FDA Approves Exciting New Drug TRYVIO For High Blood Pressure on March 20, 2024

Jul 22, 2024

What is TRYVIO prescribed for?  

TRYVIO is a prescription medicine used to treat high blood pressure (hypertension) in adults who are taking other high blood pressure medicines and whose blood pressure is not well controlled.

What is the name of the drug and what does it do?

TRYVIO pronounced try-vee-oh, (generic name: aprocitentan) is designed to treat hypertension (high blood pressure) in adults who are not adequately controlled with other antihypertensive medications (drugs that help lower high blood pressure). 

Lowering blood pressure reduces the risk of serious cardiovascular events, such as strokes and heart attacks.

How does it work?

TRYVIO is an endothelin receptor antagonist (ERA). Endothelin-1 (ET-1) is a substance in the body that can cause blood vessels to constrict (narrow), leading to increased blood pressure. 

TRYVIO works by blocking the effects of this substance (ET-1) on its receptors (ETA and ETB), preventing the constriction of blood vessels, reducing blood pressure, and potentially minimizing damage to blood vessel walls.

What did the research discover?

In a phase 3 clinical study named PRECISION, TRYVIO was tested on adults with uncontrolled high blood pressure despite using at least three antihypertensive medications. 

The study demonstrated that TRYVIO, when taken at a dose of 12.5 mg once daily, significantly lowered sitting systolic blood pressure (SiSBP-the top number in a blood pressure reading.

 It measures the pressure in your arteries when your heart beats and pushes blood out to the rest of your body) compared to a placebo. 

The drug also showed sustained blood pressure reduction over a long-term treatment period. 

The primary efficacy endpoint was the change in SiSBP from baseline to Week 4, showing a notable decrease in blood pressure in patients treated with TRYVIO.

What are some of the side effects?

The side effects listed are from the product manufacturer. As health scientists, we share this information to keep you informed without causing undue worry. Many side effects diminish over time, and not all patients experience them. If prescribed medication, take it as directed and consult your healthcare professional if you have any concerning side effects.

  • Edema (swelling due to fluid retention)
  • Anemia (low red blood cell count)
  • Hypersensitivity reactions (such as rash or allergic edema)
  • Decreases in hemoglobin concentration
  • Potential liver toxicity (hepatotoxicity)
  • Fluid retention

What are the dosage recommendations and how is it prescribed?

The recommended dosage of TRYVIO is 12.5 mg taken orally once daily, with or without food.

It is important to take TRYVIO exactly as prescribed by your healthcare provider. If you miss a dose, skip it and take the next dose at the regular time. Do not take two doses on the same day.

Source:

Highlights of Prescribing Information for TRYVIO (aprocitentan). Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217686s000lbl.pdf. Accessed 16 July 2024.

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