Document Detail


Irbesartan/hydrochlorothiazide for the treatment of isolated systolic hypertension: a subgroup analysis of the INCLUSIVE trial.
MedLine Citation:
PMID:  19397219     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
This post hoc analysis of the Irbesartan/Hydrochlorothiazide (HCTZ) Blood Pressure Reductions in Diverse Patient Populations (INCLUSIVE) trial evaluated the efficacy and safety of fixed-dose irbesartan/HCTZ in patients with isolated systolic hypertension. Adults with uncontrolled systolic blood pressure (SBP) (140-179 mm Hg; 130-179 mm Hg in type 2 diabetes) after 4 weeks or more of antihypertensive monotherapy once-daily treatment with placebo for 4-5 weeks, followed by HCTZ 12.5 mg for 2 weeks, irbesartan/HCTZ 150/12.5 mg for 8 weeks, and then irbesartan/HCTZ 300/25 mg for 8 weeks, in a prospective, multicenter, open-label, single-arm study. In patients with isolated systolic hypertension (n = 443) and the total study population (n = 736), irbesartan/HCTZ treatment for 16 weeks provided comparable mean blood pressure (BP) reductions from baseline (21.4/10.1 mm Hg vs 21.5/10.4 mm Hg; p < .001 vs baseline) and high SBP control rates (74% vs 77%). Patients with isolated systolic hypertension and concomitant type 2 diabetes experienced smaller BP reductions (17.9/8.7 mm Hg vs 22.9/10.7 mm Hg) and lower rates of SBP control (< 130 mm Hg, 47%) than those without diabetes (< 140 mm Hg, 87%). BP reductions from baseline and SBP control rates were similar across isolated systolic hypertension subgroups (> or = 65 vs < 65 years, sex, race, and metabolic syndrome status). Irbesartan/HCTZ was well tolerated, with drug-related adverse events (dizziness, < or = 3%; upper respiratory tract infection, < or = 2%) occurring with similar rates in the isolated systolic hypertension and total population. Fixed-dose irbesartan/HCTZ combination treatment provided effective and well-tolerated BP lowering in a diverse population of patients with isolated systolic hypertension.
Authors:
Steven G Chrysant; Joel M Neutel; Keith C Ferdinand;
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of the National Medical Association     Volume:  101     ISSN:  0027-9684     ISO Abbreviation:  J Natl Med Assoc     Publication Date:  2009 Apr 
Date Detail:
Created Date:  2009-04-28     Completed Date:  2009-11-05     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7503090     Medline TA:  J Natl Med Assoc     Country:  United States    
Other Details:
Languages:  eng     Pagination:  300-7     Citation Subset:  IM    
Affiliation:
Oklahoma Cardiovascular and Hypertension Center and the University of Oklahoma School of Medicine, 5850 W Wilshire Blvd, Oklahoma City, OK 73132, USA. schrysant@yahoo.com
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MeSH Terms
Descriptor/Qualifier:
Aged
Angiotensin II Type 1 Receptor Blockers / adverse effects,  therapeutic use*
Antihypertensive Agents / adverse effects,  therapeutic use*
Biphenyl Compounds / adverse effects,  therapeutic use*
Blood Pressure / drug effects
Confidence Intervals
Diuretics / adverse effects,  therapeutic use*
Drug Therapy, Combination
Female
Humans
Hydrochlorothiazide / adverse effects,  therapeutic use*
Male
Middle Aged
Prospective Studies
Risk Factors
Tetrazoles / adverse effects,  therapeutic use*
Chemical
Reg. No./Substance:
0/Angiotensin II Type 1 Receptor Blockers; 0/Antihypertensive Agents; 0/Biphenyl Compounds; 0/Diuretics; 0/Tetrazoles; 138402-11-6/irbesartan; 58-93-5/Hydrochlorothiazide
Investigator
Investigator/Affiliation:
L Altschul / ; Z Ansari / ; P Arcuri / ; G L Bakris / ; H Bays / ; H Biermann / ; N Bittar / ; J Bloom / ; K Bordenave / ; D Brautigam / ; P Buchanan / ; A Carr / ; J Champlin / ; D Cheung / ; J Clower / ; G Collins / ; W C Cushman / ; M DeBruin / ; E Denoia / ; V Desai / ; M Dewan / ; M El Shahawy / ; A Elkind / ; R D Ferrera / ; J Fidelholtz / ; N Fraser / ; L Gidday / ; L Gilderman / ; R Ginsburg / ; E Hare / ; D Hassman / ; M Heitbrink / ; M Henriquez / ; J Herron / ; G Hilliard / ; P Hughes / ; H Ibrahim / ; T Isakov / ; W Jacobs / ; J Jernigan / ; L Judy / ; D Kereiakes / ; B Kerzner / ; L Koehler / ; M Koren / ; M Kozinn / ; E Kunst / ; G Lankin / ; A Lewin / ; T Littlejohn / ; B Lubin / ; R Madder / ; R Marple / ; J Mersey / ; F Messerli / ; N Messina / ; M Mollen / ; P Narayan / ; S Nesbitt / ; E O Ofili / ; S Ong / ; S Oparil / ; R Owens / ; C Patel / ; M Peshimam / ; F Pettyjohn / ; A Phillips / ; I Plisco / ; M Pohl / ; J Quesada / ; G Raad / ; B Rankin / ; D Riff / ; S Rosansky / ; E Roth / ; G Ruoff / ; J Sandoval / ; J Saponaro / ; E Saunders / ; S Shahzad / ; K Sheehan / ; T Sherraden / ; D Sica / ; J Siemienczuk / ; N Singh / ; G Smith / ; W Smith / ; J Soufar / ; J R Sowers / ; W Starling / ; K Stone / ; C Strout / ; R Strzinek / ; D Sugimoto / ; G Szenkiel / ; R Tidman / ; M Tonkon / ; M S Touger / ; H Underwood / ; C Uy / ; J Wadleigh / ; V Wassily / ; J Wayne / ; M A Weber / ; V Weber / ; R Weiss / ; N Winer / ; D Young / ; J Zebrack /

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