24-hour efficacy and safety of Triple-Combination Therapy With Olmesartan, Amlodipine, and Hydrochlorothiazide: the TRINITY ambulatory blood pressure substudy

Abstract

This 12-week, multicenter, randomized, double-blinded, 4-arm study in 440 patients with moderate to severe hypertension compared ambulatory blood pressure (ABP) responses with a triple-combination regimen (olmesartan medoxomil [OM] 40 mg, amlodipine besylate [AML] 10 mg, and hydrochlorothiazide [HCTZ] 25 mg) and its component dual-combination regimens at similar doses. At week 12, the triple combination resulted in a greater reduction in mean 24-hour systolic and diastolic blood pressure (-30.3/-18.0 mm Hg) compared with the 3 dual-combination regimens (OM 40 mg/AML 10 mg: -23.5/-13.9, OM 40 mg/HCTZ 25 mg: -23.9/-14.5, and AML 10 mg/HCTZ 25 mg: -18.5 mm Hg/-10.7 mm Hg; P<.0001 each). Greater efficacy was also found during daytime and nighttime hours and during the last 6, 4, or 2 hours of the dosing interval. The authors conclude that the triple combination of OM 40 mg/AML 10 mg/HCTZ 25 mg demonstrated superior efficacy and sustained reductions in ABP compared with its dual-combination components.

Figure 1

Hourly mean systolic (A) and diastolic (B) 24‐hour ambulatory blood pressure (ABP) by regimen. AML indicates amlodipine besylate; HCTZ, hydrochlorothiazide; OM, olmesartan medoxomil.

Figure 2

Change from baseline to week 12 in mean (standard deviation [SD]) 24‐hour, daytime, and nighttime systolic and diastolic ambulatory blood pressure (ABP) by regimen. *P<.0001 vs baseline; ^† P<.0001 vs each dual‐combination regimen; ^‡ P≤.0001 vs each dual‐combination regimen; ^§ P≤.018 vs each dual‐combination regimen. Doses (mg) are OM/AML (n=96), OM/HCTZ (n=101), AML/HCTZ (n=83), and OM/AML/HCTZ (n=100), respectively. AML indicates amlodipine besylate; DBP, diastolic blood pressure; HCTZ, hydrochlorothiazide; OM, olmesartan medoxomil; SBP, systolic blood pressure.

Figure 3

Change from baseline to week 12 in mean (standard deviation [SD]) systolic and diastolic ambulatory blood pressure (ABP) during the last 6, 4, and 2 hours of the dosing interval by regimen. *P<.0001 vs baseline; ^† P≤.0111 vs each dual‐combination regimen; ^‡ P≤.0157 vs each dual‐combination regimen; ^§ P≤.0090 vs each dual‐combination regimen. Doses (mg) are OM/AML (n=96), OM/HCTZ (n=101), AML/HCTZ (n=83), and OM/AML/HCTZ (n=100), respectively. AML indicates amlodipine besylate; DBP, diastolic blood pressure; HCTZ, hydrochlorothiazide; OM, olmesartan medoxomil; SBP, systolic blood pressure.