A Role for the Newest Heart Failure Agents

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The MD Magazine Peer Exchange “Managing Heart Failure Today: Current Best Practices and New Treatment Options” features a panel of physician experts discussing key factors to consider when making treatment decisions for patients with heart failure and their own clinical experiences with recently approved medications for the treatment of heart failure.

This Peer Exchange is moderated by Peter Salgo, MD, professor of medicine and anesthesiology at Columbia University College of Physicians and Surgeons, and an associate director of Surgical Intensive Care at New York-Presbyterian Hospital.

The panelists are:

• Michael Felker, MD, MHS, professor of medicine and chief of the Heart Failure Section at Duke University School of Medicine, in Durham, NC
• Milton Packer, MD, Distinguished Scholar in Cardiovascular Science, Baylor Heart and Vascular Hospital, Baylor University Medical Center, in Dallas, TX
• Scott Solomon, MD, Senior Physician and director of Non-Invasive Cardiology at Brigham and Women’s Hospital, and Edward D. Frohlich Distinguished Chair and professor of medicine at Harvard Medical School, in Boston, MA
• John R. Teerlink, MD, director of Heart Failure at San Francisco Veterans Affairs Medical Center and professor of medicine at UCSF in San Francisco, CA

Peter Salgo, MD: Now, we have these 2 new drugs. We’ve got to decide who to put on these drugs. Do you have selection criteria for ivabradine or for sacubitril/valsartan?

Milton Packer, MD: You still need a framework. I’s not a matter of selection. It’s a matter of a thought process. The framework is that at the end of a reasonable period of time (this is really quite important), when you see a patient with heart failure with reduced ejection fraction, you want to say to yourself that within a certain period of time—and I’ll make up a period of time that we can either agree or disagree with, such as in 6 to 8 weeks—I want to have that patient on 3 life-saving drugs. I want to have that patient on an angiotensin receptor/neprilysin inhibitor. I want to have that patient on a beta-blocker. And, I want to have that patient on spironolactone or eplerenone. Okay?

Peter Salgo, MD: Okay.

Milton Packer, MD: I know I want to have that because, if I combine all of those drugs—each of which reduces mortality by about 30% to 35%—I am going to get a very additive, perhaps even synergistic, effect on mortality, and transform the natural history of that patient.

I see a patient with heart failure, and I know those are the goals I need to reach. How I get to those goals is a very important question. A lot of people are already taking an ACE (angiotensin-converting enzyme) inhibitor, and those people would need to be switched, with all the cautions that are required, to an angiotensin receptor/neprilysin inhibitor. Patients who are not taking an adequate dose of a beta-blocker should be uptitrated to an adequate dose of a beta-blocker. If they’re on a maximal-tolerated dose of a beta-blocker, and their heart rate is still up, then ivabradine can be added.

The patient should be on a mineralocorticoid receptor antagonist. But, what the physician has to do is keep, very clearly, in his or her mind the fact that there are 3 goals of treatment which have to be achieved, simultaneously, within a reasonable period of time. How one gets there could be a matter of patient selection, physician experience, or preferences. But, those are the 3 treatment goals now, in 2016.

Peter Salgo, MD: Now, these are relatively new drugs—these 2 new drugs we talked about. Does anybody have experience? You mentioned physician experience and patient experience—has anybody been giving these drugs, other than in a trial?

Michael Felker, MD, MHS: Yeah. Ivabradine has been approved in Europe for a number of years, and has just recently been approved in the United States. Sacubitril/valsartan was approved, obviously, just recently, worldwide. So, I think we’ve all been developing some experience. I’ll speak to both of them.

The biggest challenge [is that] most of the patients you see who have heart failure already have a standing diagnosis of heart failure. They’re not coming to you de novo with a new diagnosis. If you’re doing the right thing, [most patients] are already on an ACE inhibitor or an ARB (angiotensin-receptor blocker).

Frequently, a patient says, “I’ve been on these [other] drugs. You were telling me these are very important drugs to be on, and I feel like I’m doing well. Why do I need to now switch to this new drug?” [Meaning] the ARNI (angiotensin receptor/neprilysin inhibitor) that might be more expensive or have risks.

I think that what people in clinical practice with the ARNIs are really grappling with is how to decide to switch somebody. And then, once you decide to switch them, how do you switch them? I think the guidelines make it pretty clear that that’s a class I recommendation.

Peter Salgo, MD: Do you think it’s the patient who has a problem with that, or the physician?

Michael Felker, MD, MHS: It’s both. I think there’s reluctance to change something that seems to be effective.

Scott Solomon, MD: Let me speak to this issue a little bit because the US guidelines were very clear about this. If a patient has symptomatic heart failure, class II or III, and they can tolerate being on an ACE inhibitor or ARB, they should be switched to sacubitril/valsartan.

Now, [pertaining to] the issue of, “I feel okay, why should I do this?” Or, “My patient’s feeling okay, why should I do this?” We’ve actually looked at this in the PARADIGM Heart Failure trial. Many of the patients in that study had never had a prior decompensation, and had never been hospitalized for heart failure. Some have been hospitalized in the very remote past, and we looked at whether those patients benefited any less than the patient who had decompensated more recently. As it turns out, there was no evidence that they benefited any less. But, they still had a very high rate of dying suddenly. They still had a very high rate of being hospitalized. So, to get back to this issue we talked about before, there is no such thing as a stable, heart-failure patient.