Tryvio (aprocitentan) is a groundbreaking medication in a new class of drugs designed to target endothelin, a hormone responsible for regulating blood vessel movements. It is approved for use as an add-on therapy for patients whose blood pressure is not adequately controlled by other medications alone.
Key Takeaways
- Tryvio is a once-daily medication designed for individuals with poorly controlled high blood pressure.
- The most common side effects include swelling, fluid retention, and anemia.
- Tryvio carries a black box warning for birth defects and should not be taken by those who are pregnant or planning to become pregnant.
The U.S. Food and Drug Administration (FDA) has recently approved a novel medication designed for individuals who struggle to control their high blood pressure with existing treatments.
The new medication, Tryvio (aprocitentan), belongs to a class of drugs called endothelin receptor antagonists. These drugs function by inhibiting the activity within blood vessels that leads to their constriction, a key factor that elevates blood pressure. According to a statement from its developer, Idorsia, Tryvio is the first oral medication of its kind aimed at managing hypertension through this mechanism.
The FDA has authorized the use of Tryvio as an adjunct therapy, meaning it should be used in conjunction with older blood pressure medications when these conventional treatments fail to provide adequate control. This approval offers a new avenue of hope for patients whose hypertension remains difficult to manage despite the use of other pharmacological interventions.
“Today, there are millions of Americans whose blood pressure is not well-controlled despite existing therapies,” Jean-Paul Clozel, MD, the chief executive officer of Idorsia, said in the statement. “This is a major public health issue leading to a high incidence of cardio- and cerebrovascular events.”
Endothelin is a hormone that plays a crucial role in regulating the movement of blood vessels, leading to a process known as vasoconstriction, where blood vessels narrow. Tryvio works by blocking the effects of this hormone, thereby promoting vasodilation, or the relaxation and widening of blood vessels.
“This dilation helps to lower blood pressure by reducing resistance to blood flow through the vessels, ultimately decreasing the workload on the heart,” Gaetano Santulli, MD, PhD, an associate professor of cardiology at Montefiore University Hospital at the Albert Einstein College of Medicine in New York City, also shared.
Tryvio Successfully Lowered Blood Pressure During Clinical Trials
“By adding Tryvio to the treatment regimen, it can provide additional blood-pressure-lowering effects, potentially addressing underlying causes of hypertension that were not adequately controlled with previous medications,” Dr. Santulli said.
In a late-stage clinical trial, researchers investigated the efficacy of Tryvio as an add-on treatment for 730 patients with poorly controlled hypertension, despite being on at least three different blood pressure medications.
During the initial phase of the trial, participants were randomly assigned to receive either one of two doses of Tryvio or a placebo for four weeks. By the end of this period, those taking Tryvio showed a significant reduction in systolic blood pressure—the “top number” indicating the pressure exerted against artery walls when the heart beats—according to a statement from Idorsia.
In the subsequent phase, all participants were administered the higher 25 milligram (mg) dose of Tryvio for 32 weeks. For the final phase, half of these participants were switched from the higher dose of Tryvio to a placebo for 12 weeks. By the end of the study, individuals who continued taking Tryvio maintained significantly lower systolic blood pressure compared to those who were switched to the placebo.
The trial also demonstrated similar positive outcomes with the lower 12.5 mg dose of Tryvio. Notably, this 12.5 mg dose is the only one that received FDA approval, as stated by the company.
Side Effects of Tryvio for Treatment of High Blood Pressure
The most common side effects observed during the trial included swelling, fluid retention, and anemia.
However, Tryvio comes with a black box warning—the FDA’s strictest warning for serious and potentially life-threatening side effects—due to its risk of causing birth defects. Individuals who can become pregnant must undergo a negative pregnancy test before beginning treatment with Tryvio. They are also advised to use effective birth control and undergo monthly pregnancy tests while on the medication. If pregnancy occurs, they must discontinue the drug immediately.
According to Dr. Deepak Bhatt, MD, MPH, director of Mount Sinai Fuster Heart Hospital at the Icahn School of Medicine at Mount Sinai in New York City, Tryvio will likely be primarily reserved for patients who are already on the highest possible doses of available generic blood pressure medications but still struggle with uncontrolled hypertension.
“Right now, there aren’t great options for patients who are maxed out on currently available blood pressure drugs,” Dr. Bhatt said. “So, having a new option is going to be useful to treat such patients.”
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