Initiating sacubitril/valsartan during hospitalization resulted in similar withdrawal rates (17.0% vs 11.5%; P=0.13) and adverse effects compared to outpatient initiation.
Cohort (n=527)
Yes
Does initiating sacubitril/valsartan during hospitalization have a similar safety profile compared to outpatient initiation in a non-selected real-world cohort?
Initiating sacubitril/valsartan during hospitalization in a real-world setting is safe and has a similar adverse event profile to outpatient initiation, despite inpatients having a higher risk profile.
Absolute Event Rate: 17% vs 11.5%
p-value: p=0.13
AIMS: Sacubitril/valsartan is safe when initiated during hospitalization in a clinical trial setting. Its safety in real-life population is not stablished. We compared the initiation of sacubitril/valsartan during hospitalization in a non-selected population, in the PIONEER-HF trial, and in non-selected outpatients. METHODS AND RESULTS: Multicentre registry included 527 patients: 100 were started on sacubitril/valsartan during hospitalization (19.0%) and 427 as outpatients (81.0%). Compared with those in the pivotal trial, inpatients in our cohort were older (71 ± 12 vs. 61 ± 14 years; P < 0.001); had more frequently Functional Class II (41 41.0% vs. 100 22.7%; P < 0.001), higher levels of N-terminal pro-B type natriuretic peptide (4044 1630-8680 vs. 2013 1002-4132 pg/mL; P < 0.001), better glomerular filtration rate (63.5 51.0-80.0 vs. 58.4 47.5-71.5 mL/min; P = 0.01), and higher systolic blood pressure (121 110-136 vs. 118 110-133 mmHg; P = 0.03); and received angiotensin-converting enzyme inhibitors/angiotensin receptor blockers more frequently (92 92.0% vs. 208 52.7%; P < 0.001). Compared with non-selected outpatients, inpatients were older (71 ± 12 vs. 68 ± 12 years, P = 0.02), had more frequent Functional Class III-IV (58 58.0% vs. 129 30.3%, P < 0.001), had higher levels of N-terminal pro-B type natriuretic peptide (4044 1630-8680 vs. 2182 1134-4172; P < 0.001), and were receiving angiotensin-converting enzyme inhibitors/angiotensin receptor blockers target dose less frequently (55 55.0% vs. 335 78.5%; P < 0.001). They also started sacubitril/valsartan with a low dose (50 mg/12 h) more frequently (80 80.0% vs. 209 48.8%, P < 0.001). The initiation of sacubitril/valsartan in outpatients was an independent predictor of high-dose use (OR 3.1; 95% confidence interval 1.7-5.6, P < 0.001). The follow-up time in both cohorts, including all patients enrolled, was similar (7.0 ± 0.1 vs. 7.2 ± 2.6 months, P = 0.72). All-cause admissions during follow-up were more frequent in inpatients (30 30.0% vs. 68 outpatients 15.9%, P = 0.001), with no relevant differences in all-cause mortality. There was no significant difference in sacubitril/valsartan withdrawal rate (17 inpatients 17.0% vs. 49 outpatients 11.5%, P = 0.13). The incidence of adverse effects was also similar: hypotension (16 inpatients 16.0% vs. 71 outpatients 16.7%, P = 0.88), worsening renal function (7 inpatients 7.0% vs. 29 outpatients 6.8%, P = 0.94), and hyperkalaemia (1 inpatient 1.0% vs. 21 outpatients 4.9%, P = 0.09). We did not register any case of angioedema. CONCLUSIONS: It is safe to initiate sacubitril/valsartan during hospitalization in daily clinical practice. Inpatients have a higher risk profile and receive low starting doses more frequently than outpatients.
López‐Azor et al. (Fri,) conducted a cohort in Heart failure (n=527). Sacubitril/valsartan (inpatient initiation) vs. Sacubitril/valsartan (outpatient initiation) was evaluated on Sacubitril/valsartan withdrawal rate (p=0.13). Initiating sacubitril/valsartan during hospitalization resulted in similar withdrawal rates (17.0% vs 11.5%; P=0.13) and adverse effects compared to outpatient initiation.