Can a patient with impaired renal function undergoing dialysis take Entresto (sacubitril/valsartan)?

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From the FDA Drug Label

5.4 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)].

Dialysis patients can be at risk of decreased renal function when taking sacubitril and valsartan.

  • The drug label recommends closely monitoring serum creatinine in these patients.
  • Down-titration or interruption of sacubitril and valsartan may be required if a clinically significant decrease in renal function occurs.
  • However, the label does not explicitly state that dialysis patients cannot take sacubitril and valsartan, but rather that they require careful monitoring.
  • It is essential to weigh the benefits and risks of using sacubitril and valsartan in dialysis patients, considering their individual condition and medical history 1.

From the Research

Entresto (sacubitril/valsartan) can be used in dialysis patients, but requires careful monitoring and dose adjustment, as it has been shown to improve cardiac function and reduce the risk of cardiovascular hospitalization in these patients 2.

Key Considerations

  • For patients on dialysis, a lower starting dose is typically recommended, usually 24/26 mg twice daily, with potential gradual increases based on tolerance.
  • Dialysis does not significantly remove Entresto from the bloodstream, so no supplemental dosing after dialysis is needed.
  • These patients require close monitoring of blood pressure, kidney function, and potassium levels, as they may be more susceptible to hypotension and electrolyte imbalances.

Mechanism of Action

  • The medication works by combining an angiotensin receptor blocker (valsartan) with a neprilysin inhibitor (sacubitril) to improve heart function in heart failure patients.

Clinical Benefits

  • Entresto can provide cardiovascular benefits for dialysis patients with heart failure, including improved left ventricular ejection fraction (LVEF) and reduced risk of cardiovascular hospitalization 2.
  • The decision to use Entresto should be made by a nephrologist and cardiologist together, considering the patient's overall condition, blood pressure stability during dialysis, and other medications.

Safety and Monitoring

  • Regular assessment of the patient's clinical response and potential side effects is essential for safe and effective treatment.
  • Serum potassium should be monitored during treatment, as the risk of hyperkalemia may be slightly higher in dialysis patients taking Entresto 3.

Overall Recommendation

  • Based on the most recent and highest quality study available 2, Entresto can be a valuable treatment option for dialysis patients with heart failure, but requires careful monitoring and dose adjustment to minimize potential risks and maximize benefits.

References

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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