Fixed-dose combination ARB plus CLD significantly lowers blood pressure

June 3, 2011

An investigational fixed-dose therapy showed promising results in lowering blood pressure compared with study comparators, according to the results of three phase 3 studies presented at the 26th annual American Society of Hypertension (ASH) Scientific Meeting and Exposition in New York.

An investigational fixed-dose therapy showed promising results in lowering blood pressure compared with study comparators, according to the results of three phase 3 studies presented at the 26th annual American Society of Hypertension Scientific Meeting and Exposition in New York.

Two randomized, double-blind studies compared an investigational fixed-dose combination of azilsartan medoxomil plus chlorthalidone (CLD) versus a fixed-dose combination of olmesartan medoxomil plus hydrochlorothiazide (HCTZ) on the effects of clinic systolic blood pressure (SBP). Results showed that the investigational combination reduced clinic SBP significantly more than fixed-dose olmesartan medoxomil plus HCTZ. The third 8-week, randomized, double-blind, factorial study evaluated 6 fixed-dose combinations of azilsartan medoxomil plus CLD in 1,714 patients with stage 2 hypertension versus azilsartan medoxomil or CLD alone. The study demonstrated the 6 fixed-dose combinations lowered trough SBP by a range of 22.9 mmHg to 29.8 mmHg from baseline at week 8. All reductions were significantly greater than those of azilsartan medoxomil monotherapies (12.1 mmHg to 15.1 mmHg) or CLD monotherapies (12.7 mmHg to 15.9 mmHg).

“We were pleased with the results of the fixed-dose combination of azilsartan medoxomil plus chlorthalidone studies,” said Domenic Sica, MD, professor of internal medicine and nephrology at Virginia Commonwealth University Medical Center and lead investigator of the study. “If approved, the fixed-dose combination of azilsartan medoxomil plus chlorthalidone will be the first and only fixed-dose therapy in the United States that combines an ARB with the diuretic, chlorthalidone. This combination therapy can potentially provide a new treatment option for the millions of patients who are at risk of serious health consequences due to hypertension.”

An azilsartan medoxomil plus CLD fixed-dose combination New Drug Application was submitted to FDA in February and was supported by 5 phase 3 clinical trials involving more than 5,000 patients with hypertension.