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01.03.2018 | Original Research Article

Utilisation and Safety of Deferasirox: Results from an Observational Cohort Study in England

verfasst von: Vicki Osborne, Miranda Davies, Deborah Layton, Saad A. W. Shakir

Erschienen in: Drug Safety | Ausgabe 3/2018

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Abstract

Introduction

Deferasirox (EXJADE^®, Novartis, UK) is an oral iron-chelating agent primarily used to reduce chronic iron overload in patients receiving blood transfusions for various chronic anaemias and some non-transfusion dependant anaemias.

Objective

The aim of this study was to examine the utilisation and safety of deferasirox used in general practice in England.

Method

A single exposure observational cohort study design was used. Patients were identified from dispensed prescriptions for deferasirox between September 2006 and September 2014. Outcome data were collected via postal questionnaires sent to prescribers ≥ 6 months after first dispensed prescription for an individual patient. Summary descriptive statistics were calculated.

Results

The evaluable cohort consisted of 122 patients, of which 41.8% were aged 2–17 years. Frequent reasons for prescribing were sickle cell anaemia (27/103 where specified, 26.2%) and beta thalassaemia (26, 25.2%). The majority of patients (43/51, 84.3%) were prescribed the licensed doses of 10 or 20 mg/kg/day at start. Prior measurements of serum creatinine were only reported for a small proportion this study (18/122, 14.8%). In total, 91 incident events were reported, including two of raised serum creatinine.

Conclusion

These results show that deferasirox is largely being prescribed for its licensed indications in general practice in England and events reported were consistent with the known safety profile.

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An ‘event’ in PEM is defined as “any new diagnosis, any reason for referral to a consultant or admission to hospital, any unexpected deterioration (or improvement) in a concurrent illness, any alteration of clinical importance in laboratory values, or any other complaint that was considered of sufficient importance to enter in the patient’s notes.”

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Titel: Utilisation and Safety of Deferasirox: Results from an Observational Cohort Study in England
verfasst von: Vicki Osborne
Miranda Davies
Deborah Layton
Saad A. W. Shakir
Publikationsdatum: 01.03.2018
Verlag: Springer International Publishing
Erschienen in: Drug Safety / Ausgabe 3/2018
Print ISSN: 0114-5916
Elektronische ISSN: 1179-1942
DOI: https://doi.org/10.1007/s40264-017-0606-2

Springer Medizin

Abstract

Introduction

Objective

Method

Results

Conclusion

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