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CPRD StudyPrimary Care PASS Study

Utilisation Of Dulaglutide In Primary Care In England: Interim Results From A Post Authorisation Safety Study

Utilisation Of Dulaglutide In Primary Care In England: Interim Results From A Post Authorisation Safety Study

Authors: Miranda Davies 1, 2, Lorna Hazell 1, 2, Sandeep Dhanda 1, 2, Vicki Osborne 1,2, Ayad K Ali 3, Saad Shakir 1, 2

Affiliations: 1 Drug Safety Research Unit, 2 University of Portsmouth, 3 Eli Lilly and Company

Background

Dulaglutide is a once-weekly injectable long acting glucagon-like peptide-1 receptor agonist (GLP-1 RA) authorised in England for the treatment of type 2 diabetes mellitus (T2DM).

Objectives

To assess the utilisation of dulaglutide in real-world primary care practice in England.

Methods

A descriptive cohort study (Modified Prescription-Event Monitoring) identified dulaglutide users from dispensed primary care prescriptions of dulaglutide between 2015-2017 in England. Patient characteristics and drug utilisation data were collected from prescribing general practitioners (GPs) via questionnaires sent ≥12 months after the 1st prescription issued for each patient. Summary descriptive statistics were calculated.

Results

1467 evaluable dulaglutide users with T2DM diagnosis confirmed. Median age: 58 yrs (IQR 51, 66); 775 males (52.8%). Baseline obesity (Body Mass Index (BMI) ≥30 kg/m2) was present in 45.9% of the cohort (89.9% where BMI specified), while poor T2DM control, indicated by Haemoglobin A1c ≥58 mmol/mol (7.5%) was observed in 60.1% of patients (93.1% where specified). Median duration of T2DM was 10.0 yrs (IQR 6.0, 14.1). The decision to initiate dulaglutide was most frequently made by a specialist nurse (n=766, 52.2%) followed by the GP (n=352, 24.0%), and hospital doctor (n=299, 20.4%). Most patients were prescribed 0.75mg once- weekly (n=233, 15.9%) or 1.5mg once-weekly (n=762, 51.9%). There were a small number of reports (n=14, 0.9%) of >once-weekly usage. In the majority of patients, dulaglutide was prescribed as either add-on dual therapy (n=469, 32.0%) or add-on triple therapy (n=908, 61.9%); the most frequently reported concomitant anti-diabetes medication (ADM) was metformin (n=624, 42.5%). In sub-populations not previously studied in clinical trials, the most frequently reported usage was in patients ≥75 yrs (n=80, 5.5%).

Conclusions

This interim analysis suggests that dulaglutide is largely being prescribed in accordance with prescribing recommendations and national T2DM management guidelines. Results suggest most frequent use in patients with poor diabetic control where existing treatment with alternative ADM may not have achieved optimum control. This preliminary analysis of baseline data will be updated in the final report.

Disclosure Statement: The DSRU is an independent charity (No 327206) which works in association with the University of Portsmouth. The DSRU has received funding from Eli Lilly and Co., the manufacturer of Trulicity®.