Effect of azilsartan versus candesartan on nocturnal blood pressure variation in Japanese patients with essential hypertension

Figures & data

Table I. Patient characteristics at baseline (Week 0 unless indicated otherwise).

	Azilsartan		Candesartan
	Dipping^a (n = 145)	Non-dipping^b (n = 128)	Dipping^a (n = 141)	Non-dipping^b (n = 134)
Age (years)	55.1 ± 9.34	58.9 ± 9.33	56.2 ± 10.02	57.8 ± 9.90
Male, n (%)	81 (55.9)	79 (61.7)	93 (66.0)	77 (57.5)
BMI (kg/m^2) at Week − 4	26.0 ± 4.34	25.1 ± 3.99	25.6 ± 3.99	25.1 ± 3.56
Duration of hypertension (years)	7.4 ± 7.19	9.9 ± 8.63	7.2 ± 6.46	8.3 ± 7.79
Sitting BP, HR
SBP (mmHg)	158.7 ± 7.15	161.2 ± 8.27	158.7 ± 6.85	160.1 ± 7.09
DBP (mmHg)	100.2 ± 4.32	100.4 ± 4.16	100.4 ± 4.17	100.2 ± 4.06
HR (beats/min)	71.1 ± 8.87	70.1 ± 9.15	69.5 ± 8.44	68.3 ± 8.20
ABPM: 24-h
SBP (mmHg)	152.2 ± 12.32	157.0 ± 14.48	153.2 ± 13.48	155.9 ± 13.56
DBP (mmHg)	93.4 ± 9.80	95.3 ± 9.41	94.0 ± 9.34	94.8 ± 9.74
HR (beats/min)	71.7 ± 8.22	69.5 ± 9.04	71.6 ± 8.17	69.0 ± 8.04
ABPM: daytime (awake)
SBP (mmHg)	160.7 ± 13.01	159.0 ± 14.50	161.3 ± 13.77	157.7 ± 13.72
DBP (mmHg)	98.7 ± 10.73	97.5 ± 9.63	99.0 ± 9.48	96.6 ± 9.96
HR (beats/min)	75.9 ± 8.80	73.3 ± 9.60	75.8 ± 8.71	72.9 ± 8.65
ABPM: night-time (sleeping)
SBP (mmHg)	134.1 ± 12.38	152.8 ± 16.02	135.4 ± 13.52	152.0 ± 14.88
DBP (mmHg)	82.2 ± 9.23	90.6 ± 10.59	83.2 ± 9.64	90.8 ± 10.16
HR (beats/min)	62.9 ± 7.95	61.4 ± 8.67	62.7 ± 8.25	61.4 ± 7.98
ABPM: early morning
SBP (mmHg)	158.2 ± 15.93	162.3 ± 16.18	158.0 ± 15.44	160.1 ± 15.08
DBP (mmHg)	98.5 ± 12.62	99.7 ± 11.47	99.5 ± 11.57	98.9 ± 12.06
HR (beats/min)	72.7 ± 10.81	69.7 ± 10.66	71.5 ± 10.24	69.6 ± 8.36
Nocturnal BP falls
SBP (%)	16.5 ± 4.99	3.9 ± 5.34	16.0 ± 4.55	3.6 ± 5.58
DBP (%)	16.5 ± 6.57	7.1 ± 6.72	16.0 ± 5.77	5.9 ± 5.54
Plasma renin activity (ng/ml/hr) at Week − 2	0.64 ± 0.577	0.62 ± 0.523	0.72 ± 0.750	0.51 ± 0.409
eGFR (ml/min/1.73 m^2)	79.35 ± 13.569	74.21 ± 14.087	77.89 ± 16.620	75.27 ± 12.304
Previous antihypertensive therapy	106 (73.1)	103 (80.5)	101 (71.6)	102 (76.1)
Concurrent medical conditions
Diabetes mellitus	30 (20.7)	23 (18.0)	34 (24.1)	28 (20.9)
Dyslipidemia	88 (60.7)	75 (58.6)	68 (48.2)	82 (61.2)

Values are expressed as mean (± standard deviation) or as number of patients (%) for the variables of gender, prior antihypertensive therapy, and concurrent medical conditions. ^aDipping = ≥ 10% nocturnal SBP fall. Nocturnal SBP fall (%) = 100×[1 − mean nocturnal SBP/mean daytime SBP]. ^bNon-dipping = < 10% nocturnal SBP fall. BMI, body mass index; BP, blood pressure; HR, heart rate; SBP, systolic blood pressure; DBP, diastolic blood pressure; ABPM, ambulatory BP monitoring; eGFR, estimated glomerular filtration rate.

Figure 1. Twenty-four-hour time-course changes in mean systolic blood pressure (SBP) at baseline (Week 0) and Week 14 according to dipping status in patients with essential hypertension treated with azilsartan or candesartan: (a) non-dipping group; (b) dipping group.

Figure 2. Changes from baseline (Week 0) to Week 14 in mean systolic blood pressure (SBP) according to dipping status in patients with essential hypertension treated with azilsartan or candesartan: (a) non-dipping group; (b) dipping group.

Table II. Changes in mean systolic blood pressure (SBP, mmHg) from baseline to Week 14 according to baseline dipping pattern in patients with essential hypertension receiving azilsartan or candesartan.

	Azilsartan		Candesartan		LS mean (95% CI)^a (Azil–Cand)	p-value (Azil vs Cand)
Variable	n	Mean change	n	Mean change
Dipping group^b mean SBP
Daytime	145	− 14.1	141	− 10.2	− 4.3 (− 7.48, − 1.15)	0.0077
Night-time	145	− 10.9	141	− 9.6	− 1.9 (− 4.49, 1.17)	0.2252
Non-dipping group^c mean SBP
Daytime	128	− 9.9	134	− 4.8	− 4.5 (− 7.60, − 1.44)	0.0042
Night-time	128	− 20.2	134	− 15.6	− 4.2 (− 7.64, − 0.66)	0.02

^aThe point estimate of the least square (LS) mean and its two-sided 95% confidence interval (CI) for each treatment group were calculated using analysis of covariance (ANCOVA) in which plasma renin activity (< 0.5 or ≥ 0.5 ng/ml/h) at Week ‐2 and treatment group served as independent variables and baseline values served as covariates. ^bDipping = ≥ 10% nocturnal SBP fall; Nocturnal SBP fall (%) = 100×[1 − mean nocturnal SBP/mean daytime SBP]. ^cNon-dipping = < 10% nocturnal SBP fall. Azil, azilsartan; Cand, candesartan.

Table III. Changes in mean diastolic blood pressure (DBP, mmHg) from baseline to Week 14 according to baseline dipping pattern in patients with essential hypertension receiving azilsartan or candesartan.

	Azilsartan		Candesartan		LS mean (95% CI)^a (Azil–Cand)	p-value (Azil vs Cand)
Variable	n	Mean change	n	Mean change
Dipping group^b mean DBP
Daytime	145	− 8.5	141	− 6.5	− 2.2 (− 4.17, − 0.33)	0.0221
Night-time	145	− 6.9	141	− 6.3	− 1.1 (− 3.04, 0.89)	0.2822
Non-dipping group^c mean DBP
Daytime	128	− 6.0	134	− 2.8	− 2.8 (− 4.55, − 1.06)	0.0017
Night-time	128	− 10.0	134	− 7.9	− 2.0 (− 4.07, 0.33)	0.0534

^aThe point estimate of the least square (LS) mean and its two-sided 95% confidence interval (CI) for each treatment group were calculated using analysis of covariance (ANCOVA) in which plasma renin activity (< 0.5 or ≥ 0.5 ng/ml/h) at Week ‐2 and treatment group served as independent variables and baseline values served as covariates. ^bDipping = ≥ 10% nocturnal SBP fall; Nocturnal SBP fall (%) = 100×[1 − mean nocturnal SBP/mean daytime SBP]. ^cNon-dipping = < 10% nocturnal SBP fall. Azil, azilsartan; Cand, candesartan.