Safety and effectiveness of empagliflozin in Japanese patients with heart failure: a 1-year post-marketing surveillance study stratified by age
Year: 2025
Type: article
Study design: Observational Study
Abstract: Background The sodium-glucose cotransporter-2 (SGLT2) inhibitor empagliflozin was approved in Japan for the treatment of heart failure (HF) with reduced left ventricular ejection fraction (HFrEF) in November 2021 and HF with preserved left ventricular ejection fraction (HFpEF) in April 2022. We conducted a post-marketing surveillance study of empagliflozin for HF indications in Japan.Research design and methods This was a 1-year prospective, multicenter, observational study of patients with chronic HF who had not previously received empagliflozin before enrollment. The primary endpoint was the incidence of adverse drug reactions (ADRs). Prespecified effectiveness endpoints were all-cause death, cardiovascular (CV) death, and hospitalization for HF (HHF).Results The safety analysis set included 1,166 patients (61.0% of patients were male and mean age was 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 comorbid type 2 diabetes. ADRs occurred in 61 (5.2%) patients overall, in 5.8% of those aged ≥75 years, 6.2% of those aged 65 to <75 years, and 2.2% of those aged <65 years. Incidence of ADRs of special interest in elderly patients, including dehydration and blood pressure decrease were low. The incidences of all-cause death, CV death, and HHF were 3.0, 0.9, and 2.5 per 100 PY, respectively.Conclusions In this 1-year post-marketing surveillance study, empagliflozin was generally well-tolerated in patients with HF in Japan.Trial registration ClinicalTrials.gov identifier is NCT05262764
Source: Expert Opinion on Drug Safety
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W4411277604