title: Efficacy of an amlodipine/olmesartan treatment algorithm in patients with or without type 2 diabetes and hypertension (a secondary analysis of the BP-CRUSH study).
abstract: A prespecified subgroup analysis of an open-label, multicenter, single-arm, dose-titration study is presented. The efficacy and safety of 20-week treatment with an amlodipine (AML)/olmesartan medoxomil (OM)±hydrochlorothiazide (HCTZ) algorithm were assessed in patients with hypertension and type 2 diabetes mellitus (T2DM) who were uncontrolled by antihypertensive monotherapy. Eligible patients received AML/OM 5/20 mg for 4 weeks, followed by stepwise uptitration to AML/OM 5/40 mg, AML/OM 10/40 mg, AML/OM 10/40 mg+HCTZ 12.5 mg and AML/OM 10/40 mg+HCTZ 25 mg at 4-week intervals if blood pressure (BP) remained uncontrolled. The primary end point was the achievement of the seated cuff systolic BP (SeSBP) goal (<140 mm Hg, or <130 mm Hg for patients with T2DM) at week 12. Seated cuff BP was significantly reduced from baseline at all titration dose periods. At week 12, the cumulative SeSBP goal was achieved by 57.9% and 80.1% of patients in the T2DM and non-T2DM subgroups, respectively. Treatment was well tolerated, with low rates of peripheral edema. In summary, switching to a treatment algorithm based on AML/OM±HCTZ after failed monotherapy was safe and improved BP control in patients with hypertension and T2DM.
authors.affiliation: Division of Hypertension, UT Southwestern Medical Center, Dallas, TX 75390-8586, USA. Shawna.Nesbitt@UTSouthwestern.edu
authors.forename: S D
authors.initials: SD
authors.lastname: Nesbitt
authors.forename: A
authors.initials: A
authors.lastname: Shojaee
authors.forename: J-F
authors.initials: JF
authors.lastname: Maa
authors.forename: M R
authors.initials: MR
authors.lastname: Weir
mesh_terms: D000328:Adult; D000368:Aged; D000465:Algorithms; D017311:Amlodipine / Q000009:adverse effects / Q000627:therapeutic use*; D047228:Angiotensin II Type 1 Receptor Blockers / Q000009:adverse effects / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects*; D002121:Calcium Channel Blockers / Q000009:adverse effects / Q000627:therapeutic use*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications* / Q000175:diagnosis; D004338:Drug Combinations; D057915:Drug Substitution; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006852:Hydrochlorothiazide / Q000627:therapeutic use; D006973:Hypertension / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D007093:Imidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D000068557:Olmesartan Medoxomil; D011446:Prospective Studies; D049993:Sodium Chloride Symporter Inhibitors / Q000627:therapeutic use; D013777:Tetrazoles / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D000959:Antihypertensive Agents; D002121:Calcium Channel Blockers; D004338:Drug Combinations; D007093:Imidazoles; D049993:Sodium Chloride Symporter Inhibitors; D013777:Tetrazoles; D006852:Hydrochlorothiazide; D017311:Amlodipine; D000068557:Olmesartan Medoxomil