What to add to amlodipine when it alone is not enough for hypertension?
Treating hypertension is a daily task for not only general practitioners and cardiologists. Polish doctors evaluated the effect of adding bisoprolol on the blood pressure of patients with inadequately controlled hypertension on amlodipine monotherapy in a placebo-controlled AMCOR study.
Study Methodology
This was an 8-week prospective randomized double-blind placebo-controlled study. The effectiveness of adding the beta-blocker (BB) bisoprolol at a dose of 5 mg/day or placebo to the calcium channel blocker (CCB) amlodipine at a dose of 5 mg/day was compared in patients with inadequately controlled hypertension on amlodipine monotherapy 5 mg/day.
A total of 367 patients aged 43 to 72 years (average age 57.6 years) with uncontrolled hypertension were included in the study. All of them were using amlodipine in monotherapy at a daily dose of 5 mg. They were randomized in a 1:1 ratio to receive either 5 mg bisoprolol or placebo.
Results
In the bisoprolol group, blood pressure decreased by 7.2 ± 12.74/3.95 ± 8.85 mmHg after 4 weeks of therapy and by 5.5 ± 12.44/3.84 ± 9.46 mmHg after 8 weeks. Patients in the bisoprolol group also had a lower heart rate compared to the placebo group by 7.23 ± 9.84/min after 4 weeks and by 6.25 ± 9.26/min after 8 weeks of therapy.
The target blood pressure was achieved after 4 weeks in 62% of patients on the antihypertensive combination compared to 41% of patients on amlodipine and placebo; after 8 weeks, it was 65% compared to 46%. Systolic pressure < 140 mmHg was achieved in 68% and 69% of patients with bisoprolol + amlodipine at weeks 4 and 8, respectively, compared to 45% and 50% with placebo + amlodipine.
Adverse events were reported in 34 patients with bisoprolol + amlodipine and in 22 with placebo + amlodipine. The BB had to be discontinued in 7 patients, mainly due to asymptomatic bradycardia. No serious adverse events occurred.
Conclusion
According to the results of the AMCOR study, it can be expected that in patients with inadequately controlled hypertension on amlodipine monotherapy (5 mg/day), adding bisoprolol (5 mg/day) will result in an average blood pressure reduction of 7/4 mmHg.
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Source: Jędrusik P., Placha G., Gaciong Z.; AMCOR Trial Investigators. 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. Curr Med Res Opin 2023 Jul; 39 (7): 939−946, doi: 10.1080/03007995.2023.2223915.
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