By Annette R. Karnash, R.N., M.N.

Recent studies have identified several positive results from taking Byetta.  Byetta is known to help in weight loss by not only reducing the appetite, thus allowing the patient to feel sated and by decreasing the amount of time it takes for food to pass from the stomach, thereby resulting in a sensation of fullness for a longer period of time.  It also works on the pancreas to produce more insulin and on the liver to decrease glucose production.  In addition, Byetta reduces blood sugars and A1C levels to 7% or less and has significantly reduced the amount of insulin needed.

In an Italian study, Byetta was either able to regenerate or produce healthy beta cells after one year of treatment when it was discovered that type 2 patients had an increase in C-Peptide secretion, a byproduct of the body’s insulin output.

There have been reports of type 2 patients taking Byetta developing acute pancreatitis, especially after the does was doubled.  However, this was reversed and symptoms did subside when the does was decreased or discontinued.

Byetta has been used in conjunction with other diabetes medications since its introduction into the market in 2005, but Amylin and Lilly Pharmaceuticals will petition the FDA in the near future to offer it as a monotherapy for type 2 diabetes.  A long acting release (LAR) version of Byetta, injected only once a week as compared to the present twice a day version will also be considered and would be a significant improvement in the treatment of type 2 diabetes.  This may provide and additional option in the use of Byetta before starter insulin earlier in the continuum of care is considered in the treatment of diabetes.

In May, the New England Journal of Medicine linked the diabetic drug rosiglitazine (Avandia, Avandamet & Avandaryl) to heart attacks and heart related deaths.  The FDA on Nov. 14th, modified its black box warning to include information about potential increased risk for heart attacks.  The FDA warning is confusing however and provides no useful guidance to patients or physicians.  The new warning it is felt, should be revised to clearly note that using this drug carries serious risks.  Some entities have taken it upon themselves to prevent people from using this drug.

After conducting its own review in October 2007, the Department of Veterans Affairs removed rosiglitazone from the list of drugs its doctors may prescribe, concluding that “for some patients rosiglitazone may not afford the same margin of safety as alternative drug therapies”.

In November, Health Canada, the Canadian equivalent of the FDA, issued broad restrictions on the use of rosiglitazone.  It is no longer approved as a single treatment for diabetes or for use in combination with sulfonylureas (except for patients unable to take Metformin).  Neither is it approved for patients taking insulin or for patients diagnosed with either past or current heart failure, even if it is mild.  Health Canada advises patients to talk about the benefits and risks of continuing therapy, especially those with Heart Disease or at high risk for heart attack or heart failure.

It is felt that the FDA needs to ban this drug from the US market because there is not evidence of any beneficial clinical outcome for this drug and instead growing evidence of unique risks in multiple organ systems.  US citizens at risk from heart attack and failure should not take this drug.  Until the FDA takes appropriate steps to inform the American public about its dangers, Health Canada remains the sole source of this vital information.