PARSIPPANY, N.J. An investigational treatment made by Daiichi Sankyo for hypertension significantly lowers blood pressure in patients with hard-to-treat hypertension and diabetes, according to results of a late-stage clinical trial presented at a scientific meeting Monday.
The Japanese drug maker said at the 70th annual Scientific Sessions of the American Diabetes Association in Orlando, Fla., that the single-pill triple combination of Benicar (olmesartan medoxomil), amlodipine and hydrochlorothiazide in the respective 40 mg, 10 mg and 25 mg strengths resulted in a statistically significant reduction in blood pressure compared with Benicar and hydrochlorothiazide or amlodipine and hydrochlorothiazide. Amlodipine, which Pfizer sells under the brand name Norvasc, and hydrochlorothiazide are widely available as generics.
The phase 3 trial, called “TRINITY,” enrolled 2,492 patients, of whom 15.5% had hypertension and diabetes. Of those taking the triple combination, 41% experienced reductions in blood pressure, compared with 10% and 16% of those in the two-drug combination groups. The triple combination was well tolerated, with side effects described as mild to moderate in severity, Daiichi Sankyo said.
“In addition to taking medications to treat high blood pressure, patients with diabetes often need to take several other medications to ensure glucose and cholesterol levels also are within recommended target levels,” University of Alabama medical professor Suzanne Oparil said in a statement on behalf of Daiichi Sankyo. “Therefore, having a blood pressure-lowering treatment option that combines three medications into one pill will likely help patients take all of their medications as prescribed.”