Antihypertensive efficacy of Irbesartan/HCTZ in men and women with the metabolic syndrome and type 2 diabetes.

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

Research output: Contribution to journalArticle

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Abstract

This subgroup analysis of the Irbesartan/Hydrochlorothiazide (HCTZ) Blood Pressure Reductions in Diverse Patient Populations (INCLUSIVE) trial evaluated the efficacy and safety of irbesartan/HCTZ fixed combinations in adults with uncontrolled systolic blood pressure (SBP) (140-159 mm Hg; 130-159 mm Hg for 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). In the intent-to-treat analysis, mean change from baseline (end of placebo phase) off all previous therapy to Week 18 (study end) in T2DM patients (n=227) was -18.2+/-14.1 mm Hg for SBP (primary end point; p<0.001) and -8.7+/-8.2 mm Hg for diastolic blood pressure (p<0.001). Mean SBP/diastolic blood pressure changes in patients with the metabolic syndrome (n=345) were -21.0+/-14.3/-10.4+/-8.5 mm Hg (p<0.001). Overall, 56% (95% confidence interval, 49%-62%) of T2DM and 73% (95% confidence interval, 68%-77%) of metabolic syndrome patients achieved SBP goal (<140 mm Hg; <130 mm Hg for T2DM). Goal attainment rates were significantly higher among women with the metabolic syndrome than men. Treatments appeared to be well tolerated. Irbesartan/HCTZ fixed combinations achieved SBP goals in over half of the T2DM patients and nearly three quarters of patients with the metabolic syndrome, with SBP uncontrolled on antihypertensive monotherapy.

Original languageEnglish (US)
Pages (from-to)470-480
Number of pages11
JournalJournal of clinical hypertension (Greenwich, Conn.)
Volume8
Issue number7
DOIs
StatePublished - Jan 1 2006
Externally publishedYes

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irbesartan
Hydrochlorothiazide
Type 2 Diabetes Mellitus
Antihypertensive Agents
Blood Pressure

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Cardiology and Cardiovascular Medicine

Cite this

Antihypertensive efficacy of Irbesartan/HCTZ in men and women with the metabolic syndrome and type 2 diabetes. / Sowers, James R.; Neutel, Joel M.; Saunders, Elijah; Bakris, George L.; Cushman, William; Ferdinand, Keith C.; Ofili, Elizabeth O.; Weber, Michael A.

In: Journal of clinical hypertension (Greenwich, Conn.), Vol. 8, No. 7, 01.01.2006, p. 470-480.

Research output: Contribution to journalArticle

Sowers, James R. ; Neutel, Joel M. ; Saunders, Elijah ; Bakris, George L. ; Cushman, William ; Ferdinand, Keith C. ; Ofili, Elizabeth O. ; Weber, Michael A. / Antihypertensive efficacy of Irbesartan/HCTZ in men and women with the metabolic syndrome and type 2 diabetes. In: Journal of clinical hypertension (Greenwich, Conn.). 2006 ; Vol. 8, No. 7. pp. 470-480.
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