Rosiglitazone Delays Treatment Failure in Patients with Type 2 Diabetes

Initial treatment with rosiglitazone slowed the progression to monotherapy failure more effectively than either metformin or glyburide. Overall, the adverse effect profile differed significantly among the different agents, with the risk for congestive heart failure associated with rosiglitazone similar to metformin, a risk that was higher in both drugs when compared with glyburide.

William Herman, MD, of the University of Michigan, Ann Arbor, one of the ADOPT investigators," told Diabetes in Control Newsletter that, in terms of the primary outcome, it is clear that rosiglitazone prevents monotherapy failure as we defined it in this study," "No matter how we looked at the outcome, rosiglitazone did considerably better than glyburide and moderately better than metformin, which has come to be the standard of care. The side effect profiles of the drugs are very different though, and both treatment alternatives to rosiglitazone are generic, so there is a big cost difference. I think, based on this study, rosiglitazone would be preferred to glyburide as initial therapy, but it’s more of a judgment call when it comes to metformin."

The results of study, known as A Diabetes Outcome Progression Trial (ADOPT), were presented at the World Diabetes Congress in Cape Town, South Africa, and published in the Dec. issue of The New England Journal of Medicine. In their article, investigators, conclude that "the relative costs of these medications, their profiles of adverse events, and their potential risks and benefits should all be considered to help inform the choice of pharmacotherapy for patients with type 2 diabetes."

In an editorial published with the ADOPT article, David Nathan, MD, of the Harvard Medical School in Boston, Massachusetts, argues that the data are simply not sufficient to consider the use of rosiglitazone as initial monotherapy in the treatment of type 2 diabetes. "Given the modest glycemic benefit of rosiglitazone (with the risk of fluid retention and weight gain) and higher cost (including the need for more statins and diuretics), metformin remains the logical choice when initiating pharmacotherapy for type 2 diabetes," writes Dr. Nathan.

Dr. Herman stated that, glycated hemoglobin levels were not selected as the primary outcome because the guidelines at the initiation of the study, which began enrollment in 2000, focused largely on plasma glucose levels.

Publishers comment: Treatment with a single drug was called a failure when a SINGLE fasting blood glucose level reached 180 or higher. It was NOT based on glycosylated hemoglobin (HbA1c), the standard gauge for glycemic control.

When comparing HbA1c levels, rosiglitazone’s effect is much less impressive. Rosiglitazone keeps HbA1c at acceptable levels in 40% of patients, compared to 36% with metformin after 5 years. And glitazones such as rosiglitazone are NOT recommended first line due to their downside…weight gain… edema…and risk of congestive heart failure. And rosiglitazone costs much more than metformin.

N Engl J Med. Published online December 4, 2006.

================================

Dr. Bernstein will be doing another live teleconference call soon. If you would like to ask a question or just register for the free teleconference call, just go to www.askdrbernstein.com and register. There were over 600 people on the last call. More info at www.diabetes911.net

================================

Advertisement
See clinical data on the sustained benefits of BYETTA for the treatment of type 2 diabetes. BYETTA delivers sustained glycemic control, with most patients losing weight, and simple, fixed BID dosing before morning and evening meals. Click here: