Chapters Transcript Video New Frontiers in Heart Failure Therapies Dr. Edward Sawey explores the need for new pharmocotherapy in treating heart failure. Hey, good afternoon. Um uh Before I start a little bit of a shameless plug, there is another side of the heart. It's called the right side of the heart. Um We've talked a lot about the left side of the heart. Um We uh do treat a, you know, a very significant number of people like was mentioned with uh RV shock in our pulmonary hypertension program. And we have a symposium on October 11th in Waiter Hall over uh by the hospital. So please, if you uh are interested at all on the other half of the heart uh please on come on down and uh we'll have a good talk about it. So, um so uh what are we doing with this talk? Uh The question is, do we need new heart failure therapies? Right? I mean, so we had ace inhibitors beta blockers. We were pretty good with those. Uh You know, we thought to Jackson all the way since Vincent Van Gogh. Um but you know, uh do we need new heart failure therapies? Don't we have enough? Isn't there enough pill burden uh for these patients expense? Um And that's something that we need to address and we will address what's new. Um And there's a couple of things that are new that we're going to go over and how will this help my patient? So, uh everyone knows that we have the four pillars of GDMT and two out of the four, the and the SGLT twos uh really have kind of come to high prevalence over the past five years and have been uh somewhat of a sea change. We had uh graph uh before of overall one year survival with advanced heart failure and five year survival is about 50% with heart failure. It's a progressive disease. Five year mortality is still 25% with the current therapies. I don't know about you, but that's not particularly acceptable. Um The cost of medications is unaffordable for many, um, pill burden with the populations. Uh There's many comorbidities. Uh if you have uh crain at 2.5 guess what? I can't use most of my medicines with you. Um You know, at least not the ones that we're talking about today and we will, we will talk about some others that maybe can be used and pharmacotherapy that are easy to implement. So 6.5 million Americans over the year age of 20 have heart failure. It's the number one cause of hospitalization for Medicare. If you work in the hospital at all, you are already very familiar with this. 88.5% of cardiovascular deaths in the USA are due to heart failure, exacerbation. I told you about the five year survival uh with one year survival of 10 to 20% in the advanced heart failure population. And the cost uh was in 2012 $21 billion and it's projected to be $53 billion in 2023. So I don't even think Elon Musk can afford that. Um So what is new, what are some of the new players that we have um on our Armamentarium, so to speak, and we're gonna speak about four different uh modalities. We're gonna speak about car. I challenge you to say that three times fast. So Tala flows in and subcutaneous fisma. So uh in the Victoria trial, uh they, they tested and uh s is very unique in that it doesn't necessarily have that blood blood pressure lowering that many of our medications do have. You know, I think uh many of the times we're in the advanced heart failure clinic and we, we are trying to uptitrate medications, but we're limited by blood pressure. The blood pressure is 90 people are freaking out and like, how do you feel? Do you feel? OK. And they're like, yeah, I feel OK, it gets down to 85 gets down to 80 they're like, I can't stand without feeling dizzy and you really have nowhere to go. Um And so in this trial, uh there were improved outcomes versus placebo in patients with heart failure, reduced ejection fraction following worsening heart failure event. And you can see the primary composite end point. Um you know, there was a hazard ratio of 0.9. Um you know, highly statistically significant um and a decrease in all cause mortality though it, the confidence interval crossed. Uh it was all cardiovascular uh heart failure mortality benefit. Uh Now in the Victoria trial, what they were looking is um they were starting with uh you know, a recent heart failure event, multiple heart failure events, uh anti propan p greater than 100,000. Um And then, um you know, this was the check within less than six months. Uh They have a new trial called the Victor Trial. And um they're going to be starting it in people who have no recent heart failure. Uh you know, nothing within the next uh the last three months, no need of for IV diuretics within the last three months. So a lot of the patients that you're gonna be seeing out there in the clinic, uh not necessarily with the referral to us and no recent changes in of GDMT. So fairly stable patients and we're gonna be uh they're moving forward to do an analysis on this, but uh I is available for you to use today. Um And I highly encourage you to consider it when you're um uh you know, kind of struggling with your four pillars of GDMT. Now, this uh is about camp from Mac, there's the galactic HF trial. This uh was particularly exciting. This was uh going to be our oral inotrope, so to speak. Um The slide was shown about um you know, inotropes, uh the 2008 or 2002 paper about oral m. Um And those of, you know, we use a lot of merino, oral merino caused um uh higher mortality. Uh that was quite a concern also kind of to note back then, I CD prevalence was not quite as high um uh then as it was now. And I'm kind of curious if the outcomes would have been the same. Also, I wish I didn't have to send so many people home on IBM therapy. I wish I could give it to them oral, but nobody's going to make uh oral me go through the FDA pro uh procedure um to get it approved as a generic. So we have the galactic trial. Um And this was very exciting and as you can see the cumulative incident of, you know, uh of heart failure uh in the blue, the hazard ratio was 0.00 0.92. So this was another significant improvement in the ability of people to uh be well. Now, it didn't necessarily have an effect on cardiac death, but, but hospitalization now, unfortunately, this medication did not get approved by the FDA. Uh And there is a reason why there was and I know this is extraordinarily small and I apologize. Uh This was very helpful uh for people who did not have a fib. And you can see um I don't know if this is that top, top, right with the big box, you see that it uh favors a camp of maccabe and those are people without atrial fibrillation, not taking to Jackson. Look over on the top, on the right side over there. And what you're seeing is it favors placebo if you have a fib and to um heart failure, a fib pretty common, not necessarily deason but a fib. Uh So there was a signal for harm here. Uh And it was not approved by the FDA. Now, they're appealing this to say that if we're able to screen for people who don't have a FIB. Um and don't have uh deason if this would be a beneficial drug. More is to come on that. Now we have closin another eosin. Um We have empagliflozin um and uh Lysin in everybody. I mean, well, what can you not use that drug for? I'd like to ask um diabetes, half, half all of this. Well, you can't really use it if your JFR is less than 25. So, CYO um kind of affects both the SGLT one and the SGLT two inhibitors. Um The SGLT one is uh effect of absorption of glucose in the gut. It's not insulin or kidney function dependent. Again, not kidney function dependent. There are many people that I'm struggling with GDMT and I cannot use one of the four pillars of GDMT because they are uh on dialysis or they're stage five kidney disease. So they uh this study is ongoing. Um And the, the results are quite promising. Um The placebo you can see uh much more events and CYO and uh much, much more um separation of curves than the others that I showed you. Uh the primary end point being cardiovascular death, hospitalizations for heart failure and urgent visits for heart failure. So, again, another win for our um SGLT one or two. And uh here in the New England Journal, uh you know, uh because these events were so striking, what you're looking at uh is uh per patient year. If you are on telos versus placebo, you're, you're looking at um you know, 7.5 per events per 100 patient years on placebo versus 5.6. It's, it's a significant difference. Uh you know, uh and when, when you start to pair these on top of each other, this starts to become more and more survival. Um normal side effects, you know, uh uh are, are pretty much the same as what you would have with the TT two inhibitors last, but not least we have subcutaneous fero. Um And uh this um is a wonderful device uh that we have now and that's available to us. Now, what is it it is exactly what it says. Uh you um have this device and it infuses 80 mg of Vios into your subcutaneous tissue. Um Now, in the initial study, they didn't, they didn't show necessarily huge difference in standard medical care. But what they did show was that you got a much more rapid improvement uh when compared to standard care. Um you know, if you look on the right um the improvement uh in body weight change was uh more than standard care 2.8 kg, your dysnea scores uh at five months uh or sorry, five day, three days. Um your six minute walk test was um was better. All of these things, the composite score was you were feeling better. Um And then sorry, I want to go back and then uh I didn't include the slide but recently, what they did is they compared I bromide 1 60 to uh subcutaneous S 80 what they found at their equivalent. Um So if you were gonna send somebody and you wanna, I don't know, let's say they, they're sick enough to maybe be needing to go to the infusion clinic for that 100 mg of IV lax. You wanted to get them started, not that they uh you know, can get this right after your visit. But if this is the type of patient that you have, um they can infuse this infuses over a couple of hours uh into a subcutaneous area and they can save this, um, this medication at home, it lasts for a long time. And if they're in trouble it, once they have the device, you can send them home or they can know that they can take this. Whereas, you know, very commonly we're struggling with absorption issues. So, um, so the benefits are competition driving down costs, right? How many times have we prescribed? Um, one of the SGLT twos or um, a which there's only one. and you, um they come back to you and they say I can't afford this, you ask them how much their copay is and they say $200 a month, $300 a month, $400 a month. And you refer them to the, you know, assistance program and they make, you know, just a little bit too much money to be able to be, to help. Um So, you know, any degree of competition is absolutely beneficial. Um The um you know, the SLT 21 inhibitor, um you, they're gonna have a better side effect profile as well as various, so Tagle flows and may be able to be used in ESRD, like I mentioned and like uh Sin and Lysin, it's good across all LVEEF levels. I mean SGLT two inhibitors we're using in pulmonary hypertension as well. Uh I mean, it really is uh something that you, you, you, you are almost hard pressed not to find an indication to use. Um camp may be useful in a subset of patients. Uh F FDA review is going to be coming and subcutaneous fios is available now to help people who you are having a very difficult time with oral diuretic dosing. Um And with that, yep, I think um yeah, I beat the clock. So um. Published October 18, 2023 Created by Related Presenters Edward J. Sawey, M.D. Sentara Advanced Heart Failure Center View full profile
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