Use of sacubitril/valsartan in patients with heart failure in primary care in Germany: the AURORA-HF noninterventional study.

BACKGROUND:Sacubitril/valsartan (Sac/Val) is the first angiotensin receptor-neprilysin inhibitor indicated for symptomatic chronic heart failure (HF) with reduced ejection fraction (HFrEF). Given most patients with HF in Germany are managed by general practitioners, AURORA-HF investigated the baseline characteristics and 1‑year follow-up of patients starting Sac/Val in primary care in Germany. METHODS:This was a prospective, multicenter, observational study, with all treatment decisions independent of participation. The only inclusion criteria were adults (age ≥ 18 years) with symptomatic HFrEF. The study comprised four groups, depending on therapy on entry: initiation of (1) Sac/Val or (2) other HF therapy; and no change in HF regimen that (3) included or (4) did not include Sac/Val. Baseline data were captured for all groups; 1‑year follow-up was recorded in groups 1 and 2. RESULTS:Of 1278 patients in the baseline analyses, 513 (40.1%) had newly started Sac/Val (449 [87.5%] completing the 1‑year follow-up), 265 (20.7%) had newly started other HF regimens (245, 92.5%) with 1‑year follow-up, while 249 with Sac/Val (19.5%) and 251 without Sac/Val (19.6%) patients had unchanged therapies. Patients treated with Sac/Val had a higher New York Heart Association (NYHA) class at baseline and more often a left ventricular ejection fraction (LVEF) < 35%. The only baseline parameter significantly correlating with Sac/Val discontinuation during the 1‑year follow-up was diabetes mellitus (odds ratio: 2.44; 95% confidence interval: 1.14-5.24). In the Sac/Val group, 30.7% of patients were in NYHA class I/II on study entry, improving to 51.0% at 1‑year follow-up. In the no Sac/Val group, the corresponding rates of NYHA I and II classes were 49.8% and 58.2%, respectively. The overall adverse event profile of Sac/Val was good, with only 6.0% patients experiencing serious adverse events leading to permanent discontinuation. CONCLUSION:In patients with symptomatic HFrEF treated in primary care, the group in whom Sac/Val was initiated was characterized by a higher NYHA class and lower LVEF compared to patients in whom Sac/Val was not initiated. Sac/Val was well tolerated, with a high proportion completing 1 year of therapy.