Journal Information
Vol. 56. Issue 7.
Pages 472-473 (July 2020)
Vol. 56. Issue 7.
Pages 472-473 (July 2020)
Letter to the Editor
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Discrepancies Between GEMA and GINA in the Classification of Inhaled Corticosteroids
Discrepancias en la clasificación de los glucocorticoides inhalados entre GEMA y GINA
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Vicente Plazaa,
Corresponding author
vplaza@santpau.cat

Corresponding author.
, Antonio Gómez-Outesb, Santiago Quirce Gancedoc, Isam Alobidd, Cesáreo Álvarez Rodrígueze, Marina Blanco Apariciof, Gabriel Garcíag, Fernando Gómez Ruizh, Antonio Hidalgo Requenai, Javier Korta Muruaj, Jesús Molina Parísk, Francisco J. Pellegrini Belinchónl, Montserrat Pérez Encinasm, Javier Plaza Zamoran, Manuel Praena Crespoo, Concha Sánchez Pinap, José Sanz Ortegaq
a Comité Ejecutivo de GEMA, Sociedad Española de Neumología y Cirugía Torácica (SEPAR), Servicio de Neumología, Hospital Santa Creu i Sant, Barcelona, Spain
b Comité Ejecutivo de GEMA, Sociedad Española de Farmacología Clínica (SEFC), Servicio de Área Terapéutica Clínica: Cardiovascular y Respiratorio, Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Madrid, Spain
c Comité Ejecutivo de GEMA, Sociedad Española de Alergología e Inmunología Clínica (SEAIC), Servicio de Alergia, Hospital Universitario La Paz, Madrid, Spain
d Comité Ejecutivo de GEMA, Sociedad Española de Otorrinolaringología (SEORL), Consultoría Otorrinolaringológica, Hospital Clínic, Barcelona, Spain
e Comité Ejecutivo de GEMA, Sociedad Española de Medicina de Urgencias y Emergencias (SEMES), Servicio de Urgencias, Hospital de Verín, Orense, Spain
f Comité Ejecutivo de GEMA, Sociedad Española de Neumología y Cirugía Torácica (SEPAR), Servicio de Neumología, Complejo Hospitalario Universitario de A Coruña, La Coruña, Spain
g Comité Ejecutivo de GEMA, Asociación Latinoamericana de Tórax (ALAT), Servicio de Neumonología, Hospital Rossi, La Plata, Argentina
h Comité Ejecutivo de GEMA, Sociedad Española de Médicos Generales y de Familia (SEMG), Medicina de Familia, Centro de Salud de Bargas, Bargas (Toledo), Spain
i Comité Ejecutivo de GEMA, Sociedad Española de Médicos de Atención Primaria (SEMERGEN), Medicina de Familia, Centro de Salud Lucena I, Lucena (Córdoba), Spain
j Comité Ejecutivo de GEMA, Sociedad Española de Neumología Pediátrica (SENP), Sección de Neumología Infantil, Servicio de Pediatría, Hospital Universitario Donostia, San Sebastián, Spain
k Comité Ejecutivo de GEMA, Sociedad Española de Medicina Familiar y Comunitaria (SEMFYC), Centro de Salud Francia, Fuenlabrada (Madrid), Spain
l Comité Ejecutivo de GEMA, Sociedad Española de Pediatría Extrahospitalaria y Atención Primaria (SEPEAP), Atención Primaria, Centro de Salud Pizarrales, Salamanca, Spain
m Comité Ejecutivo de GEMA, Sociedad Española de Farmacia Hospitalaria (SEFH), Servicio de Farmacia, Hospital Universitario Fundación Alcorcón, Alcorcón (Madrid), Spain
n Comité Ejecutivo de GEMA, Sociedad Española de Farmacia Comunitaria (SEFAC), Farmacia Comunitaria, Farmacia Dres. Zamora Navarro, Mazarrón (Murcia), Spain
o Comité Ejecutivo de GEMA, Asociación Española de Pediatría de Atención Primaria (AEPAP), Universidad de Sevilla, Sevilla, Spain
p Comité Ejecutivo de GEMA, Asociación Española de Pediatría de Atención Primaria (AEPAP), Atención Primaria, Madrid, Spain
q Comité Ejecutivo de GEMA, Sociedad Española de Inmunología Clínica, Alergología y Asma Pediátrica (SEICAP), Unidad de Alergia y Neumología Infantil, Hospital Universitario Casa de Salud, Valencia, Spain
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To the Editor,

We read with interest the letter signed by Doctors Entrenas-Costa and Entrenas-Castillo1 in which they suggest that the classification of the dose of 100μg of fluticasone furoate (FF) once a day (OD) that appears in the GEMA guidelines as medium dose2 should be “corrected” and classified in line with the GINA guidelines as low dose.1

GEMA is a clinical practice guideline drawn up by independent experts from 15 different scientific societies.2 The classification of 100μg FF OD as a medium dose is evidence-based and consistent with the approved Summary of Product Characteristics (SPC) for FF3 and with the classifications of other relevant international guidelines, such as SIGN 158 in the UK and the Australian Asthma Handbook. Few direct comparisons are available with FF and other inhaled glucocorticoids, particularly at low doses, so it is difficult to establish the exact equipotent dose (equivalent in efficacy and safety) of FF. According to the SPC, a daily dose of 100μg of FF in asthma is approximately equivalent to 250μg of fluticasone propionate (FP) twice a day (BID, medium dose), while 200μg FF OD is approximately equivalent to 500μg FP BID (high dose).3 A low dose of FF is not approved in asthma. Evidence of efficacy and safety with 50μg of FF OD in mild-moderate asthma is low and inconsistent, although at least one of the published studies indicates greater efficacy than placebo and approximately similar efficacy to that of low-dose FP (100μg BID) in mild asthma.4

With regard to safety, the authors comment that the dose of 100μg FF does not suppress cortisol, based on a pharmacokinetic/pharmacodynamic model and limited data from a 6-week study.1 However, in a 52-week study of 503 adults and adolescents with asthma specifically designed to assess safety, 24-h urinary cortisol excretion at the medium dose of 100μg FF OD was similar to that obtained at the high dose of 500μg FP BID after 1 year of treatment, and about 10% of patients treated with 100μg FF had persistently low urinary cortisol levels (<40nmol/24h) during treatment.5 All inhaled glucocorticoids present a risk of systemic (e.g. pneumonia, cortico-adrenal axis suppression, osteoporosis, glaucoma, etc.) and local (candidiasis, etc.) adverse effects, all of which are dose-dependent.

As a result, until new data become available, we believe that the classification of 100μg FF as a medium dose is the most correct and prudent option. Treatment for asthma maintenance should be administered at the minimum dose required to maintain disease control2 in order to minimize the risk of adverse effects.

References
[1]
L.M. Entrenas-Costa, M. Entrenas-Castillo.
Discrepancias en la clasificación de los glucocorticoides inhalados entre GEMA y GINA.
[2]
Comité Ejecutivo de la GEMA.
GEMA 4.4. Guía española para el manejo del asma.
(2019),
[3]
Ficha técnica de Relvar Ellipta.
(2013),
[4]
E.D. Bateman, E.R. Bleecker, J. Lötvall, A. Woodcock, R. Forth, H. Medley, et al.
Dose effect of once-daily fluticasone furoate in persistent asthma: a randomized trial.
Respir Med, 106 (2012), pp. 642-650
[5]
W.W. Busse, P.M. O’Byrne, E.R. Bleecker, J. Lötvall, A. Woodcock, L. Andersen, et al.
Safety and tolerability of the novel inhaled corticosteroid fluticasone furoate in combination with the β2 agonist vilanterol administered once daily for 52 weeks in patients ≥12 years old with asthma: a randomised trial.

Please cite this article as: Plaza Moral V, Gómez-Outes A, Quirce Gancedo S, Alobid I, Álvarez Rodríguez C, Blanco Aparicio M, et al. Discrepancias en la clasificación de los glucocorticoides inhalados entre GEMA y GINA. Arch Bronconeumol. 2020;56:472–473.

Copyright © 2019. SEPAR
Archivos de Bronconeumología

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