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 4

Summary of AE frequencies in the different patient subpopulations, based on treated patients.

	T80	T80/H25
Overall	(n = 289)	(n = 586)
Patients with any AE, N (%)	49 (17.0)	94 (16.0)
Patients with treatment-related AEs, N (%)	8 (2.8)	27 (4.6)
Patients with AEs leading to discontinuation, N (%)	8 (2.8)	6 (1.0)
Patients with serious AEs, N (%)	0 (0)	0 (0)
DM, yes	(n = 34)	(n = 72)
Patients with any AE, N (%)	6 (17.6)	5 (6.9)
Patients with treatment-related AEs, N (%)	1 (2.9)	2 (2.8)
Patients with AEs leading to discontinuation, N (%)	0 (0)	0 (0)
Patients with serious AEs, N (%)	0 (0)	0 (0)
DM, no	(n = 255)	(n = 514)
Patients with any AE, N (%)	43 (16.9)	89 (17.3)
Patients with treatment-related AEs, N (%)	7 (2.7)	25 (4.9)
Patients with AEs leading to discontinuation, N (%)	8 (3.1)	6 (1.2)
Patients with serious AEs, N (%)	0 (0)	0 (0)
eGFR category <60 mL/min/1.73 m^2	(n = 21)	(n = 36)
Patients with any AE, N (%)	4 (19.0)	12 (33.3)
Patients with treatment-related AEs, N (%)	0 (0)	6 (16.7)
Patients with AEs leading to discontinuation, N (%)	0 (0)	1 (2.8)
Patients with serious AEs, N (%)	0 (0)	0 (0)
eGFR category ≥60 mL/min/1.73 m^2	(n = 266)	(n = 546)
Patients with any AE, N (%)	45 (16.9)	81 (14.8)
Patients with treatment-related AEs, N (%)	8 (3.0)	21 (3.8)
Patients with AEs leading to discontinuation, N (%)	8 (3.0)	5 (0.9)
Patients with serious AEs, N (%)	0 (0)	0 (0)
BMI < 25 kg/m^2	(n = 59)	(n = 128)
Patients with any AE, N (%)	8 (13.6)	29 (22.7)
Patients with treatment-related AEs, N (%)	2 (3.4)	10 (7.8)
Patients with AEs leading to discontinuation, N (%)	2 (3.4)	3 (2.3)
Patients with serious AEs, N (%)	0 (0)	0 (0)
BMI 25–<30 kg/m^2	(n = 118)	(n = 217)
Patients with any AE, N (%)	22 (18.6)	25 (11.5)
Patients with treatment-related AEs, N (%)	4 (3.4)	7 (3.2)
Patients with AEs leading to discontinuation, N (%)	3 (2.5)	2 (0.9)
Patients with serious AEs, N (%)	0 (0)	0 (0)
BMI ≥ 30 kg/m^2	(n = 112)	(n = 241)
Patients with any AE, N (%)	19 (17.0)	40 (16.6)
Patients with treatment-related AEs, N (%)	2 (1.8)	10 (4.1)
Patients with AEs leading to discontinuation, N (%)	3 (2.7)	1 (0.4)
Patients with serious AEs, N (%)	0 (0)	0 (0)
CHD1 (10-year risk <10%)	(n = 183)	(n = 439)
Patients with any AE, N (%)	35 (19.1)	72 (16.4)
Patients with treatment-related AEs, N (%)	4 (2.2)	18 (4.1)
Patients with AEs leading to discontinuation, N (%)	4 (2.2)	5 (1.1)
Patients with serious AEs, N (%)	0 (0)	0 (0)
CHD2 (10-year risk ≥10–<20%)	(n = 76)	(n = 108)
Patients with any AE, N (%)	10 (13.2)	17 (15.7)
Patients with treatment-related AEs, N (%)	2 (2.6)	7 (6.5)
Patients with AEs leading to discontinuation, N (%)	2 (2.6)	1 (0.9)
Patients with serious AEs, N (%)	0 (0)	0 (0)
CHD3 (10-year risk ≥20%)	(n = 30)	(n = 39)
Patients with any AE, N (%)	4 (13.3)	5 (12.8)
Patients with treatment-related AEs, N (%)	2 (6.7)	2 (5.1)
Patients with AEs leading to discontinuation, N (%)	2 (6.7)	0 (0)
Patients with serious AEs, N (%)	0 (0)	0 (0)

AE: adverse event; BMI: body mass index; CHD: coronary heart disease; DM: diabetes mellitus; eGFR: estimated glomerular filtration rate; H25: hydrochlorothiazide 25 mg; T80: telmisartan 80 mg.