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The Yale Associate Chief of Cardiovascular Medicine discusses improved use of available drug classes, as well as the potential approval for omecamtiv mecarbil.
The coming months are poised to be busy, if not fruitful, for the state of cardiovascular intervention.
At least 1 US Food and Drug Administration (FDA) decision will consider a novel therapy for the treatment of heart failure, and the American College of Cardiology (ACC) 2022 Scientific Sessions will present an opportunity for clinicians and investigators to reconvene on the state of organizational guidance and expert consensus decision pathways for any of the increasingly prevalent therapies for disease management and risk reduction.
Just prior to this impending surge of developments, HCPLive spoke to an expert with perspective on each and every cardiovascular intervention trend.
Nihar Desai, MD, MPH, Associate Professor of Medicine and Associate Chief of the Section of Cardiovascular Medicine at Yale University School of Medicine, joined HCPLive for a discussion on the state of PCSK9 inhibitor prescribing in the US, the potential approval of omecamtiv mecarbil, needs in guided heart failure treatment strategies, and promising news to come from ACC 2022.
HCPLive: Could you provide a brief update on the current clinical landscape of available PCSK9 inhibitors? What has been their utility in US practice? What are the limitations to their use? What are key needs in continued research?
Desai: Yeah, I think it's been a really interesting journey, you know, with the PCSK9 inhibitors. There's been obviously very well done clinical trials that have demonstrated the efficacy and safety of both Repatha (evolocumab) and Praluent (alirocumab), in broad clinical trials, populations of patients with established cardiovascular disease, or patients with a recent acute coronary syndrome. I mean, those trials have demonstrated the PCSK9 inhibitors can substantially lower LDL cholesterol levels, frankly, to ranges that we've never seen before—and that that was associated with reductions in events that matter to patients: recurrent heart attacks, recurrent strokes, need for coronary revascularization and others.
I think there was a challenge out of the get go in terms of access and adoption of these therapies. I will say that the landscape does seem to have changed over the last couple of years, as the evidence continues to accumulate. And I think access has gotten better, both because payer restrictions have eased and, frankly, because the price has come down. I think that providers are getting much more comfortable with using these therapies for the patients in whom they are indicated. So, I'm frankly quite excited that we're going to get to a place where more patients who need or would benefit from these therapies will actually get them.
HCPLive: With omecamtiv mecarbil’s PDUFA date set for later this year, could you provide perspective on what it brings either new or improved to the state of heart failure treatment?
Desai: Yeah, I mean, we are really excited about what omecamtiv can bring to our patients with heart failure, and with systolic heart failure, specifically. Omecamtiv has a novel mechanism, really getting to the fundamental pathobiological underpinnings of heart failure, and really sensitizing the contractile elements in a way that they actually work better. So it really does address the fundamental lesion, if you will, in systolic heart failure. The clinical trials program, the large outcomes trial has now been reported out. There was a significant reduction in heart failure hospitalizations, kind of a broad composite endpoint. And what we've learned more actually, as additional scientific analyses have come forward based on that clinical trial's dataset, is that there do seem to be a subset of patients with systolic heart failure, that seem to even derive even greater benefit. And so I'm quite excited that the addition of omecamtiv now adds additional tools to the broad armamentarium for what's available for our patients with systolic heart failure.
HCPLive: Given the increase in both available and investigative therapies, what are our current issues in heart failure treatment strategies?
Desai: Yeah, it's a great question, where we are in terms of heart failure. The armamentarium does continue to expand on the pharmacotherapeutic side. We've seen SGLT-2 inhibitors, omecamtiv, vericiguat and others in late-phase clinical testing. If I was going to comment on what I saw as one of the linchpin challenges that we face, it's really this substantial gap between clinical evidence and clinical practice that, despite overwhelming evidence from clinical trials, despite, guideline recommendation or expert consensus decision pathways from our professional societies, too few patients with heart failure are actually getting therapies that are highly effective. So, I think the field really has to confront this question of, "How do we deliver high-quality, high-value therapies to patients that will benefit in a consistent way?" And I think that really is where the field really has to make a big step forward.
HCPLive: What are you most looking forward to at ACC 2022?
Desai: Yeah, it's a great question, where we are in terms of heart failure. The armamentarium does continue to expand on the pharmacotherapeutic side. We've seen SGLT-2 inhibitors, omecamtiv, vericiguat and others in late-phase clinical testing. If I was going to comment on what I saw as one of the linchpin challenges that we face, it's really this substantial gap between clinical evidence and clinical practice that, despite overwhelming evidence from clinical trials, despite, guideline recommendation or expert consensus decision pathways from our professional societies, too few patients with heart failure are actually getting therapies that are highly effective. So I think the field really has to confront this question of, "How do we deliver high-quality, high-value therapies to patients that will benefit in a consistent way?" And I think that really is where the field really has to make a big step forward. Yeah, we're really excited for ACC 2022. Being in Washington, DC, I will say that, after a couple of years of not being together with colleagues face-to-face, I think one of the things that I'm really looking forward to is just seeing people again, and catching up with people. And, you know, Zoom or other similar platforms are great, and we've been able to kind of adapt and get worked done in the midst of the pandemic. But there really is no substitute for being together and obviously being together with colleagues. And so I think one thing that I'm really looking forward to at ACC 2022 in Washington, DC is just being together with people and seeing friends, collaborators and colleagues. And that'll certainly be something that I've cherished and very much look forward to for this year.
In addition, I think it is poised to be a great lineup, in terms of science. I'm really excited for the late-breaking clinical trial sessions, some of the updates. I think there'll be some new guidelines and some panel discussions that we're really excited about. And in particular, I would say that I'm really looking forward to some of the more novel clinical trials that will be presented at ACC. You know, there's an intervention that's looking at grocery stores and how they can actually lead to improved outcomes for patients with cardiovascular disease. There's an implementation science trial that actually, my colleagues and I will be presenting from Yale New Haven Health System called PROMPT-HF and lots of other important scientific sessions. So, it's going to be a great ACC 2022 and I'm very much looking forward to being there in Washington.