Authors: Sandeep Dhanda 1, 2, Vicki Osborne 1, 2, Debabrata Roy 1, 2, Saad Shakir 1, 2
Affiliations: 1 Drug Safety Research Unit, 2 University of Portsmouth
Exenatide extended-release (Bydureon®) is a glucagon-like peptide-1 receptor agonist administered once-weekly by subcutaneous injection. Approved in 2011, Bydureon® is licensed to improve glycaemic control in combination with other antidiabetes medications (ADMs) in patients (pts) with type 2 diabetes mellitus (T2DM) when current therapy, with diet and exercise, is inadequate. A Post Authorisation Safety Study (PASS) was conducted to monitor the use and safety of Bydureon® in primary (1o) care in England.
To describe the utilisation of Bydureon® in 1o care.
A cohort study identified pts from dispensed Bydureon® prescriptions in England (2012-2016). Pt characteristics and drug utilisation data was collected from prescribing general practitioners (GPs) via questionnaires sent ≥12 months after the 1st Bydureon® prescription issued for each pt. Summary descriptive statistics were calculated.
Questionnaire response rate = 37.2% (7752/20860). Evaluable cohort = 6294 pts prescribed Bydureon® for T2DM (median age 57 years [IQR 50, 65]; 55.2% male). 2 pts were <18 years. 16 pts had an off-label indication of type 1 diabetes mellitus and were excluded from analyses. At baseline, where specified, 91.7% of pts (n=2390) were obese (BMI ≥30 kg/m2) and/or had an HbA1c ≥7.5% (n=1986, 90.0%); of those pts with a raised HbA1c, 66.0% (n=1311) had measurements of ≥9.0% indicating very poor diabetic control. Bydureon® was mostly prescribed in 1o care (n=3269, 51.9%); ‘specialist decision’ was the overwhelming reason for prescribing (n=3113, 49.5%). The majority of pts were exenatide naïve (n=4556, 72.4%), whilst 25.9% (n=1629) were previous Byetta® (exenatide twice-daily) users. For 109 pts (1.7%) prior exposure to Byetta® was unknown. Nearly all pts (n=5948, 94.5%) were taking Bydureon® 2mg once/week, in accordance with the product label. Pts predominantly started Bydureon® as triple therapy (n=3876, 61.6%) or dual therapy (n=1936, 30.8%); monotherapy use was lower (n=161, 2.6%). Metformin (n=5753, 81.5%) and sulphonylureas (n=2382, 45.0%) were the most frequent concomitant ADMs at index.
Bydureon® was largely used in accordance with prescribing recommendations in 1o care in England, with most frequent use in pts with poor diabetic control where treatment with alternative ADMs may have been unsuccessful. In addition, characteristics of pts prescribed Bydureon® are in keeping with the T2DM pt profile. This study design allowed for the timely collection of drug utilisation data directly from GPs and suggests shared Bydureon® T2DM treatment arrangements between 1o and 2o care.
The DSRU is an independent charity (No 327206), which works in association with the University of Portsmouth. The DSRU has received funding from AstraZeneca AB, the manufacturer of Bydureon®. The DSRU makes the final decision on the publication of external communications.