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.

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.