Newly released heart failure (HF) guidelines extended the recommendation for use of SGLT2 inhibitors as a pillar of therapy for symptomatic HF regardless of ejection fraction or diabetes status -- but also challenge practice to develop strategies to boost their use.
"The guidelines show the extent of the science that has progressed, especially in the last years," said David Dudzinski, MD, JD, of the Massachusetts General Hospital in Boston. "While we have the science, this is really all about operations, implementation, and delivery to our patients. That is a huge theme in the guidelines."
The guideline update from the American College of Cardiology (ACC), American Heart Association, and Heart Failure Society of America was launched on the eve of the ACC meeting in Washington D.C.
It gave a class 1a recommendation for use of SGLT2 inhibitors in symptomatic chronic HF with ejection fraction of 40% or less (HFrEF) to reduce hospitalization for HF and cardiovascular mortality, irrespective of the presence of type 2 diabetes.
In HF patients with preserved ejection fraction or the newly defined category of HF with mildly reduced ejection fraction (41-49% and increased LV filling pressures), SGLT2 inhibitors got a class 2a recommendation for a potential benefit in decreasing HF hospitalizations and cardiovascular mortality -- above the 2b recommendation for other classes of medication.
"To see this area of medicine go from these drugs were not even on radar about 10 years to being a class 1 recommendation is a really impressive story," Dudzinski told ѻý.
Guideline writing committee chair Paul Heidenreich, MD, of Stanford University in California, emphasized the "huge" evidence base for this class of medication.
"The uptake is not bad," he said, "given, historically, how often slow it is for new therapies to be adopted. In some ways this is going a little faster than one might have expected looking at other heart failure therapies in the past."
However, with that speed have come some challenges in keeping the entire field up to speed.
"These were certainly developed as diabetes drugs; they are squarely cardiovascular drugs," Dudzinski said. "Whether that's still a public perception or in some parts of our profession at large, we really need to own this and not defer it to colleagues -- certainly working with colleagues -- but ensuring that cardiologists are prescribing, titrating, using these medications."
In many cases, that means working together with internists, endocrinologists, nephrologists, inpatient teams, and multidisciplinary care teams to make sure these drugs are being used, he said.
"We have to bring this to every individual healthcare environment, healthcare practitioner, and their patients where they are. Every different environment and venue will have unique, idiosyncratic challenges in how that's interpreted. Some places can use performance measures and a top-down approach to say these are our goals as a system," Dudzinski noted. "Smaller clinics may have different ways they do that."
"In some places it may be nursing led, in some places it may be physician-led, in some places it may be a pharmacist integrated into the team," he added. "I don't think it will be one thing nationally that will work, it will be individualized for specific system, cohort, clinic, patient group."
Strategies may need to rely on technology as well.
For example, the recent PROMPT-HF study showed that electronic health record alerts, designed to highlight which of the four pillars of guideline-directed medical therapy were missing for patients with HFrEF, yielded a relative 41% boost in patients who added one or more of those classes to their regimen.
While those findings were in the outpatient setting, Heidenreich noted that SGLT2 inhibitors can be easier to start while patients are hospitalized. "And because of the opposing effects on potassium, you can potentially get people on other heart failure and reduced ejection fraction therapies a little easier if you already have them on an SGLT2 inhibitor."
Prior to the latest HF guidelines, the 2017 ACC for HF treatment offered useful how-tos: from how to initiate guideline-directed medications to optimizing them based on imaging data, biomarkers, and filling pressures and addressing the challenges of care coordination.
Care coordination is especially important with regard to SGLT2 inhibitor use, the consensus document said, which at the time was recommended for HF patients with type 2 diabetes.
It pointed to two options: "In a consultative approach, the CV specialist consults with the diabetes clinician and/or the patient in the provision of their care. In a team approach, an interprofessional multidisciplinary group of clinicians (e.g., primary care, endocrinologists, cardiologists, pharmacists, nurses, advanced practice professionals, and dietitians) consider novel therapies collectively."
"Regardless, all approaches to HFrEF management need to be patient-centered, use shared decision-making, and involve communication across disciplines," the document stated.
For patients, copays on this class can be a barrier, though, Heidenreich acknowledged. "It's very unfortunate. This is not in the guidelines, but many of us strongly believe that something with a class recommendation within the guidelines should have no patient copay. We don't want a barrier put in place for that particular patient."
No champion has emerged for this issue, but "if various societies come together and speak with one voice about this, that could be successful," Heidenreich suggested. "But it will take a unified voice saying this is how we need to do it."
Disclosures
Dudzinski and Heidenreich disclosed no relevant relationships with industry.