COMPLETE AF INTERVIEW
17 Pages;
Call Leader 2: Hello.
Slingshot Admin: Hey, Adam. Good morning.
Doctor: Good morning.
Slingshot Admin: Hi Doctor. Just dialing in the other Call Leader here. Hopefully, he accepts and then we'll get started.
Call Leader 2: Dr. Budoff. It's Adam. Nice to meet you.
Doctor: Oh, nice to meet you as well.
Call Leader 2: Thank you for doing this. Appreciate it very much.
Doctor: Certainly.
Slingshot Admin: Damian, are you there?
Call Leader 1: Yes. Hello.
Slingshot Admin: Oh terrific. It worked. Okay. Well Dr. Budoff, thank you very much for taking the time for this call today. We're looking forward to hearing your thoughts on the space.
For compliance purposes, I would like to confirm a few points which I'll read through and you can grant your verbal consent at the end. Okay?
Doctor: Yes.
Slingshot Admin: First, this call is being recorded and transcribed. Second, you the expert attest that you will not disclose any confidential or material nonpublic information. And finally, you attest that if you are a physician participating in a clinical trial, you will not discuss information not yet in the public domain. If you're a member of a Scientific Advisory Board, Clinical Trial Steering Committee and/or Data Safety Monitoring Board, you will not disclose any information that is not publicly available or information that will break confidentiality agreements by which you are bound. Do you agree to these terms, Doctor?
Doctor: Yes.
Slingshot Admin: Great. And Adam and Damian, you are required to keep any material nonpublic information confidential as well. If you're currently a public company employee or have been employed by a public company within the last 12 months, you attest that you will not share material nonpublic information or information that will break any confidentiality agreements by which you are bound. Do you agree to these terms, Adam?
Call Leader 2: Yes.
Slingshot Admin: And Damian?
Call Leader 2: Yes.
Slingshot Admin: Great. Additionally, I'd just like to note this call is intended for informational purposes only, not investment advice. The contents of this call, including any and all information provided regarding individual securities or industries do not constitute financial, legal or tax advice. With that said, we're joined today by STAT reporters, Adam Feuerstein and Damian Garde. Both cover biotech markets for STAT News, a national publication focused on health, medicine and life sciences. They'll dig into Vascepa and Amarin's REDUCE-IT trial. So, with that I'll turn it over to you guys, Adam and Damian. Thanks.
Call Leader 2: Great. Thanks, Joe. This is Adam Feuerstein, and again I'm joined by my colleague, Damian Garde. The purpose of this call was to kind of just do a preview and prep for the upcoming REDUCE-IT study of Vascepa. It's a pretty big event. The trial has been ongoing for many years and finally reaching a conclusion point where we're going to be hopefully seeing results read out by the end of the third quarter. So we thought it was a good idea to get an expert on the line, someone who's familiar with the product, with Vascepa, who can maybe walk us through the trial design and his thoughts on kind of what we might see from an outcome.
So with that background, Dr. Budoff, thanks for doing the call with us. We appreciate it.
Doctor: No, it's my pleasure. I'm glad to be on.
Call Leader 2: So maybe just to start, just at the top if we can get rid of sort of the financial disclosure question and maybe just kind of give us just your, any consulting work that you do for Amarin or any other sort of cardiovascular related company.
Doctor: Yeah. I'm on the Speaker's Bureau for a few companies in this field, in kind of the preventive cardiology space. PCSK9s, Vascepa, other lipid agents over the years, Lipitor, Crestor. I've been on ... I have a research study going on with Amarin. It's an investigator sponsored trial, so I'm in charge of it. They just provided funding and some of the product so I can conduct the trial, but I'm doing a trial called EVAPORATE, which is looking at plaque buildup under the influence of Vascepa versus placebo, so it's a doubled-blinded, placebo-controlled, randomized trial looking at plaque progression over the course of 18 months. And kind of a mechanistic study of REDUCE-IT, if you will. And that's generally my primary role with Amarin.
Call Leader 2: Alright, great. Thank you very much. Damian, you wanna kick off some of the questions?
Call Leader 1: Yeah, absolutely. So I think it might be helpful to kind of set the stage a little bit, Dr. Goodoff about like, if you could give us kind of an overview of your practice and little bit about Vascepa fits into it and how triglycerides kind of play into the overall, I guess, kaleidoscope of lipid management and of cardiovascular disease.
Doctor: Oh sure. My practice is preventive cardiology. I'm the endowed chair of preventive cardiology here at my institution. I see patients to try to prevent either their first cardiac event or their second. And we focus a lot on established risk factors such as cholesterol and triglycerides, blood pressure and other things. I'm treating patients daily and at the conclusion of this interview, I will be going over to see my patients this morning.
Call Leader 1: So maybe tell us a little bit about ... Obviously, Vascepa is approved right now-
Doctor: Oh sure.
Call Leader 1: For patients with very high triglycerides levels. Just maybe give us a little background or tell us a little about your experience using Vascepa in patients, kind of where, how it sort of fits into your practice.
Doctor: Yeah, so I've been using Vascepa for a number of years now. I don't know if I disclosed it, but I was an investigator or am an investigator in REDUCE-IT. I'm not privy to any inside information, but I did have a few patients in the trial so I had an opportunity to use it both in a research environment, as well as a clinical environment. But I use it for patients who have elevated triglycerides. I typically consider that above 200, so I use Vascepa as well as other triglyceride lowering medications, not only in those patients with severe hypertriglyceridemia, but in a more moderate environment as well.
Call Leader 1: And maybe can you characterize maybe the different drugs or different treatments that you use in those patient populations? You mentioned Vascepa's one, you use others. What sort of the pluses and minuses are, your experience with these products.
Doctor: Sure. Fibrates have been most widely used in the field. I don't use them as much anymore because they tend to raise the LDL cholesterol, and I think that that offsets some of the potential benefit. And there's been a couple negative trials now in a row with fibrate.
There is also EPA-DHA combinations. Lovaza is currently on the market. And I've used that as well. But again, the DHA tends to raise LDL cholesterol so I've kind of moved away from that and more towards Vascepa, where I don't see that LDL raising in my patients. So I think Vascepa has an advantage there in that it doesn't increase ApoB or LDL cholesterol. Niacin has been used historically. I've never used it for high triglycerides. I've used it more for low HDL, and I still do use it for low HDL. But I don't consider it as much as triglyceride drug, but it's typically listed in that spectrum.
Call Leader 2: I think you bring up a good point and something that I know, when we ... as writers, as reporters, when we start talking to laypeople, we often refer to Vascepa as prescription grade fish oil. We try to ... It's kind of like the layman's explanation, but obviously that doesn't sort of get into the characteristics of the product. But again it's ... Maybe you can kind of talk a little bit about the differentiation between Vascepa and sort of purified EPA versus more of a mixed EPA-DHA compound.
Doctor: No, absolutely. Purified EPA again, two things we know that make it, that I think make it a little unique. Number one, is its very high purity. It's on average about 98% EPA. So when patients take 1000 mg capsule, they're getting 980 milligrams of fish oil and EPA. If they take a dietary supplement, something that's available without a prescription, they're really not regulated. And most of them have on the order of half of that or less. So they might have half of the capsule may literally be just filler. So they think they're getting 1000 milligrams of fish oil, and in reality they're getting 500 milligrams of fish oil or 400 milligrams of fish oil. And the net result is they're getting in a lot of saturated fat in the pill that's not good fat, that's not the fish oil that they're going for. So they tend to under dose themselves cause they think they're getting more than they really are, just cause the purity of those capsules are not very high.
Call Leader 1: So getting to the study we're talking about, REDUCE-IT, as we mentioned, it's a long study. It's 8,000 patients, more than 8,000 patients, looking at the change in major cardiovascular events over the long period. And so I'm curious from your perspective, kind of piggybacking on what you just said, the differences between Vascepa and some of these other agents, do those differences, does that affect how you view the potential outcome of REDUCE-IT? Are you more optimistic or less optimistic based upon the differentiation you just described?
Doctor: Yeah, so I think that there is a dose response, and I think more fish oil will lead to better results. And this is the first study looking at four grams of fish oil in any capacity. So not only four grams but four grams of, if you will, pure EPA, so I do believe that this will be beneficial. There was a meta analysis done recently that said that we don't see the robust responses from fish oil that we hoped, but most of those or all of those trials were low-dose. And the trials that had higher doses had better responses, but higher doses in that analysis was 1.8 grams. So now we're talking about four grams. So if we do think there's a dose response, and I do believe that there is a dose response, that four grams of EPA will be much more effective than a lot of the earlier studies with 1.8 grams or one gram of fish oil.
Call Leader 2: So the REDUCE-IT is what's commonly known as a cardiovascular outcomes trial that we see these large kind of studies done in the cardiovascular world. Can you just describe a little bit about what exactly the endpoint is and sort of what the company's trying to do with the study? Just as sort of background for people who may not be familiar.
Doctor: Of course. So REDUCE-IT is enrolling, has enrolled over 8,000 patients. They are looking at cardiovascular endpoints, so they're looking at things like heart attack and cardiovascular death to see if these agents compared to placebo lowers cardiac risk. Now it's important to recognize that everybody in the trial has to be on established good therapy, including traditional cholesterol medicines like statins, and they have to have good LDL control. Their bad cholesterol or LDL cholesterol has to already be controlled when they're entered into the trial, and now we're just focusing on the triglyceride levels. So our goal is to see if patients with elevated triglyceride levels who are already taking good therapy will have additional benefit to lower cardiac risk.
Call Leader 1: So in terms of the results that we might expect, I know that the trial is powered to show a roughly 15% reduction in those cardiac events versus placebo. And we've seen roughly that from the long-term outcome studies of PCSK9 therapies, other LDL lowering therapies and so I'm curious what do you think we might see in terms of an actual percent reduction from REDUCE-IT?
Doctor: You know, you brought up an interesting point. 15% seems to be a recurrent number. It's not only seen with the two PCSK9 studies that both showed 15%, but the CANTOS trial, which looked at an anti-inflammatory on top of a statin, also showed 15%. The only other study we have with EPA as an outcome study is called the JELIS trial, J-E-L-I-S, and it demonstrated a 19% reduction adding EPA to a statin. Now that was in a Japanese population and the doses were different so there are some caveats, but I do believe we'll be in the 15 to 20% reduction range with adding EPA to a statin.
Call Leader 2: So when the company does announce results some time later on in this quarter, what do you suggest? What should people be looking for? What will you be looking for? Obviously we'll probably get ... The first thing we'll get is a press release with top line results before we see a publication or a presentation. But what will you be looking for when you read that announcement?
Doctor: Yeah, so I would be looking for, again, it'll say that it either met its goal or it didn't as a top line result before we see the presentation, but I would be interested in a double digit reduction in events. I think that if you can achieve more than a 10% additional reduction as compared to good statin therapy on top of good statin therapy, I believe that will be seen as a very desired benefit. And it is fish oil, which is basically more or less a natural derivative, so patients tend to like taking fish oils more than some of the other types of medications that we prescribe in cardiology.
And the cost, the price point of EPA is infinitely lower than either PCSK9s or canakinumab that was used in the CANTOS trial, so if we talk about bang for your buck, if we can get an additional 15% event reduction with a drug that costs $180 a month instead of $1,200 a month, I think that will be very desirable by all.
Call Leader 1: I'm curious, is there sort of ... Let's establish like a band of potential outcomes. So 15% or more would be the best case scenario in terms of reduction in these events. And then let's say on the lower end, it's something like five to seven, not dissimilar to what you saw with ezetimibe long-term outcome study. How might your prescribing patterns be affected along that band? If it's as low as, let's say, seven versus if it's as high as let's say 15 or more?
Doctor: Right. So I think if it's 15 or more, I think it definitely establishes the role in patients with triglycerides above 150 or above 200 depending on where most of the patients fall out in the final study. But I think those patients with moderately elevated triglycerides should be treated with Vascepa on top of a statin if they have residual hypertriglyceridemia.
If you get 15% or more, I think that, that's a very robust number, and I think that should change practice. I think if it's five to seven percent, I think we're gonna need to look for selective use. In other words, look at the subgroups that might have done better. Maybe diabetics with triglycerides above 200 did better and had a 10 or 12%. But I would be personally looking for subpopulations that had at least a 10% or roughly 10% or more event reduction. Cause some patients may have no benefit. There might be ... who knows? Men under the age of 60 that had no benefit at all and maybe that's a group that we don't have to be as robust in. I don't like to rely heavily on subgroups, but if we're in that five to seven percent range, I think we need to look at subgroups to try to garner some patients that might derive more benefit until another study can be done.
Call Leader 2: Speaking to other physicians, I wonder how your prescribing patterns maybe differ or similar to other physicians. Is there, given the fact that we've seen these meta analyses of different sort of grades of prescription fish oil or [inaudible 00:17:18] fish oils and the mixed results that we've seen, is there a reluctance on the part of the cardiologist community to prescribe these ... prescribe something like Vascepa today and that may change pending the outcome of REDUCE-IT?
Doctor: I think it would change dramatically. I think that most of the fish oil trials, if we just list major fish oil trials that have been published, most of them are negative, neutral, maybe not negative, maybe neutral, didn't show a benefit by being on fish oil. They almost all used one gram of fish oil a day, and they all used a mix of EPA and DHA. So I think that when doctors think about the recent trials that have been done with fish oils, they think, "Oh, those have been negative. We really haven't seen any positive studies." So I think that there is a natural reluctance by a large portion of the population of physicians. Now the lipidologists, some endocrinologists, some cardiologists who focus on prevention probably still treat, but I think that will widely change once this trial comes out if it's positive. If we can show incremental value of adding EPA to a statin in a large population of patients, I think that will change practice patterns for a large number of physicians out there today.
Call Leader 1: And I'm curious on the safety side, I know that there haven't been emergent adverse event concern so far in Vascepa's late stage development, but is there anything you've seen or anything mechanistically about the drug that leads to any concern on your part that something might emerge over the course of this very long and very large trial that could be limiting to adoption regardless of the efficacy results?
Doctor: So I think the one thing that I'd be looking towards that we haven't seen yet in late stage development is bleeding. We did see that in the JELIS trial, in the Japanese trial with a large population on an EPA formulation, albeit a slightly different one. And we know that fish oil is a slight blood thinner. A lot of these patients are gonna be on aspirin and maybe on other therapies as well. So I would be looking towards ... My guess will be if we do see a signal, it'll be bleeding. It may be minor bleeding only, but I think we need to look at the bleeding risk of being on fish oil and who maybe shouldn't be on it based on an excess of risk of bleeding. If that does occur.
Call Leader 2: So we got some great questions from people who dialed into the call so I wanna jump on some of them that maybe we haven't touched on yet. But one of the questions I think kind of gets to the mechanism, and I know you're, as you said you're doing some mechanistic work with your trial, but what do you believe would be the main driver for cardiovascular risk reduction with Vascepa? Is it lowering of triglycerides? Anti-inflammatory properties? Or other factors? What is the mechanism here?
Doctor: Yeah, so I think the primary mechanism honestly is triglycerides. I know that there's a lot of other potential value. I think the way triglycerides lower risk we still need to explore. So that's one of the reasons why we're doing the EVAPORATE trial is to see, does the lowering triglycerides lower plaque in the coronaries.
But I also do think people need to remember that after statins, the only other drug that we have really that's used in a cardiovascular arena today that lowers C-reactive protein reliably is EPA. And I think there is an anti-inflammatory benefit. I think the CANTOS trial demonstrated that.
Obviously I don't think we're gonna use canakinumab in cardiology cause of the price concerns and the increased risk of infection, but I do think that it does prove that inflammation's important, and we have seen a consistent benefit with EPA on inflammation.
So I would say first and foremost, it lowers triglycerides, triglycerides are atherogenic and therefore we're gonna see benefit. I think secondarily it lowers C-reactive protein and other inflammatory markers, and I think that's beneficial. And then finally, it has a very minor effect on reducing ApoB, and I think ApoB is bad, and I think if we reduce ApoB, that is also another benefit. So kind of almost an LDL effect if you will, reducing the bad cholesterol.
Call Leader 1: One thing ... go ahead. Adam, were you about to-
Call Leader 2: No, go ahead. No go ahead Damian. I'm sorry. Go ahead.
Call Leader 1: I was interested in, this is kind of a left turn, but in compliance, my understanding is that the four gram dose of Vascepa, that's four pills per day. Has that been an issue in your practice so far with the actually approved use in ensuring patient compliance with that?
Doctor: Yeah. I mean I have to say that there are some patients ... They are big capsules. There are smaller ones as well. They're relatively easy to swallow, but they still are fairly big capsules. That there is some compliance issues, and I would say probably some of my patients are taking two grams a day instead of four grams a day just for logistical reasons, and we won't know the full benefit of that but I think most patients that I've treated and certainly the patients I've enrolled in the studies ... Our EVAPORATE trial has 80 patients in it, and they are all compliant with the four grams a day. We keep very close tabs on them in a clinical trial setting. So I do think that if patients are properly motivated, but I agree with you, four capsules a day, twice a day does lend itself to slight lower compliance over time.
Call Leader 2: Another one of our listeners wanted to get your thoughts about the other cardiovascular outcomes trials that are ongoing today using low dose Omega-3s. There's the VITAL trial, I think there's the trial called ASCEND. Any thoughts about, I think some of these are gonna be reading out relatively soon along with REDUCE-IT. Any thoughts about the impact of those studies on the field and maybe in particular on Vascepa?
Doctor: Yeah, so I think the other trials that are reporting out in the near term are both one gram trials of mixed EPA-DHA. I don't understand, to be honest, I don't understand why they would do those trials given the plethora of negative studies that we've seen with one gram of EPA-DHA. I don't see the purported benefit or the angle.
I think REDUCE-IT is much different. It's four grams of pure EPA rather than one gram of mixed EPA-DHA. So I personally think that they will be negative. That they will be neutral trials and will not show outcome benefit. If they do, then I think we're gonna have to look at the population studied and compare the two and see, was there more benefit by using four grams of EPA or was it similar benefit? Obviously, if it's similar benefit of using four grams of EPA as far as event reduction and one gram of mixed DHA-EPA, then patients and doctors are gonna favor the one gram dose, but I don't believe that will happen.
The other trial of interest I think is the STRENGTH trial, which is four grams of DHA-EPA that's ongoing. It's still a little ways out, but I think that will be another very interesting trial in this arena. Looking at high dose fish oil to see if there's an event reduction associated with it.
Call Leader 2: Is the STRENGTH trial, is that the Epanova that's used, AstraZeneca's Epanova?
Doctor: Yes. Steve Nichols is the principal investigator of that one. That's an ongoing study that I think has great interest as well among preventive doctors and lipid doctors, but I do think that, that's a few years out. My understanding is they're still enrolling so they're not quite at the completion stage like ...
They're not quite in the homestretch like we are with the REDUCE-IT trial.
Call Leader 2: And from what I understand, Epanova, that's a mixed EPA-DHA product right?
Doctor: Yeah, it's a free fatty acid formulation. It's thought to be a little different. And it is more pure than some of the other ones that have been out there so there are some potential reasons why it may work better than some of the earlier trials, and it also is being studied in a higher dose, the four gram dose rather than the low dose. So I think there's some differences as compared to earlier iterations of EPA-DHA studies.
Call Leader 2: [crosstalk 00:26:27]. I'm sorry, go ahead Damian. I'm sorry. We're supposed to be switching off, so your turn. Sorry.
Call Leader 1: This is kind of a left turn as well but you mentioned the Japanese trial, the JELIS trial that found a 19% reduction in cardiovascular events using EPA plus statins. I've always found that kind of interesting because that seems like a fairly dramatic result, but when you talk to people kind of handicapping REDUCE-IT, they often discount the results of that trial for various reasons. So I was curious your opinion on basically whether that trial might be predictive of what we see with REDUCE-IT and if not entirely, what are the caveats that people should consider when looking at it?
Doctor: I think, a great question. I think the intrinsic differences between JELIS and REDUCE-IT or STRENGTH or some of these other high dose statin, I mean EPA trials, is that the JELIS trial was a general population of patients with very high cholesterol so they weren't well controlled LDL cholesterol patients. They weren't necessarily high triglycerides patients either, so I think they're quite a different population than what we're studying in REDUCE-IT.
I do think it was very reassuring that adding 1.8 grams of EPA to a statin did lower events, but it was neither a triglyceride lowering trial, triglycerides only went down by five percent, and it was really not an add-on to optimal therapy trial because the baseline cholesterols were very, very high and the doses of statins used in Japan are very, very low. So I think that JELIS is, like the FDA says, is supportive but not conclusive. That lowering triglycerides or using fish oil will be beneficial, and I think we really need the REDUCE-IT trial to fill in the gap there.
Call Leader 2: Just maybe flipping the script here a little bit, Dr. Goodoff. I mean, what happens if this study, if we get the readout from REDUCE-IT and the study fails? So there's either a very small relative risk reduction or it's not statistically significant. The study does not meet its primary endpoint, what happens at that point? What happens to the current use of Vascepa in your practice or in other doctor's practices? Maybe talk a little bit about sort of that side of it.
Doctor: Sure. First, again I think that it would be in a large trial that it's at least of interest to look at some of the pre specified subgroups just to see if some group had a great benefit. Again, I would guess that diabetics with high triglycerides or those with higher triglycerides above 250, above 300, may derive more benefit, so I would look towards subgroups just for a hint of something that's biologically plausible that may lend itself to continued use while waiting for the second trial. I think if it completely doesn't work and there's no benefit at all and it works out like the CETP inhibitors where it's really just neutral, then I think that Vascepa will be largely used in those patients with higher triglycerides where we have serious concerns about not only cardiovascular disease but also about pancreatitis and other consequences of high triglycerides.
Call Leader 1: And so if it does hit, you mentioned how the patient populations of this outcomes trial are different from the ones in the PCSK9 and other sort of LDL management therapies that we've seen, but if this trial does hit with something akin to 15% risk reduction, could Vascepa possibly cut into the market for those PCSK9 therapies? Is there a sort of Venn diagram patient who might be a candidate for both who might get this instead because of the difference in cost that you mentioned earlier?
Doctor: Yeah. I think of obviously PCSK9s as more of a pure LDL phenomenon, and EPA will be a much more predominantly triglyceride thing. But you're right, there are gonna be patients with overlap, and I would think that if they both afford a 15% event reduction, let's say, then you might start with this and then selectively add on PCSK9 if the LDL still remains very high or if the patient has more risk. I think that the cost and the price point will favor this over PCSK9s. And I think if the ezetimibe trial worked and showed a significant reduction in events, I think that, that would have been a lot higher on doctors' algorithms than PCSK9s because of the price point. But I don't think the data was very robust from IMPROVE-IT, so a lot of us are not very enthusiastic about ezetimibe and utilization remains fairly low.
Call Leader 2: I always ask these questions of experts that I talk to and some like to answer it and some don't. So I'll just pose it to you. If you had to put odds on this coming out as a win for Vascepa and the REDUCE-IT study, a statistically significant, clinically meaningful risk reduction, zero to 100%, what sort of odds of success would you give this study?
Doctor: I'd give it about an 85%. I think-
Call Leader 2: 85%?
Doctor: Yeah, I think that the study was done well. I think that they enrolled patients with high triglycerides. I think that they had them on appropriate doses of statins. I think it's a large enough trial with a high enough event rate that if there is a benefit of being on EPA, that they will show it. And I think there is a benefit of high dose EPA, so I'll give it 85% chance of success.
Call Leader 1: Alright. One question. So let's assume that it does hit, what are the barriers to wider adoption of Vascepa? Obviously, Amarin, the manufacturer, would need to take those data to the FDA under an sNDA and change the label, etc., but is there anything else? Like are there ACC guidelines that might need to change if this trial is positive? I guess what I'm asking is what might the next two years of regulatory and practice look like in the event of this trial being a success?
Doctor: Right. So I would anticipate if this trial works that the current cholesterol guidelines, which are now being basically rewritten every single year ... You have to recognize now that the ACC/AHA wrote guidelines in 2013 that were actually published in '14 that then they revised them and added PCSK9s in 2016. And then they revised that again in 2017, and now we're expecting another cholesterol guideline in 2018.
That, that type of consideration would be given if this trial was overtly positive. So I think if this trial hits its mark, let's say it hits 15% event reduction, it's highly statistically significant for Vascepa being better than placebo, I believe that the next year's guidelines will incorporate this and will discuss this as another option in the treatment algorithm. Cause that's been the pattern of the ACC and AHA and the National Lipid Association and the diabetes organizations, both the ACE and ADA, so I think all of those organizations will rewrite their guidelines or at least update their guidelines in the context of another major agent showing benefit.
Call Leader 2: You've [inaudible 00:34:27] this with a lot of great perspective today and information. We really appreciate it. Is there anything else, any questions that we haven't covered or topics related to REDUCE-IT that you feel are important for people to understand prior to the results coming out?
Doctor: I just think that we really can't go lower on LDL cholesterol. If we already look at, let's say, the ODYSSEY or four-year trials and we still have patients who are having events. So we know that there's residual risk even when we get LDLs down to what some might deem very low values in the 20's and 30's LDL. There's still patients having events.
I think CANTOS was informative that there's a potential for treating inflammation as a target and so therefore, I think that there is a big potential here to attack that residual risk in those patients with high triglycerides.
I mean, if you look at the PROVE-IT study the PROVE-IT study got LDLs down nicely, down to the 60's in patients on atorva 80 and those patients who had residual high triglycerides had twice the event rate as those patients who had low triglycerides. So I think that even with good LDL control, triglycerides still play out as a bad player, and I think that this is a potential benefit. If we can show in REDUCE-IT that lowering triglycerides in these patients who are already on a statin, already well controlled and we have a positive effect on ApoB and CRP and triglycerides and that reduces events, I think that, that will change guidelines and that will change practice patterns for doctors who are still struggling with their patients who are on statin and aspirin, a blood pressure pill and still at risk or still having cardiovascular progression or events.
Call Leader 2: Well thanks again Dr. Goodoff for taking the time. We know you have patients to see so we will let you go. So thanks everybody for calling in. Joe, did you have a spiel to wrap this up?
Slingshot Admin: No. Thanks, Dr. Goodoff. We'll follow up with you over email. I appreciate you guys doing this today.
Doctor: My pleasure.
Call Leader 1: [crosstalk 00:36:43] Thanks very much for your time. Thank you very much.
Doctor: Absolutely. And if there's anything that needs clarification, I'm glad to provide that. You can send me an email if there's anything that didn't come out right or you need to clarify before you publish.
Call Leader 2: Sure. And for anyone, for folks listening on the call, if there's any other follow-up questions that you feel like we didn't answer or anything that you wanted to follow up with us, you can also reach out to Damian or I and we'll try to help you out. Thanks again for everyone for dialing in.
Slingshot Admin: Thanks guys.
Call Leader 2: Bye.
Slingshot Admin: Bye.
