Irbesartan/HCTZ fixed combinations in patients of different racial/ethnic groups with uncontrolled systolic blood pressure on monotherapy
Ofili, E.O.; Ferdinand, K.C.; Saunders, E.; Neutel, J.M.; Bakris, G.L.; Cushman, W.C.; Sowers, J.R.; Weber, M.A.
Journal of the National Medical Association 98(4): 618-626
2006
ISSN/ISBN: 0027-9684 PMID: 16623075 Document Number: 601098
The Irbesortan/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 >= 18 years old with uncontrolled systolic blood pressure (SBP, 140-159 mmHg; 130-159 mmHg for type-2 diabetes mellitus patients) after >= 4 weeks of anti hypertensive monotherapy. This analysis focused on different racial/ethnic subgroups. Treatment was sequential: placebo (4-5 weeks), HCTZ 12.5 mg (two weeks), irbesortan/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% Cl, 66%, 74%) of Caucasian, 66% (95% Cl, 59%, 74%) of African-American and 65% (95% Cl, 57%, 74%) of Hispanic/Latino patients achieved dual SBP/DBP goal. Treatments appeared to be well tolerated. In conclusion, irbesortan/HCTZ treatment provided SBP/DBP goal attainment in approximately two-thirds of Caucasian, African-American and Hispanic/Latino patients with SBP uncontrolled on anthypertensive monotherapy.