Byetta (exenatide) is the first incretin mimetic or Glucagon Like Peptid-1 (GLP-1) analogue approved as odd-on to metformin and/or sulfonylurea (SU) for treatment of type 2-diabetes. The recommended dose is 10 micrograms injected subcutaneously twice daily.
After 16 – 30 weeks of treatment as add-on to metformin, SU, glitazones or combinations of these, Byetta proved superior to placebo with regards to HbA1c reduction. After 52 weeks of treatment Byetta was found to be non-inferior to basal and biphasic insulinanalogues. In all studies a reduction of approximately 1 percentage point on HbA1c was seen. Statistically significant weight reductions compared with the insulinanalogues were also observed. As yet there is no documented effect on diabetic complications or mortality.
Gastrointestinal adverse effects as nausea and vomiting was seen in about half of the exposed. However, the intensity and frequency did decline with time.
The price for treatment in one month is 970 DKr, which is more expensive than most other medicines with the same indication. The status of reimbursement is per 27 April 2007 unresolved.
Byetta could be a possibility for overweight patients with type 2-diabetes whose blood glucose cannot be controlled by life style changes, metformin and/or SU, and who are ready for subcutaneous therapy.
Byetta was marketed 23 April 2007.
Institute for Rational Pharmacotherapy, 2 May 2007.