International Journal of Clinical Pharmacology and Therapeutics. 2001;39:529-533.

Montelukast and improvement of eczema: observations from a prescription event monitoring study in England



P. Biswas, L.V. Wilton and S.A.W. Shakir

Drug Safety Research Unit, Bursledon Hall, Blundell Lane Southampton, SO31 1AA, UK

Abstract

Objective: Montelukast is an leered cysteinyl receptor antag-ved for the treatment of asthma.  There is pharmacological plausibility of its effectiveness in the treatment of other immu-nologically mediated conditions such as eczema and urticaria.  The objective ofthis study was to determine whether there are any beneficial effects of montelukast on eczema and urticaria.

Method: A non-interventional observational cohort study was conducted between February 1998 and December 1998 using Prescription-Event Monitoring (PEM).  During PEM studies, patients are systematically identified from dispensed prescription data and questionnaires are sent to the prescribing general practitioner (GP) asking them to report events occurring during and af-ter treatment.  In this study, events reported as eczema or urticaria improved were identified.  A simple questionnaire was sent to the GPs for additional information.

Results: The cohort comprised 15,612 patients, in which 16 reports of eczema or urticaria improved were identified.  Questionnaires were sent to the GPs for additional information.  Fifteen of the 16 questionnaires were returned.  In 5 cases the GPs thought that there was an improvement of eczema or urticaria with montelukast treatment in patients who had history of long-standing eczema or urticaria.  Of the remaining 11 cases there was an alternative explanation for the improvement of eczema or urticaria in 10 cases and one was unassessable.

Conclusion: PEM is conducted to monitor the safety of medicines, and doctors report events including improvement in pre-existing conditions.  Although the number of cases of improvement of eczema or urticaria in this cohort is small, there is a possibility that leukotriene inhibitors may be helpful in the treatment of these diseases.  Further studies are needed to provide evidence as to whether montelukast will have a role in the treatment of these conditions.

KEY WORDS -
beneficial effects,  eczema,  prescription-event monitoring,  urticaria