Safety outcomes of apixaban in patients with nonvalvular atrial fibrillation and severe renal impairment
| Autor: | Ross M Nesbit, Robert A Moye, Terry A Hodge, Maura J Jones, Andrea S. Franks, Sarah T Eudaley |
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| Rok vydání: | 2020 |
| Předmět: |
Male
medicine.medical_specialty Time Factors Pyridones Renal function Administration Oral Hemorrhage 030204 cardiovascular system & hematology Kidney Risk Assessment Severity of Illness Index Drug Administration Schedule 03 medical and health sciences 0302 clinical medicine Pharmacokinetics Risk Factors Internal medicine Atrial Fibrillation medicine Clinical endpoint Humans 030212 general & internal medicine Aged Retrospective Studies Aged 80 and over Hematology business.industry Incidence (epidemiology) Atrial fibrillation Retrospective cohort study Middle Aged medicine.disease Stroke Treatment Outcome Pyrazoles Apixaban Female Kidney Diseases Cardiology and Cardiovascular Medicine business medicine.drug Factor Xa Inhibitors |
| Zdroj: | Journal of thrombosis and thrombolysis. 50(2) |
| ISSN: | 1573-742X |
| Popis: | Apixaban is prescribed for stroke prevention in nonvalvular atrial fibrillation (NVAF) in patients with varying degrees of renal dysfunction. While pharmacokinetic data support apixaban in severe renal impairment, clinical safety outcomes data are limited. This retrospective cohort analysis was conducted to evaluate the safety of apixaban in patients with NVAF and renal impairment. A total of 340 patients with NVAF receiving apixaban 5 mg or 2.5 mg twice daily were included for analysis; 287 preserved renal function (pRF: CrCl ≥ 25 ml/min and SCr ≤ 2.5 mg/dl) and 53 impaired renal function (iRF: CrCl 25 ml/min and/or SCr 2.5 mg/dl). The primary endpoint was major bleeding in patients taking apixaban 5 mg. Secondary endpoints included major bleeding with apixaban 2.5 mg and minor bleeding in both groups. There was no difference in major bleeding events in the 5 mg pRF group (4.41%) versus iRF group (3.57%) (P = 0.66). Similar rates occurred between the 2.5 mg pRF and iRF groups. Minor bleeding events were similar regardless of renal function. The incidence of bleeding in the 5 mg group was 11.45% with pRF versus 10.71% with iRF (P = 0.6). In the 2.5 mg group, bleeding incidence was 10% with pRF versus 16% with iRF (P = 0.47). There were no observed differences in bleeding between groups with pRF or iRF, regardless of apixaban dose. Because patients with severe renal impairment were excluded from original trials, this study contributes clinical safety outcomes to the limited data for use of apixaban in this patient population. |
| Databáze: | OpenAIRE |
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