Safety Outcomes After Sacubitril/Valsartan Initiation in a Community Teaching Hospital: A Retrospective Observational Study

TL;DR

This study examines the safety of sacubitril/valsartan in heart failure patients, finding common side effects like kidney issues and low blood pressure, with a low rate of hypoglycemia.

Contribution

The study provides new insights into the safety profile of sacubitril/valsartan, particularly its rare association with hypoglycemia and its impact on diabetic patients.

Findings

Acute kidney injury was the most common adverse effect at 14.02% of patients.

Hypoglycemia occurred in only 0.47% of patients, contrasting with prior reports.

Diabetic patients had worse safety outcomes and higher 30-day readmission rates.

Abstract

Background: Sacubitril/valsartan is one of the main foundational medications in heart failure (HF), and recent data show that it provides a mortality benefit in this patient population. Some of the main safety concerns associated with this drug class include hypotension, hyperkalemia, angioedema, and acute kidney injury (AKI). Other studies have focused on sacubitril/valsartan effects on blood glucose levels, which is a newer concept that has not been as researched. This study seeks to explore the safety of angiotensin receptor-neprilysin inhibitors (ARNi) when initiated in acute hospitalized patients, where data on tolerability will assist in patient selection and monitoring. The results of this study will help distinguish the HF population at a community teaching hospital and aid clinician decision-making.

Methods: This was a single-center, retrospective, observational review utilizing electronic health records. To be included in this study, patients had to be 18 years or older with an HF diagnosis and must have taken at least two doses of sacubitril/valsartan before discharge. Primary safety outcomes will include discontinuation of sacubitril/valsartan, incidence of angioedema, hyperkalemia, AKI, hypotension, and hypoglycemia. Secondary outcomes included hospital length of stay and 30-day readmission rate.

Results: Data were collected for a total of 227 patients. AKI was the most common primary safety adverse effect captured with 30 patients (14.02%), followed by hypotension in 20 patients (9.35%), and hyperkalemia in 19 patients (8.9%). Only one patient (0.44%) experienced both angioedema and hypotension, and it happened to be the same patient. Additionally, only one patient (0.47%) was found to be hypoglycemic. Sacubitril/valsartan was discontinued in 41 patients (18.1%), and 20 of those patients (8.8%) were restarted at a lower dose. Lastly, 63 patients (27.8%) were readmitted within 30 days of discharge. Patents that also had diabetes had worse safety outcomes and were associated with 30-day readmission.

Conclusions: This study of patients admitted with HF and started on sacubitril/valsartan found similar rates of efficacy and safety outcomes to previously published reports. However, the rate of hypoglycemia associated with sacubitril/valsartan was low in only one patient, and it was strongly associated with previous antidiabetic medication use. This differs from previously published reports and analyses on the association of sacubitril/valsartan and hypoglycemia. More research is needed for the argument that sacubitril/valsartan has an effect on glycemic outcomes. Patients with diabetes were found to have worse safety outcomes and a higher 30-day readmission. Providers should consider monitoring these patients closely and making sure that patients are on guideline-directed medication therapy before discharge. Other common safety events associated with sacubitril/valsartan were also seen in this population.