Azilsartan is More Effective than Olmesartan in Reducing BP in Hypertensive Patients

Aim

To assess the anti-hypertensive efficacy and safety of the latest angiotensin II receptor blocker (ARB), azilsartan medoxomil, compared to placebo and another ARB, olmesartan medoxomil

Patient Profile

• 1275 patients with primary hypertension [defined as sitting through clinic systolic blood pressure (SBP) ≥150 mm Hg and ≤ 180 mm Hg and 24-hour mean SBP ≥130 mm Hg and ≤ 170 mm Hg]

Method

Study Design

• Randomized, multicenter, parallel-group, double-blind, placebo-controlled trial

Treatment Strategy

• Patients were randomized to receive either placebo, azilsartan medoxomil 20/ 40/ 80 mg/day or olmesartan medoxomil 40 mg/day

Duration

• 6 weeks

Key Primary End Point

• Change in 24-hour mean SBP assessed by ambulatory blood pressure monitoring (ABPM)

Key Secondary End Point

• Change in trough sitting clinic SBP

Other Secondary End Points

• Change from baseline in trough sitting clinic diastolic BP (DBP) by ABPM and proportion of responders (patients who had a reduction in clinic SBP to <140 mm Hg and/or a reduction of ≥ 20 mm Hg)

Results

• Both azilsartan medoxomil and olmesartan medoxomil reduced 24-hour mean SBP and clinic SBP, but 80 mg azilsartan offered significantly greater reduction as compared to 40 mg of olmesartan (Figure 1 & 2)

• Similarly, reduction in clinic DBP was significantly greater with the 80-mg dose of azilsartan medoxomil compared with olmesartan medoxomil 40 mg, with a treatment difference of -1.5 mm Hg (P=0.044)
• The proportion of responders were 48%, 50%, and 57% with azilsartan medoxomil 20 mg, 40 mg, and 80 mg, respectively, as compared to 53% with olmesartan medoxomil 40 mg
• Azilsartan was overall well-tolerated, with adverse event profile of both ARBs being similar to placebo.

Conclusion

• Azilsartan medoxomil was more effective and well tolerated at its maximal dose than the highest dose of olmesartan medoxomil.

J Clin Hypertens (Greenwich). 2011; 13: 81–8.