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Defibrotide for the Treatment and Prophylaxis of Hepatic Veno-Occlusive Disease

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Defibrotide for the Treatment and Prophylaxis of Hepatic Veno-Occlusive Disease Defibrotide for the treatment and prophylaxis of hepatic veno-occlusive disease Systematic Review Decision Support Document No. 84 ISSN online: 1998-0469 Defibrotide for the treatment and prophylaxis of hepatic veno-occlusive disease Systematic Review Vienna, March 2015 Project Team Project Leader: Dr. med. Anna Nachtnebel, MSc Authors: Dr. med. Eleen Rothschedl Dr. med. Anna Nachtnebel, MSc Internal Review: Dr. rer.nat. Agnes Kisser Project Support Systematic Literature Search: Tarquin Mittermayr, BA External Review: Prof. Dr. med. Wolfgang Bethge Medizinische Universitätsklinik II Hämatologie/Onkologie Allogene Stammzelltransplantation Universitätsklinikum Tübingen Correspondence Dr. med. Eleen Rothschedl, e-mail: [email protected] This report should be referenced as follows: Rothschedl E., Nachtnebel A. Defibrotide for the treatment and prophylaxis of hepatic veno-occlusive disease. Decision Support Document No. 84; 2015. Vienna: Ludwig Boltzmann Institute for Health Technology Assessment. Conflict of interest All authors and reviewers involved in the production of this report have declared they have no conflicts of interest in relation to the technology assessed according to the Uniform Requirements of Manuscripts Statement of Medical Journal Editors (www.icmje.org). Commissioned by the Austrian Ministry of Health, this report systematically assessed the intervention described herein as decision support for the inclusion in the catalogue of benefits. CONTENT INFORMATION Publisher: Ludwig Boltzmann Gesellschaft GmbH Nußdorferstr. 64, 6 Stock, A-1090 Wien http://www.lbg.ac.at/de/lbg/impressum Responsible for content: Ludwig Boltzmann Institute for Health Technology Assessment (LBI-HTA) Garnisongasse 7/20, A-1090 Vienna http://hta.lbg.ac.at/ Decision support documents of the LBI-HTA do not appear on a regular basis and serve to publicize the research results of the Ludwig Boltzmann Institute of Health Technology Assessments. Decision support documents of the LBI-HTA are only available to the public via the Internet at http://eprints.hta.lbg.ac.at Decision Support Document No. 84 ISSN-online: 1998-0469 © 2015 LBI-HTA – All rights reserved Content Summary ................................................................................................................................................................ 7 Zusammenfassung ............................................................................................................................................. 12 1 Scope .................................................................................................................................................................... 19 1.1 Research questions ..................................................................................................................................... 19 1.2 Inclusion criteria ........................................................................................................................................ 19 1.3 Literature search ......................................................................................................................................... 20 1.4 Flow chart study of selection ..................................................................................................................... 21 2 Description and technical characteristics of technology ............................................................................. 23 2.1 Methods ....................................................................................................................................................... 23 2.2 Results ......................................................................................................................................................... 23 3 Health problem and current use ...................................................................................................................... 29 3.1 Methods ....................................................................................................................................................... 29 3.2 Results ......................................................................................................................................................... 29 4 Clinical effectiveness ......................................................................................................................................... 35 4.1 Methods ....................................................................................................................................................... 35 4.2 Results ......................................................................................................................................................... 36 5 Safety .................................................................................................................................................................... 41 5.1 Methods ....................................................................................................................................................... 41 5.2 Results ......................................................................................................................................................... 42 6 Quality of evidence ............................................................................................................................................ 45 7 Discussion ........................................................................................................................................................... 49 8 Recommendation ............................................................................................................................................... 53 9 References ............................................................................................................................................................ 55 Appendix .................................................................................................................................................................... 59 Evidence tables of individual studies included for clinical effectiveness and safety ..................................... 59 Risk of bias tables ................................................................................................................................................ 65 Applicability table ............................................................................................................................................... 68 Search Strategies .................................................................................................................................................. 69 Medline Search Strategy ..................................................................................................................................... 69 Embase Search Strategy ...................................................................................................................................... 70 CRD Search Strategy .......................................................................................................................................... 70 Search Strategy for the Cochrane Library ........................................................................................................ 71 Ongoing research ................................................................................................................................................. 72 LBI-HTA | 2015 3 Defibrotide for the treatment and prophylaxis of hepatic veno-occlusive disease List of figures Figure 1.4-1: Flow chart of study selection (PRISMA Flow Diagram) ....................................................................... 21 List of tables Table 1.2-1: Inclusion criteria ........................................................................................................................................... 19 Table 6-1: Evidence profile: efficacy and safety of defibrotide for the prophylaxis of VOD.................................. 46 Table 6-2: Evidence profile: efficacy and safety of defibrotide for the treatment of VOD ..................................... 47 Table 8-1: Evidence-based recommendations .............................................................................................................. 53 Table 8-2: Evidence-based recommendations .............................................................................................................. 53 Table A1-1: VOD prophylaxis – results from RCTs ...................................................................................................... 59 Table A1-2: VOD prophylaxis – results from non-randomised clinical trials ............................................................ 61 Table A1-3: Defibrotide for the treatment of VOD – results from uncontrolled trials ............................................. 63 Table A2-1: Risk of bias – study level (randomised studies) ......................................................................................... 65 Table A2-2: Risk of bias – study level (non-randomised studies) ................................................................................. 65 Table A2-3: Risk of bias – outcome level ......................................................................................................................... 66 Table A3-1: Summary table characterising the applicability of a body of studies ....................................................
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