J Clin Med Res

Journal of Clinical Medicine Research, ISSN 1918-3003 print, 1918-3011 online, Open Access

Article copyright, the authors; Journal compilation copyright, J Clin Med Res and Elmer Press Inc

Journal website http://www.jocmr.org

Original Article

Volume 11, Number 3, March 2019, pages 202-207

Effect of Switching to Azilsartan From Fixed-Dose Combination of an Angiotensin II Receptor Blocker and Calcium Channel Blocker or a Thiazide in Patients With Hypertension

Figure 1. Study protocol. ARB/CCB: angiotensin II receptor blocker and amlodipine 5 mg or azelnidipine 16 mg; AEB/HCT: angiotensin II receptor blocker and hydrochlorothiazide 6.25 mg or 12.5 mg; BP: blood pressure.

**Table 1.** Patients’ Characteristics
Data are presented as mean ± standard deviation or n (%). ARB: angiotensin II receptor blocker.
Age (years)	77 ± 6
Male sex	18 (45)
Body mass index, kg/m²	23.7 ± 3.7
Diabetes mellitus	5 (13)
Dyslipidemia	20 (50)
Chronic kidney disease	5 (18)
History of coronary artery disease	9 (23)
History of cerebrovascular disease	2 (7)
Current smoker	2 (7)
Baseline antihypertensive drug
ARB and calcium channel blocker	25 (63)
Valsartan 80 mg/amlodipine 5 mg	9 (23)
Olmesartan 20 mg/azelnidipine 16 mg	8 (20)
Candesartan 8 mg/amlodipine 5 mg	6 (15)
Irbesartan 100 mg/amlodipine 5 mg	1 (3)
Telmisartan 40 mg/amlodipine 5 mg	1 (3)
ARB and diuretic	15 (38)
Valsartan 80 mg/hydrochlorothiazide 6.25 mg	8 (20)
Telmisartan 40 mg/hydrochlorothiazide 6.25 mg	4 (10)
Candesartan 8 mg/hydrochlorothiazide 6.25 mg	2 (5)
Losartan 50 mg/hydrochlorothiazide 12.5 mg	1 (3)

Table 1. Patients’ Characteristics

Data are presented as mean ± standard deviation or n (%). ARB: angiotensin II receptor blocker.

Age (years)

77 ± 6

Male sex

18 (45)

Body mass index, kg/m²

23.7 ± 3.7

Diabetes mellitus

5 (13)

Dyslipidemia

20 (50)

Chronic kidney disease

5 (18)

History of coronary artery disease

9 (23)

History of cerebrovascular disease

2 (7)

Current smoker

2 (7)

Baseline antihypertensive drug

ARB and calcium channel blocker

25 (63)

Valsartan 80 mg/amlodipine 5 mg

9 (23)

Olmesartan 20 mg/azelnidipine 16 mg

8 (20)

Candesartan 8 mg/amlodipine 5 mg

6 (15)

Irbesartan 100 mg/amlodipine 5 mg

1 (3)

Telmisartan 40 mg/amlodipine 5 mg

1 (3)

ARB and diuretic

15 (38)

Valsartan 80 mg/hydrochlorothiazide 6.25 mg

8 (20)

Telmisartan 40 mg/hydrochlorothiazide 6.25 mg

4 (10)

Candesartan 8 mg/hydrochlorothiazide 6.25 mg

2 (5)

Losartan 50 mg/hydrochlorothiazide 12.5 mg

1 (3)

**Table 2.** Change in Blood Pressure
	Baseline	12 weeks	24 weeks	P value^a	P value^b	P value^b	P value^b
Data are presented as mean ± standard deviation. SBP: systolic blood pressure; DBP: diastolic blood pressure; HR: heart rate; CCB, calcium channel blocker. ^aP value by one-way repeated analysis of variance. ^bP value by the Bonferroni post hoc analysis. *P < 0.05 vs. at 24 weeks.
All (n = 40)
Office SBP	136 ± 13	137 ± 17	135 ± 14	0.567	1.000	1.000	0.731
Office DBP	74 ± 9	73 ± 8	74 ± 8	0.921	1.000	1.000	1.000
Office HR	69 ± 13	71 ± 12	70 ± 12	0.329	0.552	1.000	0.731
Home SBP	133 ± 14	136 ± 14	135 ± 11	0.407	0.724	0.873	1.000
Home DBP	71 ± 9	73 ± 8	74 ± 9	0.066	0.339	0.109	1.000
Home HR	69 ± 12	68 ± 10	67 ± 11	0.109	0.743	0.220	0.655
Without addition of a CCB (n = 33)
Office SBP	137 ± 12	135 ± 17	134 ± 14	0.715	1.000	1.000	1.000
Office DBP	74 ± 8	72 ± 8	72 ± 6	0.182	0.956	0.164	1.000
Office HR	67 ± 12	69 ± 11	67 ± 11	0.274	0.572	1.000	0.511
Home SBP	132 ± 12	134 ± 13	136 ± 12	0.246	1.000	0.433	0.880
Home DBP	71 ± 8	72 ± 7	74 ± 8	0.054	0.947	0.094	0.370
Home HR	68 ± 12	66 ± 10	65 ± 11	0.101	0.817	0.218	0.817
With addition of a CCB (n = 7)
Office SBP	135 ± 20	150 ± 11*	134 ± 10	0.270	0.180	1.000	0.012
Office DBP	73 ± 11	77 ± 8	82 ± 10	0.072	0.821	0.178	0.166
Office HR	79 ± 15	80 ± 11	81 ± 9	0.906	1.000	1.000	1.000
Home SBP	135 ± 20	141 ± 17	132 ± 10	0.338	1.000	1.000	0.616
Home DBP	74 ± 12	78 ± 12	75 ± 11	0.373	0.621	1.000	0.942
Home HR	75 ± 7	75 ± 8	73 ± 9	0.950	1.000	1.000	1.000

Table 2. Change in Blood Pressure

Baseline

12 weeks

24 weeks

P value^a

P value^b

Baseline vs. 12 weeks

Baseline vs. 24 weeks

12 weeks vs. 24 weeks

Data are presented as mean ± standard deviation. SBP: systolic blood pressure; DBP: diastolic blood pressure; HR: heart rate; CCB, calcium channel blocker. ^aP value by one-way repeated analysis of variance. ^bP value by the Bonferroni post hoc analysis. *P < 0.05 vs. at 24 weeks.

All (n = 40)

Office SBP

136 ± 13

137 ± 17

135 ± 14

0.567

1.000

0.731

Office DBP

74 ± 9

73 ± 8

74 ± 8

0.921

1.000

Office HR

69 ± 13

71 ± 12

70 ± 12

0.329

0.552

1.000

0.731

Home SBP

133 ± 14

136 ± 14

135 ± 11

0.407

0.724

0.873

1.000

Home DBP

71 ± 9

73 ± 8

74 ± 9

0.066

0.339

0.109

1.000

Home HR

69 ± 12

68 ± 10

67 ± 11

0.109

0.743

0.220

0.655

Without addition of a CCB (n = 33)

Office SBP

137 ± 12

135 ± 17

134 ± 14

0.715

1.000

Office DBP

74 ± 8

72 ± 8

72 ± 6

0.182

0.956

0.164

1.000

Office HR

67 ± 12

69 ± 11

67 ± 11

0.274

0.572

1.000

0.511

Home SBP

132 ± 12

134 ± 13

136 ± 12

0.246

1.000

0.433

0.880

Home DBP

71 ± 8

72 ± 7

74 ± 8

0.054

0.947

0.094

0.370

Home HR

68 ± 12

66 ± 10

65 ± 11

0.101

0.817

0.218

0.817

With addition of a CCB (n = 7)

Office SBP

135 ± 20

150 ± 11*

134 ± 10

0.270

0.180

1.000

0.012

Office DBP

73 ± 11

77 ± 8

82 ± 10

0.072

0.821

0.178

0.166

Office HR

79 ± 15

80 ± 11

81 ± 9

0.906

1.000

Home SBP

135 ± 20

141 ± 17

132 ± 10

0.338

1.000

0.616

Home DBP

74 ± 12

78 ± 12

75 ± 11

0.373

0.621

1.000

0.942

Home HR

75 ± 7

75 ± 8

73 ± 9

0.950

1.000

**Table 3.** Change in Biochemical Parameters
	Baseline	6 months	P value
Data are presented as mean ± standard deviation. Na: sodium; K: potassium; Cl: chloride; BUN: blood urea nitrogen; LDL: low-density lipoprotein; HDL: high-density lipoprotein.
Na (mEq/L)	140.2 ± 1.7	140.0 ± 2.9	0.429
K (mEq/L)	4.2 ± 0.4	4.4 ± 0.5	0.013
Cl (mEq/L)	103.3 ± 5.8	103.2 ± 2.9	0.367
BUN (mg/dL)	20.2 ± 6.1	19.5 ± 6.9	0.847
Serum creatinine (mg/dL)	0.87 ± 0.20	0.98 ± 0.34	0.115
Hemoglobin A1c (%)	5.9 ± 0.6	5.8 ± 0.7	0.167
Triglyceride (mg/dL)	96.7 ± 41.9	112. 2 ± 30.6	0.916
LDL-cholesterol (mg/dL)	98.3 ± 36.9	94.5 ± 24.6	0.572
HDL-cholesterol (mg/dL)	62.9 ± 13.6	56.8 ± 12.7	0.086
Uric acid (mg/dL)	5.4 ± 1.3	5.8 ± 1.8	0.630

Table 3. Change in Biochemical Parameters

Baseline

6 months

P value

Data are presented as mean ± standard deviation. Na: sodium; K: potassium; Cl: chloride; BUN: blood urea nitrogen; LDL: low-density lipoprotein; HDL: high-density lipoprotein.

Na (mEq/L)

140.2 ± 1.7

140.0 ± 2.9

0.429

K (mEq/L)

4.2 ± 0.4

4.4 ± 0.5

0.013

Cl (mEq/L)

103.3 ± 5.8

103.2 ± 2.9

0.367

BUN (mg/dL)

20.2 ± 6.1

19.5 ± 6.9

0.847

Serum creatinine (mg/dL)

0.87 ± 0.20

0.98 ± 0.34

0.115

Hemoglobin A1c (%)

5.9 ± 0.6

5.8 ± 0.7

0.167

Triglyceride (mg/dL)

96.7 ± 41.9

112. 2 ± 30.6

0.916

LDL-cholesterol (mg/dL)

98.3 ± 36.9

94.5 ± 24.6

0.572

HDL-cholesterol (mg/dL)

62.9 ± 13.6

56.8 ± 12.7

0.086

Uric acid (mg/dL)

5.4 ± 1.3

5.8 ± 1.8

0.630