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

• Published in: Hypertension (Dallas, Tex. 1979) Tex. 1979), 2005-09, Vol.46 (3), p.508-513
• Main Authors: Weir, Matthew R, Ferdinand, Keith C, Flack, John M, Jamerson, Kenneth A, Daley, William, Zelenkofske, Steven
• Format: Article
• Language: English
• Subjects: Adult; African Continental Ancestry Group; Aged; Amlodipine - administration & dosage; Amlodipine - adverse effects; Amlodipine - therapeutic use; Angiotensin II Type 1 Receptor Blockers - administration & dosage; Angiotensin II Type 1 Receptor Blockers - adverse effects; Angiotensin II Type 1 Receptor Blockers - therapeutic use; Antihypertensive agents; Arterial hypertension. Arterial hypotension; Biological and medical sciences; Blood and lymphatic vessels; Blood Pressure - drug effects; Calcium Channel Blockers - administration & dosage; Calcium Channel Blockers - adverse effects; Calcium Channel Blockers - therapeutic use; Cardiology. Vascular system; Cardiovascular system; Clinical manifestations. Epidemiology. Investigative techniques. Etiology; Diuretics - administration & dosage; Diuretics - adverse effects; Diuretics - therapeutic use; Dose-Response Relationship, Drug; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Hydrochlorothiazide - administration & dosage; Hydrochlorothiazide - adverse effects; Hydrochlorothiazide - therapeutic use; Hypertension - drug therapy; Hypertension - ethnology; Hypertension - physiopathology; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Prospective Studies; Tetrazoles - administration & dosage; Tetrazoles - adverse effects; Tetrazoles - therapeutic use; Treatment Outcome; Valine - administration & dosage; Valine - adverse effects; Valine - analogs & derivatives; Valine - therapeutic use; Valsartan
• ISSN: 0194-911X; 1524-4563
• DOI: 10.1161/01.HYP.0000180457.82483.6b

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