Open AccessAntihypertensive Efficacy of Irbesartan/HCTZ in Men and Women With the Metabolic Syndrome and Type 2 Diabetes
Author(s) -
Sowers James R.,
Neutel Joel M.,
Saunders Elijah,
Bakris George L.,
Cushman William C.,
Ferdinand Keith C.,
Ofili Elizabeth O.,
Weber Michael A.
Publication year - 2006
Publication title -
the journal of clinical hypertension
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.909
H-Index - 67
eISSN - 1751-7176
pISSN - 1524-6175
DOI - 10.1111/j.1524-6175.2006.05486.x
Subject(s) - irbesartan , medicine , hydrochlorothiazide , blood pressure , placebo , metabolic syndrome , type 2 diabetes , confidence interval , diabetes mellitus , combination therapy , urology , endocrinology , type 2 diabetes mellitus , cardiology , alternative medicine , pathology
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 ≥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.