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(Hypertension. 2005;46:508.)
© 2005 American Heart Association, Inc.

Original Articles

A Noninferiority Comparison of Valsartan/Hydrochlorothiazide Combination Versus Amlodipine in Black Hypertensives

Matthew R. Weir; Keith C. Ferdinand; John M. Flack; Kenneth A. Jamerson; William Daley; Steven Zelenkofske for the AADVANCE Investigators

From the Division of Nephrology (M.R.W.), Department of Medicine, University of Maryland School of Medicine, Baltimore; Heartbeats Life Center and Department of Clinical Pharmacology (K.C.F.), Xavier University of Louisiana, College of Pharmacy, New Orleans; Departments of Internal Medicine and Community Medicine (J.M.F.), Wayne State University and Detroit Medical Center, Michigan; Department of Internal Medicine (K.A.J.), University of Michigan, Ann Arbor; Novartis Pharmaceuticals Corporation (W.D., S.Z.), East Hanover, NJ.

Correspondence to Matthew R. Weir, MD, Division of Nephrology, University of Maryland School of Medicine, 22 S Greene St, Room N3W143, Baltimore, MD 21201. E-mail mweir{at}medicine.umaryland.edu

The objective of the study was to demonstrate that reduction in mean 24-hour diastolic blood pressure with 160 mg valsartan and 12.5 mg hydrochlorothiazide was not inferior to 10 mg amlodipine in hypertensive blacks. A total of 482 blacks with stage 1 and stage 2 hypertension (mean seated blood pressure 140 to 180/90 to 110 mm Hg) were enrolled in a double-blind, randomized, prospective study. After a placebo run-in period, patients were randomized to 160 mg valsartan or 5 mg amlodipine for 2 weeks, then force-titrated to 160 mg valsartan and 12.5 mg hydrochlorothiazide or 10 mg amlodipine for an additional 10 weeks. Blood pressure was assessed by 24-hour ambulatory blood pressure monitoring. Other assessments included quality of life, peripheral edema, and safety. Noninferiority of valsartan/hydrochlorothiazide to amlodipine was demonstrated by comparable reductions in mean 24-hour diastolic blood pressure with both treatments (–10.2±8.6 mm Hg versus –9.1±8.3 mm Hg, respectively; P<0.001 for noninferiority), as well as in mean 24-hour systolic blood pressure (–15.9±12.1 mm Hg versus –14.5±12.2 mm Hg; P<0.001 for noninferiority). The proportion of patients reporting adverse events and the incidence of most events were similar in both treatment groups, although more patients treated with amlodipine reported peripheral edema (5.8% versus 1.7%; P=0.03) and joint swelling (2.9% versus 0%; P=0.008) compared with valsartan/hydrochlorothiazide. We conclude that a starting dose of valsartan/hydrochlorothiazide (160/12.5 mg) is as effective as high-dose amlodipine (10 mg) in reducing blood pressure in blacks with stage 1 and stage 2 hypertension, and valsartan/hydrochlorothiazide is better tolerated.

Key Words: blacks • antihypertensive therapy • hypertension

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