A Drug Utilisation Study of Rifaximin 550mg

Date of ISAC Approval: 
23/05/2016
Lay Summary: 
Rifaximin- is a prescription only antibacterial drug which is used to treat gastrointestinal infections. Since January 2013 rifaximin has also been licensed in a higher dose (550mg) in adults for the treatment of Hepatic Encephalopathy, a decline in brain function caused by severe liver disease. This study aims to describe the prescribing patterns of rifaximin- 550mg in terms of dosing, formulation and patient characteristics in order to better understand when and why it is being prescribed. The study will be conducted in three different data sources containing anonymised electronic health records, The Clinical Practice Research Datalink (CPRD), IMS Disease Analyser Germany and the Hospital Treatment Insights and Clinical Practice Research Datalink combined (HTI-CPRD GOLD link).
Technical Summary: 
Rifaximin- is an antibacterial drug which has been marketed for many years as a 200mg tablet for various gastrointestinal infections such as travellers' diarrhoea. In November 2012, Norgine received decentralised procedure approval for rifaximin- (XIFAXAN/TARGAXAN) 550mg. This is a prescription-only medication that is used in adults with liver disease to reduce the recurrence of episodes of overt Hepatic Encephalopathy (HE). In January 2013, the UK was the first to launch the 550mg product in Europe. A drug utilisation study will be conducted in CPRD GOLD, IMS Disease Analyser Germany and the HTI-CPRD GOLD link to understand the dosing, the formulation, the indications and the patient demographics associated with rifaximin- 550mg tablets across the UK and Germany following launch in January 2013. Tables of descriptive data (including counts, mean, median, standard deviation and inter-quartile range) on each patient cohort will be presented. The aim of this analysis it to address three regulatory concerns about the new drug, interactions with other treatments, potential off label use for other indications and potential off label paediatric use.
Health Outcomes to be Measured: 
Rifaximin- 550mg is the exposure of interest, for which there is one gemscript code available in CPRD.
Collaborators: 

Ms Jennifer Campbell - Chief Investigator - CPRD
Mr Bharat Amlani - Collaborator - Norgine
Dr Hanna Sodatonou - Collaborator - Norgine
Ms Jennifer Campbell - Corresponding Applicant - CPRD

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