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

Secondary care
Erdosteine (Erdotin ) UKMi

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 are the authors
NSAPC own & may not necessarily reflect those of the Local Health Economy. The complete and fully referenced review is available from angela.davis@uhns.nhs.uk Page 1of 1
REVIEW