암환자의 정맥혈전색전증 치료에서 rivaroxaban과 dalteparin의 출혈 부작용 비교
Comparisons of Bleeding Risks between Rivaroxaban and Dalteparin for Treatment of Venous Thromboembolism in Cancer Patients
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Background: Venous thromboembolism (VTE) is a common and life-threating condition in cancer patients. Low molecular weight heparins (LMWH), such as dalteparin, are recommended in the treatment of VTE. Also, rivaroxaban, an orally administered direct factor Xa inhibitor, was approved for the treatment of VTE. It showed similar efficacy to standard therapy (LMWH or warfarin) and was associated with significantly lower rates of major bleedings. However, in the real world, bleeding has been reported to occur frequently in cancer patient receiving rivaroxaban. The goal of this research was to analyze bleeding risks between rivaroxaban and dalteparin for treatment of VTE in cancer patients. Methods: Medical records of oncology patients who were treated with rivaroxaban or dalteparin for VTE from July 2012 to June 2014 were retrospectively reviewed. Data collected were as follows: age, sex, weight, height, cancer types and stages, ECOG (eastern cooperative oncology group) PS (performance score), VTE types, concurrently used medications, study drug information (dose and duration of therapy), INR (international normalized ratio), PT (prothrombin time), and platelet counts. Bleeding was classified into major bleedings, clinically relevant non-major bleedings, and minor bleedings. Results: A total of 399 patients were included in the study. Of these patients, 246 were treated with rivaroxaban and 153 with dalteparin. Bleeding rates were significantly higher in the rivaroxaban group than in the dalteparin group (adjusted odds ratio (AOR) 2.09, 95% CI 1.22-3.60) after adjusting for confounders. In addition, rivaroxaban remained independentlyassociated with 1.78-fold (95% CI 1.14-2.76) shorter time to bleeding compared to dalteparin after adjusting other factors known to be associated with poor outcomes. Conclusion: This study suggested that rivaroxaban was associated with an increased risk of bleedings in cancer patients.
Abstract
Background: Venous thromboembolism (VTE) is a common and life-threating condition in cancer patients. Low molecular weight heparins (LMWH), such as dalteparin, are recommended in the treatment of VTE. Also, rivaroxaban, an orally administered direct factor Xa inhibitor, was approved for the treatment of VTE. It showed similar efficacy to standard therapy (LMWH or warfarin) and was associated with significantly lower rates of major bleedings. However, in the real world, bleeding has been reported to occur frequently in cancer patient receiving rivaroxaban. The goal of this research was to analyze bleeding risks between rivaroxaban and dalteparin for treatment of VTE in cancer patients. Methods: Medical records of oncology patients who were treated with rivaroxaban or dalteparin for VTE from July 2012 to June 2014 were retrospectively reviewed. Data collected were as follows: age, sex, weight, height, cancer types and stages, ECOG (eastern cooperative oncology group) PS (performance score), VTE types, concurrently used medications, study drug information (dose and duration of therapy), INR (international normalized ratio), PT (prothrombin time), and platelet counts. Bleeding was classified into major bleedings, clinically relevant non-major bleedings, and minor bleedings. Results: A total of 399 patients were included in the study. Of these patients, 246 were treated with rivaroxaban and 153 with dalteparin. Bleeding rates were significantly higher in the rivaroxaban group than in the dalteparin group (adjusted odds ratio (AOR) 2.09, 95% CI 1.22-3.60) after adjusting for confounders. In addition, rivaroxaban remained independentlyassociated with 1.78-fold (95% CI 1.14-2.76) shorter time to bleeding compared to dalteparin after adjusting other factors known to be associated with poor outcomes. Conclusion: This study suggested that rivaroxaban was associated with an increased risk of bleedings in cancer patients.
참고문헌 (17)
- Sallah S, "Venous thrombosis in patients with solid tumors: determination of frequency and characteristics", J Thromb Haemost, 87(4), pp.575~579 (2002)
- Prandoni P, "Cancer and venous thromboembolism", Lancet Oncol, 6(6), pp.401~410 (2005)
- Buller HR, "Cancer and thrombosis:from molecular mechanisms to clinical presentations", J Thromb Haemost, 5(1), pp.246~254 (2007)
- Lyman GH, "American Society of Clinical Oncology guideline: recommendations for venous thromboembolism prophylaxis and treatment in patients with cancer", J Clin Oncol, 25(34), pp.5490~5505 (2007)
- Kearon C, "Antithrombotic therapy for venous thromboembolic disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition)", Chest, 133(6), pp.454S~545S (2008)
- Kubitza D, "Safety, pharmacodynamics, and pharmacokinetics of single doses of BAY 59-7939, an oral, direct factor Xa inhibitor", Clin Pharmacol Ther, 78(4), pp.412~421 (2005)
- Agnelli G, "Oral rivaroxaban for symptomatic venous thromboembolism", N Engl J Med, 363(26), pp.2499~2510 (2010)
- Buller HR, "Oral rivaroxaban for the treatment of symptomatic pulmonary embolism", N Engl J Med, 366(14), pp.1287~1297 (2012)
- Prins MH, "Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism:a pooled analysis of the EINSTEIN-DVT and PE randomized studies", Thromb J, 11(1), pp.21~ (2013)
- Beyer-Westendorf J, "Rates, management, and outcome of rivaroxaban bleeding in daily care: results from the Dresden NOAC registry", Blood, 124(6), pp.955~962 (2014)
- Chang HY, "Risk of gastrointestinal bleeding associated with oral anticoagulants: population based retrospective cohort study", BMJ, 350, pp.h1585~ (2015)
- Chew HK, "Incidence of venous thromboembolism and its effect on survival among patients with common cancers", Arch Intern Med, 166(4), pp.458~464 (2006)
- Patel MR, "Rivaroxaban versus warfarin in nonvalvular atrial fibrillation", N Engl J Med, 365(10), pp.883~891 (2011)
- Yamada N, "Oral rivaroxaban for Japanese patients with symptomatic venous thromboembolism-the J-EINSTEIN DVT and PE program", Thromb J, 13(2), pp.b13~ (2015)
- Lalibert F, "Real-world comparative effectiveness and safety of rivaroxaban and warfarin in nonvalvular atrial fibrillation patients", Curr Med Res Opin, 30(7), pp.1317~1325 (2014)
- Wasserlauf G, "Meta-analysis of rivaroxaban and bleeding risk", Am J Cardiol, 112(3), pp.454~460 (2013)
- Cohen AT, "Rivaroxaban for thromboprophylaxis in acutely ill medical patients", N Engl J Med, 368(6), pp.513~523 (2013)