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 5
Frequency of the most commonly observed treatment-related AEs occurring in patients receiving SPC T80/H25 treatment: by treatment group and patient subpopulation; N (%): based on treated patients.
Total N in subgroup
Dizziness
Syncope
Pollakiuria
Blood uric acid increased
T80
T80/H25
T80
T80/H25
T80
T80/H25
T80
T80/H25
T80
T80/H25
Overall
289
586
3 (1.0)
11 (1.9)
0 (0)
3 (0.5)
0 (0)
5 (0.9)
0 (0)
3 (0.5)
DM, yes
34
72
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
1 (1.4)
DM, no
43
89
3 (1.2)
11 (2.1)
0 (0)
3 (0.6)
0 (0)
5 (1.0)
0 (0)
2 (0.4)
BMI < 25
59
128
0 (0)
5 (3.9)
0 (0)
0 (0)
0 (0)
2 (1.6)
0 (0)
1 (0.8)
BMI 25–<30
118
217
1 (0.8)
4 (1.8)
0 (0)
1 (0.5)
0 (0)
1 (0.5)
0 (0)
2 (0.9)
BMI ≥ 30
112
241
2 (1.8)
2 (0.8)
0 (0)
2 (0.8)
0 (0)
2 (0.8)
0 (0)
0 (0)
eGFR < 60
21
36
0 (0)
2 (5.6)
0 (0)
1 (2.8)
0 (0)
0 (0)
0 (0)
0 (0)
eGFR ≥ 60
266
546
3 (1.1)
9 (1.6)
0 (0)
2 (0.4)
0 (0)
5 (0.9)
0 (0)
3 (0.5)
CHD1
183
439
3 (1.6)
10 (2.3)
0 (0)
2 (0.5)
0 (0)
2 (0.5)
0 (0)
1 (0.2)
CHD2
76
108
0 (0)
1 (0.9)
0 (0)
1 (0.9)
0 (0)
2 (1.9)
0 (0)
2 (1.9)
CHD3
30
39
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
1 (2.6)
0 (0)
0 (0)
Data based on treated set. eGFR expressed in mL/min/1.73 m2; BMI expressed in kg/m2. BMI: body mass index; CHD: coronary heart disease; DM: diabetes mellitus; eGFR: estimated glomerular filtration rate; H25: hydrochlorothiazide 25 mg; T80: telmisartan 80 mg.
