Abigail Coughtrie, Deborah Layton, Qing Qiao and Saad Shakir
Bydureon®, licensed in 2011, is indicated for treatment of type 2 diabetes mellitus (T2DM). Favourable changes in health parameters in T2DM patients (pts) can help reduce cardiovascular disease risk and improve glucose homeostasis. A post-marketing safety study is underway as part of the EU Risk Management Plan.
To quantify mean changes at group level in health parameters (weight, body mass index (BMI), systolic blood pressure (SBP) and HbA1c) in Bydureon® users at interim.
An observational, population-based cohort study in primary care in UK. Pts were identified from dispensed prescriptions (Rx) issued by GPs Sep 2011-Sep 2015 (interim datalock). GPs were sent questionnaires 12 months after each pts’ 1st Rx for exposure, outcome and risk factor information from medical charts. For pts continuing treatment to the end of 12 months, changes in each pts’ health parameters were calculated from index (1st Rx) to 12 months post-index (12m) to estimate mean change (Δ) at group level. Denominators are pts with both index and 12m data provided.
Interim evaluable cohort=2538 pts; 55.6% (n=1410) males; median age 57 yrs (IQR 50;65). At end of the 12 months 1752/2538 (69.0%) pts remained on treatment. Of these pts, 1384/1495 (92.6%) were obese and 521/1129 (46.1%) had HbA1c>9% at index. Mean weight Δ=-3.0kg [SD 6.7] (index 109.4kg [22.0]; 12m 106.4kg [21.7]; N=1395). Mean BMI Δ=-0.9kg/m2 [2.5] (index 38.0kg/m2 [6.7]; 12m 37.0kg/m2 [6.6]; N=1292). Mean SBP Δ=-2.1mmHg [16.2] (index 133.8mmHg [14.2]; 12m 131.6mmHg [14.2]; N=1509). Mean HbA1c Δ=-7.6mmol/mol [18.9] (index 75.9mmol/mol [19.3]; 12m 68.3mmol/mol [19.5]; N=1057).
Overall at aggregate level.,Bydureon® use appears to be associated with favourable changes in health parameters over 12 months in this single group study in primary care setting. However the clinical significance of such changes is unclear. Limitations are lack of adjustment for concurrent medications and potential regression towards the mean as pts prescribed Bydureon® may be extreme relative to the T2DM population (obese and/or poor diabetes control). This analysis will be superseded once final cohort accrual and analysis are complete.