In an interview for ESC Congress 2021, Deepak L. Bhatt, MD, MPH, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital Heart & Vascular Center and professor of medicine at Harvard Medical School, describes the treatment outlook for patients with heart failure with preserved ejection fraction (HFpEF).
Having an effective therapy in HFpEF will lead to an enormous shift in cardiovascular medicine, but we still need to keep thinking about why patients have HFpEF in the first place, emphasized Deepak L. Bhatt, MD, MPH, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital Heart & Vascular Center and professor of medicine at Harvard Medical School.
What is the treatment forecast for HFpEF?
Terrific question. HFpEF is one of those really big uncharted frontiers in cardiovascular medicine, and there's a lot of HFpEF out there. If we're speaking in broad terms, there's more HFpEF than HFrEF [heart failure with reduced ejection fraction] that we're seeing these days. This is especially true in some demographics, such as older women—parenthetically, we also saw consistent benefit in our pooled SCORED/SOLOIST analysis with sotagliflozin. But now with EMPEROR-Preserved—at least at the time you and I are speaking right now, neither of us know the actual data, we just know what the press release showed—presumably, the data will show what the press release has said: that it's a positive trial in HFpEF.
I think this is going to be an enormous shift in cardiovascular medicine, to have an effective therapy in HFpEF, and I think having a confirmatory trial is really important. Because some doctors, when they saw SOLOIST said, “Well, it's one trial; it's a subgroup modest number of patients.” Many aren't aware that SCORED also showed that benefit in HFpEF patients or may not be aware of the pooled analysis, which isn't published, it just was presented as a late breaker [at ESC].
Now we have a second independent trial, second compound—broadly speaking, in the same class of SGLT2 inhibitors—that also shows a benefit in HFpEF. To have 2 different programs, drug development programs, 2 different drugs, showing a benefit in HFpEF I think will really move things along. And then when the [DAPA-CKD] data come—again assuming, that's positive, which I'm thinking it will be—I'm hoping that the majority of patients with HFpEF will be treated with SGLT2 inhibitors, respective of whether they have diabetes or not.
In the sotagliflozin program, everyone we studied had diabetes. In fact, we wanted to study those without diabetes. We had a trial amendment approved and ready to go to study those without diabetes, but then there were financial issues that kept us from implementing those parts of the trials. But with EMPEROR-Preserved, we'll have those data. I didn't see in the press release a breakdown of diabetes or no diabetes, but I'm assuming there's a consistent benefit there. I'm assuming the same thing will be seen with [dapagliflozin].
If the benefits in HFpEF are consistent in those with and without diabetes, as was the case in the HFrEF trials, then [we could have] a new therapy for a hard-to-treat, very common condition. That's a really big deal in cardiovascular medicine. I think on top of that, it'll lead to a lot more thinking about HFpEF, a lot less lumping together, because some of those patients have amyloid, and now there are also new therapies for amyloid that I think are quite effective. Some are rather expensive, but still, for the right patients, I think it's the correct thing to do.
There are some super novel therapies, things like CRISPR and so forth, people are thinking and talking about for amyloid could be really exciting as well. And there's new medicines coming out for HFpEF, where there is hypertrophic cardiomyopathy, or HCM—a bunch of therapies coming down the pipe for that.
I think there's a lot of excitement in HFpEF, where we went from really having nothing, [to] now, evidence-based therapies—certainly with sotagliflozin, and it seems like with empagliflozin as well—and these therapies for amyloid and for HCM, many of those patients also are having heart failure with preserved ejection fraction. So heart failure with preserved ejection fraction, or HFpEF, has become really exciting where we can help patients. But I do think we need to think carefully about why is this patient having HFpEF, thinking about amyloid, thinking about HCM. When they don't have those things, if nothing else, at least now we have SGLT2 inhibitors.