Document Detail

Efficacy and safety of fixed combinations of irbesartan/hydrochlorothiazide in hypertensive women: the inclusive trial.
MedLine Citation:
PMID:  18681815     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: This post hoc analysis of the Irbesartan/Hydrochlorothiazide Blood Pressure Reductions in Diverse Patient Populations (INCLUSIVE) trial evaluated the efficacy and safety of irbesartan/hydrochlorothiazide (HCTZ) in a diverse population of hypertensive women.
METHODS: INCLUSIVE was a multicenter, prospective, open-label, single-arm trial. Adult subjects had uncontrolled systolic blood pressure (SBP 140-159 mm Hg; 130-159 mm Hg for those with type 2 diabetes mellitus [T2DM]) after > or =4 weeks of antihypertensive monotherapy. Treatment was sequential: placebo (4-5 weeks), HCTZ 12.5 mg (2 weeks), irbesartan/HCTZ 150/12.5 mg (8 weeks), and irbesartan/HCTZ 300/25 mg (8 weeks). Mean changes from baseline to treatment end in SBP and diastolic blood pressure (DBP), BP goal attainment, and safety were assessed.
RESULTS: Treatment with irbesartan/HCTZ was associated with significant mean reductions in BP (intent-to-treat population, n = 370; SBP/DBP: -22.9/-10.3 +/- 14.7/8.8 mm Hg). Improvements in SBP were observed in all subgroups (p < 0.001): Caucasian (n = 207) -23.5 +/- 13.5 mm Hg; African American (n = 93) -21.0 +/- 17.2 mm Hg; Hispanics/Latino (n = 66) -23.6 +/- 14.3 mm Hg; age <65 years (n = 281) -22.5 +/- 14.7 mm Hg; age > or =65 years (n = 89) -24.3 +/- 14.5 mm Hg; T2DM (n = 97) -19.0 +/- 15.1 mm Hg; and metabolic syndrome (n = 187) -22.1 +/- 14.6 mm Hg. Overall, 82% (95% confidence interval [CI] 78%-86%) of women achieved their SBP goal, 86% (95% CI 83%-90%) achieved their DBP goal, and 76% (95% CI 71%-80%) achieved their dual SBP/DBP goal. Treatments were well tolerated in all groups.
CONCLUSIONS: Irbesartan/HCTZ treatment was effective and well tolerated in a diverse population of women whose BP was previously uncontrolled on monotherapy.
Elizabeth O Ofili; Greg Cable; Joel M Neutel; Elijah Saunders
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of women's health (2002)     Volume:  17     ISSN:  1931-843X     ISO Abbreviation:  J Womens Health (Larchmt)     Publication Date:    2008 Jul-Aug
Date Detail:
Created Date:  2008-08-06     Completed Date:  2008-09-25     Revised Date:  2013-06-05    
Medline Journal Info:
Nlm Unique ID:  101159262     Medline TA:  J Womens Health (Larchmt)     Country:  United States    
Other Details:
Languages:  eng     Pagination:  931-8     Citation Subset:  IM    
Morehouse School of Medicine, Atlanta, Georgia 30310, USA.
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MeSH Terms
Antihypertensive Agents / administration & dosage*,  adverse effects
Biphenyl Compounds / administration & dosage*,  adverse effects
Blood Pressure / drug effects*
Diabetes Mellitus, Type 2 / complications,  physiopathology
Drug Combinations
Hydrochlorothiazide / administration & dosage*,  adverse effects
Hypertension / complications,  drug therapy*,  physiopathology
Middle Aged
Prospective Studies
Tetrazoles / administration & dosage*,  adverse effects
Grant Support
Reg. No./Substance:
0/Antihypertensive Agents; 0/Biphenyl Compounds; 0/Drug Combinations; 0/Tetrazoles; 138402-11-6/irbesartan; 58-93-5/Hydrochlorothiazide

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