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      Predictive factors for effectiveness and safety of enoxaparin for total knee arthroplasty in aged Japanese patients: a retrospective review

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          Abstract

          Background

          The aims of this study were to investigate predictive factors involved in effectiveness and safety of enoxaparin for prevention of postoperative venous thromboembolism in aged Japanese total knee arthroplasty (TKA) patients.

          Methods

          Japanese patients over 65 years old who were administered enoxaparin for TKA were enrolled in this study. Their medical records were retrospectively reviewed. Data were corrected at the Izumi Regional Medical Center, from September 2009 to March 2014. Patients were stratified into groups according to whether enoxaparin was effective (no deep vein thrombosis event up to postoperative day 7) or not, and whether they had an adverse drug event (ADE) or not.

          Results

          A total of 128 patients were included in this study. One hundred five (82.0%) patients were in the effective group and 20 (15.6%) in the adverse drug event (ADE) group. Anemia (13 patients), abnormalities in liver function tests (4 patients), clinically relevant non-major bleeding (4 patients) and urticaria (1 patient) were observed as ADEs. Multivariate logistic regression analysis showed that the serum total protein level at postoperative day 1 (POD1, before enoxaparin administration), was associated with effectiveness of enoxaparin, while the serum total protein and hemoglobin level at POD1 were involved in ADE caused by enoxaparin.

          Conclusions

          Although further large scale studies will be warranted, our results suggest that serum total protein level just before enoxaparin treatment for TKA relates to the effectiveness and safety of enoxaparin in a Japanese aged population. In addition, the results indicate that the development of anemia should be carefully monitored during enoxaparin treatment for TKA, particularly in patients with lower levels of serum hemoglobin before treatment.

          Electronic supplementary material

          The online version of this article (doi:10.1186/s40780-017-0075-x) contains supplementary material, which is available to authorized users.

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          Most cited references24

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          Measuring the accuracy of diagnostic systems.

          J Swets (1988)
          Diagnostic systems of several kinds are used to distinguish between two classes of events, essentially "signals" and "noise". For them, analysis in terms of the "relative operating characteristic" of signal detection theory provides a precise and valid measure of diagnostic accuracy. It is the only measure available that is uninfluenced by decision biases and prior probabilities, and it places the performances of diverse systems on a common, easily interpreted scale. Representative values of this measure are reported here for systems in medical imaging, materials testing, weather forecasting, information retrieval, polygraph lie detection, and aptitude testing. Though the measure itself is sound, the values obtained from tests of diagnostic systems often require qualification because the test data on which they are based are of unsure quality. A common set of problems in testing is faced in all fields. How well these problems are handled, or can be handled in a given field, determines the degree of confidence that can be placed in a measured value of accuracy. Some fields fare much better than others.
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            Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition).

            William H Geerts, David Bergqvist, Graham F. Pineo … (2008)
            This article discusses the prevention of venous thromboembolism (VTE) and is part of the Antithrombotic and Thrombolytic Therapy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Grade 1 recommendations are strong and indicate that the benefits do or do not outweigh risks, burden, and costs. Grade 2 suggestions imply that individual patient values may lead to different choices (for a full discussion of the grading, see the "Grades of Recommendation" chapter by Guyatt et al). Among the key recommendations in this chapter are the following: we recommend that every hospital develop a formal strategy that addresses the prevention of VTE (Grade 1A). We recommend against the use of aspirin alone as thromboprophylaxis for any patient group (Grade 1A), and we recommend that mechanical methods of thromboprophylaxis be used primarily for patients at high bleeding risk (Grade 1A) or possibly as an adjunct to anticoagulant thromboprophylaxis (Grade 2A). For patients undergoing major general surgery, we recommend thromboprophylaxis with a low-molecular-weight heparin (LMWH), low-dose unfractionated heparin (LDUH), or fondaparinux (each Grade 1A). We recommend routine thromboprophylaxis for all patients undergoing major gynecologic surgery or major, open urologic procedures (Grade 1A for both groups), with LMWH, LDUH, fondaparinux, or intermittent pneumatic compression (IPC). For patients undergoing elective hip or knee arthroplasty, we recommend one of the following three anticoagulant agents: LMWH, fondaparinux, or a vitamin K antagonist (VKA); international normalized ratio (INR) target, 2.5; range, 2.0 to 3.0 (each Grade 1A). For patients undergoing hip fracture surgery (HFS), we recommend the routine use of fondaparinux (Grade 1A), LMWH (Grade 1B), a VKA (target INR, 2.5; range, 2.0 to 3.0) [Grade 1B], or LDUH (Grade 1B). We recommend that patients undergoing hip or knee arthroplasty or HFS receive thromboprophylaxis for a minimum of 10 days (Grade 1A); for hip arthroplasty and HFS, we recommend continuing thromboprophylaxis > 10 days and up to 35 days (Grade 1A). We recommend that all major trauma and all spinal cord injury (SCI) patients receive thromboprophylaxis (Grade 1A). In patients admitted to hospital with an acute medical illness, we recommend thromboprophylaxis with LMWH, LDUH, or fondaparinux (each Grade 1A). We recommend that, on admission to the ICU, all patients be assessed for their risk of VTE, and that most receive thromboprophylaxis (Grade 1A).
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              Further analysts of the data by akaike' s information criterion and the finite corrections

              Nariaki Sugiura (2007)
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                Author and article information

                Contributors
                Akihiro Sonoda: akihiro_sonoda@cronos.ocn.ne.jp
                Yuki Kondo:
                ORCID: http://orcid.org/0000-0003-1456-7721
                ykondo@kumamoto-u.ac.jp
                Yasuhiro Tsuneyoshi: everluckyhiro@yahoo.co.jp
                Yoshitaka Iwashita: yakuzai@akunehp.com
                Shoji Nakao: pharmacy@akunehp.com
                Kazuhisa Ishida: k_ishida@akunehp.com
                Kentaro Oniki: oniken@kumamoto-u.ac.jp
                Junji Saruwatari: junsaru@gpo.kumamoto-u.ac.jp
                Tetsumi Irie: tirie@gpo.kumamoto-u.ac.jp
                Yoichi Ishitsuka: y-zuka@gpo.kumamoto-u.ac.jp
                Journal
                Journal ID (nlm-ta): J Pharm Health Care Sci
                Journal ID (iso-abbrev): J Pharm Health Care Sci
                Title: Journal of Pharmaceutical Health Care and Sciences
                Publisher: BioMed Central (London )
                ISSN (Electronic): 2055-0294
                Publication date (Electronic): 18 January 2017
                Publication date PMC-release: 18 January 2017
                Publication date Collection: 2017
                Volume: 3
                Electronic Location Identifier: 6
                Affiliations
                [1 ]ISNI 0000 0001 0660 6749, GRID grid.274841.c, Department of Clinical Chemistry and Informatics, Graduate School of Pharmaceutical Sciences, , Kumamoto University, ; 5-1 Oe-honmachi, Kumamoto, Chuo-ku 862-0973 Japan
                [2 ]Department of Pharmacy, Izumi Regional Medical Center, 4513 Akasegawa, Akune, Kagoshima 899-1611 Japan
                [3 ]Department of Orthopedic Surgery, Izumi Regional Medical Center, 4513 Akasegawa, Akune, Kagoshima 899-1611 Japan
                [4 ]ISNI 0000 0001 0660 6749, GRID grid.274841.c, Division of Pharmacology and Therapeutics, Graduate School of Pharmaceutical Sciences, , Kumamoto University, ; 5-1 Oe-honmachi, Kumamoto, Chuo-ku 862-0973 Japan
                [5 ]ISNI 0000 0001 0660 6749, GRID grid.274841.c, Center for Clinical Pharmaceutical Sciences, Faculty of Pharmaceutical Sciences, , Kumamoto University, ; 5-1 Oe-honmachi, Kumamoto, Chuo-ku 862-0973 Japan
                Author information
                http://orcid.org/0000-0003-1456-7721
                Article
                Publisher ID: 75
                DOI: 10.1186/s40780-017-0075-x
                PMC ID: 5241995
                SO-VID: 194e4c81-fb45-4bd9-b8df-976d741f4911
                Copyright © © The Author(s). 2017
                License:

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                Date received : 28 September 2016
                Date accepted : 6 January 2017
                Categories
                Subject: Research Article
                Custom metadata
                issue-copyright-statement © The Author(s) 2017

                Keywords: enoxaparin,total knee arthroplasty,adverse drug event,serum total protein,anemia,venous thromboembolism
                Data availability:
                Keywords: enoxaparin, total knee arthroplasty, adverse drug event, serum total protein, anemia, venous thromboembolism

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