About one-third of real-world outpatients with heart failure (HF) are eligible for treatment with empagliflozin and dapagliflozin when selection criteria in clinical trials are strictly applied, according to a study in the Journal of Cardiac Failure.
Investigators analyzed the eligibility for dapagliflozin and empagliflozin in a real-world cohort of patients with HF based on selection criteria of DAPA-HF, DELIVER, and EMPEROR trials.
Data from the Swedish HF registry (SwedeHF) were analyzed from May 2000 to December 2018, and the National Patient Registry (NPR) was used for data on additional baseline comorbidities that were not included in SwedeHF.
The researchers considered 3 scenarios for eligibility rates calculation for each trial: a “trial scenario” in which all the inclusion/exclusion criteria from the trials that could be assessed were applied; a “pragmatic scenario” that included the most clinically relevant criteria; and a “label scenario” following regulatory agency labels.
A total of 49,317 patients were included in the analysis. Of these patients, 55% had an ejection fraction (EF) of less than 40%, while 45% of patients had an EF of 40% or more (with 45% of these having EF ≥50%). Among the participants with EF of less than 40% and EF of 40% or more, 27% and 40% were women and the median age was 73 (IQR, 64-80) and 75 (IQR, 67-82) years, respectively.
In the trial scenario, 35% of outpatients with EF of less than 40% were eligible for treatment with dapagliflozin. In the pragmatic and label scenarios, 61% and 80% of patients were eligible for dapagliflozin, respectively. In addition, in the trial scenario, 31% of patients with an EF of less than 40% were eligible for empagliflozin. In the pragmatic and label scenarios, 55% and 81% of patients with EF of less than 40% were eligible for empagliflozin, respectively.
Regarding the trial scenario, 30% of patients with EF of 40% or more were eligible for treatment with dapagliflozin. For the pragmatic and label scenarios, 61% and 74% of patients with EF of 40% or more were eligible for dapagliflozin, respectively. Also in the trial scenario, 32% of patients with EF of 40% or more were eligible for empagliflozin. For the pragmatic and label scenarios, 59% and 75% of patients with EF of 40% or more were eligible for empagliflozin, respectively.
The patients who were eligible were older overall and had more severe HF vs noneligible patients. Eligible patients were also more likely to have an estimated glomerular filtration rate of less than 60 mL/min/1.73 m2, a greater cardiovascular comorbidity burden, and a history of chronic obstructive pulmonary disease.
Study limitations include the cross-sectional design and short duration of HF. Also, some data needed for defining specific inclusion/exclusion criteria are not available in SwedeHF or the NPR.
“Our data might help multiple stakeholders to improve trial design in HF by estimating the consequences of adopting specific inclusion criteria in terms of event rates, characteristics of the population enrolled, the feasibility of enrollment and generalizability,” the investigators wrote. “Further, they may provide information for payers and health care authorities to estimate potential use of SGLT2i [sodium glucose co-transporter-2 inhibitors] and ensuing costs.”
Disclosure: This research was supported by AstraZeneca and Boehringer Ingelheim. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Thorvaldsen T, Ferrannini G, Mellbin L, et al. Eligibility for dapagliflozin and empagliflozin in a real-world heart failure population. J Card Fail. Published online May 9, 2022. doi: 10.1016/j.cardfail.2022.04.011