Aim

To compare the efficacy, safety, and metabolic effects of azilsartan medoxomil vs. olmesartan in patients with prediabetes mellitus [fasting glucose of 100–125 mg/dl or a hemoglobin A1c (HbA1c) of 5.7–6.4%] and type 2 diabetes mellitus (T2DM) (HbA1c at least 6.5%)

Patient Profile

• 1998 patients with hypertension [clinic systolic blood pressure (SBP) between 150 mm Hg and 180 mm Hg, and ambulatory 24-h mean SBP between 130 mm Hg and 170 mm Hg] who were either normoglycemic (HbA1c < 5.7%) (n=793) or had prediabetes mellitus (n=823) or T2DM (n=382)

Methods

Study Design

• Pooled analysis of two randomized control trials

Study Treatment Groups

• Placebo (N=297), azilsartan medoxomil 40 mg/day (N=561), azilsartan medoxomil 80 mg/day (N=568) and olmesartan medoxomil 40 mg/day (N=572)

Duration

• 6 weeks

Key Efficacy Parameters

• Changes in ambulatory and clinic BP

Results

• Both azilsartan medoxomil 40 mg and azilsartan medoxomil 80 mg offered greater reduction in 24-hour BP vs. olmesartan medoxomil 40 mg in both prediabetes mellitus and T2DM groups (Fig. 1 & 2)

• Both azilsartan medoxomil 40 mg and azilsartan medoxomil 80 mg offered greater reduction in clinic BP vs. olmesartan medoxomil 40 mg in both prediabetes mellitus and T2DM groups (Fig. 3 & 4)

• Both azilsartan medoxomil 40 mg and azilsartan medoxomil 80 mg improved metabolic biomarkers in diabetes patients (Table 1)

Conclusion

• Azilsartan provides an additional 3–7 mm Hg systolic BP reduction in hypertensive patients with prediabetes/ T2DM, and exerts beneficial effect on metabolic parameters.
• Azilsartan can therefore be the preferred ARB for the management of hypertension in patients with prediabetes mellitus or T2DM.

J Hypertens. 2016; 34: 788-97.