V. Osborne, N. Qayum, A. Coughtrie, D. Layton, S. Shakir.
Bydureon® (exenatide) is indicated for the treatment (Rx) of Type 2 Diabetes Mellitus (T2DM) in combination with metformin, sulphonylurea (SU), thiazolidindione (TZD) alone, metformin & SU or metformin & TZD for patients (pts) who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies alone. A post-marketing observational cohort study of Bydureon® was requested as part of the EU Risk Management Plan. The final target cohort size is 5000 pts. This study is ongoing.
To describe the utilisation characteristics of pts prescribed Bydureon® at interim.
An observational, population-based cohort design in primary care. Pts in the interim cohort were identified from all dispensed prescriptions for Bydureon® in England Sept11-Jan14 (interim data lock). Data were collected from prescribers via postal questionnaires sent ≥12mths after the 1st prescription was dispensed. Summary descriptive statistics were calculated.
Evaluable cohort at interim=520 pts; median age 58yrs (IQR 51-65); 58.1% male. T2DM and time since diagnosis was specified for 493 pts; the majority were diagnosed >10yrs prior to starting Rx (210, 42.6%). Where specified (n=441), 91.1% pts were classed as obese (BMI >30.0 kg/m2) immediately prior to Rx. On starting, 48.4% (134/277) had a HbA1c >9%, representing very poor diabetes control. Most pts had HbA1c ≥7.5% (223, 80.5%). The majority of pts used 2mg once weekly (489/492, 99.4%) and most pts were prescribed Bydureon® as either second line (158/477, 33.1%) or third line co-therapy (307, 64.4%). The majority of pts were prescribed Bydureon® with metformin (417/520, 80.2%). Co-prescribing of insulin was also reported (117, 22.5%).
These interim results characterise the utilisation of Bydureon® in primary care in England. The majority of pts had T2DM, used 2mg once weekly and were co-prescribed metformin. Most pts were obese which raises the possibility of channelling by prescribers due to the purported benefits of Bydureon® in weight loss. This interim analysis will be superseded when validation and follow-up are complete for the final analysis