| Efficacy and safety of fixed combinations of irbesartan/hydrochlorothiazide in hypertensive women: the inclusive trial. | |
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MedLine Citation:
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PMID: 18681815 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Elizabeth O Ofili; Greg Cable; Joel M Neutel; Elijah Saunders |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't |
Journal Detail:
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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:
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Created Date: 2008-08-06 Completed Date: 2008-09-25 Revised Date: 2013-06-05 |
Medline Journal Info:
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Nlm Unique ID: 101159262 Medline TA: J Womens Health (Larchmt) Country: United States |
Other Details:
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Languages: eng Pagination: 931-8 Citation Subset: IM |
Affiliation:
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Morehouse School of Medicine, Atlanta, Georgia 30310, USA. eofili@msm.edu |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Antihypertensive Agents / administration & dosage*, adverse effects Biphenyl Compounds / administration & dosage*, adverse effects Blood Pressure / drug effects* Diabetes Mellitus, Type 2 / complications, physiopathology Drug Combinations Female Humans Hydrochlorothiazide / administration & dosage*, adverse effects Hypertension / complications, drug therapy*, physiopathology Middle Aged Prospective Studies Tetrazoles / administration & dosage*, adverse effects |
| Grant Support | |
ID/Acronym/Agency:
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1UO1HL084891/HL/NHLBI NIH HHS; 5P20RR11104/RR/NCRR NIH HHS; 5U54RR14758-05/RR/NCRR NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Antihypertensive Agents; 0/Biphenyl Compounds; 0/Drug Combinations; 0/Tetrazoles; 138402-11-6/irbesartan; 58-93-5/Hydrochlorothiazide |
| Comments/Corrections | |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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