Evaluation of probable treatment indications for the prescription of oral glycopyrronium in the United Kingdom - both licensed and off-label

Date of ISAC Approval: 
Lay Summary: 
Glycopyrronium is a drug that has a number of clinical uses, such as stopping people from producing too much perspiration or saliva, and reducing stomach acidity. The drug is not used very frequently but could potentially be used in a number of clinical situations such as helping to lessen dribbling in children and adults with severe disability, which would help improve their quality of life and care, and relieving the side-effect of excess saliva production experienced by people taking certain drugs. Indeed, this may already be happening in practice. The purpose of this study is to examine the data from the Clinical Practice Research Datalink and characterise what the existing uses are for this drug.
Technical Summary: 
The aim of this retrospective, descriptive study is to characterise as far as possible the treatment indications for oral glycopyrronium within UK primary care using the CPRD GOLD dataset. The study will inform a regulatory submission to the MHRA by the study's funder, Kinedexe UK Ltd. Glycopyrronium is an anticholinergic drug that inhibits aspects of the parasympathetic nervous system. Until recently, its licensed indications in the UK were hyperhidrosis (excessive perspiration) and peptic ulcer, but in January 2017 a glycopyrronium product became licensed to treat sialorrhoea (excessive or uncontrolled salivation) in children and adolescents. It is widely accepted, however, that glycopyrronium has been prescribed off-label for this symptom for some years before this, although little is currently known about the extent of that historic prescribing. We wish to analyse data from CPRD GOLD in order to address this evidence gap. Children and adults having at least one prescription for oral glycopyrronium (1mg or 2mg tablet or solution/liquid formulations) from January 2008 to June 2018 will be selected and classified by their age at prescription and probable indication, the latter being based on associated clinical and referral records for the licensed indications for glycopyrronium (hyperhidrosis, peptic ulcer, sialorrhoea) and medical conditions associated with hypersalivation (cerebral palsy, Parkinson's disease, motor neurone disease), and on prescription records for drugs (antipsychotic drugs and cholinergic agonists) associated with the side-effect of hypersalivation. Patients with more than one indication or with no discernible indication will be classified as such. We will present patient numbers and the frequency and duration of prescribing by age group and probable indication. Findings will be summarised with wide granularity and all stratifications with fewer than five patients will be suppressed in accordance with CPRD guidelines to prevent the risk of deductive/unintentional disclosure.
Health Outcomes to be Measured: 
Diagnoses at the time of prescribing glycopyrronium.

Professor Craig Currie - Chief Investigator - Pharmatelligence
Dr Sara Jenkins-Jones - Corresponding Applicant - Human Data Sciences
Sarah Holden - Collaborator - Human Data Sciences
Thomas Berni - Collaborator - Pharmatelligence