슬관절 전치환술 후 정맥혈전색전증 예방을 위한 Rivaroxaban과 Aspirin 사용 후의 혈액학적 변화의 비교

송무호(Moo-Ho Song),김부환(Bu-Hwan Kim),안성준(Seong-Jun Ah),유성호(Seong-Ho Yoo),김영준(Yeong-Joon Kim) 대한정형외과학회 2012 대한정형외과학회지 Vol.47 No.6

목적: 슬관절 전치환술 후 정맥혈전색전증 예방을 위해 사용하는 Rivaroxaban 또는 Aspirin 사용 후의 혈액학적 변화 및 문제점을 평가하였다. 대상 및 방법: 2010년 7월부터 2011년 3월까지 Rivaroxaban을 사용한 50명과 Aspirin을 사용한 50명의 두 군으로 나누어 혈색소 감소량 및 수혈 빈도의 차이를 비교하였다. 결과: Rivaroxaban군의 평균 혈색소 감소량은 4.7 (3.1-6.6)이었고, Aspirin군은 평균 3.6 (2.0-5.1) 감소되었다(p〈0.05). 혈색소가 8 g/dl 이하로 감소된 경우는 Rivaroxaban군 23명(46%), Aspirin군 9명(18%)이었고 수혈 받은 환자는 Rivaroxaban군 12명(24%), Aspirin군 2명(4%)으로 Rivaroxaban군에서 혈색소 감소량 및 수혈 빈도가 높았으며 통계학적으로 유의한 차이를 보였다(p〈0.05). 결론: Rivaroxaban군에서 Aspirin군보다 실혈량의 증가로 인한 수혈 대상군의 유의한 증가를 보여 표준 정맥혈전색전증 위험도 환자군에서의 Rivaroxaban 사용에 주의가 필요할 것으로 생각된다. Purpose: To compare the hematologic changes and the rates of transfusion of patients using rivaroxaban or aspirin for venous thromboembolism prophylaxis after a total knee arthroplasty. Materials and Methods: Among patients with total knee arthroplasty from July 2010 to March 2011, two groups of 100 consecutive cases were enrolled in this study, 50 patients with Rivaroxaban group and 50 patients with Aspirin group for venous thromboembolism prophylaxis after a total knee arthoplasty. Hematologic changes and transfusion rates were calculated in each group. Results: The mean of decreased hemoglobin was 4.7 (3.1-6.6) in the Rivaroxaban group and 3.6 (2.0-5.1) in the Aspirin group (p<0.05). The number of patients with decreased hemoglobin of less than 8 g/dl was observed in 23 cases (46%) in the Rivaroxaban group, and 9 cases (18%) in the Aspirin group. The numbers of patients who needed transfusion were 12 in the Rivaroxaban group, and 2 in the Aspirin group (p<0.05). Conclusion: Rivaroxaban group revealed more significant decrease of hemoglobin and needed more transfusion than the Aspirin group did. For the prevention of venous thromboembolism after total knee arthroplasty, we should be careful using Rivaroxaban for the standard risk patients of venous thromboembolism.

국내 대학병원에서의 Rivaroxaban 처방 적정성 평가

이수연,윤태원,손기호 한국병원약사회 2015 病院藥師會誌 Vol.32 No.1

Rivaroxaban is useful advantageous because it does not require routine lab monitoring,such as the PT/INR of warfarin. However, dose adjustments are recommended for patients with renalfailure. Also, deep vein thrombosis and pulmonary embolism are required for the initial treatment,and the initial dose is 15 mg twice daily for 3 weeks. Furthermore, the Health Insurance Review &Assessment Service (HIRA) has regulated the clinical use of rivaroxaban for certain indications. Theserestrictions should be reviewed before prescribing rivaroxaban. The aim of this study was to investigate and evaluate the patterns of rivaroxaban usage, and tomonitor its administration according to the recommended dose and the standards of the NationalHealth Insurance in Ulsan University Hospital (UUH). A retrospective analysis was performed by using an electronic medical record database. This study was conducted through a retrospective medical chart review of 145 patients who received rivaroxabanfrom October 1, 2013 to February 28, 2014 at UUH. The evaluation of rivaroxaban use was based on the standards of the American Society of Health-System Pharmacists, which were modified to fit this study. The results are as follows. First, there were 75 (52%) patients who were 65 years of age or older,consisting of 17 male patients and 58 female patients. Second, there were 7 (5%) patients with moderate renal failure, in which two of them showed nonvalvularatrial filbrillation and required a dosage reduction of rivaroxaban. Third, 137 of 145 patients were consistent with indication criteria (95%), and 86 patients did notreceive National Health Insurance coverage. In this case, 40% of the DUE criteria rate was suitablefor administration. Also, 33 patients suffering from an embolism (DVT or PE) were recommended forthe initial treatment, which is 15 mg twice daily for 3 weeks. However, 26 of those patients received apotentially inappropriate initial treatment, while 7 patients received an appropriate initial treatment. Finally, 4 cases reported to have adverse events. One of the reports consisted of skin rash due to anadverse drug reaction to rivaroxaban. The other three adverse events were unlikely due to rivaroxaban. The justification of use based on indications showed a high rate (95%) of its appropriateness, whilethe justification of use in the other three criteria showed a lower than average rate (37%). One case ofa skin rash was possibly related to an adverse reaction to rivaroxaban. Furthermore, the results of this study show that additional research is warranted on other new oralanticoagulants.

암환자의 정맥혈전색전증 치료에서 rivaroxaban과 dalteparin의 출혈 부작용 비교

김윤경,안숙희,김재연,정지은,곽혜선 한국임상약학회 2016 한국임상약학회지 Vol.26 No.3

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 independently associated 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.

비판막성 심방세동 환자의 뇌졸중 예방에서 dabigatran과 rivaroxaban의 임상적용의 현황

박유경,강지은,김승준,라현오,이정연 한국임상약학회 2016 한국임상약학회지 Vol.26 No.3

Objective: Prescription rate of dabigatran and rivaroxaban, which are the direct oral anticoagulants (DOAC), has increased. We have analyzed the prescription trend and medication use of dabigatran and rivaroxaban in patients with non-valvular atrial fibrillation (NVAF). Methods: It was retrospectively studied from September 2012 to April 2014 using the electronic medical records and the progress notes. Patients with NVAF (n=424) were evaluated on the medication use, prescribing preferences, adverse drug reactions (ADRs) and the availability of prescription reimbursement of dabigatran (n=210) and rivaroxaban (n=214). Results: Dabigatran was prescribed higher than rivaroxaban (23.3% versus 7.5%, p<0.001) in the neurology department, but rivaroxaban was prescribed higher compared to dabigatran in the cardiology department (87.4% versus 74.3%, p<0.001). Dabigatran was prescribed more than rivaroxaban in high risk patients with CHADS2 score ≥ 3 (44.3% versus 31.3%, p=0.006). Dabigatran patients seemed to have more ADRs than patients with rivaroxaban (25.2% versus 11.2%, p<0.001), but no serious thrombotic events and bleeding were found. Only 35.6% (n=151) were eligible for prescription reimbursement by the National Health Insurance (NHI). Bridging therapy (86, 31.5%) and direct-current cardioversion (57, 20.2%) were main reasons of ineligibility for reimbursement. Conclusion: Prescription preferences were present in choosing either dabigatran or rivaroxaban for patients with NVAF. Inpatient protocols and procedures considering patient-factors in NVAF need to be developed.

A Study on the Efficacy and Safety of Rivaroxaban in Urologic Cancer-Associated Venous Thromboembolism

Jang Ho Lee(이장호),Dalsan You(유달산),Sang-Do Lee(이상도),Yeon-Mok Oh(오연목),Jae Seung Lee(이재승) 대한비뇨기종양학회 2019 대한비뇨기종양학회지 Vol.17 No.3

Purpose: Although direct oral anticoagulants (DOACs) are recommended as an alternative to low-molecular weighted heparin for cancer-associated venous thromboembolism (VTE), there is no firm evidence on the efficacy and safety of DOACs in patients with urologic cancer. Therefore, we compared the efficacy and safety of rivaroxaban and dalteparin for treating cancer-associated VTE in urologic cancer. Materials and Methods: We reviewed the medical records of 124 eligible VTE patients with urologic cancers who were treated with dalteparin or rivaroxaban. The primary outcome was the composite event of clinically relevant bleeding or VTE recurrence. The secondary outcomes were VTE recurrence, clinically relevant bleeding events, and all-cause mortality. Results: During anticoagulation period, there was no significant difference in primary and secondary outcomes between the groups. In Cox proportional hazards model for composite events, although there was no statistical significance, rivaroxaban presented lower hazard ratio (HR) than dalteparin (HR, 0.472; 95% confidence interval [CI], 0.210-1.060; p=0.069 in univariate analysis; HR, 0.505; 95% CI, 0.206-1.234; p=0.134 in multivariate analysis). In clinically relevant bleeding events, there was no significance difference between rivaroxaban and dalteparin (HR, 0.568; 95% CI, 0.238-1.358; p=0.203 in univariate analysis; HR, 0.617; 95% CI, 0.232-1.636; p=0.331 in multivariate analysis). Conclusions: Rivaroxaban can be regarded as a valuable option for VTE in urologic cancer. Further prospective studies are warranted to prove the safety or efficacy of rivaroxaban for treating VTE in patients with urologic cancer.

A Study on the Efficacy and Safety of Rivaroxaban in Urologic Cancer-Associated Venous Thromboembolism

이장호,유달산,이상도,오연목,이재승 대한비뇨기종양학회 2019 대한비뇨기종양학회지 Vol.17 No.3

Purpose: Although direct oral anticoagulants (DOACs) are recommended as an alternative to low-molecular weighted heparin for cancer-associated venous thromboembolism (VTE), there is no firm evidence on the efficacy and safety of DOACs in patients with urologic cancer. Therefore, we compared the efficacy and safety of rivaroxaban and dalteparin for treating cancer-associated VTE in urologic cancer. Materials and Methods: We reviewed the medical records of 124 eligible VTE patients with urologic cancers who were treated with dalteparin or rivaroxaban. The primary outcome was the composite event of clinically relevant bleeding or VTE recurrence. The secondary outcomes were VTE recurrence, clinically relevant bleeding events, and all-cause mortality. Results: During anticoagulation period, there was no significant difference in primary and secondary outcomes between the groups. In Cox proportional hazards model for composite events, although there was no statistical significance, rivaroxaban presented lower hazard ratio (HR) than dalteparin (HR, 0.472; 95% confidence interval [CI], 0.210–1.060; p=0.069 in univariate analysis; HR, 0.505; 95% CI, 0.206–1.234; p=0.134 in multivariate analysis). In clinically relevant bleeding events, there was no significance difference between rivaroxaban and dalteparin (HR, 0.568; 95% CI, 0.238–1.358; p=0.203 in univariate analysis; HR, 0.617; 95% CI, 0.232–1.636; p=0.331 in multivariate analysis). Conclusions: Rivaroxaban can be regarded as a valuable option for VTE in urologic cancer. Further prospective studies are warranted to prove the safety or efficacy of rivaroxaban for treating VTE in patients with urologic cancer.

A prospective, observational study of rivaroxaban for stroke prevention in atrial fibrillation: the XANAP Korea

( Jaemin Shim ),( Young Keun On ),( Sun U. Kwon ),( Gi-byoung Nam ),( Moon-hyoung Lee ),( Hyung-wook Park ),( Keun-sik Hong ),( Nam-ho Kim ),( Pierre Amarenco ),( Seung-woon Rha ),( Dong-gu Shin ),( J 대한내과학회 2021 The Korean Journal of Internal Medicine Vol.36 No.4

Background/Aims: Atrial fibrillation (AF)-related stroke accounts for 20% of ischemic strokes. Rivaroxaban use in AF patients for preventing stroke and systemic embolism was approved in 2013 in Korea. This study was to investigate the safety and effectiveness of rivaroxaban use in Korean patients with non-valvular AF in a real-world setting. Methods: This was an analysis of the Korean patients in Xarelto for Prevention of Stroke in Patients with Atrial Fibrillation in Asia-Pacific (XANAP), which was a prospective, observational cohort study including patients with non-valvular AF starting rivaroxaban treatment to prevent stroke or non-central nervous system systemic embolism (non-CNS SE), conducted in 10 Asian countries. Results: A total of 844 patients were enrolled in the Korean portion of the XANAP study. In XANAP Korea, the mean age was 70.1 years and 62.6% were males. The mean CHADS₂ score was 2.5 and the mean CHA₂DS₂-VASc score was 3.8. 47% of the patients had experienced prior stroke or non-CNS SE or transient ischemic attack. 73.6% of the patients had CHADS₂ score ≥ 2. Incidence proportions of 0.8% of the patients (1.1 per 100 patient-years) developed adjudicated treatment-emergent major bleeding. Death was observed in 1.2% of the patients. The incidence of non-major bleeding as well as thromboembolic event were 8.4% (11.6 per 100 patient-years) and 1.5% (2.0 per 100 patient-years), respectively. Conclusions: This study reaffirmed the consistent safety profile of rivaroxaban. We found consistent results with overall XANAP population for rivaroxaban in terms of safety in non-valvular AF patients for the prevention of stroke and non- CNS SE.

CASE REPORT : Effect of Rivaroxaban on Fibrinolytic Therapy in Massive Pulmonary Embolism: Two Cases

( Hye Jin Kim ),( So My Koo ),( Nam Suk Ham ),( Ki Up Kim ),( Soo Taek Uh ),( Yang Ki Kim ) 대한결핵 및 호흡기학회 2014 Tuberculosis and Respiratory Diseases Vol.76 No.3

The risk of dying from a pulmonary embolism (PE) is estimated to be about 30% if inotropic support is required and no cardiopulmonary arrest occurs. Fibrinolysis in massive PE is regarded as a life-saving intervention, unless there is a high risk of bleeding following the use of the fibrinolytic therapy. Rivaroxaban is an oral factor Xa inhibitor, however its anticoagulation effects before or after administration of fibrinolytics in massive PE are still unknown. Two patents were admitted: 61-year-old woman with repeated syncope, and a 73-year-old woman was admitted with dyspnea and poor oral intake. Systemic arterial hypotension with radiologic confirmation led to a diagnosis of massive PE in both patients. Rivaroxaban was administered before in one, and after firbrinolytic therapy in the other. One showed similar efficacy of rivaroxaban with currently used anticoagulants after successful fibrinolysis, and the other one without antecedent administration of the fibrinolytic agent showed unfavorable efficacy of rivaroxaban.

Effect of Rivaroxaban on Fibrinolytic Therapy in Massive Pulmonary Embolism: Two Cases

Kim, Hye-Jin,Koo, So-My,Ham, Nam-Suk,Kim, Ki-Up,Uh, Soo-Taek,Kim, Yang-Ki The Korean Academy of Tuberculosis and Respiratory 2014 Tuberculosis and Respiratory Diseases Vol.76 No.3

The risk of dying from a pulmonary embolism (PE) is estimated to be about 30% if inotropic support is required and no cardiopulmonary arrest occurs. Fibrinolysis in massive PE is regarded as a life-saving intervention, unless there is a high risk of bleeding following the use of the fibrinolytic therapy. Rivaroxaban is an oral factor Xa inhibitor, however its anticoagulation effects before or after administration of fibrinolytics in massive PE are still unknown. Two patents were admitted: 61-year-old woman with repeated syncope, and a 73-year-old woman was admitted with dyspnea and poor oral intake. Systemic arterial hypotension with radiologic confirmation led to a diagnosis of massive PE in both patients. Rivaroxaban was administered before in one, and after firbrinolytic therapy in the other. One showed similar efficacy of rivaroxaban with currently used anticoagulants after successful fibrinolysis, and the other one without antecedent administration of the fibrinolytic agent showed unfavorable efficacy of rivaroxaban.

Effect of Rivaroxaban on Fibrinolytic Therapy in Massive Pulmonary Embolism: Two Cases

김혜진,김양기,구소미,함남석,김기업,어수택 대한결핵및호흡기학회 2014 Tuberculosis and Respiratory Diseases Vol.76 No.3

The risk of dying from a pulmonary embolism (PE) is estimated to be about 30% if inotropic support is required and no cardiopulmonary arrest occurs. Fibrinolysis in massive PE is regarded as a life-saving intervention, unless there is a high risk of bleeding following the use of the fibrinolytic therapy. Rivaroxaban is an oral factor Xa inhibitor, however its anticoagulation effects before or after administration of fibrinolytics in massive PE are still unknown. Two patents were admitted: 61-year-old woman with repeated syncope, and a 73-year-old woman was admitted with dyspnea and poor oral intake. Systemic arterial hypotension with radiologic confirmation led to a diagnosis of massive PE in both patients. Rivaroxaban was administered before in one, and after firbrinolytic therapy in the other. One showed similar efficacy of rivaroxaban with currently used anticoagulants after successful fibrinolysis, and the other one without antecedent administration of the fibrinolytic agent showed unfavorable efficacy of rivaroxaban.