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Safety Profile of Esomeprazole

Results of a Prescription-Event Monitoring Study of 11 595 Patients in England

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Abstract

Objective: Esomeprazole, the S-isomer of omeprazole, was launched in the UK in September 2000. The first proton pump inhibitor, omeprazole, has been marketed in the UK for over 10 years. However, the adverse event database of newly marketed drugs is limited, and it is only after widespread clinical use that the adverse effect profile of a drug is ascertained more comprehensively. This study aims to monitor the safety of esomeprazole prescribed in the primary care setting in England using prescription-event monitoring (PEM).

Methods: A postmarketing surveillance study using the observational cohort technique of PEM. Patients were identified from dispensed prescriptions for esomeprazole issued by general practitioners between September 2000 and April 2001. Questionnaires (‘green forms’) requesting clinical event data on these patients were sent to prescribers approximately 6 months after the date of the first dispensed prescription for each individual patient. Incidence densities (IDs), expressed as the number of first reports of an event/1000 patient-months of exposure (PME), were calculated. Significant differences between IDs for events reported in the first month (ID1) and the following 5 months (ID2–6) of exposure were regarded as potential signals. Other methods for signal detection such as medical evaluation of selected events and evaluation of reasons for stopping were also applied.

Results: Green forms containing clinically useful information for 11 595 patients (median age 56 years; 53.2% female) were received. Diarrhoea was the event with the highest ID1 in month 1 (8.0 per 1000 patient months of exposure). Adverse events that occurred significantly more often in the first month of treatment with esomeprazole compared with months 2–6 included diarrhoea, nausea/vomiting, abdominal pain, dyspepsia, headache/migraine, intolerance, malaise/lassitude, pruritis, unspecified adverse effects and abnormal sensation.

Conclusions: The safety profile of esomeprazole was consistent with the prescribing information and experience reported in the literature.

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Acknowledgements

The DSRU is a registered independent charity (No. 327206) that works in association with the University of Portsmouth, UK. It receives unconditional donations from pharmaceutical companies, which have no control over the conduct or the publication of studies carried out by the DSRU. The Unit has received such funds from the manufacturer of Nexium® (esomeprazole). Professor Shakir has been a member of advisory committees on other products for the manufacturer of Nexium®. Drs Davies and Wilton have no conflicts of interest that are directly relevant to the contents of this article.

The authors thank the numerous general practitioners and the UK Prescription Pricing Division (formerly Prescription Pricing Authority) for their important participation in this study. Thank you also to Mrs Lesley Flowers, Mr Shayne Freemantle and Mrs Phyl Dudley for their assistance in the preparation of this report.

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Authors and Affiliations

  1. Drug Safety Research Unit, Southampton, UK

    Miranda Davies, Lynda V. Wilton & Saad A. W. Shakir

  2. Drug Safety Research Unit, Clinical Research Fellow, Bursledon Hall, Blundell Lane, Southampton, SO31 1AA, UK

    Lynda V. Wilton & Saad A. W. Shakir

Authors
  1. Miranda Davies
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  2. Lynda V. Wilton
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  3. Saad A. W. Shakir
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Correspondence to Miranda Davies.

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Davies, M., Wilton, L.V. & Shakir, S.A.W. Safety Profile of Esomeprazole. Drug-Safety 31, 313–323 (2008). https://doi.org/10.2165/00002018-200831040-00005

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