Millions of Americans struggling to control their high blood pressure despite taking multiple medications may soon get some welcomed relief.
3 in 4 Adults With Hypertension Don’t Control It
More than half of American adults (nearly 120 million) have hypertension, but only one in four diagnosed cases is under control, according to the U.S. Centers for Disease Control and Prevention.Tryvio, a medication developed by Idorsia Ltd., is the first on the market to target endothelin receptors. If the endothelium generates excessive endothelin, it can lead to high blood pressure, heart issues, and lung problems.
Tryvio’s Clinical Success
Tryvio received FDA approval on March 19, largely based on the results of the company’s phase 3 clinical study.The study enrolled 730 patients with an average age of 62 years, of whom 60 percent were male and the majority (83 percent) were white. Many participants had advanced cardiovascular disease, as reported by the research team. More than half (54 percent) had a medical history of diabetes, 31 percent had ischemic heart disease, and one in five had congestive heart failure. Additionally, 63 percent of patients were already taking four or more antihypertensive medications.
“We did not shy away from including patients who are most at risk of the serious negative consequences of hypertension,” Dr. Alberto Gimerno, head of Global Clinical Development at Idorsia, said in the press release.
In the study, patients were randomly assigned to receive either 12.5 milligrams of Tryvio, 25 milligrams of Tryvio, or a placebo pill. After four weeks, all patients received 25 milligrams of Tryvio. Finally, after 32 weeks, patients were randomly assigned to receive either 25 milligrams of Tryvio or a placebo pill.
Side effects
Tryvio is not without risks.The medication can cause major birth defects if used by pregnant patients. In studies on rats and rabbits, researchers noted heart and lower jaw malformations in fetuses. The FDA warns patients using the medication to avoid trying to become pregnant for at least one month after stopping the medication. Due to its toxicity to embryos, the medication is available through a restricted distribution program called Tryvio REMS.
Other adverse effects include hepatotoxicity (liver injury), fluid retention, a decrease in hemoglobin, and decreased sperm count.
Furthermore, the drug is not recommended for patients with kidney failure or hepatic impairment.
