Key result
First-line aliskiren/amlodipine lowers systolic BP by an additional ~10 mmHg over amlodipine in severe hypertension.
Why the study?
The effectiveness of initiating therapy with an aliskiren/amlodipine combination compared to amlodipine alone for reducing blood pressure in subgroups of patients with moderate and severe hypertension needed to be assessed.
Does first-line combination therapy with aliskiren/amlodipine provide greater blood pressure reductions than amlodipine monotherapy at 8 weeks in patients with moderate or severe hypertension?
RCT
Double-blind
1:1
Yes
Does first-line combination therapy with aliskiren/amlodipine provide greater blood pressure reductions than amlodipine monotherapy at 8 weeks in patients with moderate or severe hypertension?
First-line combination therapy with aliskiren/amlodipine provides significantly greater blood pressure reductions, higher blood pressure control rates, and lower rates of peripheral edema than amlodipine monotherapy in patients with moderate to severe hypertension.
Answers are grounded in this paper and cite their sources.
Supports first-line aliskiren/amlodipine for greater BP reduction in moderate-severe hypertension; extends RCT evidence for initial dual therapy over monotherapy.
Objective: To assess the effectiveness of initiating therapy with aliskiren/amlodipine (ALI/AML) compared to AML alone in reducing blood pressure (BP) in the subgroups of patients with severe (baseline msSBP: ≥180 to < 200) and moderate BP (baseline msSBP ≥160 to < 180 mmHg). Methods: This was an 8-wk, multicenter, randomized, double-blind study. After a 1 - 4-wk washout period, all eligible patients (msSBP ≥160 to <200 mmHg) were randomized (1:1) to receive a once-daily dose of ALI/AML 150/5 mg or AML 5 mg for 1 wk followed by double the initial dose (ALI/AML 300/10 mg or AML 10 mg) for 7 wks. Summary statistics for blood pressure reductions were produced and treatment comparisons were made using ANCOVA with treatment and region as factors, and corresponding baseline BP as a covariate. Results: Mean baseline BP was 187.1/97.1 and 167.7/94.2 mmHg for patients in the severe and moderate subgroups. Baseline BP levels were similar for both treatment groups. At Wk 8 endpoint, mean BP reductions from baseline were -49.2/-18.1 and -35.6/-15.4 mmHg with ALI/AML combination and -39.7/-13.6 and -29.5/-12.3 mmHg with AML alone in patients for the severe and moderate subgroups, respectively. Differences in least-square mean reductions in BP for ALI/AML vs. AML were significant for both subgroups (Table; p < 0.01 from ANCOVA). The percentage of patients achieving BP control at Wk 8 was also significantly greater with ALI/AML vs. AML alone for both subgroups (Table; p < 0.05). The overall incidence of AEs was similar between ALI/AML and AML groups. Peripheral edema was the most commonly reported AE, with lower incidence in ALI/AML (14.4%) than AML (18.3%). Conclusion: In patients with severe or moderate BP, first-line use of ALI/AML provided greater BP reductions and higher rates of BP control compared to AML alone. ALI/AML combination represents an important potential first-line treatment option for patients with moderate to severe hypertension.
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Braun-Dullaeus et al. (2010) conducted an RCT in Moderate to severe hypertension. Aliskiren/amlodipine combination vs. Amlodipine alone (5 mg once daily for 1 week followed by 10 mg once daily for 7 weeks) was evaluated on Mean blood pressure reduction from baseline at Week 8 in severe and moderate hypertension subgroups (p=<0.01). First-line aliskiren/amlodipine reduced BP in severe and moderate hypertension more than amlodipine alone.
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