Evaluation of effectiveness and safety of amlodipine/valsartan/hydrochlorothiazide single-pill combination therapy in hypertensive patients: an observational study

Figures & data

Table 1. Demographic and baseline parameters.

	n (%) or Mean ± SD	Median
Total	7132 (100.0)
Gender
Male	3695 (51.8)
Female	3263 (45.8)
Missing	174 (2.4)
Age (years) at start of observation	64.8 ± 11.5	66.0
Age categorization
<65 years	3327 (46.6)
≥65 and <80 years	3110 (43.6)
≥80 years	658 (9.2)
Missing	37 (0.5)
Height (cm)	170.6 ± 9.2	170.0
Weight (kg)	85.9 ± 16.2	84.0
BMI (kg/m^2)	29.5 ± 5.0	28.7
BMI categories
Normal body weight (<25 kg/m^2)	1083 (15.2)
Pre-adiposity (≥25 and <30 kg/m^2)	3235 (45.4)
Adiposity (≥30 kg/m^2)	2689 (37.7)
Missing	125 (1.8)
Systolic blood pressure at study start	158.8 ± 17.7	160.0
Systolic blood pressure (categories) at study start
<140 mmHg	663 (9.3)
≥140 and <160 mmHg	2715 (38.1)
≥160 and <180 mmHg	2668 (37.4)
≥180 mmHg	1071 (15.0)
Missing	15 (0.2)
Diastolic blood pressure at study start	91.5 ± 10.7	90.0
Diastolic blood pressure (categories) at study start
<80 mmHg	546 (7.7)
≥80 and <90 mmHg	1755 (24.6)
≥90 and <100 mmHg	2818 (39.5)
≥100 and <110 mmHg	1586 (22.2)
≥110 mmHg	414 (5.8)
Missing	13 (0.2)
Essential hypertension
Yes	7106 (99.6)
Missing	26 (0.4)
Duration of essential hypertension (years)	8.9 ± 7.1	7.8
Duration of essential hypertension (years) categories
<1 year	637 (8.9)
≥1 and <5 years	1796 (25.2)
≥5 and <10 years	1855 (26.0)
≥10 years	2446 (34.3)
Missing	398 (5.6)
Cardiovascular risk factors (most common)
Positive family history	4328 (60.7)
Dyslipidemia	3342 (46.9)
Diabetes mellitus	2415 (33.9)
Smoker	1865 (26.1)
Coronary heart disease	1625 (22.8)
Left ventricular hypertrophy	1583 (22.1)
Missing	313 (4.4)
Anti-hypertensive pre-treatment
Anti-hypertensive pre-treatment	6659 (93.4)
No anti-hypertensive pre-treatment	449 (6.3)
Pre-treatment not specified	7 (0.1)
Missing	17 (0.2)
Prior anti-hypertensive medication (most common)
Hydrochlorothiazide	3160 (47.5)
Amlodipine	2663 (40.0)
Ramipril	1484 (22.3)
Bisoprolol	928 (13.9)
Metoprolol	801 (12.0)
Torasemide	696 (10.5)

SD, standard deviation; kg, kilogram; m², square-meter; mmHg, millimeters of mercury; cm, centimeter; BMI, body mass index.

Table 2. Treatment with single-pill combination of amlodipine/valsartan/hydrochlorothiazide (A + V + H), daily dose.

Daily dose of A + V + H (mg)	Start of observation		6 weeks		12 weeks		Last visit
	n	%	n	%	n	%	n	%
Total	7132	100.0	5312	100.0	7040	100.0	7108	100.0
5/160/12.5 mg	2644	37.1	1617	30.4	2143	30.4	2165	30.5
10/160/12.5 mg	2251	31.6	1810	34.1	2334	33.2	2351	33.1
5/160/25 mg	547	7.7	349	6.6	494	7.0	498	7.0
10/160/25 mg	907	12.7	763	14.4	1038	14.7	1041	14.6
10/320/25 mg	772	10.8	675	12.7	961	13.7	971	13.7
Missing	11	0.2	98	1.8	70	1.0	82	1.2

mg, milligram; n, number.

Table 3. Changes in treatment with amlodipine/valsartan/hydrochlorothiazide (A + V + H).

Start of			Last visit
observation	Total		5/160/12.5 mg		10/160/12.5 mg		5/160/25 mg		10/160/25 mg		10/320/25 mg		Missing
	n	%	n	%	n	%	n	%	n	%	n	%	n	%
Total	7108	100.0	2165	30.5	2351	33.1	498	7.0	1041	14.6	971	13.7	82	1.2
5/160/12.5 mg	2638	100.0	2057	78.0	372	14.1	49	1.9	62	2.4	63	2.4	35	1.3
10/160/12.5 mg	2242	100.0	69	3.1	1939	86.5	8	0.4	127	5.7	77	3.4	22	1.0
5/160/25 mg	547	100.0	15	2.7	7	1.3	415	75.9	82	15.0	24	4.4	4	0.7
10/160/25 mg	905	100.0	8	0.9	17	1.9	18	2.0	758	83.8	93	10.3	11	1.2
10/320/25 mg	769	100.0	13	1.7	16	2.1	7	0.9	11	1.4	714	92.8	8	1.0
Missing	7	100.0	3	42.9	0	0.0	1	14.3	1	14.3	0	0.0	2	28.6

mg, milligram; n, number.

Figure 1. Time course of systolic and diastolic blood pressure—Mean values. mmHg, millimeters of mercury; sys, systolic; dia, diastolic.

Figure 2. Absolute changes in blood pressure from start of observation. (a) Stratified by sBP at start of observation—Mean values. (b) Stratified by age at start of observation—Mean values. mmHg, millimeters of mercury; sys, systolic; dia, diastolic.

Table 4. Normalization of blood pressure and response at last visit.

	Total		Normalization*		Response**
	n	%	n	%	n	%
Total	7108	100.0	3090	43.5	5067	71.3
Systolic blood pressure at start of observation
<140 mmHg	661	100.0	405	61.3	413	62.5
≥140 and <160 mmHg	2711	100.0	1388	51.2	1626	60.0
≥160 and <180 mmHg	2660	100.0	992	37.3	2097	78.8
≥180 mmHg	1065	100.0	302	28.4	928	87.1
Diastolic blood pressure at start of observation
<90 mmHg	2296	100.0	1094	47.6	1348	58.7
≥90 mmHg	4803	100.0	1993	41.5	3716	77.4
Age at start of observation
<65 years	3319	100.0	1576	47.5	2475	74.6
≥65 years	3756	100.0	1497	39.9	2566	68.3
<80 years	6421	100.0	2831	44.1	4601	71.7
≥80 years	654	100.0	242	37.0	440	67.3

mmHg, millimeters of mercury; n, number.

*Normalization = blood pressure < 140/90 mmHg for non-diabetics or <130/80 mmHg for diabetics.

**Response = systolic blood pressure <140 mmHg or ≥20 mmHg decrease vs baseline and diastolic blood pressure <90 mmHg or ≥10 mmHg decrease vs baseline in non-diabetic patients and systolic blood pressure <130 mmHg or ≥20 mmHg decrease vs baseline and diastolic blood pressure <80 mmHg or ≥10 mmHg decrease vs baseline in patients with diabetes.

Table 5. Most frequently reported adverse events (≥0.05% of patients).

	Total (n = 7132)
	n	%
Edema peripheral	46	0.64
Dizziness	15	0.21
Edema	11	0.15
Nausea	10	0.14
Headache	10	0.14
Pruritus	5	0.07
Rash	4	0.06

n, number.