| アブストラクト | Edoxaban (Edx) has been approved to prevent venous thromboembolism after total knee and/or hip arthroplasty in Japan. However, the risk of anemia with Edx treatment remains elusive. No risk factors for Edx-associated anemia after orthopedic surgery have been reported. This study aimed to clarify the risk of anemia associated with Edx treatment and determine the risk factors for Edx-associated anemia after orthopedic surgery with a high risk for bleeding. First, the association between Edx treatment and the incidence of anemia-related events was retrospectively investigated by pharmacovigilance analyses using data from 5769,866 reports between the first quarters of 2016 and 2020 in the Food and Drug Administration Adverse Event Reporting System and 2752,050 reports between the fourth quarters of 2011 and 2019 in the Japanese Adverse Drug Event Report. Second, 221 patients who underwent Edx treatment after total knee and/or hip arthroplasty between July 2011 and June 2012 at a single center were included in a case-control study to clarify the risk factors for anemia. Edx treatment was associated with an increased risk of anemia-related events in orthopedic patients. Reduced renal function was identified as a critical risk factor for Edx-associated anemia after orthopedic surgery. The present study indicates that renal function should be considered in the risk management of increased Edx-associated anemia after orthopedic surgery. |
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| 投稿者 | Izushi, Yasuhisa; Takami, Yoichiro; Ushio, Soichiro; Tetsunaga, Tomonori; Shiota, Naofumi; Yamamoto, Hiroshi; Sato, Toru; Kitamura, Yoshihisa |
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| 組織名 | Department of Pharmacotherapy, School of Pharmacy, Shujitsu University, Naka-ku,;Okayama, Japan.;Division of Molecular and Cellular Medicine, Department of Clinical Science,;National Hospital Organization Okayama Medical Centre, Okayama, Japan.;Pharmaceutical Care and Health Sciences, School of Pharmacy, Shujitsu University,;Naka-ku, Okayama, Japan.;Department of Pharmacy, Okayama University Hospital, Kita-ku, Okayama, Japan.;Department of Orthopaedic Surgery, Okayama University Hospital, Kitaku, Okayama,;Japan.;Department of Orthopaedic Surgery and Rehabilitation, National Hospital;Organization Okayama Medical Centre, Kita-ku, Okayama, Japan.;Department of Pharmacy, National Hospital Organization Okayama Medical Centre,;Kita-ku, Okayama, Japan.;Department of Orthopaedic Surgery, National Hospital Organization Okayama Medical;Centre, Kita-ku, Okayama, Japan. |
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