My name is Dr. Mark Atkinson and I'm director of the Diabetes Institute at the University of Florida and a professor in the departments of pathology and pediatrics. And for this year, I serve as chairperson of the organizing committee for the 85th annual meeting of the American Diabetes Association.
I would say that if I had to say the one thing that's overriding, it's the theme of how do you best target obesity and type 2 diabetes. We could actually probably have had a whole meeting just based on that.
The benefits of weight loss are pretty obvious to many, but what's been one of the more beneficial benefits…bad grammar, but true… is the downstream effects for these drugs, meaning the benefits for both cardiovascular disease and renal disease in particular. But the benefits don't stop there.
There's been reports of improvement in memory and Alzheimer's disease, emotional benefits, relational benefits. At the same time, there's been balances of some of the potential deleterious effects. They're not serious adverse effects, but when you lose muscle mass.
And so again, I'm very proud of the ADA as an organization to not only present the latest results here in terms of weight loss and preventing complications, but also just having an open book with communications, with the meeting attendees and the professionals speaking about this.
Another other area of interest that I'm proud of at the ADA this year, probably more than ever, is in the area of stem cells.
There are not enough cadaveric islets in the United States through organ donors to possibly treat individuals with type one diabetes, nor type two diabetes, or individuals that are in need of a islet transplant. So, over the last two decades, people have been trying to generate stem cells, and we're starting to see the results from the first clinical trials using these cells. It's still an early stage, and there's challenges that occur that these stem cells usually have to be given in combination with an immunosuppressive regimen, which has its deleterious side effects.
But this is a field that is rapidly making progress and seeing essentially movement from bench to the bedside.
One more issue that I'd like to emphasize is that the exciting activities and technologies and new drugs that we hear about at this meeting, that's a great thing. But at the end of the day, how are we going to fit these into healthcare systems that are existing ones? Who's going pay for these? How are we going to provide the education on the proper use of them? What are the qualifications in order to obtain these technologies? So, I'm very proud that at this meeting, we've had a series and will have continuing discussions moving forward about how to advocate for the best use of these promising new therapeutics and technologies for people living with diabetes.
Oral Semaglutide and Cardiovascular Outcomes in High-Risk Type 2 Diabetes
I'm John Buse. I'm a professor of medicine at the University of North Carolina in Chapel Hill, North Carolina. I'm diabetes clinical trialist and diabetes doctor.
The SOUL Trial was a randomized placebo-controlled trial of oral semaglutide versus placebo in patients 50 or older who had a hemoglobin A1c between 6.5 and 10, and they all had to have clinical cardiovascular disease. So, it could be a prior stroke or a known disease in the carotid or brain circulation, heart disease, atherosclerotic heart disease or peripheral vascular disease that was symptomatic or chronic kidney disease as defined by an EGFR of less than 60.
The rationale for the study was to investigate whether oral semaglutide provides the same benefits as subcutaneous semaglutide that had previously been studied in multiple disease states.
The reason why it's a question is the oral semaglutide has to be taken in a very special way, has to be taken on an empty stomach with a small swallow of water, nothing by mouth other than that tablet and the small swallow water for at least 30 minutes after administration.
And so, there was some concern that with this oral route of delivery that maybe the same levels of semaglutide wouldn't be achieved, perhaps the same benefits wouldn't be recognized, and that's why we did the soul study.
The primary endpoint was a so-called time to first event or the first occurrence of either a heart attack, a stroke, or cardiovascular death. And what we found in the soul study was a 14% reduction in those events combined. And the intriguing thing about that is it's precisely the point estimate of the entire class of GLP-1 receptor agonists with regards to this end point, the so-called three-point mace of heart attack, stroke, cardiovascular death.
We also looked at kidney outcomes, stroke in particular, many other outcomes, which all trended in the right direction.
One of the interesting things that turned up for the first time in a statistically significant way was reducing so-called major adverse limb events, so hospitalization related to lower extremity issues related to circulation for the most part. So, that's kind of exciting. A new frontier for the GLP-1 receptor agonist class and oral semaglutide in particular
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