This study provided real-world evidence on the effectiveness and safety of sacubitril/valsartan (sac/val), among adult patients diagnosed with hypertension and heart failure (or cardiac insufficiency). Patients who discontinued therapy throughout 12 months due to sac/val related adverse events were defined as severe adverse event (SAE) group, and the others were defined as non-SAE group. Noticeably, a history of atrial fibrillation or chronic kidney disease, as well as higher baseline levels of serum creatinine, uric acid and NT-proBNP, was more likely to lead to the discontinuation of sac/val caused by its AEs. In addition, among patients who maintained sac/val therapy throughout 3–12 months, the latest values of clinic blood pressure (BP) and parameters on cardiac function significantly improved compared with those at baseline (p < 0.0001).
Abstract
What Is Known and Objective
Hypertension (HP) is associated with heart failure (HF). Sacubitril/valsartan (sac/val) has been approved for primary HP by China Food and Drug Administration (CFDA) in June 2021. The present study aimed to provide evidence on the effectiveness and safety of sac/val in Chinese patients complicated with HP and HF.
Methods
This retrospective study was conducted on adult patients diagnosed with HP and HF and treated with sac/val between July 2020 and December 2020. The potential risk factors for the discontinuation events caused by sac/val-related adverse events (AEs) were explored. The data, including blood pressure (BP), cardiac indicators, corresponding values on echocardiographic parameters, unplanned visits, and AEs throughout 3–12 months, were collected.
Results and Discussion
A total of 446 eligible patients were included in this study. The discontinuation events of sac/val were mainly attributed to its AEs (hypotension, hyperkalemia, and deterioration in kidney function). Univariate analysis revealed that history of chronic kidney disease, atrial fibrillation, higher values of serum creatinine, serum uric acid, serum N-terminal pro B-type natriuretic peptide, and lower estimated glomerular filtration rate were potential risk factors for discontinuation. Patients who maintained sac/val therapy throughout 3–12 months showed significantly improved values of clinical BP, cardiac indicators, and echocardiographic parameters compared to those at baseline (p < 0.0001).
What Is New and Conclusion
Sac/val was effective on BP and improved cardiac function in patients complicated with HP and HF. The physicians should focus on patients with renal dysfunction to take timely precautions to improve tolerability for sac/val.
