Key result
Bisoprolol 10 mg decreases FEV1 in asthmatics with angina, unlike lower doses or amlodipine combinations.
Why the study?
The efficacy and safety of bisoprolol, verapamil, and their combination in patients with stable angina and concurrent mild or moderate persistent bronchial asthma were unclear.
Does bisoprolol or bisoprolol/amlodipine compared to verapamil safely provide antianginal efficacy without worsening bronchial patency in patients with stable angina and bronchial asthma?
RCT (n=120)
Open-label
randomized
Does bisoprolol or bisoprolol/amlodipine compared to verapamil safely provide antianginal efficacy without worsening bronchial patency in patients with stable angina and bronchial asthma?
Bisoprolol up to 10 mg or combined with amlodipine is safe in stable angina with mild asthma, but bisoprolol should not exceed 5 mg in moderate asthma to avoid bronchial obstruction.
Limit bisoprolol to 5 mg in moderate asthma; extends RCT evidence on beta-blocker safety in angina with BA.
Aim To compare efficacy and safety of treatments with the calcium antagonist (CA) verapamil, the cardioselective β-blocker (BB) bisoprolol, and a combination therapy with bisoprolol and amlodipine in patients with stable angina (SA) with concurrent mild and moderate, persistent bronchial asthma (BA). Material and methods This open, prospective, randomized, comparative study included 120 patients with an IHD+BA comorbidity. Of these patients, 60 had mild persistent BA and 60 had moderate persistent BA. Each group was divided into 3 subgroup, each including 20 patients, based on the used regimen of antianginal therapy. Stepwise dose titration was performed every 2 weeks (subgroup 1 received the BB bisoprolol 2.5 mg - 5 mg - 10 mg; subgroup 2 received the CA verapamil 240 mg - 240 mg - 240 mg; subgroup 3 received bisoprolol 2.5 mg followed by the combination treatment with bisoprolol and amlodipine as a fixed combination 5+5 mg). All patients underwent a complete clinical and instrumental examination at baseline and at 2, 4, and 6 weeks of treatment. The antianginal effectivity and the effect on bronchial patency were evaluated. Results In patients with SA and mild persistent BA, the study of external respiration function (ERF) at 2, 4, and 6 weeks of treatment did not detect any significant difference in the forced expiratory volume in 1 second (FEV1) between the treatment subgroups. In patients with SA and moderate persistent BA receiving the treatment, a significant decrease in FEV1 (р=0.022) was observed in subgroup 1 receiving bisoprolol 10 mg at 6 weeks of treatment. In subgroups 2 and 3 during the treatment, significant differences were absent. In patients with SA and mild or moderate persistent BA, the heart rate was significantly decreased in all three subgroups; however, in subgroup 2 receiving verapamil, the changes were considerably smaller than in other subgroups.Conclusion The study results showed that the BB bisoprolol with dose titration every two weeks from 2.5 to 10 mg or the combination treatment with the BB bisoprolol and the CA amlodipine can be used as the antianginal therapy in patients with SA and mild persistent BA. The BB bisoprolol may be used in patients with SA and moderate persistent BA as the antianginal therapy, but only at doses not exceeding 5 mg to avoid the development of bronchial obstruction. The combination therapy with the BB bisoprolol 5 mg and the CA amlodipine 5 mg is indicated to enhance antianginal and vasoprotective effects.
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Grigorieva et al. (2022) conducted an RCT in Stable angina with concurrent mild and moderate, persistent bronchial asthma (n=120). Bisoprolol or bisoprolol plus amlodipine vs. Verapamil 240 mg was evaluated on Forced expiratory volume in 1 second (FEV1) (p=0.022). Bisoprolol 10 mg significantly decreased FEV1 at 6 weeks in patients with stable angina and moderate persistent asthma (p=0.022), whereas lower doses or combination with amlodipine did not.
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