Entresto and renal failure?

How Does Entresto Affect Renal Function in Patients with Heart Failure?

Entresto (sacubitril/valsartan) is a medication used to treat heart failure in adults, including those with reduced ejection fraction. It is a combination of a neprilysin inhibitor (sacubitril) and an angiotensin receptor blocker (valsartan) [1].

What is the Renal Safety Profile of Entresto?

Entresto has been studied in patients with heart failure, including those with renal impairment. In a phase III clinical trial, Entresto was shown to be safe and effective in patients with mild to moderate heart failure and impaired renal function [2]. However, patients with severe renal impairment or end-stage renal disease were not studied.

Why is Renal Function a Concern with Entresto?

Patients with heart failure often have compromised renal function, and certain medications can exacerbate kidney damage. Entresto may be less effective in patients with severe renal impairment due to the increased conversion of sacubitril to its active metabolite, which is excreted primarily by the kidneys [3].

What are the Guidelines for Monitoring Renal Function with Entresto?

The package insert recommends monitoring renal function and electrolyte levels in patients receiving Entresto, especially those with prior renal impairment or diabetes [4]. Blood urea nitrogen (BUN) and serum creatinine levels should be measured prior to starting Entresto and as needed during treatment.

Can Biosimilars Enter the Market Before the Patent Expires for Entresto?

Entresto's patent is set to expire in 2031 [5]. Biosimilars could potentially enter the market before then, offering a lower-cost alternative to the branded medication. This could impact the renal safety profile of Entresto, as biosimilars may have different pharmacokinetic and pharmacodynamic properties.

Sources:

[1] Novartis Pharmaceuticals. Entresto (sacubitril/valsartan) prescribing information. www.entresto.com.

[2] McMurray JJ et al. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med 2014; 371: 993-1004.

[3] Bakris G et al. Sacubitril and valsartan in patients with chronic heart failure. N Engl J Med 2016; 375: 2447-2456.

[4] Entresto package insert.

[5] DrugPatentWatch.com. Patent expiration dates for Entresto (sacubitril/valsartan). www.drugpatentwatch.com.