title: Irbesartan/HCTZ fixed combinations in patients of different racial/ethnic groups with uncontrolled systolic blood pressure on monotherapy.
abstract: 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<0.001 for each). Mean diastolic BP (DBP) changes were statistically significant (p<0.001) and similar among racial/ethnic subgroups. By week 18, 70% (95% CI, 66%, 74%) of Caucasian, 66% (95% CI, 59%, 74%) of African-American and 65% (95% CI, 57%, 74%) of Hispanic/Latino patients achieved dual SBP/DBP goal. Treatments appeared to be well tolerated. In conclusion, irbesartan/HCTZ treatment provided SBP/DBP goal attainment in approximately two-thirds of Caucasian, African-American and Hispanic/Latino patients with SBP uncontrolled on antihypertensive monotherapy.
authors.affiliation: Clinical Research Center, Morehouse School of Medicine, Atlanta, GA 30310, USA. eofili@msm.edu
authors.forename: Elizabeth O
authors.initials: EO
authors.lastname: Ofili
authors.forename: Keith C
authors.initials: KC
authors.lastname: Ferdinand
authors.forename: Elijah
authors.initials: E
authors.lastname: Saunders
authors.forename: Joel M
authors.initials: JM
authors.lastname: Neutel
authors.forename: George L
authors.initials: GL
authors.lastname: Bakris
authors.forename: William C
authors.initials: WC
authors.lastname: Cushman
authors.forename: James R
authors.initials: JR
authors.lastname: Sowers
authors.forename: Michael A
authors.initials: MA
authors.lastname: Weber
mesh_terms: D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001713:Biphenyl Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D044383:Black People; D001794:Blood Pressure / Q000187:drug effects*; D004338:Drug Combinations; D005260:Female; D006630:Hispanic or Latino; D006801:Humans; D006852:Hydrochlorothiazide / Q000008:administration & dosage / Q000627:therapeutic use*; D006973:Hypertension / Q000188:drug therapy*; D000077405:Irbesartan; D008297:Male; D011446:Prospective Studies; D016037:Single-Blind Method; D013777:Tetrazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D044465:White People; D001741:Black or African American
chemical_list: D000959:Antihypertensive Agents; D001713:Biphenyl Compounds; D004338:Drug Combinations; D013777:Tetrazoles; D006852:Hydrochlorothiazide; D000077405:Irbesartan