By sarms4muscle | 11 June 2024 | 0 Comments

Antihypertensive drug Aprocitentan CAS :1103522-45-7, ACT-132577

Drug Name: Aprocitentan

CAS :1103522-45-7
R&D Code:ACT-132577
ORIGINAL RESEARCH COMPANY: Idorsia Pharmaceuticals (a company created through a spin-off of Actelion following Johnson & Johnson's $30 billion acquisition of the company in 2017)
Indication: hypertension
The U.S. FDA approved Tryvio (aprocitentan) oral tablets on March 19, 2024. These tablets were co-developed by Idorsia and Johnson & Johnson and are intended to be used in conjunction with other anti-hypertensive medications to treat adult patients with hypertension whose blood pressure cannot be adequately controlled with other medications.
Tryvio is the first small molecule medication to reduce blood pressure based on a unique mechanism to be licensed in thirty years.
Based on an analysis of data from the previously published Phase 3 clinical trial PRECISION, aprocitentan, when used in conjunction with other background therapies for hypertension, caused and maintained statistically and clinically significant reductions in blood pressure in patients with refractory hypertension for up to 48 weeks. Approximately 700 individuals who had undergone conventional therapy consisting of three antihypertensive drugs and had a seated systolic blood pressure of greater than 140 mmHg were enrolled in the trial.
The PRECISION trial consisted of 3 parts, in the first part, patients were randomized to receive different doses of aprocitentan or placebo. after 4 weeks, patients treated with two different doses of either 12.5 mg or 25 mg of aprocitentan had significantly better systolic blood pressure reductions than the placebo group, by 3.8 mmHg (p= 0.0042) and 3.7 mmHg (p=0.0046), respectively. A similar pattern was seen in diastolic blood pressure, with patients treated with 12.5 mg or 25 mg aprocitentan experiencing a decrease in diastolic blood pressure that was 3.9 mmHg and 4.5 mmHg higher than the placebo group, respectively.
In the second phase of the trial, all patients were given 25 mg aprocitentan for 32 weeks. The research's findings demonstrated that individuals receiving aprocitentan in the initial phase of the experiment were able to sustain their lower systolic blood pressure. Within two weeks, those who received aprocitentan instead of a placebo experienced a rapid drop in blood pressure.
In the third phase of the study, patients were rerandomized to either receive a placebo or 25 mg of aprocitentan. After 4 weeks, compared to those who continued to receive aprocitentan, patients given with placebo had significantly higher systolic and diastolic blood pressures of 5.8 mmHg (p<0.0001) and 5.2 mmHg (p<0.001), respectively.
Apocitentan also exhibited good tolerance during the experiment. Mild to moderate fluid retention was the most prevalent treatment-associated adverse event (TEAE) that patients experienced, and it was largely under control.

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