Effect of Erdosteine on COPD Exacerbations in COPD Patients with Moderate Airflow Limitation

Calverley, Peter MA, Page, Clive, Dal Negro, Roberto W, Fontana, Giovanni, Cazzola, Mario, Cicero, Arrigo F, Pozzi, Edoardo and Wedzicha, Jadwiga A (2019) Effect of Erdosteine on COPD Exacerbations in COPD Patients with Moderate Airflow Limitation. INTERNATIONAL JOURNAL OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE, 14. pp. 2733-2744.

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Official URL: http://dx.doi.org/10.2147/copd.s221852

Abstract

<h4>Background</h4>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.<h4>Methods</h4>This post hoc analysis of the 254 RESTORE participants with spirometrically-defined moderate COPD (post-bronchodilator forced expiratory volume in 1 second [FEV<sub>1</sub>] 50‒79% predicted) examined exacerbation rate and duration, time to first exacerbation, and exacerbation-free time. Data were analyzed using descriptive statistics and comparisons between treatment groups used Wilcoxon rank-sum tests, Mann-Whitney <i>U</i>-tests, or log rank tests.<h4>Results</h4>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, <i>P</i>=0.003), and a 58.3% reduction in the mild exacerbation rate (0.23 vs 0.53 mild exacerbations per-patient per-year, <i>P</i>=0.001). Mean duration of exacerbations was 26% shorter in erdosteine-treated patients (9.1 vs 12.3 days for placebo, <i>P</i>=0.022), with significant reductions in the duration of mild and moderate-to-severe exacerbations. Mean time to first exacerbation was prolonged by 7.7% (182 days for erdosteine vs 169 days for placebo, <i>P</i><0.001) and the mean exacerbation-free time was increased by 51 days (279 days for erdosteine vs 228 days for placebo; <i>P</i><0.001).<h4>Conclusion</h4>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.

Item Type:	Article
Uncontrolled Keywords:	antioxidant, anti-inflammatory, chronic obstructive pulmonary disease, erdosteine, COPD exacerbations
Depositing User:	Symplectic Admin
Date Deposited:	29 Jan 2020 10:34
Last Modified:	19 Jan 2023 00:06
DOI:	10.2147/COPD.S221852
Open Access URL:	https://doi.org/10.2147/COPD.S221852
Related URLs:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3072432