As an innovative drug that has been widely used and recognised in the treatment of chronic heart failure, the potential clinical value of sakubatril valsartan has been validated one by one as the studies progress, with fruitful breakthroughs being made from heart failure to essential hypertension.

Recently, its indication for hypertension landed in China. At a recent symposium on the current state of clinical use and comprehensive evaluation in the field of hypertension, experts expressed their expectations for the new indication of sacubitril valsartan, hoping that it will bring more surprises to the clinic.

01.Effective pressure control for up to 24 hours

Most cardiovascular diseases are mutually causative, and hypertension is often the initiating factor for these diseases. How well blood pressure is controlled determines to a certain extent the chances of death from cardiovascular disease.

The first antihypertensive drug was used in the clinic in 1940, and after five iterations, the process of bringing new drugs to market stopped in the early years of the 21st century. This year, the approval of sakubatril valsartan for the treatment of hypertension broke more than a decade of silence.

Clinical experts have sensed the unique benefits of sakubatril valsartan for the treatment of hypertension. As a first-line drug in the treatment of heart failure, it is often used to save patients with heart failure. At the same time, experts have found that sakubatril valsartan alone can bring patients' blood pressure under good control.

Several studies have shown that sakubatril valsartan is more effective in lowering blood pressure than conventional antihypertensive drugs, with an average reduction of 20 mm Hg systolic and 10 mm Hg diastolic; the reduction is smoother and is particularly effective at night. A net meta-analysis showed that sakubatril valsartan was more effective than alisartanate. In addition, in clinical practice sakubatril valsartan is effective in patients with hypertension combined with complications such as coronary heart disease, cardiac insufficiency, chronic kidney disease and stroke.

Because of its many advantages, Sacubitril valsartan has been recommended by Chinese and international guidelines on hypertension. The 2020 China Ambulatory Blood Pressure Monitoring Guidelines clearly state that it is effective in reducing nocturnal blood pressure. Nocturnal blood pressure is more closely related to the risk of cardiovascular events and all-cause mortality, making it important to control nocturnal blood pressure. In contrast, sakubatril valsartan controls blood pressure for a longer and smoother period of time, allowing for 24-hour long-lasting pressure control.

02.Protects and improves heart, brain and kidney blood vessels

As the world's first angiotensin receptor enkephalinase inhibitor (ARNI), the benefits of sakubatril valsartan go beyond blood pressure control itself, as it also protects and improves cardiovascular, cerebral and renal vessels.

Studies have confirmed that Sacubitril valsartan inhibits cardiac hypertrophy and myocardial fibrosis, thereby preventing progression to heart failure; controls renal blood flow and improves glomerular filtration rate, thereby improving kidney function; resists vascular fibrosis and reduces pulse pressure difference, thereby delaying atherosclerosis; and improves insulin sensitivity, thereby improving blood glucose values.

"Not only is it an antihypertensive agent, it has a beneficial effect on stroke, end-stage renal disease and the front end of the cardiovascular event chain, such as ventricular remodelling and vascular remodelling, enabling patients to benefit throughout the cardiovascular event chain." In addition, time has proven its safety, and in the six years since its global launch, no action has been taken for safety reasons, and no dosing warnings have been received.

The effectiveness and safety of sakubatril valsartan stems from its unique eutectic structure. It is a stable eutectic complex of sakubatril anion, valsartan anion, sodium cation and water molecules in a molar ratio of 1:1:3:2.5, and is not a simple superposition of two drugs, sakubatril and valsartan. The eutectic structure gives it a single, stable melting point (138 degrees Celsius), a constant proportion of components that can be left for a week without degradation even at 50 degrees Celsius, and good solubility and permeability, high bioavailability and stable efficacy. After entering the human body, it is broken down into two drugs, sacubitril and valsartan, which act on the RAAS system and sacubitril acts on the natriuretic peptide system, inhibiting enkephalin activity. The dual mechanism of action results in a potent and long-lasting antihypertensive effect with excellent target organ protection.

03.Economical in treatment

Pharmacoeconomists have evaluated the economics of sakubatril valsartan in the treatment of hypertension. When conducting pharmacoeconomic evaluations, it is important to consider not only the benefit of blood pressure reduction per se, but also the cardioprotective effect of the drug, which also results in a lower incidence of cardiovascular events. The results of the study show that sakubatril valsartan reduces the risk of cardiovascular events and improves the quality of life of patients compared to drugs such as aliskiren, while also saving on healthcare costs associated with cardiovascular events.

Currently, the indication for Saccubatril valsartan for chronic heart failure has been included in the national health insurance catalogue, providing the basis for long-term standardised treatment for heart failure patients in China. If the negotiation mechanism of the National Health Insurance is utilised, the affordability of sakubatril valsartan in the treatment of hypertension can be further improved, while the expenditure on heart failure treatment will also obtain a reduction due to the lower price.

Saccubitril valsartan was unanimously recognised by the experts for its outstanding performance in terms of efficacy, safety, innovation and affordability. Experts at the meeting said that more than 20 antihypertensive drugs have been included in the collection, and in this context, priority should be given to patients whose target organs, such as the heart and kidneys, have been damaged according to the drug characteristics of Sacubitril valsartan, so that the treatment needs of these patients can be met and the expenditure brought about by cardiovascular events can also be reduced, further improving the efficiency of the medical insurance fund.

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