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  5. Drug Trials Snapshots: TRYVIO
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Drug Trials Snapshots: TRYVIO

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug.

Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the WINREVAIR Prescribing Information for all the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).

Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).

TRYVIO (aprocitentan)
Try vee’ oh
Idorsia Pharmaceuticals, Inc.
Approval date: March 19, 2024


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

TRYVIO is used in combination with other blood pressure drugs to lower blood pressure in adult patients who are not adequately controlled on other drugs.

How is this drug used?

TRYVIO is a tablet that is taken by mouth once a day.

TRYVIO is used in combination with other drugs to treat high blood pressure.

Who participated in the clinical trial?

The FDA approved TRYVIO based on evidence from a clinical trial (NCT03541174) of 730 patients with high blood pressure (hypertension) despite taking at least three drugs to treat high blood pressure. The trial was conducted at 138 sites in 20 countries located in Asia, Australia, Europe, and North America. Approximately 32% of patients were enrolled at sites in North America.

How was the trial designed?

TRYVIO was evaluated in a clinical trial of 730 adult patients with high blood pressure who were taking at least three drugs to treat their high blood pressure. TRYVIO was approved at the 12.5mg dose which was evaluated in 487 patients.

The trial was used to evaluate efficacy and side effects of TRYVIO in comparison to aprocitentan 25 mg or placebo. Patients were selected at random during certain parts of the trial to use either TRYVIO, aprocitentan 25 mg, or placebo.

The trial compared TRYVIO, aprocitentan 25 mg, and placebo-treated patients by measuring the difference between sitting blood pressure among patients.


DEMOGRAPHICS SNAPSHOT

Figure 1 summarizes how many male and female patients were enrolled in the clinical trial used to evaluate the efficacy of TRYVIO.

Figure 1. Baseline Demographics by Sex

Pie chart summarizing how many male and female patients were in the clinical trial. In total, 289 (59%) male patients and 198 (41%) female patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 2 summarizes how many patients by race were enrolled in the clinical trial used to evaluate the efficacy of TRYVIO.

Figure 2. Baseline Demographics by Race

Pie chart summarizing how many White, Black or African American, Asian, and other patients were in the clinical trial. In total, 405 (83%) White patients, 54 (11%) Black or African American patients, 24 (5%) Asian patients, and 4 (1%) other patients participated in the clinical trial.

Source: Adapted from FDA Review
* Other includes unknown and not reported race patients

Figure 3 summarizes how many patients by age were enrolled in the clinical trial used to evaluate the efficacy of TRYVIO.

Figure 3. Baseline Demographics by Age

Pie chart summarizing how many patients by age were in the clinical trial. In total, 273 (56%) patients between 18 and 65 years of age, 164 (34%) patients between 65 and 75 years of age, and 50 (10%) patients 75 years of age or older participated in the clinical trial.

Source: Adapted from FDA Review

Figure 4 summarizes how many patients by ethnicity were enrolled in the clinical trial used to evaluate the efficacy of TRYVIO.

Figure 4. Baseline Demographics by Ethnicity

Pie chart summarizing how many Hispanic, not Hispanic, and missing patients were in the clinical trial. In total, 51 (10%) Hispanic or Latino patients, 431 (89%) not Hispanic or Latino patients, and 5 (1%) missing ethnicity patients participated in the clinical trial.

Source: Adapted from FDA Review

What are the benefits of this drug?

In the trial, adult patients taking TRYVIO experienced lower sitting blood pressure measurements in comparison to patients who took placebo.

Were there any differences in how well the drug worked in clinical trials among sex, race, and age?

  • Sex: TRYVIO worked similarly in males and females.
  • Race: TRYVIO worked similarly in Asian, White, and Black or African American patients.
  • Age: TRYVIO worked similarly in patients younger than 65, 65 to 75, and older than 75 years of age.
  • Ethnicity: TRYVIO worked similarly in Hispanic or Latino and not Hispanic or Latino patients.

What are the possible side effects?

TRYVIO may cause harm to an unborn baby and should not be given during pregnancy.

TRYVIO may cause serious liver problems.

TRYVIO may cause decreased sperm counts in males and may affect their ability to father a child.

Common side effects of TRYVIO are edema or fluid retention (swelling) and low red blood cell levels (anemia).

Were there any differences in side effects among sex, race, and age?

  • Sex: The occurrence of side effects was similar in male and female patients./li>
  • Race: The occurrence of side effects was similar in different racial groups.
  • Age: The occurrence of edema was greater in patients 65 years of age and older.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

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