Role of triple fixed combination valsartan, amlodipine and hydrochlorothiazide in controlling blood pressure

Figures & data

Table 1 Within-treatment analyses for change from baseline to endpoint in mean sitting BP (ITT population)

Treatment	N	Mean change from baseline (SE)	95% CI for mean change from baseline	P value
Diastolic BP
AML/VAL/HCTZ 10/320/25	571	− 24.57 (0.395)	(−25.348–23.797)	<0.0001*
VAL/HCTZ 320/25	553	−19.40 (0.431)	(−20.250–18.558)	<0.0001*
AML/VAL 10/320	558	−21.41 (0.394)	(−22.186–20.639)	<0.0001*
AML/HCTZ 10/25	554	−19.60 (0.407)	(−20.399–18.801)	<0.0001*
Systolic BP
AML/VAL/HCTZ 10/320/25	571	−39.37 (0.962)	(−40.725–38.08)	<0.0001*
VAL/HCTZ 320/25	553	−31.81 (0.739)	(−33.265–30.362)	<0.0001*
AML/VAL 10/320	558	−33.37 (0.660)	(−34.668–32.077)	<0.0001*
AML/HCTZ 10/25	554	−31.86 (0.710)	(−33.264–30.475)	<0.0001*

* Indicates statistical significance ≤ 0.05.

Data obtained from the VEA A2302 Study.¹³

Abbreviations: ITT, intention to treat; AML, amlodipine; VAL, valsartan; HCTZ, hydrochlorothiazide.

Table 2 Between-treatment comparisons for change from baseline to endpoint in mean sitting BP (MSBP) (mmHg)

Treatment	LSM change from baseline	LSM difference in change from baseline (SE)	P value	Hochberg adjusted P value
Diastolic BP
AML/VAL/HCTZ 10/320/25	−24.74			<0.0001*
VAL/HCTZ 320/25	−19.69	−5.05 (0.539)	<0.0001
AML/VAL 10/320	−21.49	−3.25 (0.537)	<0.001+
AML/HCTZ 10/25	−19.46	−5.28 (0.539)	<0.0001
Systolic BP
AML/VAL/HCTZ 10/320/25	−39.68			<0.0001*
VAL/HCTZ 320/25	−32.04	−7.64 (0.848)	<0.0001
AML/VAL 10/320	−33.5	−6.18 (0.846)	<0.001**
AML/HCTZ 10/25	−31.48	−8.20 (0.848)	<0.0001

Notes: The Hochberg adjusted P values are based on the maximum P value for the three comparisons in MSDBP and the maximum P value for the three comparisons in MSSBP.

* Indicates statistical significance P ≤ 0.05.

** Maximum P values of the three comparisons.

Adapted with permission from Calhoun DA, Lacourciere Y, Chiang TY, Glazer RD. Triple antihypertensive therapy with amlodipine, valsartan and hydrochlorothiazide: A randomized clinical trial. Hypertension. 2009;54:32–39.¹³ Copyright © 2009 Lippincott, Williams & Wilkins.

Abbreviations: LSM, least squares mean; AML, amlodipine; VAL, valsartan; HCTZ, hydrochlorothiazide.

Table 3 Adverse events, regardless of study drug relationship, by preferred term and treatment

	AML/VAL/HCTZ 10/320/25 mg (n = 582)	VAL/HCTZ 320/25 mg (n = 559)	AML/VAL 10/320 (n = 566)	AML/HCTZ 10/25 mg (n = 561)	Total (n = 2268)
Preferred term	N (%)	N (%)	N (%)	N (%)	N (%)
Any preferred term	263 (45.2)	253 (45.3)	254 (44.9)	271 (48.3)	1041 (45.9)
Dizziness	45 (7.7)	39 (7)	13 (2.3)	22 (3.9)	119 (5.2)
Peripheral edema	26 (4.5)	5 (0.9)	48 (8.5)	50 (8.9)	129 (5.7)
Headache	25 (4.3)	30 (5.4)	28 (4.9)	39 (7)	122 (5.4)
Dyspepsia	13 (2.2)	5 (0.9)	6 (1.1)	2 (0.4)	26 (1.1)
Fatigue	13 (2.2)	15 (2.7)	12 (2.1)	8 (1.4)	48 (2.1)
Muscle spasms	13 (2.2)	7 (1.3)	7 (1.2)	5 (0.9)	32 (1.4)
Back pain	12 (2.1)	13 (2.3)	5 (0.9)	12 (2.1)	42 (1.9)
Nasopharyngitis	12 (2.1)	13 (2.3)	13 (2.3)	12 (2.1)	50 (2.2)
Nausea	12 (2.1)	7 (1.3)	10 (1.8)	12 (2.1)	41 (1.8)

Reproduced with permission from Calhoun DA, Lacourciere Y, Chiang TY, Glazer RD. Triple antihypertensive therapy with amlodipine, valsartan and hydrochlorothiazide: A randomized clinical trial. Hypertension. 2009;54:32–39.¹³ Copyright © 2009 Lippincott, Williams & Wilkins.

Abbreviations: AML, amlodipine; VAL, valsartan; HCTZ, hydrochlorothiazide.

Table 4 Comparison of occurrence of peripheral edema between treatment groups

Treatment comparison (A vs B)	Treatment A n/N (%)	Treatment B n/N (%)	P value
AML/VAL/HCTZ 10/320/25 vs VAL/HCTZ 320/25	26/582 (4.5)	5/559 (0.9)	0.0002
AML/VAL/HCTZ 10/320/25 vs AML/VAL 10/320	26/582 (4.5)	48/566 (8.5)	0.0057
AML/VAL/HCTZ 10/320/25 vs AML/HCTZ 10/25	26/582 (4.5)	50/561 (8.9)	0.0029

Data obtained from the VEA A2302 Study.¹³

Abbreviations: AML, amlodipine; VAL, valsartan; HCTZ, hydrochlorothiazide.

CalhounDALacourciereYChiangTYGlazerRDTriple antihypertensive therapy with amlodipine, valsartan and hydrochlorothiazide: A randomized clinical trialHypertension200954323919470877

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