Pharmacology and Clinical Efficacy of Erdosteine in Chronic Obstructive Pulmonary Disease

Maurizio Moretti

Disclosures

Expert Rev Resp Med. 2007;1(3):307-316. 

In This Article

Safety & Tolerability

Erdosteine has no direct effect on gastric mucus since both thiol groups are blocked within the molecular structure. Clinical studies demonstrate that erdosteine has good gastric tolerability after oral administration, both during short- and midterm treatment[29,41,43] and during chronic use,[42] unlike other compounds with similar therapeutic indications. It is well known that thiol agents have a high incidence – estimated at approximately 20% – of gastrointestinal side effects, such as nausea, heartburn and stomach pain. The incidence of these adverse effects decreases to approximately 7% with erdosteine, which is no higher than placebo, demonstrating an excellent safety profile (Figure 2).[48] In patients receiving erdosteine in association with amoxycillin, the occurrence of adverse events, namely those relevant to gastrointestinal area, was comparable to the group of patients treated with the antibiotic alone (7.5 vs 11.1%).[29]

Frequency of adverse reactions with erdosteine, reference drugs and placebo.

Compounds containing thiol groups often have an unpleasant smell and after intake may frequently cause gastric reflux. These problems do not occur with erdosteine. Taste disturbances (e.g., ageusia and dysgeusia) were reported occasionally.[21,48] There is no evidence of interaction between erdosteine and other drugs, expecially antibiotics (e.g., β-lactams, erythromycin and trimethoprim–sulfamethoxazole), theophylline and β2-agonists,[48] while other thiol agents may interact with antibiotics by inactivating them.[49]

Specific trials of erdosteine in geriatric subjects and in patients suffering from mild renal or hepatic failure did not show any impact on the rates of adverse reactions. However, it is suggested to halve the erdosteine dose in patients affected by severe hepatic or renal failure with a creatinine clearance less than 25 ml/min.

The postmarketing safety data on more than 30 million patients treated (including ∼7.4 million children) have always shown that erdosteine is very well tolerated and devoid of any safety concerns.[50]

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