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Swapnil N. Rajpathak Part 3, Defining Hypoglycemia For DPP-4 Inhibitors Research

In part 3 of this Exclusive Interview, Dr. Swapnil N Rajpathak talks with Diabetes in Control Publisher Steve Freed during the ADA 2017 Scientific Sessions in San Diego, CA about patient claims of hypoglycemia while on DPP4 treatment.

Swapnil N. Rajpathak, MD, MPH, DrPH is Executive Director for the Center for Observational and Real World Evidence at Merck.

Transcript of this video segment:

Steve: The new guidelines from ADA actually has actual numbers. Prior to this, the definition of hypoglycemia, it was kinda vague. We put a number on it but really wasn’t at 70. It’s when a person gets dizzy and their face falls into the plate of food. A lot things like that, but realistically this time around, the ADA actually put numbers on them. I think it was 70 that is the definition now. You can write it up hypoglycemia and they lowered it for immediate care is needed. Do you know what that number is?

Swapnil: So just for the purpose of this tape, let me just clarify that because it’s a claims database we don’t have the information on the blood glucose level. In fact, the lab data is not connected with this particular study. So, it’s purely based on the claim. So regardless of what the blood sugar level is, this is purely associated with the cost that was in the system or a claim that was associated with hypoglycemia. As long as there is a claim, it’s an added burden. It is not dependent on what the level is.  As you know when detecting hypoglycemia, [it] is not really easy, right? Even if the patient feels hypoglycemia, by the time they actually were able to measure a blood glucose level, there may be so many other factors that may change the blood glucose level at that time. I agree there is a strict definition for the purpose of the study, however it’s purely based on the claim of their hypoglycemia.

Steve: Yeah because we know people who have blood sugars in the 200-300 range will feel hypoglycemic, you know, if it’s at 200. They’ll feel hypoglycemic at 110 because their body is just not used to it so the term hypoglycemia for your study basically said if a person reports hypoglycemia, then it will be included in the report.

Swapnil: So not the person but the claim in the healthcare system. It’s a commercial database used for billing. It’s an administrative database, so what it does is that it will claim some kind of code to get billed for hypoglycemia. And the physician or the hospital will actually put that code in there. So, it’s not related to actual blood glucose entry, its related to claim. But as would you expect, there must be some documentation that triggers the coding in the system for hypoglycemia. That information was not available for the study, but I am sure it’s related to the blood glucose levels.

Steve: And I can see your point because if a person complains about hypoglycemia and they go to the emergency room, there’s a cost involved. So it really makes no difference what the number is. If treatment is given and it costs $3500, that’s what you are comparing it to.

Swapnil: Yes, absolutely

Steve: So, what you’re saying is that DPP4s obviously have less hypoglycemia. Have we seen any hypoglycemia from the DPP4s where you would put it in to warning that can this cause hypoglycemia? Can this cause hypoglycemia from the DPP4s?

Swapnil: So any diabetes therapy with monotherapy or combination therapy has potential for hypoglycemia. That’s included for all drugs. There is also a propensity for hypoglycemia. If you look at our trials or some real-world evidence, it is clear that drugs that act in a different way than the insulin secretagogues like sulfonylureas are associated with lower risk of hypoglycemia. So relatively speaking, they are always at low risk of hypoglycemia but doesn’t have elimination the possibility of hypoglycemia even in the newer drugs that don’t have the mechanism like the insulin sulfonylureas.

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