Friday, June 8, 2012

Bydureon at ADA - 2012

Efficacy and Safety of Bydureon after 4 years

Patients on Bydureon from the DURATION 1 study (30 week study comparing Bydureon to Byetta) were followed up for four years in an extension study. Out of the 248 patients who entered the extension phase on Bydureon once weekly, 176 completed 4 years of treatment. Long term treatment with Bydureon was associated with a significant A1C reduction (-1.7%), with 55% of the patients achieving A1C goal of < 7%. There was also a marked reduction in CV risk parameters (LDL - -8mg/dl, TG -13%).  Mostly mild nausea, the most common adverse event (AE) with Bydureon during the initial controlled period, decreased with ongoing therapy.  The annual event rate (events/100 y patient exposure) for nausea with EQW was 85 in wks 1-30 and 15 over the 4-y study duration. Only 2% patients withdrew due to gastrointestinal AEs over 4 y.  Annual event rates for cardiac and renal/urinary disorders were 5 and 6, respectively for Bydureon over 4years. Since there was no control arm, it is not possible to determine the relative benefit of Bydureon on CV / renal outcome.

Bydureon is superior to Insulin Detemir in patients with T2DM inadequately controlled with metformin +/- sulfonylureas
This 26 week study randomized 216 patients inadequately controlled on metformin+/- sulfonylureas  to either Bydureon or Insulin detemir (titrated to achieve fasting plasma glucose <99mg/dl). In the study a larger proportion of patients achieved HbA1c goal  < 7% with Bydureon as compared to Detemir (44% vs. 11.4%). Patients on Bydureon lost on an average -.2.68 kg, as compared to a weight gain of 0.8 kg for patients on detemir. Hypoglycemia events were comparable in both arms, while patients on Bydureon experience higher rates of GI side effects and Injection site reaction.