Abstract

Objectives: The first aim was to compare an aliskiren/amlodipine (ALI/AML) combination with high-dose amlodipine monotherapy on ambulatory blood pressure (ABP) reduction and target organ protection. The second aim was to compare the BP lowering effect of antihypertensive medication on ABP and clinic BP (CBP) between diabetes mellitus (DM) and non-DM patients. Methods: We performed a prospective, randomized, open-label trial in essential hypertensives: 105 patients (mean age: 77.1; male: 41.0%) with CBP over 140/90 mmHg with AML 5 mg were randomly allocated to ALI (150–300 mg) /AML (5 mg) (ALI/AML, n = 53) or high-dose amlodipine (10 mg) (h-dAML, n = 52), and were treated for 16 wks. To the next, we performed a subanalysis, dividing the 86 patients who completed the treatment period into the Non-DM (n = 75) and DM (n = 11), and compared reductions on ABP and CBP. Results: The ALI/AML and h-dAML group showed similarly reduced 24-h SBP, daytime SBP, nighttime SBP, and brachial-ankle pulse wave velocity. The urine albumin-to-creatinine ratio reduction was significantly greater in the ALI/AML (p = 0.02). However, ALI/AML was significantly less effective in reducing early-morning BP (4.0 ± 21.2 vs. − 10.8 ± 22.1 mmHg, p = 0.002) and morning BP surge (10.0 ± 23.2 vs. − 5.4 ± 20.3 mmHg, p = 0.001) compared to h-dAML. The Non-DM and DM group's CBP reduction was similar. However, 24-h SBP reduction (p = 0.01) and daytime SBP reduction (p = 0.01) were significantly smaller in DM compared to Non-DM patients. Conclusion: ALI/AML provided better renal protection than h-dAML. Although ALI/AML and h-dAML showed almost equal reduction on ABP, ALI/AML was significantly less effective in reducing early-morning BP and morning BP surge compared to h-dAML. The ABP reduction was weakened in DM patients.

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