The nation's leading voluntary health organization supporting diabetes research, information and advocacy - The American Diabetes Association (ADA) - is strongly urging diabetes patients on the recently controversial drug Avandia® to consult with their physician as to its benefits and risks.

Also, ADA is reminding patients not to stop taking any prescribed medications without first discussing the issue with their health care provider.

These were all ADA's response/stand on the latest information on Avandia® reported June 5 at the New England Journal of Medicine which was followed by three editorials:

Although the findings from RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes) found no significant increase in heart attack or cardiac death, but an increased risk of heart failure, this interim analysis did not have the statistical power to reach a definitive answer as to all the potential cardiovascular risks that may be associated with rosiglitazone.

As one of the accompanying editorials stated, the RECORD study demonstrated a trend toward increased cardiovascular events and, when combined with recently published data and an analysis released by the company, there is still concern about cardiovascular side effects related to this drug.

Here are the links to the said editorials:

Rosiglitazone - Continued Uncertainty about Safety by Jeffrey M. Drazen, M.D., Stephen Morrissey, Ph.D., and Gregory D. Curfman, M.D.

The clinical impact of these data needs to be clarified. To do so, we asked a diabetologist, a cardiovascular epidemiologist, and a drug-safety expert to give their interpretations, which can be found in the accompanying editorials.5,6 Both editorials express uncertainty about the safety of rosiglitazone.

Rosiglitazone and Cardiotoxicity - Weighing the Evidence by David M. Nathan, M.D.

With the continuing uncertainty regarding the safety of treatment with rosiglitazone, what should physicians and patients do? It is important to remember that there are now nine classes of antidiabetic medications available, including several older medications that are relatively efficacious in lowering glycated hemoglobin levels and are less expensive than the thiazolidinediones.7 Each class has a unique set of side effects and associated adverse events.

The Record on Rosiglitazone and the Risk of Myocardial Infarction by B.M. Psaty and C.D. Furberg

Patients and physicians will need to weigh the benefits and risks of treatment with rosiglitazone. Glycemic control and durability appear to be the major benefits. Rosiglitazone is also associated with significant weight gain, an adverse effect on low-density lipoprotein cholesterol, an increased risk of heart failure, an increased risk of fractures in women, and an apparent increase in the risk of myocardial infarction.Patients should not stop treatment on their own, but if they have concerns, they should consult their physicians. Together, patients and physicians can decide whether they wish to suspend the use of rosiglitazone.

BOTTOMLINE: you discuss the issue with your doctor and together you weigh the risks and benefits. BUT all of the above is saying that there is no certainty to the cardiovascular safety of Avandia® - even if the clinical data in the article is just interim - in lay man's term partial or preliminary, since the trial is 6-year trial that hasn't ended yet.

If you were a doctor, would you still insist that your patient continue on with the drug despite these uncertainty? On the other hand, if you were a diabetes patient, would you agree with your doctor to give you Avandia® despite the issues?

But if this is reflective of the whole diabetes patient-doctor scenario (source: IHT),

Doctors wrote 27 percent fewer prescriptions for Avandia, a GlaxoSmithKline drug, in the week that ended June 1 than they did two weeks earlier, before the Cleveland Clinic issued a report suggesting that Avandia raised the risk of heart attacks by 43 percent. Sales of Actos, its main competitor, rose 13 percent in the period, according to Wolters Kluwer Health, which collects health-care industry data.

...then I guess that both doctors and patients are hesitant (as is understandable) and are shifting or looking at shifting at another diabetes drug.

Read ADA's press release (a pdf file).