Lack of effect on adult and adolescent hypothalamic-pituitary-adrenal axis function with use of fluticasone furoate nasal spray

Patel, Deepen; Ratner, Paul H.; Clements, Diane; Wu, Wei; Faris, Melissa; Philpot, E.

doi:10.1016/s1081-1206(10)60476-0

Cited by 23 publications

(17 citation statements)

References 24 publications

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“…Recently, fluticasone furoate nasal spray, 110 g once daily, was not associated with HPA axis suppression in patients 12 years and older with perennial AR [53] .…”

Section: Fluticasone Furoatementioning

confidence: 99%

Intranasal Corticosteroids and Adrenal Suppression

Bruni¹,

Luca²,

Venturoli³

et al. 2009

Neuroimmunomodulation

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Allergic rhinitis is a common condition that frequently coexists with asthma and atopic dermatitis. It is commonly treated with intranasal corticosteroids which may increase the potential inception of side effects of the same type of drugs used for the treatment of other allergic diseases. A method to assess the systemic effect of corticosteroids is the evaluation of their effect on the hypothalamic-pituitary-adrenal (HPA) axis. However, it is not clear which test is best for detection of clinically relevant HPA axis suppression in children Morning plasma cortisol levels are twice that of late afternoon and evening values and a delay in the time of onset in peak cortisol levels has been observed in children treated with inhaled corticosteroids. Single morning cortisol level has a low sensitivity for detecting adrenal insufficiency in children. 24-Hour plasma cortisol is a good test because it is a non-invasive measure of the biologically active free cortisol levels for the entire day. For research purposes, the 24-hour integrated concentration plasma cortisol test is preferred. Studies that have looked at HPA axis suppression with intranasal corticosteroids indicate that overall, intranasal corticosteroids have a minimal effect on the HPA axis. A review of the literature reveals one study in which there was a decreased output of urinary cortisol during treatment with either budesonide or fluticasone propionate in adults. Other studies with fluticasone propionate or budesonide have shown no effect on the HPA axis in children. Beclomethasone dipropionate was shown to affect urinary cortisol output in one study on healthy volunteers. However, in a long-term study in children, no effect on the HPA axis was found. Mometasone furoate has been extensively studied in more than 20 trials of adults and children. No effects on the HPA axis were detected in either children or adults. Fluticasone furoate nasal spray was not associated with HPA axis suppression. It is unlikely that children are more sensitive to corticosteroids than adults. There is no reason to perform routine monitoring of adrenal function in children who are treated with intranasal corticosteroid unless those drugs are used concomitantly with inhaled corticosteroids and/or steroid ointments for the possible concomitant presence of asthma and/or atopic dermatitis.

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“…Recently, fluticasone furoate nasal spray, 110 g once daily, was not associated with HPA axis suppression in patients 12 years and older with perennial AR [53] .…”

Section: Fluticasone Furoatementioning

confidence: 99%

Intranasal Corticosteroids and Adrenal Suppression

Bruni¹,

Luca²,

Venturoli³

et al. 2009

Neuroimmunomodulation

View full text Add to dashboard Cite

show abstract

“…The risk of intranasal corticosteroid-associated hypothalamic-pituitary-adrenal axis suppression is low compared with that associated with the more bioavailable oral corticosteroids 48. Potential effects of fluticasone furoate nasal spray on hypothalamic-pituitary-adrenal axis function have been assessed in several studies, none of which demonstrated an effect of the drug 18,49,50…”

Section: Safety and Tolerabilitymentioning

confidence: 99%

“…The effect of fluticasone furoate nasal spray on hypothalamic-pituitary-adrenal axis function have also been assessed in studies with six-week treatment periods in patients with perennial allergic rhinitis 49,50. In a randomized, double-blind, parallel-group, placebo- and prednisone-controlled study in 112 patients 12 years of age and older with perennial allergic rhinitis, patients were administered fluticasone furoate 110 μg once daily, prednisone 10 mg once daily, or placebo for six weeks 49. Fluticasone furoate was noninferior to placebo with respect to the ratio from baseline in 24-hour serum cortisol weighted mean (treatment ratio 0.98, 95% CI 0.89–1.07) whereas prednisone significantly reduced serum cortisol secretion versus placebo (treatment ratio 0.49, 95% CI 0.43–0.57).…”

Section: Safety and Tolerabilitymentioning

confidence: 99%

Fluticasone furoate nasal spray: Profile of an enhanced-affinity corticosteroid in treatment of seasonal allergic rhinitis

Anolik

2010

JAA

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Of the classes of pharmacotherapy for seasonal allergic rhinitis, intranasal corticosteroids are the preferred treatment and are recommended in practice guidelines as first-line pharmacotherapy for rhinitis with prominent nasal congestion. The enhanced-affinity intranasal corticosteroid fluticasone furoate nasal spray (GW685698X), is one of the newest additions to the armamentarium for allergic rhinitis. This review summarizes the preclinical and clinical data on fluticasone furoate nasal spray and discusses its place in pharmacotherapy for seasonal allergic rhinitis. Important attributes of fluticasone furoate in seasonal allergic rhinitis include low systemic bioavailability (<0.5%), onset of symptom relief as early as eight hours after initiation of treatment, 24-hour symptom relief with once-daily dosing, comprehensive coverage of both nasal and ocular symptoms, safety and tolerability with daily use, and availability in a side-actuated device that makes medication delivery simple and consistent. With these attributes, fluticasone furoate nasal spray has the potential to enhance patient satisfaction and compliance and reduce the need for polypharmacy in the management of seasonal allergic rhinitis.

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“…Sixteen trials (5348 patients) fulfilled the criteria for inclusion in this review. Of them, seven studies [21][22][23][24][25][26] included SAR patients (n = 2.589) (one publication [24] presented two independent trials), and nine studies [27][28][29][30][31][32][33][34][35], PAR patients (n = 2.759) ( Fig. 1).…”

Section: Resultsmentioning

confidence: 99%