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Jim McDermott Part 1, AstraZeneca SGLT2 Trials

Feb 23, 2018

In part 1 of this Exclusive Interview, Dr. Jim McDermott explains the recent AstraZeneca SGLT2 trials in a conversation with Diabetes in Control Publisher Steve Freed during the ADA 2017 Scientific Sessions in San Diego, CA.

Jim McDermott, PhD, is the Vice President of U.S. Medical Affairs, Diabetes at AstraZeneca.

Transcript of this video segment:

Freed: This is Steve Freed with Diabetes in Control and we are here in San Diego for the American Diabetes Association 77th Scientific Sessions and we have some really great interviews with some of the top endos all across the globe. We have a very special guest with us. This is Dr. Jim McDermott who is also presenting. Why don’t we start off with you telling us a little bit about yourself or your practice?

McDermott: Yes, so I am actually a PhD – I work for AstraZeneca, I am head of the metabolics medical affairs team within the US business.

Freed: What do you do here?

McDermott: I am here because we are extremely proud of the presentations and abstracts that AstraZeneca will be presenting throughout the week. We have 51 presentations at this meeting so we are very proud in terms of how we are showing up in science and being scientific leaders in the space of diabetes.

Freed: Which is the 36th one out of those?

McDermott: Oh, I can tell you the top four. (Laughs)

Freed: Can you tell us the new CVD-REAL world evidence study analysis that are being presented from your company this week?

McDermott: Yes, happy to do so. So CVD-REAL is a large outcomes trial that was presented at ACC. The study had over 300,000 patients and we saw roughly 50 percent reduction in hospitalization for heart failure and all-cause mortality for the SGLT-2 class when it was compared to other oral agents for diabetes. So now what we have done is some additional analyses which we are presenting here at ADA. The first is when we’re looking at dapagliflozin, Farxiga, specifically, and again, looking at that compared to the DPP-4 class. Again, it just reconfirms what we saw with the overall class, the SGLT-2 class. What we are seeing is Farxiga resulted in a significant reduction in hospitalization for heart failure, significant reduction [in] hospitalization for kidney disease as well as a reduction in all-cause mortality, and that was compared against the DPP-4 class.

Freed: So out of everything that you are presenting here, you have to have a favorite one or a couple of favorites that you’re really proud of?

McDermott: Yes, I think there are several that I am really proud of. I think one that is extremely timely is the pool safety data. As you probably know there’s been a lot of questions about the safety profile of SGLT-2s, and so last year we actually did analysis where we looked at 30 clinical trials and we pulled the safety data. What was interesting there was that we did not see any sort of imbalance with amputations, we did not see any sort of imbalance with bone fractures and really low incidence of DKA, so it really reconfirms our belief in the overall safety profile of Farxiga.

Freed: What about amputations? We are hearing that people that have poor circulation are losing their toes or their feet.

McDermott: Right. So in our safety pool analysis, what we saw in over 9,000 patients treated with Farxiga, we had eight amputations reported. In the control group we had 4,000 patients treated with placebo; we saw seven patients with amputations. So you’re looking at a rate, if you look at the patient per thousand years, that’s 1.0 for Farxiga vs. 1.7 for the control group placebo group. So bottom-line, we are not seeing any amputations and we do not believe that is a class effect.

Freed: What about kidney issues? Have you seen a reduction in renal failures?

McDermott: We have not seen a reduction in renal failures. In fact what we’re doing is we have a program that we called DapaCare – it’s a large clinical trial program. We believe that Dapa has the potential to show benefit on chronic kidney disease so we are doing a study both in patients with diabetes and patients without diabetes who have chronic kidney disease, and we are going to be looking at the efficacy and results of that work.

Freed: What about a reduction in A1C?

McDermott: We are seeing great reduction in A1C. What we have seen is up to one percent reduction in A1C with Farxiga alone, great weight loss, and blood pressure reduction of 5 millimeters of mercury.

Freed: So with all these benefits, you live longer, your blood pressure goes down, your blood sugars go down and it helps to protect – at least what we’ve seen – the kidney.  When are we going to put it in the water supply?

McDermott: Well, I’m not sure it belongs in the water supply. I think it does provide a new option for physicians as well as patients because as you know it’s not just about controlling blood sugar, right? These patients have multiple comorbidities so many of them struggle with weight control, many of them struggle with blood pressure control, etc. I think there are many good agents out there, but I think an SGLT-2 like Farxiga offers a lot of clinical benefits for those types of patients that need more than just A1C reduction.

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