title: Moderate versus intensive treatment of hypertension using amlodipine/valsartan and with the addition of hydrochlorothiazide for patients uncontrolled on angiotensin receptor blocker monotherapy: results in racial/ethnic subgroups.
abstract: Combination therapy may reduce racial/ethnic differences in response to antihypertensives. In this post-hoc analysis, we evaluated treatment response by race/ethnicity among hypertensive adults enrolled in a 12-week, double-blind study in which patients previously uncontrolled (mean sitting systolic blood pressure [MSSBP] ≥150 and <200 mm Hg) on angiotensin receptor blocker (ARB) monotherapy (other than valsartan) for 28 days or more (n = 728) were randomized to amlodipine/valsartan 10/320 mg (intensive) or 5/160 mg (moderate). Treatment-naïve patients (in previous 28 days) or those who failed on a non-ARB first underwent a 28-day run-in period with olmesartan 20 mg or 40 mg, respectively. Hydrochlorothiazide (HCTZ) 12.5 mg was added to both arms at week 4; optional up-titration to 25 mg at week 8 (if MSSBP >140 mm Hg). Intensive treatment provided greater BP lowering versus moderate treatment throughout the study, regardless of race/ethnicity (474 white, 198 African American, 165 Hispanic individuals). Least-square mean reductions from baseline to week 4 in MSSBP (primary outcome) ranged from 20.4 to 23.5 mm Hg (intensive) versus 17.5 to 19.0 mm Hg (moderate), across racial/ethnic subgroups. Both regimens were well tolerated. Amlodipine/valsartan/HCTZ combination therapy was efficacious across racial/ethnic subgroups. Maximal efficacy was obtained with intensive treatment.
authors.affiliation: Morehouse School of Medicine, Atlanta, Georgia, USA. eofili@msm.edu
authors.forename: Elizabeth O
authors.initials: EO
authors.lastname: Ofili
authors.forename: Suzanne
authors.initials: S
authors.lastname: Oparil
authors.forename: Thomas
authors.initials: T
authors.lastname: Giles
authors.forename: Bertram
authors.initials: B
authors.lastname: Pitt
authors.forename: Das
authors.initials: D
authors.lastname: Purkayastha
authors.forename: Robert
authors.initials: R
authors.lastname: Hilkert
authors.forename: Rita
authors.initials: R
authors.lastname: Samuel
authors.forename: James R
authors.initials: JR
authors.lastname: Sowers
mesh_terms: D000328:Adult; D001741:Black or African American; D000368:Aged; D017311:Amlodipine / Q000008:administration & dosage*; D000959:Antihypertensive Agents / Q000008:administration & dosage*; D001794:Blood Pressure / Q000187:drug effects; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006630:Hispanic or Latino; D006801:Humans; D006852:Hydrochlorothiazide / Q000008:administration & dosage*; D006973:Hypertension / Q000188:drug therapy* / Q000208:ethnology*; D008297:Male; D008875:Middle Aged; D011945:Receptors, Angiotensin / Q000008:administration & dosage*; D013777:Tetrazoles / Q000008:administration & dosage*; D014633:Valine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000068756:Valsartan; D044465:White People
chemical_list: D000959:Antihypertensive Agents; D011945:Receptors, Angiotensin; D013777:Tetrazoles; D006852:Hydrochlorothiazide; D017311:Amlodipine; D000068756:Valsartan; D014633:Valine