Efficacy of Single-Pill Combination of Telmisartan 80 mg and Hydrochlorothiazide 25 mg in Patients with Cardiovascular Disease Risk Factors: A Prospective Subgroup Analysis of a Randomized, Double-Blind, and Controlled Trial
Table 1
Baseline characteristics in the different patient subpopulations, based on treated patients.
T40/T80
T40/H12.5/T80/H25
DM*, yes
()
()
Gender
22 male/13 female
38 male/36 female
Age, mean ± SD
61.8 ± 8.6
61.1 ± 9.2
BMI, mean ± SD
30.7 ± 5.6
31.1 ± 5.3
SBP/DBP (mm Hg), mean ± SDa
174.0 ± 9.7/103.6 ± 4.6
171.1 ± 8.4/103.3 ± 3.7
Range SBP/DBP (mm Hg)a
163–193/97–118
156–195/94–112
DM*, no
(n = 259)
(n = 520)
Gender
147 male/112 female
271 male/249 female
Age, mean ± SD
57.0 ± 12.1
56.2 ± 11.4
BMI, mean ± SD
28.9 ± 5.6
29.4 ± 5.4
SBP/DBP (mm Hg), mean ± SDa
173.1 ± 9.3/104.6 ± 5.0
172.4 ± 9.8/104.4 ± 5.0
Range SBP/DBP (mm Hg)a
155–197/92–119
131–211/87–119
eGFR < 60 mL/min/1.73 m2
(n = 21)
(n = 37)
Gender
10 male/11 female
18 male/19 female
Age, mean ± SD
70.1 ± 9.1
65.4 ± 9.4
BMI, mean ± SD
28.3 ± 5.0
30.7 ± 5.4
SBP/DBP (mm Hg), mean ± SDb
177.7 ± 10.8/103.4 ± 5.9
173.1 ± 9.6/104.2 ± 5.0
Range SBP/DBP (mm Hg)b
161–195/96–119
160–193/97–118
eGFR ≥ 60 mL/min/1.73 m2
(n = 271)
(n = 553)
Gender
159 male/112 female
288 male/265 female
Age, mean ± SD
56.6 ± 11.5
56.2 ± 11.1
BMI, mean ± SD
29.1 ± 5.4
29.5 ± 5.4
SBP/DBP (mm Hg), mean ± SDb
172.8 ± 9.2/104.6 ± 4.9
172.2 ± 9.7/104.2 ± 4.9
Range SBP/DBP (mm Hg)b
155–197/92–118
131–211/87–119
BMI < 25 kg/m2
(n = 60)
(n = 128)
Gender
38 male/22 female
69 male/59 female
Age, mean ± SD
57.6 ± 11.9
57.3 ± 13.4
BMI, mean ± SD
22.6 ± 2.0
23.2 ± 1.5
SBP/DBP (mm Hg), mean ± SDc
172.5 ± 10.0/103.9 ± 4.9
170.3 ± 9.6/103.7 ± 4.5
Range SBP/DBP (mm Hg)c
160–195/96–117
160–198/95–119
BMI 25–<30 kg/m2
(n = 120)
(n = 221)
Gender
68 male/52 female
125 male/96 female
Age, mean ± SD
59.6 ± 10.7
57.5 ± 10.1
BMI, mean ± SD
27.2 ± 1.5
27.5 ± 1.4
SBP/DBP (mm Hg), mean ± SDc
173.3 ± 8.7/103.9 ± 4.7
171.9 ± 9.6/104.1 ± 4.7
Range SBP/DBP (mm Hg)c
160–197/92–118
131–195/87–119
BMI ≥ 30 kg/m2
(n = 114)
(n = 245)
Gender
63 male/51 female
115 male/130 female
Age, mean ± SD
55.4 ± 12.7
55.9 ± 11.0
BMI, mean ± SD
34.6 ± 4.5
34.8 ± 4.1
SBP/DBP (mm Hg), mean ± SDc
173.4 ± 9.7/105.3 ± 5.1
173.6 ± 9.6/104.6 ± 5.1
Range SBP/DBP (mm Hg)c
155–194/95–119
143–211/91–119
CHD1 10-year risk <10%
(n = 187)
(n = 446)
Gender
63 male/124 female
164 male/282 female
Age, mean ± SD
55.3 ± 12.5
55.4 ± 11.7
BMI, mean ± SD
29.7 ± 6.2
29.8 ± 5.7
SBP/DBP (mm Hg), mean ± SDd
172.9 ± 9.6/104.7 ± 5.3
172.0 ± 9.7/104.4 ± 5.0
Rangea SBP/DBP (mm Hg)d
155–197/95–119
131–211/87–119
CHD2 10-year risk ≥10–<20%
(n = 77)
(n = 109)
Gender
76 male/1 female
106 male/3 female
Age, mean ± SD
59.6 ± 9.5
59.3 ± 8.0
BMI, mean ± SD
27.8 ± 4.1
28.4 ± 4.1
SBP/DBP (mm Hg), mean ± SDd
172.3 ± 9.3/104.0 ± 4.3
172.4 ± 9.5/104.0 ± 4.2
Range SBP/DBP (mm Hg)d
160–190/92–113
160–198/95–115
CHD3 10-year risk ≥20%
(n = 30)
(n = 39)
Gender
30 male/0 female
39 male/0 female
Age, mean ± SD
66.5 ± 7.1
64.8 ± 9.0
BMI, mean ± SD
29.3 ± 4.5
30.0 ± 4.5
SBP/DBP (mm Hg), mean ± SDd
176.9 ± 7.3/104.2 ± 4.8
174.7 ± 10.2/102.7 ± 3.9
Range SBP/DBP (mm Hg)d
164–191/97–118
156–195/94–115
CHD risk tertile 1 (<3.62%)
(n = 92 )
(n = 202)
Gender
11 male/81 female
26 male/176 female
Age, mean ± SD
55.8 ± 14.5
55.6 ± 14.2
BMI, mean ± SD
30.0 ± 6.5
29.6 ± 6.2
SBP/DBP (mm Hg), mean ± SDe
172.2 ± 9.8/104.8 ± 5.0
172.1 ± 10.3/103.9 ± 4.8
Rangea SBP/DBP (mm Hg)e
155–194/95–118
131–211/87–119
CHD risk tertile 2 (≥3.62–<8.66%)
(n = 83)
(n = 212)
Gender
43 male/40 female
108 male/104 female
Age, mean ± SD
54.4 ± 10.1
55.2 ± 9.4
BMI, mean ± SD
29.1 ± 5.9
30.2 ± 5.3
SBP/DBP (mm Hg), mean ± SDe
174.2 ± 9.4/105.1 ± 5.6
171.7 ± 9.2/105.0 ± 5.2
Range SBP/DBP (mm Hg)e
160–197/95–119
143–194/91–119
CHD risk tertile 3 (≥8.66%)
(n = 119)
(n = 180)
Gender
115 male/4 female
175 male/5 female
Age, mean ± SD
61.1 ± 9.6
59.9 ± 8.8
BMI, mean ± SD
28.5 ± 4.5
28.9 ± 4.5
SBP/DBP (mm Hg), mean ± SDe
173.2 ± 9.0/103.8 ± 4.3
173.1 ± 9.5/103.7 ± 4.3
Range SBP/DBP (mm Hg)e
160–191/92–118
156–198/94–117
Based on the presence of type 1 DM and type 2 DM, presence of diabetic retinopathy or diabetic nephropathy, and recognized MedDRA codes for diabetes. SBP/DBP data from FAS (n):
aDM (yes) FAS: T40/T80, n = 34; T40/H12.5/T80/H25, n = 72; DM (no) FAS: T40/T80, n = 251; T40/H12.5/T80/H25, n = 501.
beGFR < 60 FAS: T40/T80, n = 21; T40/H12.5/T80/H25, n = 36; eGFR ≥ 60 FAS: T40/T80, n = 262; T40/H12.5/T80/H25, n = 533.
cBMI < 25 FAS: T40/T80, n = 59; T40/H12.5/T80/H25, n = 122; BMI 25–<30 FAS: T40/T80, n = 115; T40/H12.5/T80/H25, n = 214; BMI ≥ 30 FAS: T40/T80, n = 111; T40/H12.5/T80/H25, n = 237.
dCHD1 FAS: T40/T80, n = 182; T40/H12.5/T80/H25, n = 430; CHD2 FAS: T40/T80, n = 75; T40/H12.5/T80/H25, n = 104; CHD3 FAS: T40/T80, n = 28; T40/H12.5/T80/H25, n = 39.
eCHD tertile 1 FAS: T40/T80, n = 90; T40/H12.5/T80/H25, n = 194; CHD tertile 2 FAS: T40/T80, n = 81; T40/H12.5/T80/H25, n = 205; CHD tertile 3 FAS: T40/T80, n = 114; T40/H12.5/T80/H25, n = 174. BMI: body mass index; CHD: coronary heart disease; DBP: diastolic blood pressure; DM: diabetes mellitus; eGFR: estimated glomerular filtration rate; FAS: full analysis set; H12.5: hydrochlorothiazide 12.5 mg; H25: hydrochlorothiazide 25 mg; MedDRA: Medical Dictionary for Regulatory Activities; SBP: systolic blood pressure; SD: standard deviation; T40: telmisartan 40 mg; T80: telmisartan 80 mg.
