Key result
Fixed-dose losartan/hydrochlorothiazide/amlodipine significantly reduced diastolic and systolic blood pressure compared to losartan/hydrochlorothiazide at 8 weeks (both p < 0.001).
Why the study?
Does fixed-dose losartan/hydrochlorothiazide/amlodipine improve blood pressure control compared to losartan/hydrochlorothiazide in Japanese patients with uncontrolled essential hypertension?
RCT
Double-blind
Does fixed-dose losartan/hydrochlorothiazide/amlodipine improve blood pressure control compared to losartan/hydrochlorothiazide in Japanese patients with uncontrolled essential hypertension?
Adding amlodipine to losartan/hydrochlorothiazide significantly improves blood pressure reduction in patients with uncontrolled essential hypertension.
Supports triple fixed-dose therapy for uncontrolled hypertension; extends dual-therapy comparisons in Japanese patients.
Japanese patients with uncontrolled essential hypertension received single-blind losartan 50 mg/hydrochlorothiazide 12.5 mg (L50/H12.5) for 8 weeks. Patients whose blood pressure (BP) remained uncontrolled were randomized double-blind to fixed-dose losartan 50 mg/hydrochlorothiazide 12.5 mg/amlodipine 5 mg (L50/H12.5/A5) or L50/H12.5 for 8 weeks followed by open-label L50/H12.5/A5 for 44 weeks. Adverse events were assessed. After 8 weeks, diastolic and systolic BP were reduced significantly more with L50/H12.5/A5 versus L50/H12.5 (both p < 0.001). Mean changes in diastolic and systolic BP were sustained for 44 weeks. L50/H12.5/A5 was well-tolerated and improved BP significantly versus L50/H12.5 in Japanese patients with uncontrolled essential hypertension.
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Rakugi et al. (2014) conducted an RCT in essential hypertension. losartan/hydrochlorothiazide/amlodipine vs. losartan 50 mg/hydrochlorothiazide 12.5 mg was evaluated on reduction in diastolic and systolic blood pressure (p=<0.001). Fixed-dose losartan/hydrochlorothiazide/amlodipine significantly reduced diastolic and systolic blood pressure compared to losartan/hydrochlorothiazide at 8 weeks (both p < 0.001).
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