Takeda Pharmaceutical Company Limited's drug is the first fixed-dose therapy in the U.S. to combine an angiotensin II receptor blocker with diuretic chlorthalidone in a once-daily, single tablet.
The recommended starting dose of Edarbyclor is 40/12.5 milligrams and the maximum dose is 40/25 milligrams.
"Ask your physician if you could benefit from a combination drug."
The drug works to lower blood pressure by blocking the action of angiotensin II, a vasopressor hormone that naturally exists within the body, while the diuretic reduces water retention by increasing urine flow.
Dr. Domenic Sica, professor of internal medicine and nephrology at Virginia Commonwealth University Medical Center, said that approval of the dual medication provides an effective treatment option to lower blood pressure in patients with hypertension who may require a combination of drugs to help achieve blood pressure goals.
He noted that controlling hypertension is critical because it also lowers the risk of serious health consequences, including stroke and heart attack.
Prior to approval, the drugmaker completed five clinical trials that involved more than 5,000 patients with high blood pressure. The studies ranged from eight weeks to 52 weeks long, with patients receiving doses of azilsartan medoxomil/chlorthalidone ranging from 20/12.5 to 80/25 milligrams once daily.
During those trials researchers found that the combination drug lowered blood pressure significantly more than either azilsartan medoxomil or chlorthalidone alone by ambulatory blood pressure monitoring.
They also found that the combination medication lowered blood pressure significantly more than the fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide at its highest approved dose. The most common adverse reactions seen in clinical studies to the combination drug were dizziness and fatigue.
"In clinical studies, Edarbyclor demonstrated statistically significant blood pressure reductions compared to its respective monotherapies and was shown to be superior to the fixed-dose combination of olmesartan medoxomil and hydrochlorothiazide at maximum respective doses," said Dr. Paulos Berhanu, executive medical director of medical and scientific affairs at Takeda.