Cardiol Res

Cardiology Research, ISSN 1923-2829 print, 1923-2837 online, Open Access

Article copyright, the authors; Journal compilation copyright, Cardiol Res and Elmer Press Inc

Journal website https://www.cardiologyres.org

Original Article

Volume 14, Number 3, June 2023, pages 211-220

A Prospective, Randomized Open-Label Study for Assessment of Antihypertensive Effect of Telmisartan Versus Cilnidipine Using Ambulatory Blood Pressure Monitoring (START ABPM Study)

Figure 3. Profile of systolic and diastolic blood pressures during 24 h according to ABPM device. ABPM: ambulatory blood pressure monitoring.

Figure 4. Column chart showing number of responders at day 56 in two groups for ABPM and manual BP measurement. ABPM: ambulatory blood pressure monitoring; BP: blood pressure.

**Table 1.** Baseline Characteristics of Subjects in Two Groups
Characteristics	Group	P value
Data are mean (SD), and 95% CI for mean for continuous variables, and number (%) for categorical variables. Percentages are based on the final analysis sample of the respective group. The P value for continuous variable is according to t-test for independent sample, while for categorical variable is using Pearson’s Chi-square test. CI: confidence interval; BMI: body mass index; BP: blood pressure; SD: standard deviation.
Age in years	41.88 (11.16); 36.15, 47.62	41.47 (12.69); 35.36, 47.59	0.651
Gender
Female	7 (41.2)	11 (57.9)	0.317
Male	10 (58.8)	8 (42.1)
Height (cm)	166.44 (6.79); 162.94, 169.93	165.15 (8.02); 161.29, 169.02	0.608
Weight (kg)	74.15 (12.91); 67.51, 80.78	70.32 (12.63); 64.24, 76.41	0.375
BMI (kg/m²)	26.84 (5.15); 24.19, 29.49	25.78 (4.41); 23.65, 27.90	0.510
BP systolic (mm Hg)	154.53 (8.45); 150.45, 158.6	155.24(8.72); 151.27, 159.21	0.795
BP diastolic (mm Hg)	99.63 (6.61); 96.45, 102.82	102.38(10.17); 97.75, 107.01	0.323
Pulse rate (/min)	90.42 (9.14); 86.02, 94.82	88.76 (10.8); 83.84, 93.68	0.605
Respiratory rate (/min)	19.79 (1.72); 18.96, 20.62	19.71 (1.19); 19.17, 20.26	0.872
Temperature (°F)	97.28 (0.69); 96.95, 97.62	97.23 (0.78); 96.88, 97.58	0.812

Table 1. Baseline Characteristics of Subjects in Two Groups

Characteristics

Group

P value

Telmisartan (n = 17)

Cilnidipine (n = 19)

Data are mean (SD), and 95% CI for mean for continuous variables, and number (%) for categorical variables. Percentages are based on the final analysis sample of the respective group. The P value for continuous variable is according to t-test for independent sample, while for categorical variable is using Pearson’s Chi-square test. CI: confidence interval; BMI: body mass index; BP: blood pressure; SD: standard deviation.

Age in years

41.88 (11.16); 36.15, 47.62

41.47 (12.69); 35.36, 47.59

0.651

Gender

Female

7 (41.2)

11 (57.9)

0.317

Male

10 (58.8)

8 (42.1)

Height (cm)

166.44 (6.79); 162.94, 169.93

165.15 (8.02); 161.29, 169.02

0.608

Weight (kg)

74.15 (12.91); 67.51, 80.78

70.32 (12.63); 64.24, 76.41

0.375

BMI (kg/m²)

26.84 (5.15); 24.19, 29.49

25.78 (4.41); 23.65, 27.90

0.510

BP systolic (mm Hg)

154.53 (8.45); 150.45, 158.6

155.24(8.72); 151.27, 159.21

0.795

BP diastolic (mm Hg)

99.63 (6.61); 96.45, 102.82

102.38(10.17); 97.75, 107.01

0.323

Pulse rate (/min)

90.42 (9.14); 86.02, 94.82

88.76 (10.8); 83.84, 93.68

0.605

Respiratory rate (/min)

19.79 (1.72); 18.96, 20.62

19.71 (1.19); 19.17, 20.26

0.872

Temperature (°F)

97.28 (0.69); 96.95, 97.62

97.23 (0.78); 96.88, 97.58

0.812

**Table 2.** Descriptive Statistics for Various ABPM-Derived Variables and Their Comparison Within Groups as Well as Comparison of Change From Baseline to Day 56 Between Groups
ABPM-derived variables (mm Hg)	Telmisartan (n = 17)	Cilnidipine (n = 19)	P value^b
Data are mean (SD), and 95% CI for mean. ^aObtained using paired t-test. ^bObtained using t-test for independent samples. P values < 0.05 indicate statistical significance. Change in BP is calculated as baseline - day 56. CI: confidence interval; BP: blood pressure; SD: standard deviation; ABPM: ambulatory blood pressure monitoring.
Systolic, 24 h	142.47 (10.55)	128.47 (11.61)	0.002	-14.00 (15.88)	140.44 (11.24)	132.83 (13.86)	0.007	-7.61 (10.51)	0.174
	126, 166	116, 156		-22.17, -5.83	123, 170	107, 174		-12.57, -2.65
Diastolic, 24 h	91.18 (6.97)	82.91 (7.51)	0.012	-8.26 (12.03)	88.39 (10.4)	84.8 (9.21)	0.087	-3.59 (8.41)	0.196
	81.4, 102	74.6, 101		-14.45, -2.08	65.2, 113	65.9, 109		-7.55, 0.37
Systolic, last 6 h	145.65 (13.09)	128.88 (12.41)	< 0.001	-16.77 (14.72)	139.48 (11.83)	135.2 (12.46)	0.148	-4.28 (12.01)	0.010
	125, 173.3	112.9, 165		-24.34, -9.2	117.8, 164.3	112.5, 162.3		-9.94, 1.37
Diastolic, last 6 h	94.69 (10.05)	83.92 (8.35)	0.002	-10.76 (12.26)	87.79 (10.31)	86.53 (7.89)	0.521	-1.26 (8.15)	0.014
	77, 110.7	73.1, 111.3		-17.07, -4.46	69.6, 109.5	70.7, 101.6		-5.1, 2.58
Systolic, morning	146.18 (13.08)	129.84 (11.54)	< 0.001	-16.34 (12.84)	141.95 (11.09)	136.21 (12.27)	0.058	-5.74 (12.07)	0.019
	125.8, 170.3	114.5, 161.7		-22.94, -9.74	126.3, 164.3	114.4, 161.8		-11.43, -0.04
Diastolic, morning	94.66 (10.41)	84.82 (7.55)	0.002	-9.85 (10.95)	89.46 (9.93)	87.35 (7.56)	0.321	-2.11 (8.47)	0.028
	77.4, 112.4	74.7, 109.1		-15.48, -4.22	70, 109.5	72.3, 101.7		-6.09, 1.88
Systolic, daytime	145.12 (10.89)	130.86 (11.35)	0.001	-14.26 (13.62)	144 (10.92)	136.95 (15.84)	0.011	-7.05 (10.62)	0.092
	129.1, 162.9	117.1, 155.7		-21.26, -7.25	129.5, 175.5	110.2, 188.1		-12.06, -2.04
Diastolic, daytime	93.58 (8.01)	84.75 (7.29)	0.004	-8.84 (10.67)	90.78 (10.82)	87.41 (10.31)	0.126	-3.37 (8.89)	0.111
	81.8, 105.1	75.5, 103.3		-14.32, -3.35	65.3, 116.7	67.2, 117.5		-7.56, 0.82
Systolic, night	137.95 (16.64)	121.85 (14.81)	0.011	-16.09 (23.17)	134.22 (14.37)	125.46 (12.62)	0.028	-8.76 (15.5)	0.263
	115.6, 178.5	106, 158.8		-28.01, -4.18	110.6, 166.1	100.1, 155.7		-16.06, -1.45
Diastolic, night	85.74 (8.29)	74.68 (7.05)	0.004	-11.07 (12.8)	82.26 (11.27)	77.69 (8.03)	0.101	-4.57 (11.53)	0.128
	72.8, 105.9	66.4, 96.5		-17.47, -4.67	59.9, 100.7	61.8, 90.7		-10.12, 0.99
Systolic, manual	155.18 (8.50)	137.07 (7.96)	< 0.001	-18.19 (11.97)	154.21 (8.22)	139.95 (9.49)	< 0.001	-14.26 (12.01)	0.104
	144, 166	123, 152		-24.56, -11.81	141, 170	119, 154		-20.05, -8.48
Diastolic, manual	98.63 (6.52)	87.00 (7.26)	< 0.001	-11.63 (9.42)	101.37 (10.45)	85.63 (7.68)	< 0.001	-15.74 (14.32)	0.367
	87, 111	76, 101		-16.86, -7.13	77, 120	72, 97		-22.64, -8.83

Table 2. Descriptive Statistics for Various ABPM-Derived Variables and Their Comparison Within Groups as Well as Comparison of Change From Baseline to Day 56 Between Groups

ABPM-derived variables (mm Hg)

Telmisartan (n = 17)

Cilnidipine (n = 19)

P value^b

Baseline

Day 56

P value^a

Change: Baseline to day 56

Baseline

Day 56

P value^a

Change: Baseline to day 56

Data are mean (SD), and 95% CI for mean. ^aObtained using paired t-test. ^bObtained using t-test for independent samples. P values < 0.05 indicate statistical significance. Change in BP is calculated as baseline - day 56. CI: confidence interval; BP: blood pressure; SD: standard deviation; ABPM: ambulatory blood pressure monitoring.

Systolic, 24 h

142.47 (10.55)

128.47 (11.61)

0.002

-14.00 (15.88)

140.44 (11.24)

132.83 (13.86)

0.007

-7.61 (10.51)

0.174

126, 166

116, 156

-22.17, -5.83

123, 170

107, 174

-12.57, -2.65

Diastolic, 24 h

91.18 (6.97)

82.91 (7.51)

0.012

-8.26 (12.03)

88.39 (10.4)

84.8 (9.21)

0.087

-3.59 (8.41)

0.196

81.4, 102

74.6, 101

-14.45, -2.08

65.2, 113

65.9, 109

-7.55, 0.37

Systolic, last 6 h

145.65 (13.09)

128.88 (12.41)

< 0.001

-16.77 (14.72)

139.48 (11.83)

135.2 (12.46)

0.148

-4.28 (12.01)

0.010

125, 173.3

112.9, 165

-24.34, -9.2

117.8, 164.3

112.5, 162.3

-9.94, 1.37

Diastolic, last 6 h

94.69 (10.05)

83.92 (8.35)

0.002

-10.76 (12.26)

87.79 (10.31)

86.53 (7.89)

0.521

-1.26 (8.15)

0.014

77, 110.7

73.1, 111.3

-17.07, -4.46

69.6, 109.5

70.7, 101.6

-5.1, 2.58

Systolic, morning

146.18 (13.08)

129.84 (11.54)

< 0.001

-16.34 (12.84)

141.95 (11.09)

136.21 (12.27)

0.058

-5.74 (12.07)

0.019

125.8, 170.3

114.5, 161.7

-22.94, -9.74

126.3, 164.3

114.4, 161.8

-11.43, -0.04

Diastolic, morning

94.66 (10.41)

84.82 (7.55)

0.002

-9.85 (10.95)

89.46 (9.93)

87.35 (7.56)

0.321

-2.11 (8.47)

0.028

77.4, 112.4

74.7, 109.1

-15.48, -4.22

70, 109.5

72.3, 101.7

-6.09, 1.88

Systolic, daytime

145.12 (10.89)

130.86 (11.35)

0.001

-14.26 (13.62)

144 (10.92)

136.95 (15.84)

0.011

-7.05 (10.62)

0.092

129.1, 162.9

117.1, 155.7

-21.26, -7.25

129.5, 175.5

110.2, 188.1

-12.06, -2.04

Diastolic, daytime

93.58 (8.01)

84.75 (7.29)

0.004

-8.84 (10.67)

90.78 (10.82)

87.41 (10.31)

0.126

-3.37 (8.89)

0.111

81.8, 105.1

75.5, 103.3

-14.32, -3.35

65.3, 116.7

67.2, 117.5

-7.56, 0.82

Systolic, night

137.95 (16.64)

121.85 (14.81)

0.011

-16.09 (23.17)

134.22 (14.37)

125.46 (12.62)

0.028

-8.76 (15.5)

0.263

115.6, 178.5

106, 158.8

-28.01, -4.18

110.6, 166.1

100.1, 155.7

-16.06, -1.45

Diastolic, night

85.74 (8.29)

74.68 (7.05)

0.004

-11.07 (12.8)

82.26 (11.27)

77.69 (8.03)

0.101

-4.57 (11.53)

0.128

72.8, 105.9

66.4, 96.5

-17.47, -4.67

59.9, 100.7

61.8, 90.7

-10.12, 0.99

Systolic, manual

155.18 (8.50)

137.07 (7.96)

< 0.001

-18.19 (11.97)

154.21 (8.22)

139.95 (9.49)

< 0.001

-14.26 (12.01)

0.104

144, 166

123, 152

-24.56, -11.81

141, 170

119, 154

-20.05, -8.48

Diastolic, manual

98.63 (6.52)

87.00 (7.26)

< 0.001

-11.63 (9.42)

101.37 (10.45)

85.63 (7.68)

< 0.001

-15.74 (14.32)

0.367

87, 111

76, 101

-16.86, -7.13

77, 120

72, 97

-22.64, -8.83

**Table 3.** Descriptive Statistics for Nocturnal Dip and Its Comparison Within Group as Well as Comparison of Its Change From Baseline to Day 56 Between Two Groups
Nocturnal dip (%)	Group	P value^b
Data are mean (SD); and 95% CI for mean. ^aObtained using paired t-test. ^bObtained using t-test for independent samples. Change in nocturnal dip is calculated as day 56 - baseline. CI: confidence interval; BP: blood pressure; SD: standard deviation
Systolic BP	4.93 (8.65); 0.48, 9.37	7.07 (4.45); 4.78, 9.36	2.14 (10.34); -3.17, 7.46	0.405	6.45 (6.4); 3.36, 9.53	7.69 (4.25); 5.64, 9.74	1.25 (8.00); -2.61, 5.11	0.505	0.771
Diastolic BP	9.05 (8.23); 4.82, 13.28	10.04 (5.38); 7.27, 12.81	0.99 (10.88); -4.60, 6.58	0.712	10.17 (7.42); 6.59, 13.74	10.21 (5.5); 7.56, 12.86	0.04 (10.01); -4.79, 4.87	0.986	0.787

Table 3. Descriptive Statistics for Nocturnal Dip and Its Comparison Within Group as Well as Comparison of Its Change From Baseline to Day 56 Between Two Groups

Nocturnal dip (%)

Group

P value^b

Telmisartan (n = 17)

Cilnidipine (n = 19)

Baseline

Day 56

Change: baseline to day 56

P value^a

Baseline

Day 56

Change: baseline to day 56

P value^a

Data are mean (SD); and 95% CI for mean. ^aObtained using paired t-test. ^bObtained using t-test for independent samples. Change in nocturnal dip is calculated as day 56 - baseline. CI: confidence interval; BP: blood pressure; SD: standard deviation

Systolic BP

4.93 (8.65); 0.48, 9.37

7.07 (4.45); 4.78, 9.36

2.14 (10.34); -3.17, 7.46

0.405

6.45 (6.4); 3.36, 9.53

7.69 (4.25); 5.64, 9.74

1.25 (8.00); -2.61, 5.11

0.505

0.771

Diastolic BP

9.05 (8.23); 4.82, 13.28

10.04 (5.38); 7.27, 12.81

0.99 (10.88); -4.60, 6.58

0.712

10.17 (7.42); 6.59, 13.74

10.21 (5.5); 7.56, 12.86

0.04 (10.01); -4.79, 4.87

0.986

0.787

**Table 4.** Comparison of Smoothness Index Between Two Groups for Systolic and Diastolic BP
Smoothness index	Parameter	All patients
^aObtained using t-test for independent samples. SD: standard deviation; BP: blood pressure; IQR: interquartile range.
Systolic BP	Mean	1.79	1.38	0.601
	SD	1.52	2.82
	Median	2.3	0.75
	IQR	1.55	1.31
Diastolic BP	Mean	1.44	0.68	0.167
	SD	1.6	1.54
	Median	1.62	0.68
	IQR	2.66	2.2

Table 4. Comparison of Smoothness Index Between Two Groups for Systolic and Diastolic BP

Smoothness index

Parameter

All patients

Group

P value^a

Telmisartan (n = 17)

Cilnidipine (n = 19)

^aObtained using t-test for independent samples. SD: standard deviation; BP: blood pressure; IQR: interquartile range.

Systolic BP

Mean

1.79

1.38

0.601

1.52

2.82

Median

2.3

0.75

IQR

1.55

1.31

Diastolic BP

Mean

1.44

0.68

0.167

1.6

1.54

Median

1.62

0.68

IQR

2.66

2.2