From the FDA Drug Label
- 4 Impaired Renal Function As a consequence of inhibiting the renin-angiotensin-aldosterone system (RAAS), decreases in renal function may be anticipated in susceptible individuals treated with sacubitril and valsartan [see Adverse Reactions (6.1)]. In patients whose renal function depends upon the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure), treatment with ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria, progressive azotemia and, rarely, acute renal failure and death Closely monitor serum creatinine, and down-titrate or interrupt sacubitril and valsartan in patients who develop a clinically significant decrease in renal function [see Use in Specific Populations (8.7) and Clinical Pharmacology (12. 3)].
The safety of sacubitril/valsartan in dialysis patients is not directly addressed in the provided drug label. However, it does mention that decreases in renal function may be anticipated in susceptible individuals treated with sacubitril and valsartan, and that closely monitoring serum creatinine is recommended.
- Key considerations for dialysis patients include the potential for worsening renal function and hyperkalemia.
- Dose adjustment or interrupting treatment may be necessary in patients who develop a clinically significant decrease in renal function 1. Given the potential risks, caution should be exercised when considering the use of sacubitril/valsartan in dialysis patients.
From the Research
Entresto (sacubitril/valsartan) can be used in dialysis patients, but it requires caution and close medical supervision, as evidenced by the most recent study in 2025 2. When considering the use of Entresto in dialysis patients, it is essential to weigh the potential cardiovascular benefits against the risks, particularly the risk of hypotension and hyperkalemia.
- The medication should be started at the lowest available dose (24/97 mg twice daily) with careful monitoring of blood pressure, potassium levels, and overall clinical status.
- Regular monitoring of these parameters is crucial during treatment to minimize the risk of adverse effects.
- The decision to use Entresto in dialysis patients should be individualized and involve consultation with both a nephrologist and cardiologist to ensure appropriate management of both heart failure and kidney disease.
- A study published in 2025 2 demonstrated that sacubitril-valsartan was effective in lowering blood pressure in patients on dialysis, with a significant reduction in office systolic blood pressure compared to irbesartan.
- Another study published in 2024 3 found that sacubitril/valsartan treatment was associated with significantly lower 5-year mortality rates and greater left ventricular ejection fraction improvement in heart failure patients with reduced ejection fraction and coexisting end-stage renal disease.
- However, it is crucial to note that the safety and efficacy of Entresto in dialysis patients are still being studied, and ongoing research is needed to fully understand its effects in this population, as highlighted in a 2025 study 4.