Safety and effectiveness of empagliflozin in Japanese patients with heart failure: a 1-year post-marketing surveillance study stratified by age

The sodium-glucose cotransporter-2 (SGLT2) inhibitor empagliflozin is approved in Japan for the treatment of heart failure (HF) with reduced left ventricular ejection fraction (HFrEF) and HF with preserved left ventricular ejection fraction (HFpEF). We conducted a post-marketing surveillance study of empagliflozin for HF in Japan. This was a 1-year prospective, multicenter, observational study of patients with chronic HF who had not previously received empagliflozin. The primary endpoint was incidence of adverse drug reactions (ADRs). Prespecified effectiveness endpoints were all-cause death, cardiovascular (CV) death, and hospitalization for HF (HHF). 1,166 patients were included (61.0% male, mean age 74.9 years). At baseline, mean left ventricular ejection fraction was 49.0%, mean body mass index was 24.2 ± 4.6 kg/m², and 34.2% had type 2 diabetes. ADRs occurred in 61 (5.2%) patients overall, 5.8% of those aged ≥ 75 years, 6.2% of those aged 65 to < 75 years, and 2.2% of those aged < 65 years. Incidences of all-cause death, CV death, and HHF were 3.0, 0.9, and 2.5 per 100 PY, respectively. In this 1-year post-marketing surveillance study, empagliflozin was generally well-tolerated in patients with HF in Japan. ClinicalTrials.gov identifier is NCT05262764