Dear ladies and gentlemen, dear colleagues, my name is Stephan Jacob. I'm here to share with you some thoughts about the GLP-1 receptor agonist, which patients should we consider, and I did bring a patient of mine who just recently was seen in my office. He's a 64-year-old male. He has been diabetic since 2015 and this summer he had an acute coronary syndrome, a PTCA and he comes to me to improve his diabetes management and his treatment for his glucose is Metformin twice daily with 1,000 mg and his HbA1c is 6.9, so the question arises, should we really modify the glucose lowering medication? And there are very many people who would say hey, no, we don't need to do this. HbA1c is good. I wish all my patients were as good as this guy. But there is a growing proportion of people who would say hey, wait a minute, no, we need to modify this because the guy is not on evidence-based medication and if we look into all the anti-diabetic medications, and all the outcome trials which were done, we must say that there are a lot of medications who have never done any randomized control trial, and no cardiovascular outcome trial. So, there is no RCT for Metformin for SU, for Acabose, there is nothing for mealtime insulin or intensified insulin treatment. There are however these randomized trials in the green boxes here and if we look at the effects on MACE, we can say yes, we do have positive data for pioglitazone. We have safety data for DPP4 inhibitors and basal insulin, basically glargine, and we have superiority data for SGLT2 inhibitors and GLP-1 receptor agonists, which gave us a great, great signal of hope for our patients. So, what would the guidelines recommend and you recall that in 2018, there was a new consensus paper by the ADA and the EASD which went on to the old one to say besides of doing individualized treatment and look at avoidance of weight gain and avoidance of hyperglycemia, there is a game changer because if you have atherosclerotic disease or if you have chronic kidney disease or heart failure, you have to use the novel agents which proved to improve outcome, and there are two situations. If the HbA1c is not at target, and if the patient is not yet on one of these medications like an SGLT-2 inhibitor or a GLP-1 receptor agonist, you need to use this drug to improve HbA1c, but the revolution is here. Even if HbA1c is at target and the patient is not treated with one of these evidence-based drugs, you have to add it on and you have to prescribe an SGLT-2 inhibitor or a GLP-1 receptor agonist irrespective of the HbA1c. This is basically also said in the ESC and EASD guidelines which were released in 2019 and the EASD/ADA guidelines, they worked further out that it looks like if you have atherosclerotic cardiovascular disease predominantly, it seems that the GLP-1 receptor agonist with a proven benefit should be preferred. However, if you have heart failure or CKD, it looks from the data that an SGLT-2 inhibitor should be preferred with evidence of reducing heart failure and improving CKD progression. So, there is a change of paradigm because in the past, we were just looking at HbA1c and we said the lower, the better, and then we learned that hypoglycemia and weight gain is not a good thing and that is why they said in the guidelines in 2015 the lower, the better for the HbA1c but stay out of hypoglycemia and weight gain and now we have advanced to a different view. We say we need to work and target to reduce cardiovascular events and we can do so by controlling blood pressure, by controlling lipid, and by using glucose lowering agents with approving safety and efficacy. So, if we look at the guidelines, we would put Mr. K on this side because Mr. K has acute coronary syndrome so he has atherosclerotic cardiovascular disease and he's at the moment not treated with a medication with a proven evidence-based improvement of outcome so this is why this man needs to get a GLP-1 receptor agonist and the best thing would be to give it once weekly because it's convenient for the patient and they also have shown tremendous effects. So, how is it in reality? Are they really used the way they should be? These are data from an American database and these are data of people who have a high CK risk and they all 100-percent should be on SGLT-2 or GLP-1 receptor agonists. In 2014, this was before the first positive CVOT. There was a low level of prescription but in 2015, we got the empiric outcome and the levels were still very, very low. In 2016, you saw a slight pick-up of the SGLT-2 and he got the first GLP-1 receptor agonist trial to show that there is an improvement in mortality and if we then follow-up we must say yes, there is a slight improvement in the prescription but many, many patients are not treated with these drugs and there is a lot of room for improvement, but the question arises, who should do it? And there is a big, big chance where we really need to look at it, because if we look at the specialties seen by patients with diabetes and atherosclerotic disease, this is a nice paper looking at that, you see that the cardiologists have a tremendous role here because they have four to six times higher rates of contact compared to the endocrine guys so this is a missed opportunity if a cardiologist sees the patient more frequently if he's not addressing the issue of improving diabetes management with one of these evidence-based medications. So, this is something where we need to work in the future. We have to cooperate but maybe we would even need a new specialty and this was indicated in the presidential address of the American Diabetes Meeting this year by Bob Eckel [ph 00:07:42] who said we need a cardio metabolic specialist, someone who got a training in cardiology and in metabolism and he tries to set up this subspecialty as a track in internal medicine in the states and we are trying to set that up in Europe because we need to have someone who knows a lot about cardiovascular medicine but also about the way to handle the metabolic problems and to help the cardiologists, the endocrinologists, and the G.P. and most importantly the patient to get the right treatment to improve his outcome. So, let me conclude here, yeah, there is a need for a change of the paradigm, and Ralph DeFranso [ph 00:08:26], a couple of years already earlier down the road said hey, treat the patient and not his sugar. Reduce his cardiovascular risk and not only the HbA1c and these days we can say yes, we have to do this. We have clear evidence that there are certain medications which can improve the outcome of our patients, especially those patients with a high cardiovascular risk, and we have seen that in people with atherosclerotic disease, GLP-1 receptor agonists seem to be the best to help our patients. Thank you very much for your attention.

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