Key result
Adding bisoprolol 5 mg to amlodipine 5 mg in patients with uncontrolled hypertension significantly increased the achievement of target blood pressure at 8 weeks (65% vs 46%; p=0.0004).
Why the study?
The study was conducted to evaluate the antihypertensive effect and safety of combining bisoprolol 5 mg with amlodipine 5 mg compared to amlodipine 5 mg alone in hypertensive patients uncontrolled on amlodipine 5 mg.
Does the addition of bisoprolol 5 mg to amlodipine 5 mg improve blood pressure control in hypertensive patients uncontrolled on amlodipine 5 mg monotherapy?
RCT (n=367)
double-blind
randomized
Yes
Does the addition of bisoprolol 5 mg to amlodipine 5 mg improve blood pressure control in hypertensive patients uncontrolled on amlodipine 5 mg monotherapy?
Absolute Event Rate: 65% vs 46%
p-value: p=0.0004
Adding bisoprolol 5 mg to amlodipine 5 mg provides significant additional blood pressure lowering for patients uncontrolled on amlodipine monotherapy.
Supports adding bisoprolol to amlodipine in amlodipine-uncontrolled hypertension; confirms additive BP reduction in this RCT.
Objective To evaluate the antihypertensive effect and safety of bisoprolol 5 mg (BISO5mg) and amlodipine 5 mg (AMLO5mg) combination in comparison to AMLO5mg in hypertensive subjects uncontrolled with AMLO5mg.Methods Phase III, prospective, randomized, double-blind, placebo-controlled, 8-week trial with parallel design (EudraCT Number: 2019-000751-13).Results 367 patients aged 57.58 ± 14.62 years were randomized to BISO5mg once daily on top of AMLO5mg (n = 181) or placebo on top of AMLO5mg (n = 186). Systolic/diastolic blood pressure (SBP/DBP) in the bisoprolol-treated group was reduced by 7.2 ± 12.74/3.95 ± 8.85 mmHg at 4 weeks (both p < .0001) and by 5.5 ± 12.44/3.84 ± 9.46 mmHg at 8 weeks (p < .0001/p < .0002) compared to placebo control. Bisoprolol-treated group had lower heart rate than placebo control (difference −7.23 ± 9.84/−6.25 ± 9.26 beats per minute at 4 and 8 weeks, respectively, both p < .0001). Both target SBP and DBP was achieved at 4 weeks by 62 vs. 41% (p = .0002) and at 8 weeks by 65 vs. 46% (p = .0004) of bisoprolol-treated patients and placebo group patients, respectively. SBP <140 mmHg was achieved at 4 and 8 weeks in 68 and 69% of bisoprolol-treated patients and 45 and 50% of placebo group patients, respectively. No deaths and serious adverse events were reported. Adverse events occurred in 34 bisoprolol-treated patients vs. 22 patients in the placebo group (p = .064). Bisoprolol was withdrawn due to adverse events in 7 patients, mostly (n = 4) due to asymptomatic bradycardia.Conclusions Addition of bisoprolol to patients uncontrolled with amlodipine monotherapy significantly improves blood pressure control. We can expect additional 7.2/3.95 mmHg SBP/DBP lowering effect by adding bisoprolol 5 mg to amlodipine 5 mg.
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Jędrusik et al. (2023) conducted an RCT in hypertension uncontrolled on amlodipine 5 mg monotherapy (n=367). Bisoprolol vs. Placebo was evaluated on Achievement of both target SBP and DBP at 8 weeks (p=0.0004). Adding bisoprolol 5 mg to amlodipine 5 mg in patients with uncontrolled hypertension significantly increased the achievement of target blood pressure at 8 weeks (65% vs 46%; p=0.0004).
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