Four in Five HF Patients Could Benefit From Dapagliflozin, Registry Study Suggests

A new study presented today shows that 4 in 5 patients with heart failure with reduced ejection fraction (HFrEF) could benefit from the sodium glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin, based on the label update the FDA approved earlier this year.

The findings, presented during the American Heart Association (AHA) Scientific Sessions and published in JAMA Cardiology, are based on a study that applied the dapagliflozin label update against an AHA registry of more than 150,000 patients who had an initial hospitalization for heart failure.

According to a statement from AstraZeneca, maker of dapagliflozin, the results are the first in a series of 6 studies that will come from TRANSLATE-HF. The platform will link data from the Get With the Guidelines Registry with CMS claims data, and researchers will track patients following hospitalization for heart failure. The TRANSLTE-HF research is supported by AstraZeneca, Novartis, Boehringer-Ingelheim, Lilly, Novo Nordisk, Sanofi, and Bayer.

Dapagliflozin, sold as Farxiga, is part of the SGLT2 inhibitor class that was first developed to treat type 2 diabetes (T2D). But after a round of cardiovascular outcomes trials showed the drugs significantly reduced hospitalization for heart failure, drug makers pursued their use to treat this condition whether or not patients had T2D.

The DAPA-HF trial, presented September 1, 2019, showed that dapagliflozin reduced the risk of worsening heart failure or cardiovascular death 26% regardless of diabetes status; the FDA approved the drug’s use to treat HFrEF in May 2020.

Although today’s results apply only to dapagliflozin, the authors note that findings for empagliflozin (Jardiance) presented during the European Society of Cardiology in August found similar efficacy in HFrEF, whether or not patients had T2D.

However, the lead author of TRANSLATE-HF and other experts have reported that not all patients who might benefit from SGLT2 inhibitors are receiving them.

“Despite accelerating scientific discoveries, few patients with heart failure are being treated with the best available treatment options in 2020,” lead author Muthiah Vaduganathan MD, MPH, and a cardiologist at Brigham and Women’s Hospital and Harvard Medical School, said in a statement. “While SGLT2 inhibitors were first developed for treatment of diabetes, these therapies have now been recognized to reduce mortality, prevent worsening heart failure events, and improve health-related quality of life in patients with HFrEF, including among those without diabetes.”

In addition to showing the missed opportunity to treat more patients with heart failure generally, the results show that better awareness and greater willingness of cardiologists to prescribe SGLT2 inhibitors might help reach women and Black patients, who were less well represented in the DAPA-HF trial.

“Although there were more older adults, women, and Black patients in the [AHA] registry than in the DAPA-HF trial, most clinical characteristics were qualitatively similar between the 2 groups,” the study authors wrote, adding that compared with the DAPA-HF trial population, “there was lower use of evidence-based HF therapies,” among patients in the AHA registry.

Earlier this year, Darren K. McGuire, MD, MHSc, told The American Journal of Managed Care®, that many cardiologists have been slow to embrace SGLT2 inhibitors because they still perceive the class as a “diabetes drug,” or they believe, erroneously, that prescribing them will cause them to become responsible for management of a patient’s glycated hemoglobin (A1C), even if the drugs are used to treat heart failure.

When cardiologists prescribe SGLT2 inhibitors, McGuire said communicating with other care providers is essential. This “engages the co-providers in a team approach,” so that the other providers understand that “we’re not stepping on their toes and we’re not embarking on glucose management in their clinic, but that we are using these medications for further cardiovascular benefits,” said McGuire.

“These data support the broad generalizability of recent trial findings evaluating the SGLT2 inhibitors to US clinical practice,” said Gregg C. Fonarow, MD, senior author of the study, who is interim chief of the division of cardiology and director of the Ahmanson-UCLA Cardiomyopathy Center, as well as co-director of the Preventative Cardiology Program, and the Eliot Corday Chair in Cardiovascular Medicine and Science at the University of California, Los Angeles. “The SGLT2 inhibitors are now established as a new pillar of care for patients with heart failure. We must now rapidly translate this knowledge to practice to improve patient outcomes.”

Reference

Vaduganathan M, Greene SJ, Zhang S, et al. Applicability of US Food and Drug Administration labeling for dapagliflozin to patients with heart failure with reduced ejection fraction in US clinical practice: he Get With the Guidelines–Heart Failure (GWTG-HF) Registry. JAMA Cardiol. Published online November 13, 2020. doi:10.1001/jamacardio.2020.5864