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Efficacy and safety of bisoprolol 5 mg plus amlodipine 5 mg in patients with hypertension uncontrolled on monotherapy with 5 mg of amlodipine, a phase III multicenter, randomized, double-blind, placebo-controlled clinical trial – the AMCOR study
Bibliografi
Author:
Jedrusik, Piotr
;
Placha, Grzegorz
;
Gaciong, Zbigniew
;
AMCOR Trial Investigators
Topik:
Bisoprolol
;
Amlodipine
;
Combination therapy
;
Hypertension
;
Antihypertensive effect
;
Safety
Bahasa:
(EN )
Penerbit:
Routledge Taylor & Francis Group
Tempat Terbit:
New York
Tahun Terbit:
2023
Jenis:
Article - diterbitkan di jurnal ilmiah internasional
Fulltext:
Efficacy and safety of bisoprolol 5 mg plus amlodipine 5 mg.pdf
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)
Abstract
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 Bisoprolol was withdrawn due to adverse events in 7 patients, mostly (n?=?4) due to asymptomatic bradycardia.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.
Kajian editorial
Article from journal : Current medical research and opinion, 2023, VOL. 39, NO. 7, 939–946
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