Introduction: Sacubitril/valsartan (sac/val) was introduced in Germany in January 2016 as a new treatment option for patients with heart failure and reduced ejection fraction. There is limited data regarding its use outside of clinical trials. The aim of this non-interventional database study was to describe the dosing patterns as well as the evolution of clinical parameters of patients who were prescribed sac/val in primary care practice (PCP) or cardiology practice (CP).

Methodology: Patients were identified using the German IMS Disease Analyzer database containing electronic medical records provided by a representative panel of >3100 physicians. Data from 1108 PCP and 41 CP were considered. The study period was from 01 Jan to 31 Dec 2016, with a look-back period to 01 Jan 2015. Adult patients with at least one prescription (Rx) of sac/val during the study period were included - the date of the first Rx was defined as index date. Evolution of clinical parameters before and after first observed sac/val Rx was estimated based on linear mixed-effects models.

Results: The study population consisted of 1643 patients (1041 from PCP; 602 from CP). Evaluable data (at least one value within 12 months both before and after Rx of sac/val) for NT-proBNP, NYHA class, HbA1c or blood pressure (BP) were available in a subset of patients in the PCP (ranging from 119 to 338). In PCP, the first documented Rx of sac/val was at the lowest dose (24/26 mg BID) in the majority of patients (63%), 31% at the intermediate dose (49/51mg BID), and 6% at the highest dose (97/103mg BID). During follow-up most Rx were issued for the lowest dose (51%); 35% for the intermediate dose and 14% for the highest dose. In CP similar results were observed. Before and after Rx of sac/val the evolution of clinical parameters showed an average decrease in NT-proBNP levels by -503 pmol/L (95% CI: -789, -218), p<0.001; HbA1c levels by -0.11 % (95% CI: -0.20, -0.01), p<0.05; systolic BP by -3.37 mmHg (95% CI: -4.73, -2.00), p<0.001; diastolic BP by -1.63 mmHg (95% CI: -2.50, -0.76), p<0.001; and a shift in the NYHA class towards less severe symptoms (p>0.05).

Conclusions: The changes in clinical parameters before and after sac/val Rx are consistent with the findings from the PARADIGM-HF study. Irrespective of the clinical setting (PCP/CP), patients were more likely to receive a prescription of the lowest dose of sac/val. These data suggest that more education on sac/val up-titration is needed.