Eligibility of Dapagliflozin and Empagliflozin in a Real-World Heart Failure Population

Abstract

Aims. This study is aimed at investigating the eligibility in a real-world heart failure population for the DAPA-HF (testing dapagliflozin) and EMPEROR-reduced (testing empagliflozin) trials, comparing the eligible real-world patients to trial participants and to characterize the noneligible patients. Methods. Medical records of all heart failure patients who had a diagnosis of heart failure from the Heart Centre or Department of Internal Medicine at Umeå University Hospital were reviewed. Results. 2433 of the hospital’s uptake population of 150 000 had a diagnosis of heart failure. 681 patients had left ventricle ejection fraction ≤ 40 % , and of these 352 (52%) and 268 (39%) patients met eligibility criteria for DAPA-HF and EMPEROR-reduced, respectively. Comparing eligible patients in our population with the DAPA-HF- and EMPEROR-reduced trial populations, we found that eligible real-world patients were older (79.0 vs. 66.2 years and 80.3 vs. 67.2 years, respectively), had worse renal function (eGFR 54.4 vs. 66.0 ml/min/1.73m2 and 49.5 vs. 61.8 ml/min/1.73m2, respectively), higher prevalence of atrial fibrillation (56.0% vs. 36.1% and 53.0% vs. 35.6%, respectively), and lower prevalence of diabetes mellitus (21.0% vs. 41.8% and 26.1% vs. 49.8%, respectively). The main reasons for ineligibility were low NT-proBNP or low eGFR. Noneligible patients differed according to reason for ineligibility, where patients with low NT-proBNP were generally younger and healthier, and patients with low eGFR were older and had more comorbidities. Conclusions. 39-52% of patients with heart failure and reduced ejection fraction in this real-world heart failure population were eligible for SGLT2-inhibitor treatment, corresponding to 11-14% of all heart failure patients. Compared to trial participants, eligible real-world patients were significantly older with worse renal function, more atrial fibrillation, and less diabetes mellitus. Trial entry criteria exclude comparatively young and healthy patients, as well as comparatively old patients with more comorbid conditions.

Eligibility for vericiguat in a real‐world heart failure population according to trial, guideline and label criteria: Data from the Swedish Heart Failure Registry

“…4,27 However, our study showed that these criteria also led to the exclusion of half and one-quarter of patients, respectively, limiting eligibility. Accordingly, our estimated eligibility for vericiguat was mostly lower than previous eligibility estimates for other HF therapies, such as sodium-glucose cotransporter 2 inhibitors (trial eligibility: 39-52% [28][29][30][31] ; label eligibility: 86% 30 ) and sacubitril/valsartan (trial eligibility: 24-38% [32][33][34][35][36] ; label eligibility: 84% 35 ), but higher than ivabradine (trial eligibility: 14%). 37 These findings highlight the difficulties in balancing enrichment strategies against feasibility of enrolment when designing trials.…”

Progress of patients hospitalized with acute heart failure treated with empagliflozin

“…In the RICA registry, which included patients aged ≥50 years admitted with HF to internal medicine departments in Spain between 2008 and 2019, the mean age was 80 years, up to a third of patients were in functional class III, more than 60% had HFpEF, and comorbidity was very common [ 17 ]. Various studies have indicated that in clinical practice, a high number of patients with HF would be eligible for treatment with SGLT2i [ 18 , 19 ]. In fact, in a recent study that analyzed the eligibility of the four pharmacologic pillars for treatment of HFrEF at discharge from hospital, SGLT2i were more frequently prescribed than RAAS inhibitors and mineralocorticoid receptor antagonists, with kidney failure being the main factor limiting prescription of these agents, in contrast with SGLT2i [ 20 ].…”

Current Role of SLGT2 Inhibitors in the Management of the Whole Spectrum of Heart Failure: Focus on Dapagliflozin

“…Robust evidence from clinical trials and sub-studies has demonstrated that dapagliflozin reduces not only HF (re-)hospitalizations, but also cardiovascular mortality (NNT = 68) and all-cause death (NNT = 67) in the whole spectrum of HF, without a loss of efficacy according to ejection fraction [92]. On the other hand, different studies have shown that a great proportion of patients with HF in clinical practice are eligible for dapagliflozin according to the DAPA-HF and DELIVER criteria [102][103][104][105][106][107][108]. In addition, the full implementation of dapagliflozin in real-life populations would prevent/postpone new worsening HF events or even death [102,[106][107][108].…”