John H. Holcombe, MD, is a clinical associate professor of pediatrics at the IndianaUniversity School of Medicine and medical fellow, diabetes, for Eli Lilly and Co.
How does Byetta make it easier for endocrinologists and primary carephysicians to treat patients with type 2?
Byetta lowers both post-meal and pre-meal blood sugar levels by stimulating the secretionof insulin only when blood sugar is high and by acutely restoring what is known as thefirst-phase insulin response—an action of cells in the pancreas, called beta cells. People withtype 2 diabetes typically lack this first-phase insulin response. One of the most incredibleand effective attributes of the drug is that it is self-regulating. It works only when the bodyneeds it to and shuts off when it doesn’t. Additionally, patients in clinical studies taking thedrug with their usual regimen of oral agents lost an average of five pounds.
With most type 2 diabetes treatments, hypoglycemia and weight gain are two of the mostchallenging side effects patients and their providers face in controlling diabetes progressionand complication onset. Byetta is an entirely new approach to treating and addressing thevicious cycle associated with the disease, and it helps endocrinologists and primary carephysicians treat their patients by tackling these two major obstacles.
Some additional advantages of Byetta:
- Fixed and simple dosing eliminates the need for complex dose adjustmentsdependent on blood glucose levels, meal frequency or volume or exercise frequencyor intensity.
- Serves as therapy for patients who have failed metformin, a sulfonylurea or acombination of both.
What particular patient profiles should endos and PCPs consider for Byettatherapy, and why?
Byetta is indicated as adjunctive therapy to improve glycemic control in patients withtype 2 diabetes mellitus who are taking metformin, a sulfonylurea or a combination of both(common oral diabetes therapies), but who have not achieved adequate glycemic control.Byetta is not a substitute for insulin in insulin-requiring patients, and it should not be usedin patients with type 1 diabetes.
Byetta is approved in an area where there is a great need—in combination with the mostcommonly used oral agents. Byetta is currently not approved for monotherapy, but the FDAhas given Byetta an “approvable” indication for monotherapy, and the Amylin-Lilly allianceis working closely with the agency to provide the necessary clinical information needed fora monotherapy indication. Byetta is not a last-resort drug but an innovative new treatmentoption that takes a unique approach to lowering blood sugar levels.
In the clinical trials, nausea was the most common side effect; most episodes were mild tomoderate in intensity, more frequent at initiation of treatment, and they decreased overtime. When used with metformin, the risk of low blood glucose is not increased, but the riskfor hypoglycemia is higher when Byetta is used along with a sulfonylurea.
Do you see patients with type 2 diabetes who don’t achieve the control you would like them to have on sulfonylurea or metformin therapy? If so, there is another option to consider: Byetta.
It has been just about a year now since Byetta was granted FDA approval as an adjunct therapy to improve blood glucose control in people with type 2. Byetta is an incretin mimetic, which, you guessed it, “mimics” the action of incretins (such as glucagon-like peptide 1), which are naturally occurring human hormones that are secreted in response to food intake and help lower blood glucose.
For full prescribing information for your patients with diabetes, log on to www.byetta.com.