Effect of Bisoprolol on the Level of Dabigatran

Nehaj, Frantisek; Sokol, Juraj; Ivankova, Jela; Mokáň, Marián; Mokáň, Marián

doi:10.1097/mjt.0000000000000786

Cited by 7 publications

(8 citation statements)

References 11 publications

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“…Baseline dabigatran plasma levels and plasma levels at 2 h following drug administration were found to be significantly higher in patients on concomitant bisoprolol (group 1) as compared to those not on bisoprolol (baseline: 161.35 ± 95.81 vs 87.94 ± 51.77 ng/mL; after 2 h: 236.87 ± 119.69 vs 151.00 ± 68.88 ng/mL). The authors concluded that an interaction between bisoprolol and dabigatran exists, and while there are no associations made between the increase in plasma drug concentrations and outcomes, this study supports further research to better define the impact these interactions have on clinical outcomes ( Nehaj et al, 2020 ) [c].…”

Section: Bisoprololmentioning

confidence: 58%

Beta adrenergic antagonists and antianginal drugs

Stever

Demitraszek

Murray

et al. 2021

Side Effects of Drugs Annual

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Section: Bisoprololmentioning

confidence: 58%

Beta adrenergic antagonists and antianginal drugs

Stever

Demitraszek

Murray

et al. 2021

Side Effects of Drugs Annual

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“…22,25,26 Although there are differences between these 2 assays, the measurement outcomes are not so different, as 20% difference is negligible from a clinical perspective. A total of 5 dabigatran-drug interaction studies [72][73][74][75][76] were identified from the search but excluded from the meta-analysis as they may affect the estimated pooled concentrations. The use of concomitant proton-pump inhibitor with dabigatran was observed in 3 studies and found to significantly decrease dabigatran concentration.…”

Section: Discussionmentioning

confidence: 99%

“…74,76 Dabigatran etexilate is a substrate of P-gp transporter, and concomitant administration of P-gp inhibitor can increase the bioavailability of dabigatran, therefore resulting in higher dabigatran concentration. 74,76 There are some limitations in this study. Seven articles were excluded from the systematic review as they were not in English.…”

Section: Discussionmentioning

confidence: 99%

A systematic review and meta‐analysis of dabigatran peak and trough concentration in adults

Tahir

Chin

et al. 2022

Brit J Clinical Pharma

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Dabigatran etexilate is an oral direct thrombin inhibitor used in preventing thromboembolism in patients with atrial fibrillation and several other conditions. Routine dabigatran concentration monitoring is not recommended in clinical practice; however, measurement of dabigatran concentration may be required in several conditions. This study aims to pool the peak and trough dabigatran concentration from real‐world studies. A systematic review was performed to identify studies that measured the peak and trough dabigatran concentrations. Observational studies reporting dabigatran peak or trough concentrations and patients' clinical characteristics of either sex, age or weight were included. Random‐effect meta‐analyses and metaregression were conducted to pool dabigatran concentrations and to identify the correlation between factors affecting dabigatran concentrations. Fifteen studies with a total of 1226 patients were included. The pooled peak dabigatran concentration was 133 ng/mL (95% CI: 113–154, I2 = 86%, n = 655), while the pooled dabigatran trough concentration was 80 ng/mL (95% CI: 69–91, I2 = 93%, n = 1010). Metaregression analyses suggested that age is significantly correlated to trough concentration, while body weight and creatinine clearance significantly correlated to peak concentration. Subgroup results revealed that dabigatran concentration when measured with liquid chromatography–tandem mass spectrometry was higher than haemoclot thrombin inhibitor assay. Several guidelines have proposed dabigatran concentrations target range and the pooled dabigatran concentrations were in line with the suggested range. Further studies to correlate dabigatran concentrations and clinical outcomes is warranted to improve the safety and efficacy monitoring of dabigatran therapy.

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“…This does not exclude that, in the context of polytherapy, other drugs may, in some way, have altered the absorption or metabolism of apixaban, considering the patient was taking bisoprolol, zofenopril, amlodipine, and furosemide for hypertension and lansoprazole for gastric protection. In the literature, there are some hints regarding bisoprolol and P-gp, and at least one evidence of interaction with dabigatran, although with contrasting evidence [ 47 , 48 , 49 , 50 , 51 , 52 ]. Therefore, considering that dabigatran itself is a substrate of P-gp, a further hypothesis is that a specific interaction regarding amlodipine, bisoprolol, or other drugs prescribed may have selectively altered the absorption (or excretion) of apixaban.…”

Section: Discussionmentioning

confidence: 99%

Cutaneous Ulcer Caused by Apixaban Treatment Is Resolved after Replacement with Dabigatran

et al. 2022

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Nowadays, novel oral anticoagulants (NOACs) have shown improved safety profile and efficacy compared to vitamin K antagonists in the prevention of thromboembolic events occurring during different pathological conditions. However, there are concerns and safety issues, mostly related to adverse events following interactions with other drugs, in real-world practice. We report the case of an 83-year-old woman who developed a non-bleeding leg ulcer not caused by trauma or other evident pathological conditions after 10 days of treatment with apixaban 5 mg/q.d. She was switched from apixaban to dabigatran and the leg ulcer rapidly improved and completely cicatrized in 40 days. The resolution of the ulcer and the toleration of dabigatran therapy suggest an apixaban-specific reaction; however, the pathological mechanism of ulcer onset is currently unclear. Careful evaluation of hospital databases of Molise region (Southern Italy) hospitals identified two similar cases between 2019 and 2021. These cases underline the necessity of careful post-marketing surveillance, considering the rapidly increasing number of patients treated with NOACs and patient’s risk factors such as old age, high polypharmacy rate, co-morbidities, and peculiar genetic background related to NOACs pharmacokinetic features.

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Effect of Bisoprolol on the Level of Dabigatran

Abstract: This study demonstrated the interaction between dabigatran and bisoprolol, which is modulated with dabigatran dosage and concomitant treatment with proton-pump inhibitor and digoxin.

Cited by 7 publications

References 11 publications

Beta adrenergic antagonists and antianginal drugs

Beta adrenergic antagonists and antianginal drugs

A systematic review and meta‐analysis of dabigatran peak and trough concentration in adults

Cutaneous Ulcer Caused by Apixaban Treatment Is Resolved after Replacement with Dabigatran

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