Hypertension, a focus on the disease

 

 A high blood pressure medication which was trialled in a study led by The University of Western Australia has been approved for use in the United States.

The US Food and Drug Administration approved TRYVIO, a drug to treat high blood pressure in patients who have shown resistance to other medications.

Professor Markus Schlaich, Dobney Chair in Clinical Research at UWA’s Medical School, led the study of aprocitentan (sold under the name TRYVIO) and the results were published in the Lancet.

However, it should be noted that TRYVIO is a drug not indicated for pregnant women for different reasons stated in following details:

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use
TRYVIO safely and effectively. See full prescribing information for
TRYVIO.

TRYVIOTM (aprocitentan) tablets, for oral use
Initial U.S. Approval: 2024
 

WARNING: EMBRYO–FETAL TOXICITY

See full prescribing information for complete boxed warning.
• TRYVIO can cause major birth defects if used by pregnant patients
and is contraindicated in pregnancy. (4.1, 5.1, 8.1)
• Patients who can become pregnant: Exclude pregnancy prior to
initiation of treatment, monthly during treatment, and for one month
after stopping TRYVIO. (2.2, 5.1, 8.3)
• Patients who can become pregnant: Use acceptable contraception
prior to initiation of treatment, during treatment, and for one month
after stopping TRYVIO. (2.2, 4.1, 5.1, 8.3)
• TRYVIO is only available through a restricted distribution program
called the TRYVIO REMS. (5.2)

INDICATIONS AND USAGE

TRYVIO is an endothelin receptor antagonist indicated for the
treatment of hypertension in combination with other antihypertensive
drugs, to lower blood pressure in adult patients who are not adequately
controlled on other drugs. Lowering blood pressure reduces the risk of
fatal and non-fatal cardiovascular events, primarily strokes and
myocardial infarctions. (1)

DOSAGE AND ADMINISTRATION

• The recommended dosage of TRYVIO is 12.5 mg orally once daily,
with or without food. (2.1)

OSAGE FORMS AND STRENGTHS

Tablets: 12.5 mg (3)

CONTRAINDICATIONS

• Pregnancy (4.1)
• Hypersensitivity (4.2)

WARNINGS AND PRECAUTIONS

• ERAs cause hepatotoxicity and liver failure. Measure serum
aminotransferase levels and total bilirubin prior to initiation of
treatment and repeat periodically during treatment and as clinically
indicated. (5.3)

• Fluid retention may require intervention (5.4)
• Decreases in hemoglobin (5.5)
• Decreased sperm counts (5.6)

ADVERSE REACTIONS

Most common adverse reactions (more frequent than placebo and
≥ 2% in TRYVIO-treated patients) are edema/fluid retention and
anemia. (6.1)
To report 

SUSPECTED ADVERSE REACTIONS, contact Idorsia
Pharmaceuticals Ltd at 1-833-400-9611 or FDA at 1-800-FDA-1088
or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

• Lactation: Advise not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and Medication
Guide.

“An estimated 1.3 billion people have hypertension, of which approximately 10 per cent have resistant hypertension,” Professor Schlaich said.

“The failure to control blood pressure with drugs that were currently available suggested that the relevant pathophysiological pathways were not being targeted.”

The study involved patients who still had high blood pressure despite having taken a minimum of three drugs at their optimal dose and sometimes up to four, five, or even six medications.

The drug trialled targeted the endothelin receptors, which when activated can constrict the smooth muscles of the blood vessels, raising blood pressure, or relax the smooth muscles of the blood vessels, lowering blood pressure.

“In conjunction with other medications we found the drug which targeted the endothelin pathway lowered blood pressure in patients who had resistant hypertension,” Professor Schlaich said.

“Aprocitentan lowered systolic and diastolic blood pressure, and this was sustained over a period of 48 weeks supporting long-term tolerability and efficiency.

“The lower blood pressure reduced the risk of fatal and non-fatal cardiovascular events, primarily strokes and heart attacks.

“This is an important milestone in our fight against high blood pressure and will facilitate improved blood pressure control for many. We hope it will be approved and available in Australia by next year.”

Pharmaceutical company Idorsia plans to make TRYVIO available in the US in the second half of 2024 to adults with resistant hypertension to be taken in combination with other antihypertensive drugs.

Hypertension is another way of saying high blood pressure. When your heart beats, it pumps blood out of your heart and into your blood vessels to nourish your body. Your blood pressure reading measures the force of your blood pushing against your artery walls when the heart contracts and rests. The systolic pressure (the top number) describes the pressure when your heart beats and the muscle contracts, and the diastolic pressure (bottom number) describes the pressure in your arteries between heartbeats, as the heart rests and fills with blood. You have hypertension when you have a systolic reading of 140 or above and a diastolic reading of 90 and above.

What Is Hypertension (High Blood Pressure)?

 
Complications of Hypertension

High blood pressure damages the artery walls, causing them to become thinned and stretched. Hypertension can cause a wide range of complications, including:

 - Vascular Weakness: When blood vessels are stretched too thin, they are more prone to rupture, causing strokes and aneurysms.

 - Blood Clots

  - Vascular Scarring: When the thin artery walls tear, car tissue can build up on the walls of the arteries and veins

 - Plaque Build Up: Plaque or cholesterol deposits can collect in the arteries where there is scar tissue. This can block blood flow, making your heart work harder. Plaque can also break off and block the flow altogether, leading to heart attacks and strokes.

 -What Causes Hypertension?

Hypertension usually develops slowly over time. If hypertension runs in your family, if you don't maintain a proper diet, are overweight, or are over 60, you are at greater risk for high blood pressure. Race also plays a role, as African Americans are more likely to have high blood pressure. Some other risk factors include:

-  Smoking

- Too much alcohol consumption.

- A diet heavy in sodium

- Not enough Vitamin D or potassium in your diet

-  Oral contraception use.

-  Stress

-  Kidney disease

-  Diabetes

- Sleep apnea

 
There are usually no symptoms of high blood pressure. You should get your blood pressure checked regularly, and if you receive consistent high blood pressure readings, you should seek treatment. If you don't control your blood pressure, you could develop one or more of the following conditions:

- Stroke

- Heart attack

- Heart failure

- Aneurysm

- Metabolic syndrome

- Treatment at Penn

Some people may be able to treat their hypertension with lifestyle and diet changes. Others may also require medication to help them get their blood pressure under control. Penn is a leader in the prevention and management of early heart disease. Penn Medicine's specialized cardiologists offer medical treatments not available at other centers. When you choose Penn, you choose to work with a dedicated team of cardiologists and heart disease experts who continue to lead the field, advancing the science.

Cassien Tribunal Aungane, Editor