The FDA approved a new once-a-day pill called TRYVIO. It targets adults whose high blood pressure hasn’t been controlled by other medicines. This drug against uncontrolled hypertension works in a new way compared to previous treatments. It should help lower blood pressure to reduce the risk of heart disease and strokes. It will be available in the second half of 2024.
Patients with uncontrolled hypertension will benefit
TRYVIO (aprocitentan) is a new medication for patients with high blood pressure. Specifcally to those whose blood pressure hasn’t been adequately controlled despite using multiple other blood pressure medications, i.e. uncontrolled hypertension. Developed by Idorsia and approved by the FDA, TRYVIO represents a significant advancement in the treatment of resistant hypertension. It a specific health condition where blood pressure remains high despite the use of three or more antihypertensive medications, including a diuretic.
The study behind the new drug
The approval of TRYVIO is based on the results of the PRECISION study. It is a comprehensive clinical trial designed to evaluate the effectiveness and safety of aprocitentan. The study involved three parts, beginning with a comparison of aprocitentan and placebo over four weeks. It was followed by a longer phase where all participants received aprocitentan, and finally, a withdrawal phase to assess the maintenance of blood pressure reduction.
Key findings from the PRECISION study demonstrated that aprocitentan significantly reduced systolic blood pressure (the top number in a blood pressure reading) compared to placebo. This reduction was sustained over long-term treatment, in the situations of uncontrolled hypertension. Moreover, the study showed that aprocitentan’s effects on lowering blood pressure were consistent throughout a 24-hour period. This included nighttime, which is crucial for reducing the risk of cardiovascular events such as heart attacks and strokes.
The study also highlighted aprocitentan’s safety profile. The participants tolerated it well. Fluid retention was the most commonly reported side effect. Importantly, the incidence of major adverse cardiac events was in line with what would be expected in this patient population. The overall safety data suggest that aprocitentan could be a valuable addition to existing treatment regimens for resistant hypertension.
The novelty in uncontrolled hypertension treatment
The introduction of TRYVIO is particularly significant because it operates through a novel mechanism of action. It targets the endothelin pathway, a key regulator of blood vessel constriction and blood pressure. The pharma industry has not therapeutically targeted this pathway by existing hypertension medications in over 40 years.
For patients struggling to control their high blood pressure with current medications, TRYVIO provides a new hope for better management of their condition.
