Key result
Olmesartan/amlodipine combination therapy reduced 24-h systolic blood pressure by up to 10.6 mm Hg compared to a 3.5 mm Hg reduction with amlodipine alone.
Why the study?
Does olmesartan/amlodipine combination therapy reduce 24-h ambulatory blood pressure more than amlodipine alone in patients with moderate-to-severe hypertension inadequately controlled by amlodipine?
RCT (n=626)
Double-blind
Computer-generated randomization schedule using a block size of eight
Yes
Does olmesartan/amlodipine combination therapy reduce 24-h ambulatory blood pressure more than amlodipine alone in patients with moderate-to-severe hypertension inadequately controlled by amlodipine?
Absolute Event Rate: -10.6% vs -3.5%
p-value: p=<0.0001
In patients with moderate-to-severe hypertension uncontrolled by amlodipine alone, adding olmesartan provides superior 24-hour blood pressure reduction and homogeneity compared to continuing amlodipine monotherapy.
Olmesartan/amlodipine improves 24-h BP control in amlodipine nonresponders; extends prior clinic data with ABPM-derived TPR and SI.
This previously unpublished, preplanned analysis investigated the efficacy of the olmesartan/amlodipine combination at different doses on 24-h blood pressure (BP) control, as well as assessed trough estimation of trough-to-peak ratio (TPR) and smoothness index (SI). Ambulatory BP monitoring was performed in patients with moderate-to-severe hypertension whose BP was inadequately controlled after 8 weeks' treatment with amlodipine 5 mg. Patients were randomized to continue with amlodipine 5 mg or to receive olmesartan/amlodipine 10/5, 20/5 or 40/5 mg for 8 weeks (Period II). Patients not achieving BP control were uptitrated to a more powerful regimen for another 8 weeks (Period III). During Period II, each olmesartan/amlodipine combination reduced 24-h systolic and diastolic BP (SBP/DBP), as well as morning and early morning SBP/DBP, significantly more than amlodipine 5 mg (P<0.001 for all). TPRs were higher in each olmesartan/amlodipine group than with amlodipine 5 mg, and SI values showed dose-related increases; olmesartan/amlodipine 40/5 mg produced a significantly higher SI for SBP and DBP (1.55 and 1.33, respectively) than amlodipine 5 mg (0.96 and 0.77, respectively, P<0.0001 for each). During Period III, uptitrated patients showed further BP reductions, which were largest in those on olmesartan/amlodipine 40/10 mg. SI values increased in uptitrated patients and were highest with olmesartan/amlodipine 40/10 mg (SBP 1.62/DBP 1.41). The olmesartan/amlodipine combination effectively reduces BP over 24 h, including the morning hours, in a dose-related manner. Compared with amlodipine alone, the olmesartan/amlodipine combination has a better 24-h coverage (TPR) and a dose-related improvement in BP lowering homogeneity (SI).
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Bilo et al. (2014) conducted an RCT in Moderate-to-severe hypertension (n=626). Olmesartan/amlodipine vs. Amlodipine 5 mg was evaluated on Change in 24-h systolic blood pressure from baseline to week 16 (p=<0.0001). Olmesartan/amlodipine combination therapy reduced 24-h systolic blood pressure by up to 10.6 mm Hg compared to a 3.5 mm Hg reduction with amlodipine alone.
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