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

Elizabeth O. Ofili, Keith C. Ferdinand, Elijah Saunders, Joel M. Neutel, George L. Bakris, William Cushman, James R. Sowers, Michael A. Weber

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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 ≥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 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.

Original languageEnglish (US)
Pages (from-to)616-626
Number of pages11
JournalJournal of the National Medical Association
Volume98
Issue number4
StatePublished - Apr 1 2006

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irbesartan
Hydrochlorothiazide
Hispanic Americans
Ethnic Groups
Blood Pressure
African Americans
Placebos
Antihypertensive Agents
Therapeutics
Type 2 Diabetes Mellitus

All Science Journal Classification (ASJC) codes

  • Medicine(all)

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Irbesartan/HCTZ fixed combinations in patients of different racial/ethnic groups with uncontrolled systolic blood pressure on monotherapy. / Ofili, Elizabeth O.; Ferdinand, Keith C.; Saunders, Elijah; Neutel, Joel M.; Bakris, George L.; Cushman, William; Sowers, James R.; Weber, Michael A.

In: Journal of the National Medical Association, Vol. 98, No. 4, 01.04.2006, p. 616-626.

Research output: Contribution to journalArticle

Ofili, Elizabeth O. ; Ferdinand, Keith C. ; Saunders, Elijah ; Neutel, Joel M. ; Bakris, George L. ; Cushman, William ; Sowers, James R. ; Weber, Michael A. / Irbesartan/HCTZ fixed combinations in patients of different racial/ethnic groups with uncontrolled systolic blood pressure on monotherapy. In: Journal of the National Medical Association. 2006 ; Vol. 98, No. 4. pp. 616-626.
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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 ≥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 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.",
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AU - Weber, Michael A.

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