Irbesartan/HCTZ fixed combinations in patients of different racial/ethnic groups with uncontrolled systolic blood pressure on monotherapy

• Published in: Journal of the National Medical Association 2006-04, Vol.98 (4), p.618-626
• Main Authors: Ofili, Elizabeth O, Ferdinand, Keith C, Saunders, Elijah, Neutel, Joel M, Bakris, George L, Cushman, William C, Sowers, James R, Weber, Michael A
• Format: Article
• Language: English
• Subjects: Antihypertensive Agents - administration & dosage; Antihypertensive Agents - therapeutic use; Biphenyl Compounds - administration & dosage; Biphenyl Compounds - therapeutic use; Black or African American; Black People; Blood Pressure - drug effects; Drug Combinations; Female; Hispanic or Latino; Humans; Hydrochlorothiazide - administration & dosage; Hydrochlorothiazide - therapeutic use; Hypertension - drug therapy; Irbesartan; Male; Prospective Studies; Single-Blind Method; Tetrazoles - administration & dosage; Tetrazoles - therapeutic use; White People
• ISSN: 0027-9684; 1943-4693

The IrbesartaN/hydroChlorothiazide (HCTZ) bLood pressUre reductionS In diVErse patient populations (INCLUSIVE) trial was a multicenter, prospective, open-label, single-arm study evaluating the efficacy and safety of irbesartan/HCTZ fixed combinations in patients > or = 18 years old with uncontrolled systolic blood pressure (SBP, 140-159 mmHg; 130-159 mmHg for type-2 diabetes mellitus patients) after > or = 4 weeks of antihypertensive monotherapy. This analysis focused on different racial/ethnic subgroups. Treatment was sequential: placebo (4-5 weeks), HCTZ 12.5 mg (two weeks), irbesartan/HCTZ 150/12.5 mg (eight weeks) and irbesartan/HCTZ 300/25 mg (eight weeks). Overall, 515 Caucasians, 191 African Americans and 119 Hispanics/Latinos completing placebo treatment were enrolled. Mean SBP changes from baseline (placebo treatment end) to week 18 were -21.5 +/- 13.8 mmHg for Caucasians, -20.7 +/- 16.5 mmHg for African Americans and -22.9 +/- 13.2 mmHg for Hispanics/Latinos, respectively (p