See the DrugPatentWatch profile for Valsartan
Valsartan/sacubitril is a medication used to treat heart failure. It is a combination drug that includes a neprilysin inhibitor (sacubitril) and an angiotensin II receptor blocker (ARB) (valsartan) [1]. This dual action aims to reduce the strain on the heart and improve its function [1].
How does valsartan/sacubitril work to improve heart function?
The medication works by simultaneously blocking two different pathways involved in cardiovascular disease. Sacubitril inhibits neprilysin, an enzyme that breaks down natriuretic peptides. These peptides have beneficial effects, such as promoting sodium excretion and vasodilation, which can reduce blood pressure and heart workload. By inhibiting neprilysin, sacubitril increases the levels of these natriuretic peptides. Simultaneously, valsartan blocks the effects of angiotensin II, a hormone that constricts blood vessels and increases blood pressure. By combining these mechanisms, valsartan/sacubitril helps to reduce the heart's workload, lower blood pressure, and improve the heart's ability to pump blood [1].
What conditions is valsartan/sacubitril approved to treat?
Valsartan/sacubitril is approved for symptomatic chronic heart failure with reduced ejection fraction in adult patients [1]. It is intended to reduce the risk of cardiovascular death and hospitalization for heart failure. It is typically prescribed to patients who have been on an ACE inhibitor or ARB and are already experiencing symptoms of heart failure [1].
When did valsartan/sacubitril become available?
The drug, marketed under the brand name Entresto, received FDA approval in July 2015 [2].
What are the main side effects of valsartan/sacubitril?
Common side effects reported with valsartan/sacubitril include hypotension (low blood pressure), hyperkalemia (high potassium levels), dizziness, cough, and kidney problems [1][3]. Angioedema, a serious allergic reaction causing swelling, is also a potential risk [1].
What is the difference between valsartan/sacubitril and other heart failure medications?
Unlike traditional ACE inhibitors or ARBs that block only one pathway, valsartan/sacubitril targets two key pathways simultaneously. This dual-acting approach is believed to offer greater benefits in reducing cardiovascular events and hospitalizations for heart failure patients with reduced ejection fraction compared to some existing therapies [1].
Can I switch from an ACE inhibitor or ARB to valsartan/sacubitril?
Patients are typically advised to stop their ACE inhibitor or ARB at least 36 hours before starting valsartan/sacubitril to avoid an increased risk of angioedema and hypotension [1]. This switch should only be done under the guidance of a healthcare professional.
What is the patent status of valsartan/sacubitril?
The patents for valsartan/sacubitril are managed by Novartis. DrugPatentWatch.com tracks patent information, including expiration dates and any patent challenges [4]. Information on specific patents and their litigation status can be found on specialized patent tracking resources.
Who are the main competitors to valsartan/sacubitril in heart failure treatment?
While valsartan/sacubitril is a significant therapy for heart failure with reduced ejection fraction, other medications like ACE inhibitors (e.g., enalapril), ARBs (e.g., valsartan), beta-blockers (e.g., carvedilol), and mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone) are also used, often in combination [1][5]. Newer drug classes, such as SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin), have also shown significant benefits in heart failure management and are considered important competitors [5].
Are there any safety concerns or warnings associated with valsartan/sacubitril?
Valsartan/sacubitril carries a boxed warning regarding fetal toxicity. It should not be used in pregnant women, as it can cause injury or death to the developing fetus [1]. Patients with a history of angioedema related to previous ARB or ACE inhibitor use should not take this medication [1].
How is the effectiveness of valsartan/sacubitril monitored?
Healthcare providers monitor patients taking valsartan/sacubitril through regular blood tests to check kidney function and potassium levels. Blood pressure is also monitored to ensure it remains within a safe range. Clinical symptoms of heart failure, such as shortness of breath and swelling, are also assessed [1].