolled. The effects of single-nucleotide polymorphisms (SNPs) in GLCCI1 on changes in lung function in response to inhaled glucocorticoids were assessed. The expression levels of GLCCI1 mRNA and cytokines were also measured.The SNP rs37973 in GLCCI1 was independently associated with changes in forced expiratory volume at one second (FEV1) and FEV1%pred. Individuals homozygous for the wild-type allele who had a percent FEV1 change greater than 5% were more common than individuals homozygous for the rare allele. When patients were stratified according to genotype, GLCCI1 expression was enhanced upon administration of low-dose dexamethasone among patients with the rs37973 A allele; however, GG homozygotes required high-dose dexamethasone to achieve enhanced GLCCI1 expression. Furthermore, the levels of some cytokines were significantly reduced after glucocorticoid treatment in individuals with the AA and AG genotypes.The genetic variant rs37973 in GLCCI1 is associated with poorer clinical therapeutic response to inhaled glucocorticoids in a Chinese asthma population.

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Section: Introductionmentioning

confidence: 99%

GLCCI1 rs37973

et al. 2017

Medicine

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“…Responsiveness to ICS is generally much lower in smokers than nonsmokers with asthma 12. Data published by Tomlinson et al13 demonstrate that, compared with nonsmokers, smokers with mild persistent asthma are insensitive to the therapeutic effect of low-dose ICS.…”

Section: Discussionmentioning

confidence: 99%

Control of moderate-to-severe asthma with randomized ciclesonide doses of 160, 320 and 640 μg/day

Pedersen¹,

Prasad²,

Goehring³

et al. 2017

JAA

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BackgroundThe inhaled corticoteroid (ICS) ciclesonide (Cic), controls asthma symptoms in the majority of patients at the recommended dose of 160 µg/day. However, the relationship between the level of asthma control and increasing doses of Cic is unknown. This study investigated whether long-term treatment with higher doses of Cic would further improve asthma symptoms in patients with uncontrolled asthma despite ICS use.Patients and methodsIn a double-blind, randomized, parallel-group study, 367 patients were allocated to one of three treatment arms (Cic 160, 320 and 640 µg/day). After a single-blind, 3-week baseline period with Cic 160 µg/day, eligible patients were randomized to receive 52 weeks of treatment with Cic 160, 320 or 640 µg/day (double-blind period) during which forced expiratory volume in 1 second (FEV1), exacerbations and Asthma Control Questionnaire (ACQ) scores were measured.ResultsTreatment with all the three doses was associated with significant improvements in ACQ scores, FEV1 and asthma symptoms (P<0.01). There were no statistically significant differences between the three doses. The results of the primary end point analysis showed a numerical improvement in the ACQ score with Cic 640 µg/day compared with Cic 160 µg/day (least square [LS] mean: −0.122; two-sided P-value: 0.30). Post hoc subgroup analyses showed that the improvement in the ACQ score with Cic 640 µg/day compared with Cic 160 µg/day was statistically significant in subjects who experience at least one exacerbation per year (LS mean: −0.586; 95% confidence interval: −1.110, −0.062, P=0.0285). Adverse events were low and consistent with the known safety profile of Cic.ConclusionIn patients with persistent, uncontrolled asthma, increasing the Cic dose from 160 to 640 µg/day provided no clear additional effect. Patients who experience more than one exacerbation per year may benefit from higher doses; however, further studies are necessary to confirm this. All Cic doses were well tolerated.

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“…Ciclesonide quickly gets metabolized in the lungs but rarely becomes activated in the oropharynx, and thus shows little systemic and topical side effects (115). Satisfactory therapeutic efficacy and safety profiles of ciclesonide in severe asthma have been demonstrated by clinical trials (115,116). However, it is noteworthy that extremely large dose of ICS may increase the risk for adverse effects, including adrenal suppression, and growth retardation in children.…”

Section: Icsmentioning

confidence: 99%