Azilsartan is Superior to Olmesartan in Hypertensives with Type 2 Diabetes/ Prediabetes

19 Jul, 17

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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)

Fig.1: Changes from baseline in 24-hour systolic BP by glycemic subgroup

Fig.2: Changes from baseline in 24-hour diastolic BP by glycemic subgroup

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)

Fig 3: Changes from baseline in clinic systolic BP by glycemic subgroup

Fig 4: Changes from baseline in clinic diastolic BP by glycemic subgroup

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

Table 1: Mean change from baseline in metabolic biomarkers

Normotensive group

Pre-diabetes group

Type 2 diabetes group

Treatment

Biomarker

Placebo

Azilsartan 40 mg

Azilsartan 80 mg

Olmesartan 40 mg

Placebo

Azilsartan 40 mg

Azilsartan 80 mg

Olmesartan 40 mg

Placebo

Azilsartan 40 mg

Azilsartan 80 mg

Olmesartan 40 mg

FPG (mmol/l)

-0.0

+0.0

-0.1*

+0.1

+0.0

-0.0

+0.5

+0.1

-0.2^*,#

+0.4

HOMA-IS

-1.1

-0.2

-0.8

+0.4^#

-0.1

+0.0

+0.7

-0.4

+1.0

+0.8

+1.2

-0.7

Adiponectin (µg/ml)

+0.4

-0.3

-0.4

+0.1

+0.7

+0.3

+0.7

+0.5

+0.1

+0.4

+0.8

-0.1

_{FPG: Fasting plasma glucose}

_{HOMA: homeostasis model assessment (Insulin sensitivity)}

_{*P≤0.05 versus olmesartan}

_{#P<0.05 versus placebo}

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.