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Azilsartan medoxomil plus chlorthalidone reduces blood pressure more effectively than olmesartan plus hydrochlorothiazide in stage 2 systolic hypertension
Hypertension, 06/20/2012  Clinical Article

Cushman WC et al. – This large, forced–titration study has demonstrated superior antihypertensive efficacy of azilsartan medoxomil/chlorthalidone fixed–dose combinations compared with the maximum approved dose of olmesartan/hydrochlorothiazide.

Methods
  • The authors compared once–daily fixed–dose combinations of azilsartan medoxomil/chlorthalidone force titrated to a high dose of either 40/25 mg or 80/25 mg with a fixed–dose combination of the angiotensin II receptor blocker olmesartan medoxomil plus the thiazide diuretic hydrochlorothiazide force titrated to 40/25 mg.
  • The design was a randomized, 3–arm, double–blind, 12–week study of 1071 participants with baseline clinic systolic blood pressure 160 to 190 mm Hg and diastolic blood pressure ≤119 mm Hg.
  • Patients had a mean age of 57 years; 59% were men, 73% were white, and 22% were black.

Results
  • At baseline, mean clinic blood pressure was 165/96 mm Hg and 24–hour mean blood pressure was 150/88 mm Hg.
  • Changes in clinic (primary end point) and ambulatory systolic blood pressures at week 12 were significantly greater in both azilsartan medoxomil/chlorthalidone arms than in the olmesartan/hydrochlorothiazide arm (P<0.001).
  • Changes in clinic systolic blood pressure (mean±SE) were –42.5±0.8, –44.0±0.8, and –37.1±0.8 mm Hg, respectively.
  • Changes in 24–hour ambulatory systolic blood pressure were –33.9±0.8, –36.3±0.8, and –27.5±0.8 mm Hg, respectively.
  • Adverse events leading to permanent drug discontinuation occurred in 7.9%, 14.5%, and 7.1% of the groups given azilsartan medoxomil/chlorthalidone 40/25 mg, azilsartan medoxomil/chlorthalidone 80/25 mg, and olmesartan/hydrochlorothiazide 40/25 mg, respectively.

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