Safety of sacubitril/valsartan in heart failure outpatients with chronic heart failure in real life in Europe: results from ARIADNE registry

Abstract Background Recently, the angiotensin receptor neprilysin inhibitor (ARNI) sacubitril/valsartan was introduced as novel therapeutic option into European guidelines for the management of heart failure. The ARIADNE registry provides information about its safety and tolerability profile in real life in outpatients with heart failure with reduced ejection fraction (HFrEF) in Europe. Methods ARIADNE was a prospective registry of patients with HFrEF treated by office-based cardiologists or selected primary care physicians (recognized as HF specialists) in a real world setting. In total, 9069 HFrEF patients in 687 centres from 17 European countries were included and prospectively followed over 12 months. Here we report the safety information from 4614 patients that received sacubitril/valsartan at baseline. Results The mean age of patients was 67.3 years at baseline. The majority of enrolled patients were in NYHA class II or III (49.7% and 48.2%, respectively). Mean LVEF was 32.7% in the S/V group. Patients with S/V had arterial hypertension (62.5%), coronary heart disease (61.0%), dyslipidemia (50.6%), atrial fibrillation (41.0%), diabetes (34.3%), and chronic kidney disease (26.0%). Co-medications were beta-blockers (83.4%), MRAs (60.1%), loop diuretics (65.2%), and digitalis (7.5%). S/V was discontinued due to an adverse event (AE) during the 12 months in 191 (4.1%) patients, of these in 180 (3.6%) due to AEs and 28 (0.6%) due to SAEs. The most frequent AE was hypotension, which was reported in 391 (7.9%) of patients, of these 74 (18.9%) discontinued S/V. Hypokalaemia was observed in 1.7% and an impairment of renal function in 1.0% of S/V patients, respectively. Total mortality was 3.8%, cardiovascular mortality 1.8% in the S/V group. Conclusions This is the first large prospective study on the use of S/V in patients with HFrEF in Europe. S/V was well tolerated with a safety profile comparable with that observed in clinical trials for S/V patients. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Novartis Pharma AG