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Dr. Ralph Defronzo talks with Diabetes in Control Publisher Steve Freed during the ADA 77th Scientific Session in San Diego about the necessity of being proactive in the treatment of prediabetes.
Dr. Ralph Defronzo, MD is Professor of Medicine and Chief of the Diabetes Division at the University of Texas Health Diabetes Center in San Antonia, Texas. Dr. Defronzo is also Deputy Director of the Texas Diabetes Institute.
Transcript of this video segment:
Steve Freed: So let’s talk about prediabetes. That’s a fairly new term. Obviously like you said, you don’t really like it because diabetes is diabetes. It causes damage even 5.7 in some ways. It may take a little longer but it’s still causing damage. So what would you like to see happen besides, it’s strange that the ADA can recommend Metformin, the FDA doesn’t even have any recommendations for prediabetes. That makes it tough for insurance companies because you can’t give them the drugs for diabetes, you can only give them Metformin. That’s a $3 drug to begin with, so that’s not a big deal. So what are your feelings about that?
Dr. Defronzo: So I was part of the Consensus Conference of course, many years ago that said that if you’re a high risk person, and particularly if lifestyle intervention didn’t work, you should consider putting the people on Metformin therapy. Unfortunately that’s not a drug nor is there any drug that is approved by the FDA. The FDA has sort of held fast that if you’re going to have a drug to treat prediabetes, you’re going to have to show a benefit in cardiovascular events. To me, that’s not appropriate. First of all, if you started the prediabetic state, you’re going to be 10 or 15 years before you’re going to be able to show a decrease in cardiovascular events. You’d need a huge number of patients. Probably 20 to 25,000 patients followed for 10 years before you’d show a statistical difference. So, what pharmaceutical company is going to do a 10 year study with 20,000 patients? I think that there needs to be a reassessment of this issue. The ADA needs to be at the forefront. The ADA, in my opinion, needs to take a stance and then say that it’s important to identify high risk patients with “prediabetes” and that they should encourage the FDA to do trials for preventing progression of prediabetes to diabetes. For the simple reason that if your glucose level doesn’t go up, you do not develop the microvascular complications of the disease. I don’t buy to the stance, just, let’s wait till the person develops diabetes and then we’ll treat them. While you’re waiting, you’re losing beta cells. That’s issue number one. Issue number two is just because you have the patient when they have prediabetes, you’re not going to follow that patient for the next three or four years to find out when they develop diabetes. These people get lost. So where I live in San Antonio, I have Mrs. Hernandez, she comes to see me. She is this “prediabetic state”. Her A1C is 6.3. I do an OGDT, and her glucose is 180. “Mrs. Hernandez, what about your mom and dad? Do they have a history?” “Oh yeah, my mother has diabetes.” “Any brothers or sisters?” “Yeah, I’ve got five brothers and two sisters.” “Any diabetes in the family?” “Oh, yeah, both my brothers and a couple of my sisters.” That person has diabetes. They’re going to get diabetes. The magic number two hour glucose 200. I don’t need to wait till they get there. This person has diabetes. I’m going to treat them. Now, we do have the option of treating off-label, but of course that makes physicians a little bit nervous. Nonetheless, when you have a person of Hispanic descent, the gestational diabetes, the components of the metabolic syndrome, family history of diabetes. They’re overweight. They got diabetes, pathophysiologically. They just didn’t reach that magic cut-point that the ADA says they have diabetes. I think these people should be treated and I think they should receive pharmacologic treatment with the intent of preserving their beta cell function and preventing the A1C from going up to a level where it could potentially inflict damage on tissues and lead to development of microvascular complications.