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Azilsartan medoxomil outperforms 2 commonly prescribed ARBs in Phase III head-to-head comparator trials

Tuesday, May 18 2010 | Comments

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What's This? Azilsartan medoxomil, an investigational angiotensin II receptor blocker (ARB), significantly reduces 24-hour mean systolic blood pressure (SBP), with an 80 mg/day dose outperforming the highest approved doses of olmesartan medoxomil and valsartan, according to data from 2 Phase III trials presented in New York at the American Society of Hypertension 25th Annual Scientific Meeting and Exposition.

The 2 trials were both 6-week, multicenter, double-blind trials in which the primary endpoint was 24-hour mean SBP measured with ambulatory BP monitoring (ABPM).

In the first trial, 1,291 patients were randomized to receive azilsartan medoxomil 40 mg/d, azilsartan medoxomil 80 mg/d, olmesartan medoxomil 40 mg/d, valsartan 320 mg/d, or placebo. Of these patients, 1,088 had baseline and week 6 ABPM data.

The results showed that 24-hour mean SBP declined 13.4 mm Hg with azilsartan medoxomil 40 mg/d, 14.5 mm Hg with azilsartan medoxomil 80 mg/d, 12 mm Hg with olmesartan medoxomil, and 10.2 mm Hg with valsartan. The reduction observed with the 80 mg/d dose of azilsartan medoxomil was significantly greater than the reductions observed with both comparator drugs, and the reduction observed with azilsartan medoxomil 40 mg/d was significantly greater than the reduction observed with valsartan.

In the second trial, 1,271 patients were randomized to receive azilsartan medoxomil 20 mg/d, azilsartan medoxomil 40 mg/d, azilsartan medoxomil 80 mg/d, olmesartan medoxomil 40 mg/d, or placebo. Final ABPM data were available for 86% of the participants.

Azilsartan medoxomil 20 mg/d, 40 mg/d, and 80 mg/d reduced 24-hour mean SBP by 10.8 mm Hg, 12.1 mm Hg, and 13.2 mm Hg, respectively. The corresponding reduction with olmesartan medoxomil was 11.2 mm Hg. The difference between the highest dose of azilsartan medoxomil and olmesartan medoxomil was statistically significant.

In addition, azilsartan medoxomil 80 mg/d was associated with a significantly greater reduction in clinic BP as compared with olmesartan medoxomil (-8.6 mm Hg vs -7.1 mm Hg).

Takeda Pharmaceutical Co. Ltd.'s Takeda Global Research & Development Center Inc. submitted a New Drug Application to the Food and Drug Administration for azilsartan medoxomil last month.

Takeda noted that the submission was supported by data from 7 Phase III trials involving >5,900 patients. The studies evaluated the safety and efficacy of the drug as a once-daily oral monotherapy or in combination with other drug classes for hypertension.

In these trials, the most commonly reported treatment-emergent adverse reactions (occurring in >=1% of patients) were dizziness (2.1%), increased blood creatine phosphokinase (1.1%), and diarrhea (1%).

This information concerns a use that has not been approved by the FDA.

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