FDA Approves the First New Type of High Blood Pressure Drug In Decades

The Food and Drug Administration (FDA) recently approved a new treatment If you have uncontrolled high blood pressure.

Uncontrolled high blood pressure, or resistant hypertension, is difficult to manage. Many people with resistant hypertension change their lifestyle and take three or more medications, including diuretics, but their blood pressure remains high.

About 20% of people with high blood pressure have resistant hypertension, which increases the risk of stroke, heart attack, and kidney failure.

Tryvio (aprocitentan), manufactured by the pharmaceutical company Idorsia, is a once-daily oral medication that helps lower blood pressure in adults with uncontrolled high blood pressure. It blocks the hormone endothelin from binding to receptors in blood vessels, preventing them from constricting.

Tryvio is the first endothelin receptor antagonist for resistant hypertension, while an endothelin receptor drug called Tracleer (bosentan) is approved to treat certain types of pulmonary arterial hypertension (high blood pressure in the lungs).

It took a long time for new ways to treat high blood pressure to emerge. The last time a new class of antihypertensive drugs called renin inhibitors was introduced was in 2007, when Tekturna (aliskiren) was approved. Endothelin receptors are not only a new class of drugs for hypertension. They are also utilizing the first new therapeutic route for lowering blood pressure in 40 years.

“Blocking the receptors for endothelin causes vasodilation, which means the diameter of the body’s small arteries expands and, as a result, blood pressure decreases.” Dr. Oscar SingoraniDirector of the Hypertension Program at Johns Hopkins School of Medicine told Berrywell.

Researchers evaluated Toribio in the PRECISION trial, which ran from 2018 to 2022. When used with other drugs, the drug was well tolerated and lowered blood pressure in a small but significant number of participants.

“Since this is a relatively new drug, we need to be aware of potential side effects that may have been missed in trials,” Singorani said.

Is Toribio safe?

Some people may experience liver problems, fluid retention, low sperm count, or anemia while taking Tryvio.

Do not take Torivio if you are pregnant or planning to become pregnant, as Toribio can cause miscarriage or birth defects. Even those who are breastfeeding avoid toribio This is because it is unknown whether this drug passes from breast milk to the infant.

“The reason I’m cautious is because we don’t have long-term data on this drug,” Singorani said. “We don’t have five or 10 years. We have long-term experience with other similar drugs and they seem to be safe,” Singorani said.

He said he plans to consider the drug as an option for patients with resistant hypertension once it becomes available to the public. Late 2024.

“The FDA took two years to approve it. I think all the research was done and the evaluation was very rigorous,” he said. “I’m sure this will be a good medicine.”

Tryvio can be used with other medicines

People with high blood pressure often take a combination of different types of drugs, including diuretics, angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin II receptor blockers (ARBs), and calcium channel blockers.

Tryvio is an endothelin A/endothelin B receptor cooperative antagonist that works through a different therapeutic pathway than other hypertension drugs. This drug is only approved for use with other antihypertensive drugs.

“It’s by no means a panacea, but that’s what we’re hoping for. If we can get a bunch of different drugs with different mechanisms of action, they work synergistically so we need fewer doses.” I guess.” Karol E. Watson, MD, PhDCardiologist, attending physician and professor of medicine and cardiology at UCLA’s David Geffen School of Medicine, told Berrywell.

Watson said side effects can be reduced by lowering the dose.

“Most people with hard-to-treat hypertension are on four different medications. And it’s not a failure of any particular class. It’s just part of the complexity of the disease process,” she says. said.

Like Singorani, Watson said she plans to keep Toribio in her toolbox to treat resistant hypertension. But this isn’t the first drug she’ll get.

“It’s not a game changer, but it’s good to have options,” Watson said.