New Pill for Tough-to-Treat High Blood Pressure Gets FDA OK
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The U.S. Food and Drug Administration (FDA) has approved a new type of medicine for people who aren’t able to control their high blood pressure with other drugs.
“Today, there are millions of Americans whose blood pressure is not well-controlled despite existing therapies,” said Jean-Paul Clozel, MD, the chief executive officer of Idorsia, 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’s involved in regulating blood vessel movements and causes what’s known as vasoconstriction, or narrowing of blood vessels. By blocking this hormone, Tryvio promotes vasodilation, or relaxation 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,” says Gaetano Santulli, MD, PhD, an associate professor of cardiology at Montefiore University Hospital at the Albert Einstein College of Medicine in New York City.
Tryvio Lowered Blood Pressure in 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 says.
In a late-stage clinical trial, researchers examined the effect of Tryvio as an addition to treatment regimens for 730 patients with poorly controlled hypertension who had already been prescribed at least three different blood pressure drugs.
For the first part of the trial, researchers randomly assigned patients to take one of two Tryvio doses or a placebo pill for four weeks. By the end of this phase, Tryvio significantly reduced systolic blood pressure — the “top number” that shows how much pressure blood exerts against artery walls when the heart beats — Idorsia said in its statement.
In the second stage of the trial, all the patients took the higher 25 milligram (mg) dose of Tryvio for 32 weeks. Then, for the final stage, researchers switched half these patients from the higher Tryvio dose to a placebo pill for 12 weeks. People who continuously took the drug had significantly lower systolic blood pressure by the end of the study than participants who stopped.
Researchers found similar results with the lower, 12.5 mg, dose, and that is the only Tryvio dose approved by the FDA, the company said.
What Are the Side Effects of Tryvio for High Blood Pressure?
The most common side effects in the trial were swelling, fluid retention, and anemia.
But the drug carries a black box warning — reserved by the FDA for the most dangerous side effects — about its potential to cause birth defects. People who can become pregnant must have a negative pregnancy test before starting treatment with Tryvio, and should use birth control and take monthly pregnancy tests while on this medicine. If they become pregnant, they must stop taking it immediately.
Tryvio will likely be reserved mostly for patients who are on the highest possible dose of currently available generic blood pressure medicines and still have poorly controlled blood pressure, says Deepak Bhatt, MD, MPH, the director of Mount Sinai Fuster Heart Hospital at the Icahn School of Medicine at Mount Sinai in New York City.
“Right now, there aren’t great options for patients who are maxed out on currently available blood pressure drugs,” Dr. Bhatt says. “So, having a new option is going to be useful to treat such patients.”
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