May 2008 Reference NOV07

North Staffordshire PCT, Stoke on Trent PCT, University Hospital of North Staffordshire NHS Trust, Combined Healthcare NHS Trust

NEW MEDICINE REVIEW AND VERDICT

Of interest to: Related guidance:

Primary care ® SMC

Erdosteine (Erdotin ) UKMi Secondary care

Verdict: Non-formulary The verdict of the Committee is that erdosteine is not to be included in the Joint Formulary. Published evidence is not robust. Trials are generally small and do not reflect UK practice. The majority compare erdosteine to placebo and there is only one active comparator controlled trial, which compares erdosteine to ambroxol, a mucolytic not used in the UK. There are no trials comparing erdosteine to carbocisteine, the mucolytic already on the Joint Formulary. There is no evidence that erdosteine reduces the duration of exacerbations or decreases hospital stay. Carbocisteine, an alternative mucolytic for long term use, is recommended for use in COPD in line with NICE guidance. Background diarrhoea, epigastric pain, urticaria, erythema and Erdosteine is an oral mucolytic agent, indicated for the eczema. symptomatic treatment of acute exacerbations of chronic bronchitis (chronic obstructive pulmonary Mucolytics may disrupt the gastric mucosal barrier and disease (COPD)) in adults. It is licensed for a should be used with caution in patients with a history maximum 10 day course. The oral mucolytic agent, of gastric ulcer. Use of erdosteine is contraindicated in carbocisteine is already on the North Staffordshire patients with active peptic ulcer. Joint Formulary and is licensed as an adjunctive therapy for respiratory tract disorders characterised by Place in therapy excessive, viscous mucous, including COPD. Although NICE has considered the use of mucolytics for managing stable COPD, they have not yet Efficacy considered mucolytic therapy during exacerbations. Four double-blind randomised controlled trials were NICE guidance currently recommends use of long term reviewed, three compared erdosteine to placebo and mucolytics for patients with COPD with a chronic one to ambroxol. All the trials measured efficacy using cough productive of sputum; the license for erdosteine symptom scores. Compared to placebo, a 7 to 10 day precludes long term use. Erdosteine has not course of erdosteine has been shown to produce a demonstrated the benefits which are seen when using statistically significant reduction in symptom score, but mucolytics over a prolonged time period. It would the clinical relevance of these findings is unknown. A appear more appropriate to initiate prolonged significant difference is reported to occur as early as mucolytics in line with NICE guidance to prevent day three of treatment in two of the trials. No exacerbations (and to continue this during an significant difference was found between erdosteine exacerbation), rather than using a periodic short term and ambroxol. mucolytic when an exacerbation is present. Until there are trials comparing these two strategies, current NICE Non of the trials addressed whether erdosteine guidance should be followed. reduces exacerbations, hospital stay or use of antibiotics. Study populations did not reflect UK Cost & Cost effectiveness patients, with concurrent use of corticosteroids and Cost comparison with other mucolytics is not useful anticholinergics frequently not permitted. Baseline because of differences in product licences. The cost symptom scores are missing in three trials. of 10 days treatment with erdosteine 300mg twice daily is £5.00. Erdosteine has not been demonstrated to be Safety cost effective. Erdosteine is generally we tolerated. All reported adverse events occur very rarely and include Risk management issues headache, taste alteration, nausea and vomiting, None identified.

The information contained in this bulletin is the best available from the resources at our disposal at the time of publication. Any opinions reflected areare the author’s NSAPC own & may not necessarily reflect those of the Local Health Economy. The complete and fully referenced review is available from [email protected] Page 1of 1 REVIEW