The FDA has approved a new medication called Tryvio (aprocitentan) for adults with high blood pressure that is difficult to control with existing therapies. Tryvio works differently than current medications and is taken once daily in combination with other blood pressure drugs.
Uncontrolled Hypertension: A Serious Problem
High blood pressure, or hypertension, is a major health concern, affecting millions of people. Even with medication, about 10% of patients struggle to keep their blood pressure under control. This can lead to serious health problems like heart disease and stroke.
Tryvio: A Novel Approach
Tryvio works by targeting a different pathway in the body compared to existing medications. Current options focus on regulating salt and water balance, or influencing hormone activity. Tryvio blocks the effects of a molecule called endothelin, which can contribute to high blood pressure.
Clinical Trial Results
The FDA based its approval on a large clinical trial (PRECISION) that studied the effectiveness and safety of Tryvio in over 730 patients with uncontrolled hypertension. The trial showed that Tryvio significantly reduced blood pressure compared to a placebo after four weeks and maintained that reduction for up to 40 weeks.
Safety and Side Effects
Tryvio was generally well-tolerated in the trial, with side effects like fluid retention reported in some patients. These side effects were mostly mild or moderate, and few patients discontinued treatment due to side effects.
Benefits for Patients and Doctors
Tryvio offers a new option for doctors to treat patients with uncontrolled hypertension. It can be easily added to existing medication regimens and has minimal drug interactions. This is a significant development for patients who haven’t been able to achieve adequate blood pressure control with current therapies.
Posted March 2024.
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