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Azilsartan medoxomil/chlorthalidone found more efficacious than olmesartan/hydrochlorothiazide for treating hypertension
Combination azilsartan medoxomil and chlorthalidone was shown to be superior to combination olmesartan medoxomil and hydrochlorothiazide in lowering BP, according to data published in Hypertension.
The phase 3 study involved 1,071 stage 2 hypertensive participants (mean age, 57 years). The cohort was 59% men, 73% white and 22% black. Baseline clinic systolic BP ranged from 160 mm Hg to 190 mm Hg and diastolic BP was ≤119 mm Hg, with a mean of 165/96 mm Hg and a 24-hour mean of 150/88 mm Hg.
The 12-week, randomized, three-arm, double blind study compared once-daily fixed-dose combination azilsartan medoxomil/chlorthalidone (Edarbyclor, Takeda Pharmaceuticals) force titrated to either 40 mg/25 mg or 80 mg/25 mg at week 8 with combination olmesartan medoxomil/hydrochlorothiazide (Benicar HCT, Daiichi Sankyo) force titrated to the maximum dose of 40 mg/25 mg at week 8.
Michael A. Weber
Researchers found significantly greater changes (P<.001) in clinic and ambulatory systolic BPs for both azilsartan medoxomil/chlorthalidone arms compared with the olmesartan medoxomil/hydrochlorothiazide arm across multiple subgroups at the end of 12 weeks.
Mean changes in clinic systolic BP were –42.5 mm Hg and –44 mm Hg for the 40-mg/25-mg and 80-mg/25-mg azilsartan medoxomil/chlorthalidone arms, respectively, and –37.1 mm Hg for the olmesartan medoxomil/hydrochlorothiazide arm. Mean 24-hour ambulatory systolic BP changes were –33.9 mm Hg, –36.3 mm Hg and –27.5 mm Hg.
Discontinuation due to adverse events for combinations at the 40-mg/25-mg dosage levels were 7.9% for azilsartan medoxomil/chlorthalidone and 7.1% for olmesartan medoxomil/hydrochlorothiazide. At the higher 80-mg/25-mg dose, azilsartan medoxomil/chlorthalidone discontinuation was 14.5%.
“The important part about having the kind of efficacy that was demonstrated with the azilsartan medoxomil and chlorthalidone combination is that a large number of patients, even those with relatively high BPs at baseline, can get their high BP controlled with just a single pill a day,” study researcher Michael A. Weber, MD, of the State University of New York Downstate Medical Center in Brooklyn, N.Y., said in an interview. “The main message from this comparative trial showing the azilsartan medoxomil and chlorthalidone combination to be more efficacious than the olmesartan medoxomil/hydrochlorothiazide combination is that it not only means that more patients would get their BP controlled with the newer combination but that a number of people might not need to use an additional medication.
“Chlorthalidone has been used previously by itself in major clinical trials that have shown the benefit of reducing BP and protecting people with hypertension from strokes and other major CV outcomes. So the availability of this new powerful combination might go beyond its effect on BP,” Weber said.
Disclosure: This study was sponsored by Takeda Global Research and Development Center Inc. Dr. Weber is a member of the speakers’ bureau and a consultant for Boehringer Ingelheim, Daiichi Sankyo, Forest, Novartis and Takeda. Other study researchers report financial ties with Abbott, AstraZeneca, Boehringer Ingelheim, CVRx, Daiichi-Sankyo, Eli Lilly, Forest, GlaxoSmithKline, Johnson & Johnson, Medtronic, Merck, Novartis, Relypsa and Takeda. Three researchers are full-time employees of Takeda.