Bydureon is indicated as an adjunctive treatment to metformin, sulfonylurea and/or thiazolidinedione, possibly in combination, for treatment of type 2 diabetes. In comparison to existing exenatide preparations Bydureon is to be injected once a week instead of twice daily (Byetta).
The reduction seen in HbA1c t with weekly administered exenatide was significantly higher than with exenatide twice daily, sitagliptin, pioglitazone, and glargine, while the reduction was inferior compared to 1.8 mg liraglutide. The efficacy studies have methodological limitations since 4 of 5 studies are unblinded, the Hb1A1c values for inclusion are very wide, only a few elderly patients > 75 years are included, and sulfonylurea is not used as active comparator.
Gastrointestinal discomforts are the most frequently reported adverse events, but the frequency is lower with weekly administration compared to daily administration of exenatide or liraglutide. Therefore Bydureon does not require up titration. A serious adverse event observed post marketing is a potential risk for developing pancreatitis and C-cell thyroid cancer. The prolonged release of exenatide also means that Bydureon stays in the body for an extended period of time and this should be included in considerations of discontinuation, adverse events and switches to other drugs. Bydureon should not be used for individuals with terminal kidney insufficiency or moderate to severe renal impairment because of the risk of increased exposition and side effects.
The changed formulation requires that the patient mixes the suspension before injection while the daily injection takes place with a prefilled delivery device ready for use.
Bydureon 2 mg in a package of 4 single dose sets (4 weeks treatment) costs 995.00 DKr. At the present time the price of 12 months treatment with Bydureon is higher than 12 months treatment with Byetta.
Based on the clinical studies, the safety profile and price IRF finds that exenatide for weekly administration rather than daily administration is only a relevant treatment alternative in selected patients based on an individual evaluation.
Bydureon was marketed October 17th 2011. At the present time Bydureon is subject to reimbursement.
Institute for Rational Pharmacotherapy (IRF), november 2011