Abigail Coughtrie, Deborah Layton, Qing Qiao and Saad Shakir
Bydureon®, licensed in 2011, is indicated for treatment of T2DM in combination with metformin (MET), sulphonylurea (SU), thiazolidinedione (TZD), MET+SU or MET+TZD for patients (pts) with inadequate glycaemic control on maximally tolerated doses of these therapies alone. A postmarketing safety study is underway as part of the EU Risk Management Plan.
To describe pts characteristics and utilisation of Bydureon® at interim (once 2500 pts accrued).
An observational, population-based cohort study in primary care. Pts were identified from dispensed prescriptions (Rx) issued by GPs Sep 2011-Sep 2015 (interim datalock). Questionnaires were sent to GPs 12 months after each pts’ 1st Rx for additional exposure, outcome and risk factor information for selected outcomes of interest recorded in medical charts. Summary descriptive statistics were calculated. A final cohort of 5000 pts is desired.
Interim evaluable cohort = 2538 pts; 1410 (55.6%) males; median age 57 years (IQR: 50, 65). At baseline, 91.5% (n=1984) of pts were obese (BMI>30.0kg/m2) and 50.0% (n=810) had HbA1c>9%, representing very poor diabetes control. A number of pts were diagnosed with T2DM >10 years (42.6%, n=1054) prior to treatment. Prior exposure to exenatide (Byetta®) was reported in 33.2% (n=826) pts. Bydureon® was prescribed in primary (50.2%, n=1245), secondary (46.3%, n=1146) and intermediate (2.9%, n=73) care settings. Bydureon® was used predominantly as 2nd (30.9%, n=744) or 3rd line cotherapy (66.6%, n=1601). MET (85.5%, n=2170) and SU (49.7%, n=1260) were frequently coprescribed antidiabetics at index. A total of 1752 pts (69.0%) continued treatment to the end of the 12-month observation period.
These interim results suggest Bydureon® is largely used in obese pts, suggesting possible channelling by prescribers to pts who are obese and/or have poor control of their diabetes. Bydureon® is largely prescribed as 2nd line co-therapy with MET or SU or 3rd line co-therapy with MET+SU, as per NICE guidelines. This interim analysis will be superseded once cohort accrual and final analysis are complete.