Effect of erdosteine on the rate and duration of COPD exacerbations: the RESTORE study



Dal Negro, Roberto W, Wedzicha, Jadwiga A, Iversen, Martin, Fontana, Giovanni, Page, Clive, Cicero, Arrigo F, Pozzi, Edoardo and Calverley, Peter MA
(2017) Effect of erdosteine on the rate and duration of COPD exacerbations: the RESTORE study. EUROPEAN RESPIRATORY JOURNAL, 50 (4). 1700711-.

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Abstract

Oxidative stress contributes to chronic obstructive pulmonary disease (COPD) exacerbations and antioxidants can decrease exacerbation rates, although we lack data about the effect of such drugs on exacerbation duration.The RESTORE (Reducing Exacerbations and Symptoms by Treatment with ORal Erdosteine in COPD) study was a prospective randomised, double-blind, placebo-controlled study, enrolling patients aged 40-80 years with Global Initiative for Chronic Obstructive Lung Disease stage II/III. Patients received erdosteine 300 mg twice daily or placebo added to usual COPD therapy for 12 months. The primary outcome was the number of acute exacerbations during the study.In the pre-specified intention-to-treat population of 445 patients (74% male; mean age 64.8 years, forced expiratory volume in 1 s 51.8% predicted) erdosteine reduced the exacerbation rate by 19.4% (0.91 <i>versus</i> 1.13 exacerbations·patient<sup>-1</sup>·year<sup>-1</sup> for erdosteine and placebo, respectively; p=0.01), due to an effect on mild events; the reduction in the rate of mild exacerbations was 57.1% (0.23 <i>versus</i> 0.54 exacerbations·patient<sup>-1</sup>·year<sup>-1</sup> for erdosteine and placebo, respectively; p=0.002). No significant difference was observed in the rate of moderate and severe exacerbations (0.68 <i>versus</i> 0.59 exacerbations·patient<sup>-1</sup>·year<sup>-1</sup> for erdosteine and placebo, respectively; p=0.054) despite a trend in favour of the comparison group. Erdosteine decreased the exacerbation duration irrespective of event severity by 24.6% (9.55 <i>versus</i> 12.63 days for erdosteine and placebo, respectively; p=0.023). Erdosteine significantly improved subject and physician subjective severity scores (p=0.022 and p=0.048, respectively), and reduced the use of reliever medication (p<0.001), but did not affect the St George's Respiratory Questionnaire score or the time to first exacerbation.In patients with COPD, erdosteine can reduce both the rate and duration of exacerbations. The percentage of patients with adverse events was similar in both the placebo and erdosteine treatment groups.

Item Type: Article
Uncontrolled Keywords: RESTORE group, RESTORE study, Humans, Pulmonary Disease, Chronic Obstructive, Thioglycolates, Thiophenes, Expectorants, Forced Expiratory Volume, Drug Monitoring, Treatment Outcome, Severity of Illness Index, Double-Blind Method, Dose-Response Relationship, Drug, Quality of Life, Aged, Middle Aged, Female, Male, Symptom Flare Up
Depositing User: Symplectic Admin
Date Deposited: 08 Aug 2019 13:46
Last Modified: 13 Feb 2024 15:01
DOI: 10.1183/13993003.00711-2017
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3051293