Azilsartan: Current Evidence and Perspectives in Management of Hypertension

Table 2

Major azilsartan studies and their results.

	Major trials/studies of azilsartan
	Design	Number of patients	Inclusion criteria	Duration	Dose	Primary outcome	Results
Sica et al. [13]	RCT, double blinded, placebo controlled	984	SBP 150–180 mm Hg and 24-hour mean SBP 130–170 mm Hg	24 weeks	Azilsartan 40 or 80 mg OD vs. valsartan 320 mg OD	Change in 24-hour mean SBP by ABPM from baseline	Azilsartan 40 mg (−14.9) and 80 mg (−15.3) significantly improved 24-hour mean SBP (−11.3)
Bakris et al. [14]	RCT, double blinded, placebo controlled	1275	SBP 150–180 mm Hg or 24-hour mean SBP 130–170 mm Hg	6 weeks	Azilsartan 20, 40, 80 mm Hg OD vs. olmesartan 40 mg OD vs. placebo	Change in 24-hour mean SBP by ABPM from baseline	Azilsartan 80 mg (−14.6) significantly improved mean SBP vs. olmesartan (−12.6) () 40 mg dose was noninferior to olmesartan
White et al. [15]	RCT, double blinded, placebo controlled	1291	SBP 150–180 mm Hg and 24-hour mean SBP 130–170 mm Hg	6 weeks	Azilsartan 40, 80 mg OD vs. olmesartan 40 mg OD vs. valsartan 320 mg OD	Change in 24-hour SBP by ABPM from baseline	Azilsartan 80 mg (−14.5) significantly improved mean SBP more than olmesartan (−11.7) and valsartan (−10.2). Azilsartan 40 mg (−13.4) noninferior to olmesartan
Rakugi et al. [16]	RCT, double blinded, placebo controlled	622	Grade I-II essential hypertension	16 weeks	Azilsartan 20–40 mg OD vs. candesartan 8–12 mg OD	Change in sitting SBP, DBP, and ABPM	Azilsartan significantly improved DBP (−12.4) vs. candesartan (−9.8) () and SBP azilsartan (-21.8) vs. candesartan (−17.5) ()
Gitt et al. (EARLY registry) [17]	Prospective, observational, national, multicenter registry	3849	>18 year, essential hypertension	12 months	Azilsartan 40 and 80 mg vs. ACE-inhibitor (mainly ramipril 10 mg)	Change in clinic SBP, DBP, and ABPM	Azilsartan 40 and 80 mg reduced both clinic systolic BP and mean ambulatory systolic BP significantly more than ramipril at a dose of 10 mg. Clinic SBP −20.6 + −0.9 with 40 mg and −21.2 ± 0.9 with 80 mg Vs. ramipril −12.2 ± 0.9
Takagi et al. [18]	Meta-analysis	6152	Essential hypertension	—	Azilsartan 40 mg vs. control	Change in SBP and DBP	SBP reduction difference −4.2 mm Hg; DBP reduction difference −2.58; SBP (ABPM) −3.33 mm Hg; DBP (ABPM) −2.12 mm Hg ()
Kario et al. [19]	RCT	668	Stage I and II hypertension	8 weeks	Azilsartan 20 mg vs. amlodipine 5 mg	Sleep ABPM	Among those >60 years, similar control rate of sleep BP, despite a trend favouring amlodipine (35% vs. 30%)