Safety, tolerability, and efficacy of a fixed-dose combination of olmesartan 40 mg and hydrochlorothiazide 12.5/25 mg in daily practice

Figures & data

Table 1 Patient baseline characteristics*

	n = 3318
Age, years (mean ± SD)	63.2 ± 11.46
Age ≥75 years, n (%)	558 (16.8)
Female, n (%)	1614 (48.6)
BMI, mean ± SD (kg/m^2)	29.1 ± 4.82
Duration of hypertension >5 years, n (%)	1,526 (46.0)
Antihypertensive pretreatment, n (%)	2,970 (89.5)
Mean BP at study entry (mmHg) ± SD
Systolic	159.6 ± 15.28
Diastolic	93.5 ± 9.52
Comedication, n
Lipid-lowering drugs	1,327 (57.2)
Asa	861 (37.1)
Oral antidiabetic drugs	753 (32.5)
NSAID/COX 1 inhibitors	307 (13.2)
Oral anticoagulants	174 (7.5)
Psychotropic drugs	254 (11.0)
Reason for study participation (%)
Lack of prior treatment efficacy	2,587 (80.0)
Simplification of treatment	646 (20.0)

Note:

* Missing values not considered in calculated percentages.

Abbreviations: AH, antihypertensives; ARB, angiotensin receptor blocker; ASA, acetylsalicylic acid; BMI, body mass index; BP, blood pressure; CCB, calcium channel blocker; COX, cyclo-oxygenase; FDC, fixed-dose combination; NSAID, nonsteroidal anti-inflammatory drug; SD, standard deviation.

Table 2 Overview of adverse drug reactions or serious adverse drug reactions based on the safety set

Type of ADR	n = 3318	Percent
Total number of ADRs	19
Number of patients with at least one ADR	16	0.48
Drug discontinuation due to ADR	12	0.36
Serious ADR	0	0
Total number of ADRs by clinical complications
Cough/flushing	0	0
Peripheral edema	0	0
Renal complications	1	0.03
Dizziness	3	0.09
Hypotension	2	0.06
Other	13	0.39

Abbreviation: ADR, adverse drug reaction.

Figure 1 Blood pressure reduction (mmHg) between study start and end.

Abbreviations: BP, blood pressure; Olm, olmesartan; HCTZ, hydrochlorothiazide.

Figure 2 BP target achievement* and BP response** (% of patients).

Notes: *BP<140/90 mmHg; **BP<140/90 mmHg or ∆ systolic BP>20 mmHg or ∆ diastolic BP>10 mmHg.
Abbreviations: BP, blood pressure; LAE, last available examination; Olm, olmesartan; HCTZ, hydrochlorothiazide.

Table 3 Efficacy according to European Society of Hypertension/European Society of Cardiology 2007 blood pressure (BP) categories (n = 3301)

	Study start	Study end*
	n (%)	n (%)
At least high normal** BP (<139 mmHg and/or <89 mmHg)	147 (4.5)	2,199 (66.7)
Grade 1 (140–159 mmHg and/or 90–99 mmHg)	708 (21.4)	349 (10.6)
Grade 2 (160–179 mmHg and/or 100–109 mmHg)	1,357 (41.1)	42 (1.3)
Grade 3 (≥180 mmHg and/or ≥110 mmHg)	468 (14.2)	11 (0.3)
Isolated systolic hypertension (≥140 mmHg,<90 mmHg)	621 (18.8)	696 (21.1)

Notes:

* At last available visit (n = 3,297);

** includes patients with optimal, normal, and high normal BP.

Abbreviation: BP, blood pressure.

Table 4 Efficacy according to patient subgroup at last available visit (n = 3,301)

	Proportion of patients (%) at BL	∆ Systolic/diastolic blood pressure
		Yes	No
Any cardiovascular risk factor	70.6	−25.7/−12.5	−27.5*/−13.8**
Women	48.7	−26.5/−12.8	−26.0/−13.0
Patients ≥75 years	16.8	−24.0/−10.7	−26.7**/−13.3**
Stroke/TIA	4.8	−27.3/−12.4	−26.2/12.9
Diabetes	28.9	−26.0/−12.4	−26.3/−13.1
Heart failure	9.0	−25.7/−12.4	−26.3/−13.0
Impaired renal function	0.4	−23.1/−10.4	−26.3*/−13.0*

Note:

* P < 0.05;

** P < 0.001.

Abbreviations: Bl, baseline; TIA, transient ischemic attack.

Figure 3 Sum of weekly energy costs at baseline.

Abbreviations: obs, observations; Std, standard.

Table 5 Efficacy and safety of the fixed-dose combination of olmesartan 40 mg and hydrochlorothiazide 12.5/25 mg in more and less physically active patients (n = 2327)

	Less active patients (sum of weekly energy costs ≤ median)	More active patients (sum of weekly energy costs > median)
Female (%)	42.7	54.1
Mean body weight at study start (kg ± SD)	85.5 ± 15.36	83.6 ± 15.85
Beta-blocker comedication (%)	33.1	32.3
BP at BL (mean ± SD), mmHg
Systolic	160.0 ± 14.72	158.9 ± 16.01
Diastolic	93.8 ± 9.23	92.9 ± 9.61
BP decrease (mean ± SD) at LAE, mmHg
Systolic	26.6 ± 15.86	26.2 ± 15.73
Diastolic	13.3 ± 10.32	13.0 ± 10.28
Target BP achieved at LAE* (%)	67.5	68.7
ADR (%)	4	5

Note:

* n = 1,575.

Abbreviations: ADR, adverse drug reaction; BL, baseline; BP, blood pressure; LAE, last available visit; SD, standard deviation.