Obstructive Lung Diseases: Airways 1 |

Frequency of Exacerbations in COPD: The Efficacy of Carbocysteine Lysine Salt With or Without Inhaled Steroids FREE TO VIEW

Federico Saibene, MD; Gregorino Paone, MD; Luigi Lanata, MD; Renato Delli Colli, MD; Giovanni Puglisi, MD
Author and Funding Information

Dompé Farmaceutici SpA, Milan, Italy

Copyright 2016, American College of Chest Physicians. All Rights Reserved.

Chest. 2016;150(4_S):826A. doi:10.1016/j.chest.2016.08.926
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SESSION TYPE: Original Investigation Poster

PRESENTED ON: Wednesday, October 26, 2016 at 01:30 PM - 02:30 PM

PURPOSE: Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death in the world and it is characterized by airflow limitation. Pathophysiologically COPD involves many components including mucus hypersecretion, oxidative stress and inflammation, contributing to corticosteroid resistance. Carbocysteine lysine salt (CLS) is a mucoactive drug with mucoregulatory, anti-inflammatory, antioxidative effects and could also restore steroid sensitivity, offering promise for treatment. Assessment of COPD is also based on risk of exacerbation. The results of PEACE study showed that long-term use of carbocysteine lead to a 25% reduction of exacerbations in GOLD II-IV, with significant benefit in patients with > 1 exacerbation. However, only 17% of PEACE study patients received background therapy including inhaled steroids (IS). The aim of this observational prospective real life clinical trial was to evaluate the correlation between frequency of exacerbations in patients that experienced more than 2 episodes during the study and treatment adopted, included CLS with or without IS.

METHODS: Participants were eligible for inclusion if they were aged between 41 and 79, were diagnosed as having COPD (GOLD stage II-IV) with a FEV1 between 25% and 79% of predicted value and had a history of at least two COPD exacerbations within the previous year. The primary endpoint is to compare the frequency of >2 exacerbations over a 1-year treatment period with CLS added to background therapy either with or without IS.

RESULTS: As of Sept-2015, 216 patients with a minimum 3-month follow-up were included in the study and 108 patients completed the 1 year study period (60 males and 48 females). Of these, 67 patients had ≥2 exacerbations at baseline: in 24 patients (68.6%) CLS+IS were added to background therapy, in 43 (58.9%) patients only CLS was added. Patients with ≥2 exacerbations at baseline were 43 (58.9%) in CLS group and 24 (68.6%) in CLS+IS group. After 1 year patients that experienced ≥2 exacerbations were 11 (31.4%) in CSI+IS group and 16 (21.9%).

CONCLUSIONS: In conclusion, the results show that treatment with CLS with or without IS plays an important role in the reduction of exacerbations in patients with > 2 exacerbations at baseline. As already demonstrated in the literature, the daily administration of mucolytics such as carbocysteine for prolonged periods, in addition to background therapy can be considered a good strategy for reducing the number of exacerbations in patients affected by COPD.

CLINICAL IMPLICATIONS: CLS in patients with > 2 exacerbations at baseline allows significant reduction of COPD exacerbations either if they are in background therapy with or without IS. Reduction of exacerbation could leed to a better quality of life.

DISCLOSURE: Federico Saibene: Employee: Medical Manager Luigi Lanata: Employee: Medical Affairs Director The following authors have nothing to disclose: Gregorino Paone, Renato Delli Colli, Giovanni Puglisi

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