Safety analysis of sacubitril/valsartan in patients with heart failure in Vitória, Espírito Santo

ABSTRACT

Background: Sacubitril/valsartan has proven its efficacy to reduce cardiovascular mortality, all-cause mortality and sudden death in heart failure with reduced ejection fraction (HFrEF). Thus, it becomes important to evaluate the safety profile of the medication in clinical practice. Objectives: This study aimed to assess safety outcomes on the use of sacubitril/valsartan in patients with HFrEF attended in a Brazilian specialized service. Methods: Prospective observational study that included patients with HFrEF from a specialized ambulatory service, in functional class II-IV, initiated on sacubitril/valsartan as per clinical indication, with a four-month follow-up. Primary outcomes were the occurrence of symptomatic arterial hypotension, hyperkalemia and reduction of renal function. Serum potassium values, blood pressure and creatinine clearance were analyzed at inclusion and at the end of follow-up. A 5% significance level was considered for comparisons. Results: Twenty-six patients were analyzed, 57.7% male, mean age 57.8 ± 10 years, average left ventricle ejection fraction 29.9 ± 7.7%. Symptomatic hypotension occurred in 53.8%, hyperkalemia in 19.2% and reduction of renal function in 6.7%. There was significant difference from initial to final systolic (122 ± 24mmHg versus 109 ± 15mmHg; p=0.024) and diastolic (76 ± 18mmHg versus 66 ± 12mmHg; p=0.022) blood pressure, but no difference in serum potassium (4.8 ± 0.4mEq/L versus 5.0 ± 0.3mEq/L; p=0.07) and creatinine clearance (65 ± 23mL/min/1.73m² versus 66 ± 29mL/min/1.73m²; p=0.89). Conclusions: Symptomatic hypotension was the most frequent side-effect of sacubitril/valsartan. Reduction of blood pressure was observed at the end of follow-up, but no reduction of renal function or significant increase of serum potassium.