Erdosteine ( Erdotin ), a drug approved for the treatment of acute and chronic pulmonary diseases, has been shown to be an effective treatment for chronic bronchitis or COPD ( CB/COPD ) in several studies, although marked differences in the perception of its usefulness still remain.
Researchers have tested the available evidence for the efficacy of Erdosteine in adults with stable or exacerbated chronic bronchitis or chronic obstructive pulmonary disease ( COPD ).
It has conducted a meta-analysis of individual patient data from both published and unpublished randomized controlled trials ( RCTs ) comparing Erdosteine with placebo / mucolytics, given for up to 10 days in association with standard therapy ( RCTs used for regulatory drug approval ).
Endpoints were symptom scores ( cough frequency and intensity, sputum viscosity and purulence, difficulty to expectorate, catarrh rhonchi at auscultation, dyspnoea ), a cumulative global efficacy index ( cGEI ), and an overall physician efficacy assessment ( OA ).
Individual data from 1046 patients from 15 RCTs ( 12 on exacerbated and 3 on stable CB/COPD ) were obtained.
Erdosteine induced a significant reduction of cGEI vs comparators ( -1.02; p=0.0006 ), both placebo and mucolytics.
On individual symptoms, Erdosteine positively impacted on cough frequency ( -0.19 ) and intensity ( -0.30 ), sputum viscosity ( -0.28 ), difficulty to expectorate ( -0.24 ), and catarrh ronchi at auscultation ( -0.35 ).
The effects on dyspnoea were only significant versus placebo, whereas sputum purulence was not significantly modified.
The overall physician efficacy assessment also favoured Erdosteine, doubling the chance of success compared with placebo and mucolytics: OR ( odds ratio ) 2.06.
The treatment with Erdosteine was well tolerated. Adverse events, mainly gastrointestinal, were reported by 10.2% of patients compared to 11.0% in the reference groups.
In conclusion, the treatment with Erdosteine is associated with a significant benefit in terms of symptom amelioration both versus placebo and mucolytics in patients with chronic bronchitis or COPD.
Although with some limitations ( e.g. not fully validated scores ) this review reinforces the use of Erdosteine, in combination with standard therapy, in respiratory diseases characterized by increased expectoration, namely acute CB/COPD exacerbations. ( Xagena )
Cazzola M et al, Pulm Pharmacol Ther 2010; 23: 135-144