title: The efficacy and safety of low- and high-dose fixed combinations of irbesartan/hydrochlorothiazide in patients with uncontrolled systolic blood pressure on monotherapy: the INCLUSIVE trial.
abstract: This multicenter, prospective, open-label, single-arm study determined the efficacy and safety of irbesartan/hydrochlorothiazide (HCTZ) fixed combinations in patients (n=1005), aged 18 years and older, with uncontrolled systolic blood pressure (SBP) of 140-159 mm Hg (130-159 mm Hg for type 2 diabetes mellitus) after at least 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). Enrolled patients (n=844) were aged 57.3+/-11.2 years; 52% were women, 23% were African American, and 14% were Hispanic. Thirty percent had type 2 diabetes mellitus, 46% had metabolic syndrome, and baseline blood pressure was 154.0+/-10.3/91.3+/-8.8 mm Hg. The mean change in SBP from placebo end to the primary end point, Week 18 (intent-to-treat population, n=736) was -21.5+/-14.3 mm Hg (p<0.001). The mean change in diastolic blood pressure (DBP) was -10.4+/-8.7 mm Hg (p<0.001). The mean Week 18 SBP/DBP was 132.9+/-13.8/81.1+/-9.7 mm Hg. Overall, 77% (95% confidence interval, 74%-80%) of patients achieved SBP goal (<140 mm Hg; <130 mm Hg for type 2 diabetes mellitus); 83% (95% confidence interval, 80%-86%) achieved DBP goal (<90 mm Hg; <80 mm Hg for type 2 diabetes mellitus); and 69% (95% confidence interval, 66%-72%) achieved dual SBP/DBP goal. Treatments were well tolerated. This irbesartan/HCTZ treatment regimen achieved SBP goals in more than 75% of patients uncontrolled on monotherapy.
authors.affiliation: Orange County Research Center, Tustin, CA 92780, USA. jmneutel@aol.com
authors.forename: Joel M
authors.initials: JM
authors.lastname: Neutel
authors.forename: Elijah
authors.initials: E
authors.lastname: Saunders
authors.forename: George L
authors.initials: GL
authors.lastname: Bakris
authors.forename: William C
authors.initials: WC
authors.lastname: Cushman
authors.forename: Keith C
authors.initials: KC
authors.lastname: Ferdinand
authors.forename: Elizabeth O
authors.initials: EO
authors.lastname: Ofili
authors.forename: James R
authors.initials: JR
authors.lastname: Sowers
authors.forename: Michael A
authors.initials: MA
authors.lastname: Weber
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001713:Biphenyl Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D001794:Blood Pressure / Q000187:drug effects*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000503:physiopathology; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006852:Hydrochlorothiazide / Q000008:administration & dosage* / Q000009:adverse effects; D006973:Hypertension / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D000077405:Irbesartan; D008297:Male; D024821:Metabolic Syndrome / Q000150:complications / Q000503:physiopathology; D008875:Middle Aged; D011446:Prospective Studies; D013777:Tetrazoles / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D001713:Biphenyl Compounds; D004338:Drug Combinations; D013777:Tetrazoles; D006852:Hydrochlorothiazide; D000077405:Irbesartan