Diabetes Mega-Trials: 'We Are Entering a New Era of Thinking'

Leszek Czupryniak, MD, PhD


December 16, 2011

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Good morning. My name is Leszek Czupryniak. I am from Poland, and currently I am in Dubai during the International Diabetes Federation's (IDF) World Diabetes Congress. I am the President of the Polish Diabetes Professional Association, Diabetes Poland, and I have the pleasure to talk to you today about one of the main topics discussed during the IDF meeting.

Some of the largest sessions have been devoted to the clinical meaning of the results from the "mega-trials" in diabetes. In 2008, the main results of the 3 most important trials since UKPDS (United Kingdom Perspective Diabetes Study) were reported: the ADVANCE study, the VADT (Veterans Affair Diabetes Trial) study, and probably the most important of the 3, the ACCORD trial. The results, as you must have heard and you probably might remember, have been conflicting. In some of the studies, intensive glycemic control provided some benefit, especially in terms of microvascular complications. In other trials, especially in the ACCORD study, intensive glycemic control was clearly detrimental in terms of increasing the risk for macrovascular complications.

The first interpretation of these results was basically unfavorable toward intensive diabetes control. And we diabetologists were afraid for a while that perhaps what we were trying to do on an everyday basis was actually harming our patients. However, by looking in more detail at the results -- and this is the issue largely discussed these days in Dubai -- now we know that one [patient with] diabetes is not equal to another [patient with] diabetes. We should no longer adopt one target for [the whole] diabetes population; we should be able to differentiate among patients.

In my opinion -- but not only mine, it has been a shared view during this meeting -- the final interpretation of these studies is rather striking, because now we clearly know that intensive diabetes control is absolutely beneficial for subjects who have just diabetes with no complications, who are relatively young, and who have had diabetes for a shorter time, less than 5 years.

What does this mean, and why is it striking or paradoxic? It means that we should adopt an intensive strategy in patients that we usually think don't need intensive treatment, so-called "healthy" patients. [These are] people whose only problem is elevated blood glucose level and perhaps elevated blood pressure, and that’s i. Practically speaking, as diabetologists we somehow neglect these patients, thinking, "Well, it's mild diabetes or it's just the beginning of the disease, nothing serious happens." We pay more attention to patients with significantly more advanced diabetes, who have had myocardial infarctions, stroke, foot amputation, or laser coagulation in the eye. We think, "Oh yes, these are the patients who need our treatment, who need our attention." And we throw all sorts of treatments at them.

The results of those mega-trials show that is probably the wrong thing to do. We cannot restore the vasculature to its previous state or to the normal condition after it has been damaged by high glucose for 10 or 20 years. What we can do is prevent complications, using all the intensive strategies in subjects with intact cardiovascular systems.

Therefore, what we should do -- and this is called the changing paradigm of type 2 diabetes treatment -- is focus more on younger people who are newly diagnosed. We should strive to maintain their hemoglobin A1c level at 6% to 6.5% and not let it go up for years to come. We should be relatively more relaxed with subjects who have long-standing diabetes and multiple complications, who have been treated with insulin 3 or 4 times a day. We should be happy their A1c level is 7% to 7.5%, or even 8% or more.

Is this good news or bad news? It is good news for patients because we should now be able to use diabetes treatment in a safer manner and in a more effective manner in terms of prolonging life and preventing complications. It is actually, in a way, bad news for us, because we can no longer use one stance, one pattern to treat every patient with diabetes.

When seeing a new patient, we should decide within minutes whether the patient's cardiovascular system is in good condition, and therefore [the patient] needs a lot of attention and a lot of drugs such as blood pressure-lowering medications, statins, or perhaps aspirin. When you have a patient with long-standing diabetes, you should also quickly decide that there is no need to push diabetes control so low as you maybe would like to.

We all have to learn to behave in a new way, and we have to adopt this new paradigm of type 2 diabetes treatment. It has not only been widely discussed, but I also have a profound feeling that it has been widely accepted during this meeting. If you look at the new treatment algorithm presented at this IDF congress, it says aim for an A1c level of 7%, not 6.5%, as IDF stated 6 years ago. You can go lower if it is safe, and if the patient has a short history of diabetes, or you can go higher if it is a patient with multiple comorbidities and complications.

You might not have noticed it yet, but we are entering a new era of thinking in type 2 diabetes treatment as we have more and more treatment strategies available and as the lifespans of our patients increase.

Thank you very much.


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