Serious asthma events with mometasone furoate plus formoterol compared with mometasone furoate.
Formoterol
asthma exacerbations
long-acting β-agonists
mometasone furoate
persistent asthma
serious asthma events
Journal
The Journal of allergy and clinical immunology
ISSN: 1097-6825
Titre abrégé: J Allergy Clin Immunol
Pays: United States
ID NLM: 1275002
Informations de publication
Date de publication:
04 2019
04 2019
Historique:
received:
21
03
2018
revised:
10
10
2018
accepted:
19
10
2018
pubmed:
12
12
2018
medline:
24
4
2020
entrez:
12
12
2018
Statut:
ppublish
Résumé
The safety of long-acting β-agonists added to inhaled corticosteroids for the treatment of persistent asthma has been controversial. We sought to determine whether administering formoterol in combination with mometasone furoate increases the risk of serious asthma outcomes (SAOs) compared with mometasone furoate alone. This clinical trial is registered as NCT01471340. We conducted a 26-week, randomized, double-blind trial in adolescent and adult patients (≥12 years) with persistent asthma in 35 countries with the primary objective of evaluating whether mometasone furoate-formoterol increases the risk of SAOs (adjudicated hospitalization, intubation, or death) compared with mometasone furoate alone. The key efficacy end point was asthma exacerbation (composite of hospitalization of ≥24 hours, emergency department visits of <24 hours requiring systemic corticosteroids, or use of systemic corticosteroids for ≥3 consecutive days). Among 11,729 patients (mometasone furoate-formoterol, n = 5,868; mometasone furoate, n = 5,861), a total of 81 SAOs, all asthma-related hospitalizations, were observed in 71 patients: 45 events from 39 patients receiving mometasone furoate-formoterol and 36 events from 32 patients receiving mometasone furoate. The hazard ratio for the first SAO in the mometasone furoate-formoterol versus mometasone furoate group was 1.22 (95% CI, 0.76-1.94; P = .411). Asthma exacerbation occurred in 1,487 patients: 708 receiving mometasone furoate-formoterol and 779 receiving mometasone furoate. The hazard ratio for the first asthma exacerbation in the mometasone furoate-formoterol versus mometasone furoate group was 0.89 (95% CI, 0.80-0.98; P = .021). The addition of formoterol to mometasone furoate maintenance therapy did not increase the risk of serious asthma-related events and reduced the risk of asthma exacerbation.
Sections du résumé
BACKGROUND
The safety of long-acting β-agonists added to inhaled corticosteroids for the treatment of persistent asthma has been controversial.
OBJECTIVE
We sought to determine whether administering formoterol in combination with mometasone furoate increases the risk of serious asthma outcomes (SAOs) compared with mometasone furoate alone. This clinical trial is registered as NCT01471340.
METHODS
We conducted a 26-week, randomized, double-blind trial in adolescent and adult patients (≥12 years) with persistent asthma in 35 countries with the primary objective of evaluating whether mometasone furoate-formoterol increases the risk of SAOs (adjudicated hospitalization, intubation, or death) compared with mometasone furoate alone. The key efficacy end point was asthma exacerbation (composite of hospitalization of ≥24 hours, emergency department visits of <24 hours requiring systemic corticosteroids, or use of systemic corticosteroids for ≥3 consecutive days).
RESULTS
Among 11,729 patients (mometasone furoate-formoterol, n = 5,868; mometasone furoate, n = 5,861), a total of 81 SAOs, all asthma-related hospitalizations, were observed in 71 patients: 45 events from 39 patients receiving mometasone furoate-formoterol and 36 events from 32 patients receiving mometasone furoate. The hazard ratio for the first SAO in the mometasone furoate-formoterol versus mometasone furoate group was 1.22 (95% CI, 0.76-1.94; P = .411). Asthma exacerbation occurred in 1,487 patients: 708 receiving mometasone furoate-formoterol and 779 receiving mometasone furoate. The hazard ratio for the first asthma exacerbation in the mometasone furoate-formoterol versus mometasone furoate group was 0.89 (95% CI, 0.80-0.98; P = .021).
CONCLUSIONS
The addition of formoterol to mometasone furoate maintenance therapy did not increase the risk of serious asthma-related events and reduced the risk of asthma exacerbation.
Identifiants
pubmed: 30537475
pii: S0091-6749(18)31740-8
doi: 10.1016/j.jaci.2018.10.065
pii:
doi:
Substances chimiques
Bronchodilator Agents
0
Mometasone Furoate, Formoterol Fumarate Drug Combination
0
Mometasone Furoate
04201GDN4R
Banques de données
ClinicalTrials.gov
['NCT01471340']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1395-1402Informations de copyright
Copyright © 2018 Merck & Co., Inc. All rights reserved.