title: Efficacy and tolerability of triple-combination therapy with olmesartan, amlodipine, and hydrochlorothiazide: a subgroup analysis of patients stratified by hypertension severity, age, sex, and obesity.
abstract: This prespecified subgroup analysis of a phase III study examined the effect of adding hydrochlorothiazide (HCTZ) to olmesartan (OLM)/amlodipine (AML) in patients with moderate to severe hypertension stratified by age, sex, body mass index, and hypertension severity. A total of 2690 patients, aged 18 years and older, with seated blood pressure (SeBP) ≥160/100 mm Hg received placebo or OLM/AML 20/5 mg, 40/5 mg, or 40/10 mg during a 2-week, double-blind, run-in period, after which they were allocated to one of eight treatment groups with the same OLM/AML dose or with HCTZ 12.5 mg or 25 mg added for 8 weeks. By week 10, greater reductions in SeBP were observed in each OLM/AML/HCTZ group (P<.05, respectively) compared with the corresponding dual dose. Adding HCTZ increased blood pressure-lowering efficacy in all subgroups, with a higher proportion of blood pressure goal achievement vs dual therapy. OLM/AML/HCTZ reduced SeBP to a greater extent than OLM/AML in patients with moderate to severe hypertensive; this was unaffected by baseline hypertension severity, age, sex, and obesity.
authors.affiliation: Institute of Clinical Pharmacology and Toxicology, Charité, Universtitätsmedizin -, Berlin, Germany.
authors.forename: Reinhold
authors.initials: R
authors.lastname: Kreutz
authors.forename: Bettina
authors.initials: B
authors.lastname: Ammentorp
authors.forename: Petra
authors.initials: P
authors.lastname: Laeis
authors.forename: Alejandro
authors.initials: A
authors.lastname: de la Sierra
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D017311:Amlodipine / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D015992:Body Mass Index; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006852:Hydrochlorothiazide / Q000008:administration & dosage / Q000627:therapeutic use*; D006973:Hypertension / Q000145:classification* / Q000188:drug therapy*; D007093:Imidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000145:classification / Q000150:complications*; D012737:Sex Factors; D013777:Tetrazoles / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D007093:Imidazoles; D013777:Tetrazoles; D006852:Hydrochlorothiazide; D017311:Amlodipine; C437965:olmesartan