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Dabigatran etexilate: appropriate use in patients with chronic kidney disease and in the elderly patients
Mauro Molteni1, Mario Bo2, Giovanni Di Minno3
1Internal Medicine, Vimercate Hospital, Vimercate, MB, Italy. mauro.molteni@asst-vimercate.it.
Insights
Dabigatran etexilate (DE) is safe for elderly patients and those with mild-to-moderate kidney issues. Evidence shows its benefits outweigh risks, challenging physician concerns about using this direct thrombin inhibitor in these populations.
Area of Science:
- Pharmacology and Therapeutics
- Cardiology
- Nephrology
Background:
- Dabigatran etexilate (DE) is a direct thrombin inhibitor approved for non-valvular atrial fibrillation (AF) and venous thromboembolism (VTE).
- Physician concerns persist regarding DE use in patients with mild-to-moderate renal impairment and the elderly, despite robust safety and efficacy data.
- Patients with AF and chronic kidney disease (CKD) face elevated risks of stroke, bleeding, and mortality, necessitating careful anticoagulation management.
Purpose of the Study:
- To review scientific evidence supporting the use of dabigatran etexilate (DE) in patients with mild-to-moderate renal impairment and the elderly.
- To address physician perceptions and provide evidence-based guidance on DE prescribing in these specific patient groups.
Main Methods:
- Review of randomized clinical trials and independent observational studies on dabigatran etexilate (DE) safety and efficacy.
- Analysis of clinical benefit and safety data in patients with non-valvular atrial fibrillation (AF) and varying degrees of renal function.
- Evaluation of DE's performance in elderly populations, including comparisons with warfarin.
Main Results:
- The clinical benefit of DE versus warfarin is independent of renal function in patients without contraindications.
- In the elderly, DE 110 mg BID demonstrates comparable safety to warfarin, with preserved reduction in intracranial hemorrhages.
- DE 150 mg BID is not recommended for patients aged 80 years or older.
Conclusions:
- Mild and moderate chronic kidney disease (CKD) and advanced age should not be contraindications for prescribing dabigatran etexilate (DE).
- The clinical benefit of anticoagulation with DE is maintained across different age groups and renal function levels.
- The anticipated availability of a specific antidote for DE is expected to further enhance its clinical safety profile.
Abstract:
Dabigatran etexilate (DE) is a direct thrombin inhibitor, which has been approved for the treatment of non-valvular atrial fibrillation (AF), and for the prevention and treatment of venous thromboembolism (VTE). Despite large randomized clinical trials and independent observational studies providing robust data concerning DE safety and efficacy, some physicians still perceive mild-to-moderate renal impairment and old age as a relative contraindication to its use. In this article, we review the available scientific evidence supporting the use of DE in these clinical situations. Patients with AF and chronic kidney disease (CKD) are per se at high risk of stroke, bleeding and mortality. Although there is evidence of clinical benefit of anticoagulation in these patients, anticoagulant therapy requires caution and demands careful clinical monitoring, regardless of the drug used. In patients with no contraindication to its use, the clinical benefit of DE versus warfarin is independent of renal function. The elderly with AF are frequently undertreated because of the perception of high bleeding risk and limited clinical benefit. However, the clinical benefit of anticoagulation is independent of patient age, and age per se should not represent a contraindication to anticoagulation. DE has been extensively studied in the elderly, both in randomized clinical trials and in observational studies: DE 150 mg BID should not be used in patients 80 years of age or older, while DE 110 mg BID is as safe as warfarin. Intracranial haemorrhages reduction by DE compared with warfarin is preserved in the elderly. Therefore, mild and moderate CKD and being elderly should not deter physicians from prescribing DE. Furthermore, the availability of a specific antidote is expected to improve the safety of the use of DE in clinical practice.
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