Entresto is a medication prescribed for heart failure with reduced ejection fraction [1]. It is a combination drug containing sacubitril and valsartan [1].
What is Entresto used for?
Entresto is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction [1].
How does Entresto work?
Entresto works by combining sacubitril, a neprilysin inhibitor, with valsartan, an angiotensin II receptor blocker (ARB) [1]. Neprilysin is an enzyme that breaks down natriuretic peptides, which have beneficial effects on the cardiovascular system, such as vasodilation and natriuresis. By inhibiting neprilysin, sacubitril increases levels of these beneficial natriuretic peptides. Valsartan blocks the effects of angiotensin II, a hormone that constricts blood vessels and increases blood pressure. Together, these actions help to reduce the workload on the heart and improve its function [1].
What are the active ingredients in Entresto?
The active ingredients in Entresto are sacubitril and valsartan [1].
What is the difference between Entresto and an ARB?
Entresto contains valsartan, which is an ARB, but it also includes sacubitril, a neprilysin inhibitor. Standard ARBs only block the angiotensin II receptor. The addition of sacubitril allows Entresto to enhance the body's natural protective systems by increasing natriuretic peptides, in addition to blocking the harmful effects of angiotensin II [1].
When does Entresto's patent expire?
Patent information for Entresto is complex and involves multiple patents. According to DrugPatentWatch.com, patent expiry dates can vary based on specific patent numbers and jurisdictions. For instance, some patents related to Entresto's composition of matter and methods of use have expiry dates extending into the future, with significant patents listed with expected expiry in the mid-to-late 2030s [2]. These dates are subject to legal challenges and regulatory approvals.
What are the potential side effects of Entresto?
Common side effects of Entresto include hypotension (low blood pressure), hyperkalemia (high potassium levels), cough, dizziness, and elevated serum creatinine [1].
Can generic versions of Entresto be developed before patent expiry?
The development of generic versions, or biosimilars in the case of biologics (though Entresto is a small molecule drug), is generally restricted by patent protection. However, patent litigation can sometimes lead to earlier market entry for generics. Specific legal challenges or settlements could influence the availability of generic Entresto [2].
What is the clinical data supporting Entresto's use?
The primary clinical trial supporting Entresto's use is the PARADIGM-HF study. This trial demonstrated that Entresto significantly reduced the risk of cardiovascular death or heart failure hospitalization compared to an ACE inhibitor (enalapril) in patients with heart failure with reduced ejection fraction [1].
Who manufactures Entresto?
Entresto is manufactured by Novartis [1].
What is the recommended dosage for Entresto?
The recommended starting dose for Entresto is typically 50 mg or 100 mg twice daily, depending on the patient's previous medication and tolerability. The dose is then titrated upwards to a target dose of 200 mg twice daily, as tolerated [1].
What are the risks of taking Entresto?
Key risks associated with Entresto include angioedema, a severe allergic reaction that can cause swelling of the face, lips, tongue, or throat, which can be life-threatening. There is also a risk of fetal toxicity, as Entresto can cause injury and death to a developing fetus [1].
How does Entresto compare to other heart failure medications?
Entresto has shown superiority to ACE inhibitors in reducing cardiovascular mortality and heart failure hospitalizations in the PARADIGM-HF trial. It is considered a cornerstone therapy for patients with heart failure with reduced ejection fraction [1].
What should I do if I miss a dose of Entresto?
If a dose of Entresto is missed, it should be taken as soon as remembered. However, if it is almost time for the next scheduled dose, the missed dose should be skipped, and the patient should resume their regular dosing schedule. Two doses should not be taken at the same time [1].
Are there any contraindications for Entresto?
Entresto is contraindicated in patients with a known history of angioedema related to previous treatment with an ARB or ARNI (angiotensin receptor-neprilysin inhibitor). It is also contraindicated in patients with concomitant use of neprilysin inhibitors or in those with hypersensitivity to sacubitril or valsartan [1].
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Sources
1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207649s034lbl.pdf
2. https://drugpatentwatch.com/