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[black up pointing small triangle] Amlodipine/valsartan/hydrochlorothiazide (HCTZ) is a fixed-dose combination of the well established antihypertensive agents amlodipine (a calcium channel antagonist), valsartan (an angiotensin II receptor antagonist), and HCTZ (a thiazide diuretic).

[black up pointing small triangle] In patients with moderate or severe hypertension, triple combination therapy with amlodipine valsartan HCTZ produced significantly greater reductions from baseline in mean sitting systolic and diastolic BP (msSBP and msDBP) than either valsartan HCTZ, amlodipine HCTZ, or amlodipine valsartan in a large, 8-week, randomized, double-blind, multinational, phase III trial.

[black up pointing small triangle] Furthermore, the proportion of patients achieving overall BP control at endpoint was significantly greater with the triple combination regimen than with any of the dual regimens, with significantly more triple combination recipients achieving msSBP and msDBP control at each assessment throughout the trial.

[black up pointing small triangle] Subgroup analyses of this study suggested that amlodipine valsartan HCTZ was generally more effective in reducing BP and providing overall BP control than the dual combination therapies, irrespective of age, race, gender, ethnicity, or hypertension severity.

[black up pointing small triangle] Several smaller studies provide data that support the efficacy of amlodipine valsartan HCTZ in patients whose BP is inadequately controlled with amlodipine valsartan, amlodipine HCTZ, or valsartan HCTZ dual combination therapy.

[black up pointing small triangle] Treatment with amlodipine valsartan HCTZ for up to 8 weeks was generally well tolerated in the large, phase III trial, with most adverse events being transient and of mild to moderate severity.

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