Takeda Pharmaceuticals Korea said Friday it published new phase 3 trial data that supports the safety and efficacy profile of hypertension drug Edarbi in Korean patients with hypertension.
Hypertension, also known as high blood pressure, is a chronic condition wherein the blood pressure in the arteries is persistently elevated. Patients who struggle with elevated blood pressure long-term are at risk for coronary artery disease, stroke, and heart failure, among many other complications.
Edarbi (ingredient: azilsartan medoxomil potassium) lowers blood pressure by blocking the angiotensin II hormone, which increases blood pressure. The national insurance agency granted reimbursement for the drug in Korea last December for hypertension patients who have a systolic blood pressure exceeding 140 mmHg or a diastolic blood pressure exceeding 90 mmHg and have no comorbidities and complications.
The local study studied two doses of the drug versus placebo on 328 Korean adult patients with hypertension for six weeks. The randomized, double-blind phase 3 trial showed patients who took a 40 mg dose of Edarbi saw a -22.1 mmHg reduction while those that received 80 mg had a -23.7 mmHg reading. In contrast, those in the placebo group had an average of -8.8 mmHg, the company said.
Those taking Edarbi also tolerated the drug better, and the incidence of adverse effects remained similar between Edarbi and the placebo arm, the company said.
“Edarbi has been available and approved in many countries, including the U.S. and Europe for eight years, and its efficiency in managing uncontrolled hypertension has been well demonstrated,” said Takeda Korea President Mahender Nayak.
“The results from this local study now further establish that Edarbi, with its strong blood-lowering activity, can also significantly help Korean patients suffering from hypertension,” he added.
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