Post-marketing surveillance study of valsartan/amlodipine combination in Taiwanese hypertensive patients

Figures & data

Figure 1. Patient disposition.

Table I. Demographic and baseline characteristics.

Characteristics	Baseline value (N = 1029)
Age (years), mean (SD)	63.3 (12.9)
Gender
Males, n (%)	582 (56.56%)
Females, n (%)	447 (43.44%)
Body mass index (kg/m^2), mean (SD)	26.5 (4.0)
≥ 27	413 (40.14%)
< 27	616 (59.86%)
Duration of hypertension (months), mean (SD)	80.4 (90.2)
Number of concomitant drugs, mean (SD)	3.6 (2.5)
Cardiovascular risk factors, n (%)
Dyslipidemia	523 (50.83%)
Diabetes mellitus	410 (39.84%)
Positive family history	328 (31.88%)
Coronary heart disease	302 (29.35%)
Smoking	195 (18.95%)
Mean SBP (mmHg), mean (SD)	147.7 (18.1)
Mean DBP (mmHg), mean (SD)	85.7 (13.1)
Pulse rate, mean (SD)	74.2 (10)80.86 (13.05)

SBP, systolic blood pressure; DBP, diastolic blood pressure.

Figure 2. Investigators’ evaluation of efficacy and tolerability at Week 12.

Figure 3. Control rates between treatment groups and subgroups at Week 12.

Table II. Summary of adverse events (AEs).

Total number of AEs, n	164
Number of patients with AEs, n (%)	125 (12.15%)
Number of patients with treatment-related AEs	28 (17.07%)
Number of treatment discontinuations due to an AE, n (%)	14 (1.36)
Most commonly reported AEs, n (%)
Dizziness	27 (2.62%)
Cough	10 (0.97%)
Palpitations	5 (0.49%)
Peripheral edema	5 (0.49%)
Bronchitis	5 (0.49%)
Number of serious adverse events (SAEs), n	27
Number of patients with SAEs, n (%)	17 (1.65%)

Table IIIa. Overall change in blood pressure by treatment groups.

Change in blood pressure	Overall (ENR)(N = 1029)	Valsartan/amlodipine alone (n = 385)	Valsartan/amlodipineas add-on therapy (n = 644)
Systolic blood pressure
Baseline to Week 4
Mean (SD) mmHg	−10.0 (17.1)	− 10.9 (16.70)	− 9.5 (17.2)
95% CI	(−11.08, −9.00)	(−12.56, − 9.21)	(− 10.87, − 8.20)
P value^#	< 0.0001	< 0.0001	< 0.0001
Baseline to Week 12
Mean (SD) mmHg	−12.5 (18.0)	−12.2 (17.6)	−12.7 (18.2)
95% CI	(−13.62, −11.42)	(− 13.97, − 10.44)	(− 14.12, −11.30)
P value^#	< 0.0001	< 0.0001	< 0.0001
Diastolic blood pressure
Baseline to Week 4
Mean (SD) mmHg	−5.2 (10.7)	− 5.9 (10.9)	− 4.7 (10.6)
95% CI	(− 5.81, −4.50)	(− 6.97, –4.79)	(–5.54, –3.90)
P value^#	< 0.0001	< 0.0001	< 0.0001
Baseline to Week 12
Mean (SD) mmHg	− 6.5 (11.8)	− 6.9 (12.0)	− 6.2 (11.6)
95% CI	(2 7.20, − 5.76)	(− 8.08, − 5.67)	(− 7.14, − 5.34)
P value^#	< 0.0001	< 0.0001	< 0.0001

ENR, enrolled set ^#p < 0.0001 between baseline and Week 4 and Week 12.

Table IIIb. Change in blood pressure in non-diabetic and diabetic patients (Subgroup analysis).

Change in blood pressure	Non-diabetics (n = 619)	Diabetics (n = 410)	p- value
Systolic blood pressure
Baseline to Week 12
Mean (SD) mmHg	−13.7 (18.3)	−10.7 (17.4)	0.0093*
P value^#	< 0.0001	< 0.0001
Diastolic blood pressure
Baseline to Week 12
Mean (SD) mmHg	−6.9 (11.8)	−5.8 (11.7)	0.1400
p-value^#	< 0.0001	< 0.0001

*p < 0.05 between subgroups. ^#p < 0.0001 between baseline and Week 12.

Table IIIc. Change in blood pressure based on the baseline BP condition.

Change in blood pressure	Stage 1 hypertension (n = 537)	Stage 2 hypertension (n = 311)	Isolated systolic hypertension (n = 338)
Systolic blood pressure
Baseline to Week 4
Mean (SD) mmHg	−11.1 (14.6)	−21.1 (18.3)	−12.5 (16.0)
95% CI	(−12.31, −9.83)	(−23.16, 219.06)	(−14.19, −10.77)
p-value^#	< 0.0001	< 0.0001	< 0.0001
Baseline to Week 12
Mean (SD) mmHg	−12.9 (14.7)	−25.3 (19.0)	−15.8 (16.7)
95% CI	(−14.12, −11.63)	(−27.41, −23.17)	(−17.60, 214.03)
p-value^#	< 0.0001	< 0.0001	< 0.0001
Diastolic blood pressure
Baseline to Week 4
Mean (SD) mmHg	−6.0 (9.4)	−10.1 (12.1)	−2.0 (8.0)
95% CI	(−6.84, −5.24)	(−11.40, −8.71)	(−2.90, 21.18)
p-value^#	< 0.0001	< 0.0001	< 0.0001
Baseline to Week 12
Mean (SD) mmHg	−7.3 (9.7)	−11.8 (13.7)	−3.6 (10.2)
95% CI	(−8.10, 26.45)	(−13.33, −10.27)	(−4.72, −2.54)
p-value^#	< 0.0001	< 0.0001	< 0.0001

^#p < 0.0001 between baseline and Week 4 and Week 12.