Effect of Erdosteine on COPD Exacerbations in COPD Patients with Moderate Airflow Limitation.
Adult
Aged
Aged, 80 and over
Antioxidants
/ adverse effects
Disease Progression
Double-Blind Method
Europe
Expectorants
/ adverse effects
Female
Forced Expiratory Volume
Humans
Lung
/ drug effects
Male
Middle Aged
Pulmonary Disease, Chronic Obstructive
/ diagnosis
Recovery of Function
Severity of Illness Index
Thioglycolates
/ adverse effects
Thiophenes
/ adverse effects
Time Factors
Treatment Outcome
COPD exacerbations
anti-inflammatory
antioxidant
chronic obstructive pulmonary disease
erdosteine
Journal
International journal of chronic obstructive pulmonary disease
ISSN: 1178-2005
Titre abrégé: Int J Chron Obstruct Pulmon Dis
Pays: New Zealand
ID NLM: 101273481
Informations de publication
Date de publication:
2019
2019
Historique:
received:
04
07
2019
accepted:
31
10
2019
entrez:
11
12
2019
pubmed:
11
12
2019
medline:
28
4
2020
Statut:
epublish
Résumé
The RESTORE study, a multi-national randomized, placebo-controlled study, showed that erdosteine - a muco-active antioxidant that modulates bacterial adhesiveness - reduced the rate and duration of exacerbations in moderate and severe COPD with a history of exacerbations. How much benefit patients with less severe disease experience when taking this drug remains unclear. This post hoc analysis of the 254 RESTORE participants with spirometrically-defined moderate COPD (post-bronchodilator forced expiratory volume in 1 second [FEV Patients with moderate COPD received erdosteine 300 mg twice daily (n=126) or placebo (n=128) added to usual COPD therapy for 12 months. During this time, there were 53 exacerbations in the erdosteine group and 74 in the placebo group, with 42.1% and 57.8% of patients, respectively, experiencing an exacerbation. There was a 47% reduction in the mean exacerbation rate with erdosteine compared to placebo (0.27 vs 0.51 exacerbations per-patient per-year, respectively, These results indicate that adding erdosteine to usual COPD maintenance therapy reduces the number of mild, and duration of all, exacerbations in patients with moderate COPD and a history of exacerbations.
Sections du résumé
Background
The RESTORE study, a multi-national randomized, placebo-controlled study, showed that erdosteine - a muco-active antioxidant that modulates bacterial adhesiveness - reduced the rate and duration of exacerbations in moderate and severe COPD with a history of exacerbations. How much benefit patients with less severe disease experience when taking this drug remains unclear.
Methods
This post hoc analysis of the 254 RESTORE participants with spirometrically-defined moderate COPD (post-bronchodilator forced expiratory volume in 1 second [FEV
Results
Patients with moderate COPD received erdosteine 300 mg twice daily (n=126) or placebo (n=128) added to usual COPD therapy for 12 months. During this time, there were 53 exacerbations in the erdosteine group and 74 in the placebo group, with 42.1% and 57.8% of patients, respectively, experiencing an exacerbation. There was a 47% reduction in the mean exacerbation rate with erdosteine compared to placebo (0.27 vs 0.51 exacerbations per-patient per-year, respectively,
Conclusion
These results indicate that adding erdosteine to usual COPD maintenance therapy reduces the number of mild, and duration of all, exacerbations in patients with moderate COPD and a history of exacerbations.
Identifiants
pubmed: 31819405
doi: 10.2147/COPD.S221852
pii: 221852
pmc: PMC6896911
doi:
Substances chimiques
Antioxidants
0
Expectorants
0
Thioglycolates
0
Thiophenes
0
erdosteine
76J0853EKA
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
2733-2744Subventions
Organisme : Medical Research Council
ID : G0800570
Pays : United Kingdom
Organisme : Medical Research Council
ID : G1001365
Pays : United Kingdom
Organisme : Medical Research Council
ID : G1001372
Pays : United Kingdom
Informations de copyright
© 2019 Calverley et al.
Déclaration de conflit d'intérêts
EP is employed by Edmond Pharma. PC, CP, RDN, GF, MC, and AC report personal fees from Edmond Pharma. The authors report no other conflicts of interest in this work.
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