DOCSLIB.ORG

The Efficacy and Safety of Topical Tranexamic Acid

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
The Efficacy and Safety of Topical Tranexamic Acid Transfusion Medicine Reviews xxx (2018) xxx–xxx Contents lists available at ScienceDirect Transfusion Medicine Reviews journal homepage: www.tmreviews.com The efficacy and safety of topical tranexamic acid: A systematic review and meta-analysis Joshua Montroy a,b, Brian Hutton a,b, Preveshen Moodley c, Nicholas A. Fergusson a, Wei Cheng a, Alan Tinmouth a, Luke T. Lavallée a,c, Dean A. Fergusson a,b,c, Rodney H. Breau a,c,⁎ a Clinical Epidemiology Program, Centre for Practice Changing Research, Ottawa Hospital Research Institute, Ottawa, ON, Canada b University of Ottawa, School of Epidemiology, Community Medicine and Preventive Medicine, Ottawa, ON, Canada c Division of Urology, Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada article info abstract Available online xxxx Tranexamic acid (TXA) is an effective hemostatic agent used for the reduction of blood loss and transfusion. How- ever, the safety profile of TXA remains in question due to a potential increased risk of venous thromboembolism. Keywords: By applying TXA topically as opposed to intravenously, systemic absorption may be reduced and unwanted side- Tranexamic acid effects mitigated. The objective of our review is to investigate the efficacy and safety of topically applied Lysine analogue tranexamic acid compared to both placebo, and the intravenous administration. Cochrane Central Register of Surgery Controlled Trials, MEDLINE, Embase, ISI Web of Science, PubMed, and Clinicaltrials.gov were searched from in- Blood transfusion ception to November, 2016. We included randomized controlled trials that compared topical tranexamic acid Venous thromboembolism Topical to either placebo (or standard care) or intravenous administration, in adult patients. Surgical and non-surgical trials were included. Abstract, full-text selection, data extraction and risk of bias assessment were all performed in duplicate. In total, 67 studies involving 6,034 patients met inclusion criteria. The majority of trials evaluated orthopedic procedures. Compared to placebo, the administration of topical TXA significantly reduced the odds of receiving a blood transfusion (pooled OR 0.28, 95% CI 0.20 to 0.38; P b 0.001) and significantly reduced mean blood loss (WMD -276.6, 95% CI -327.8 to -225.4; P b 0.0001). When compared to the intravenous administra- tion, there was no difference between the two groups in terms of transfusion requirements (pooled OR 1.03, 95% CI 0.72 to 1.46; P=0.88) or blood loss (WMD -21.95, 95% CI -66.61 to 27.71; P=0.34). There was no difference in the odds of developing a venous thromboembolic complication between the topical TXA and control groups (pooled OR=0.78, 95% CI 0.47 to 1.29; P=0.33) or the topical and intravenous groups (pooled OR=0.75, 95% CI 0.39 to 1.46; P=0.40). The topical application of TXA effectively reduces both transfusion risk and blood loss compared to pla- cebo, without increasing thromboembolic risks. There were no major differences between topical and intravenous tranexamic acid with respect to safety and efficacy, and both were superior to placebo with regards to blood loss and transfusion requirements. Further study of the topical application is required outside of the field of orthopedics. © 2018 Elsevier Inc. All rights reserved. Contents Background&Rationale............................................................ 0 Methods................................................................... 0 . EligibilityCriteria......................................................... 0 . LiteratureSearchStrategy...................................................... 0 . StudySelectionProcess....................................................... 0 . DataExtractionandRiskofBiasAssessment............................................. 0 . DataAnalysis........................................................... 0 Results................................................................... 0 . CharacteristicsofIncludedStudies.................................................. 0 . StudyQualityandRiskofBias.................................................... 0 ⁎ Corresponding author at: Rodney H. Breau, MsC, MD, FRCSC, Surgical Oncology, Division of Urology, Associate Scientist, Ottawa Hospital Research Institute, The Ottawa Hospital/Uni- versity of Ottawa, 501 Smyth Rd, Box 222, Ottawa, ON K1H8L6, Canada. E-mail address: [email protected] (R.H. Breau). https://doi.org/10.1016/j.tmrv.2018.02.003 0887-7963/© 2018 Elsevier Inc. All rights reserved. Please cite this article as: Montroy J, et al, The efficacy and safety of topical tranexamic acid: A systematic review and meta-analysis, Transfus Med Rev (2018), https://doi.org/10.1016/j.tmrv.2018.02.003 2 J. Montroy et al. / Transfusion Medicine Reviews xxx (2018) xxx–xxx . EffectoftopicalTXAontransfusionrate................................................ 0 . Comparedtoplacebo.................................................... 0 . Comparedtointravenousadministration........................................... 0 . EffectoftopicalTXAdoseontransfusionrate............................................. 0 . EffectoftopicalTXAonbloodloss.................................................. 0 . Comparedtoplacebo.................................................... 0 . Comparedtointravenousadministration........................................... 0 . EffectoftopicalTXAontherateofvenousthromboembolicevents................................... 0 . Comparedtoplacebo.................................................... 0 . Comparedtointravenousadministration........................................... 0 . EffectoftopicalTXAontheriskofdeath............................................... 0 . EffectoftopicalTXAontheriskofstroke............................................... 0 . EffectoftopicalTXAontheriskofmyocardialinfarction........................................ 0 . PublicationBias........................................................... 0 Discussion.................................................................. 0 Conclusion.................................................................. 0 Funding................................................................... 0 ConflictofInterestStatement.......................................................... 0 AppendixA. Supplementarydata....................................................... 0 AppendixA. Supplementarydata....................................................... 0 References.................................................................. 0 Background & Rationale interventions, we performed a systematic review and meta-analysis to evaluate the efficacy and safety of topically administered tranexamic Allogenic blood transfusions, although potentially life-saving, acid. may be associated with an increased risk of infection and immune reactions, which may be a major source of morbidity for patients [1,2]. Methods A number of strategies are available that limit surgical blood loss and transfusions. Use of hemostatic agents has increased over the last Our review was registered on Prospero (no. CRD42016035902). A decade [3] with antifibrinolytics emerging as popular agents in review protocol was prepared according to the PRISMA-P checklist both medical and surgical practice. Antifibrinolytic lysine analogues [21] and is available upon request. The final report was prepared in ac- have been shown to be effective in reducing blood loss during surgery cordance with the Preferred Reporting Items for Systematic Reviews and trauma as well as non-surgical diseases such as anemia related and Meta-analyses (PRISMA) [22]. to cancer [4-6]. Tranexamic acid (TXA) is a lysine analogue and is a widely used antifibrinolytic. Systemic use of TXA has been shown in Eligibility Criteria meta-analyses to be safe and effective at reducing blood loss in cardiac [7], orthopedic [8], pelvic [5], and spinal surgeries [9], among others, We included randomized controlled trials (RCTs) that compared and is listed on the World Health Organization’s List of Essentials topical tranexamic acid to either placebo (or standard care) or intrave- Medicines. nously administered tranexamic acid in adult patients. Surgical and Due to the mechanism of action of lysine analogues, there exists a non-surgical trials were included. We did not restrict inclusion by theoretical increased risk of developing venous thromboembolic (VTE) drug dose or timing of administration. Our primary outcome was the complications such as deep venous thrombosis (DVT) or pulmonary risk of blood transfusion defined as the number of patients requiring embolism (PE) [10]. In one of the largest trauma trials to date, the at least one unit of red blood cells transfused. Our secondary outcomes CRASH-2 trial (Clinical Randomisation of an Antifibrinolytic in Signifi- included blood loss and adverse events (mortality, myocardial infarc- cant Hemorrhage), the efficacy and safety of TXA was assessed in over tion (MI), stroke, and venous thromboembolic events). We did not 20,000 adult trauma patients and no increase in thromboembolic events impose any language restrictions. was reported. However the precision of the safety estimate was low and therefore a potential for increased risk of VTE was not ruled out [6]. Literature Search Strategy Many systematic reviews have examined the relationship between ly- sine analogues and VTE risk, with point estimates remaining imprecise A comprehensive literature search of indexed databases was con- and thus unable to rule out a potential increased risk of VTE [5,11-13]. ducted to identify all relevant studies in
Load more

Recommended publications
  • Thrombocytopenia
    © Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 | Fax 503-947-2596 Drug Class Review: Thrombocytopenia Date of Review: January 2019 End Date of Literature Search: 11/05/2018 Purpose for Class Review: Treatments for thrombocytopenia are being reviewed for the first time, prompted by the recent approval of three new drugs; avatrombopag (Doptelet®), fostamatinib (Tavalisse™) and lusutrombopag (Mulpleta®). Research Questions: 1. What is the evidence for efficacy and harms of thrombocytopenia treatments (avatrombopag, eltrombopag, lusutrombopag, fostamatinib, and romiplostim)? 2. Is there any comparative evidence for therapies for thrombocytopenia pertaining to important outcomes such as mortality, bleeding rates, and platelet transfusions? 3. Is there any comparative evidence based on the harms outcomes of thrombocytopenia treatments? 4. Are there subpopulations of patients for which specific thrombocytopenia therapies may be more effective or associated with less harm? Conclusions: Three guidelines, six randomized clinical trials and five high-quality systematic reviews and meta-analyses met inclusion criteria for this review. There was insufficient direct comparative evidence between different therapies to treat thrombocytopenia. A majority of trials were small and of short duration. Guidelines recommend corticosteroids and intravenous immunoglobulin (IVIg) as first-line therapy for most adults with idiopathic thrombocytopenia (ITP). Thrombopoietin receptor agonists (TPOs) and the tyrosine kinase inhibitor, fostamatinib, are recommended as second-line treatments after failure of at least one other treatment.1–3 Avatrombopag and lusutrombopag are only approved for short-term use before procedures in patients with chronic liver failure.
    [Show full text]
  • Review Article
    SHOCK, Vol. 41, Supplement 1, pp. 44Y46, 2014 Review Article TRANEXAMIC ACID, FIBRINOGEN CONCENTRATE, AND PROTHROMBIN COMPLEX CONCENTRATE: DATA TO SUPPORT PREHOSPITAL USE? Herbert Scho¨chl,*† Christoph J. Schlimp,† and Marc Maegele‡ *AUVA Trauma Centre Salzburg, Academic Teaching Hospital of the Paracelsus Medical University Salzburg, Salzburg; and †Ludwig Boltzmann Institute for Experimental and Clinical and Traumatology, AUVA Research Centre, Vienna, Austria; and ‡Department of Trauma and Orthopedic Surgery, University of Witten/Herdecke, Cologne-Merheim Medical Center, Cologne, Germany Received 15 Sep 2013; first review completed 1 Oct 2013; accepted in final form 8 Nov 2013 ABSTRACT—Trauma-induced coagulopathy (TIC) occurs early after severe injury. TIC is associated with a substantial increase in bleeding rate, transfusion requirements, and a 4-fold higher mortality. Rapid surgical control of blood loss and early aggressive hemostatic therapy are essential steps in improving survival. Since the publication of the CRASH-2 study, early administration of tranexamic acid is considered as an integral step in trauma resuscitation protocols of severely injured patients in many trauma centers. However, the advantage of en route administration of tranexamic acid is not proven in prospective studies. Fibrinogen depletes early after severe trauma; therefore, it seems to be reasonable to maintain plasma fibrinogen as early as possible. The effect of prehospital fibrinogen concentrate administration on outcome in major trauma patients is the subject of an ongoing prospective investigation. The use of prothrombin complex concentrate is potentially helpful in patients anticoagulated with vitamin K antagonists who experience substantial trauma or traumatic brain injury. Beyond emergency reversal of vitamin K antagonists, safety data on prothrombin complex concentrate use in trauma are lacking.
    [Show full text]
  • December 4 Saturday
    ASH Meeting – Dec 5-8, 2020 CanVECTOR Oral & Poster Presentations Day / Time / Session Title Presenter Wednesday – December 2 December 2- 7:05 AM-8:30 AM The Immunohemostatic Response to Ed Pryzdial, PhD Infection Overview Program: Scientific Workshops @ ASH Session: The Immunohemostatic Response to Infection Friday – December 4 December 4 - 7:05 AM-8:05 AM Approach to Pregnancy and Delivery in Michelle Sholzberg, MDCM, FRCPC, MSc Women with Bleeding Disorders Program: Scientific Workshops @ ASH Session: Thrombosis and Bleeding in Pregnancy Prevention and Treatment of Venous Leslie Skeith, MD Thromboembolism in Pregnancy Saturday – December 5 December 5 - 7:00 AM-3:30 PM A Retrospective Cohort Study Evaluating the Kanza Naveed, Grace H Tang, MSc, McKenzie Safety and Efficacy of Peri-Partum Quevillon, RN, BScN, MN, Filomena Meffe, MD, MSc, Program: Oral and Poster Abstracts Tranexamic Acid for Women with Inherited Rachel Martin, MD, Jillian M Baker, MD, MSc, and Bleeding Disorders Michelle Sholzberg, MDCM, FRCPC, MSc Session: 322. Disorders of Coagulation or Fibrinolysis: Poster I Number: 863 Page 1 of 7 Day / Time / Session Title Presenter December 5 - 7:00 AM-3:30 PM A Retrospective Cohort Study Evaluating the Kanza Naveed, Grace H Tang, MSc, McKenzie Safety and Efficacy of Peri-Partum Quevillon, RN, BScN, MN, Filomena Meffe, MD, MSc, Program: Oral and Poster Abstracts Tranexamic Acid for Women with Inherited Rachel Martin, MD, Jillian M Baker, MD, MSc, and Bleeding Disorders Michelle Sholzberg, MDCM, FRCPC, MSc Session: 322. Disorders of Coagulation or Fibrinolysis: Poster I Number: 863 Frequency of Venous Thromboembolism in Mark Crowther, MD, David A.
    [Show full text]
  • Reversal of Anticoagulation in GI Bleeding
    Blood and Guts Reversal of anticoagulation in GI Bleeding John Hanley Consultant Haematologist Newcastle Hospitals NHS Trust [email protected] Healthy situation Haemostatic seesaw in a happy balance Clinical Thrombosis Atrial Fibrillation Deep Vein Thrombosis Pulmonary Embolus Cerebral Sinus Thrombosis Mesenteric Vein Thrombosis Arterial Embolus or Thrombosis Metallic Heart Valves Ventricular Assist Devices Antiphospholipid syndrome Anticoagulation Therapy Atrial Fibrillation Deep Vein Thrombosis Pulmonary Embolus ANTICOAGULANT Cerebral Sinus Thrombosis Mesenteric Vein Thrombosis DRUG Arterial Embolus or Thrombosis Metallic Heart Valves Ventricular Assist Devices Antiphospholipid syndrome Successful Anticoagulation Atrial Fibrillation Deep Vein Thrombosis Pulmonary Embolus Cerebral Sinus Thrombosis Mesenteric Vein Thrombosis Arterial Embolus or Thrombosis ANTICOAGULANT Metallic Heart Valves DRUG Ventricular Assist Devices Antiphospholipid syndrome Unsuccessful Anticoagulation Atrial Fibrillation Deep Vein Thrombosis Pulmonary Embolus Cerebral Sinus Thrombosis Mesenteric Vein Thrombosis Arterial Embolus or Thrombosis Metallic Heart Valves Ventricular Assist Devices Antiphospholipid syndrome ANTICOAGULANT DRUG Steady increase in numbers of patients receiving anticoagulation ≈1-2% of the UK population anti-coagulated AF 70% VTE 25% Other 5% 70000 60000 50000 40000 30000 20000 10000 0 1996 1998 2000 2002 2004 2006 2008 2010 2012 2014 Anticoagulants / Anti-platelets Unfractionated Heparin Low Molecular Weight Heparin Warfarin Other Vit
    [Show full text]
  • Reversal of Anticoagulation 14
    Table 6. Continued from page 4. References Continued from page 5. Primary 7. Kearon C. Hirsh J. Management of anticoagulation before and after elective surgery. New England Journal of Medicine. 336(21):1506-11, 1997. Anticoagulant Anticoagulation Reversal Anticoagulant Half-Life Excretion Therapeutic Anticoagulation Dose 8. Hanley JP. Warfarin reversal. Journal of Clinical Pathology. 57(11):1132-9, 2004 Nov. Action Monitoring Agents Mode 9. Holland L. Warkentin TE. Refaai M. Crowther MA. Johnston MA. Sarode R. Suboptimal effect of a three-factor prothrombin complex concen- trate (Profilnine-SD) in correcting supratherapeutic international normalized ratio due to warfarin overdose. Transfusion. 49(6):1171-7, 2009 Pediatrics Adults 10. Bauer KA. New anticoagulants. Hematology Am Soc Hematol Educ Program. 2006:450-6. Xa-Inhibitors 11. O'Connell NM. Perry DJ. Hodgson AJ. O'Shaughnessy DF. Laffan MA. Smith OP. Recombinant FVIIa in the management of uncontrolled hemorrhage. Transfusion. 43(12):1711-6,2003. Winter 2011 Fondaparinux: 17-21 Renal Anti-thrombin 0.15 mg/kg, daily, SC <50 kg: 5 mg, SC, Typically no rFVIIa 12. O'Connell KA, Wood JJ, Wise RP, Lozier JN, Braun MM. Thromboembolic adverse events after use of recombinant human coagulation factor (Arixtra) hours mediated inhibi- daily monitoring (NovoSeven) VIIa. JAMA. 2006 Jan 18;295(3):293-8. tion of factor Xa 50-100 kg: 7.5 mg, required SC, daily Anti-factor Xa 13. Riess HB. Meier-Hellmann A. Motsch J. Elias M. Kursten FW. Dempfle CE. Prothrombin complex concentrate (Octaplex) in patients requiring >100 kg: 10 mg daily (Calibrated with immediate reversal of oral anticoagulation.
    [Show full text]
  • A Randomized Study of 4-Factor Prothrombin Complex Concentrate and Authors: Jerrold H
    A Randomized Study of 4-Factor Prothrombin Complex Concentrate and Tranexamic Acid on Bleeding, Thrombin Generation, and Pharmacodynamics After Punch Biopsies in Rivaroxaban Treated Subjects With Supratherapeutic Drug Levels Authors: Jerrold H. Levy, MD1; Kenneth T. Moore, MS2; Matthew D. Neal, MD3; David Schneider, MD4; Victoria S. Marcsisin, MS2; Jay Ariyawansa, MS2; Jeffrey I. Weitz, MD5 1Duke University School of Medicine, Durham, North Carolina, United States; 2Janssen Pharmaceuticals, Janssen Scientific Affairs, Titusville, New Jersey, United States; 3University of Pittsburgh, Pittsburgh, Pennsylvania, United States; 4University of Vermont, Burlington, Vermont, United States; 7057 Figure 3 dra 1.4 5 This tagline is for informaon only; McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, Ontario, Canada DO NOT PRINT Figure 3. Time course of (A) prothrombin time (PT) and (B) endogenous thrombin Introduction Results potential (ETP) on mean absolute values change from baseline for treatment with 4F-PCC (Group A), TXA (Group B), and placebo (saline control) (Group C). • Oral factor Xa (FXa) inhibitors, including rivaroxaban, are replacing vitamin K • Of the 147 subjects enrolled (49 in each of the 3 cohorts), 145 (98.6%) completed A End of 4F-PCC/Placebo Infusion antagonists such as warfarin for many thromboembolic indications the study End of TXA/Placebo Infusion • Reversal of the anticoagulant effects of FXa inhibitors is important in the event of • Subject characteristics were comparable between the 3 cohorts (Table 1) clinically relevant bleeding 4F-PCC – The majority of subjects enrolled were male (70.1%) and white (66.0%), with a 25 2 TXA • Currently, there are no therapies approved for reversing oral FXa inhibitors, but median age of 28.0 years and a mean BMI of 25.0 kg/m Saline 4-factor prothrombin concentrate (4F-PCC) and tranexamic acid (TXA) have been suggested for this purpose lues, seconds Table 1.
    [Show full text]
  • Avatrombopag and Lusutrombopag For
    Journals Library Health Technology Assessment Volume 24 • Issue 51 • October 2020 ISSN 1366-5278 Avatrombopag and lusutrombopag for thrombocytopenia in people with chronic liver disease needing an elective procedure: a systematic review and cost-effectiveness analysis Nigel Armstrong, Nasuh Büyükkaramikli, Hannah Penton, Rob Riemsma, Pim Wetzelaer, Vanesa Huertas Carrera, Stephanie Swift, Thea Drachen, Heike Raatz, Steve Ryder, Dhwani Shah, Titas Buksnys, Gill Worthy, Steven Duffy, Maiwenn Al and Jos Kleijnen DOI 10.3310/hta24510 Avatrombopag and lusutrombopag for thrombocytopenia in people with chronic liver disease needing an elective procedure: a systematic review and cost-effectiveness analysis Nigel Armstrong ,1* Nasuh Büyükkaramikli ,2 Hannah Penton ,2 Rob Riemsma ,1 Pim Wetzelaer ,2 Vanesa Huertas Carrera ,1 Stephanie Swift ,1 Thea Drachen ,1 Heike Raatz ,1 Steve Ryder ,1 Dhwani Shah ,1 Titas Buksnys ,1 Gill Worthy ,1 Steven Duffy ,1 Maiwenn Al 2 and Jos Kleijnen 1 1Kleijnen Systematic Reviews, York, UK 2Erasmus School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, the Netherlands *Corresponding author Declared competing interests of authors: Rob Riemsma is a member of the National Institute for Health Research Health Technology Assessment and Efficacy and Mechanism Evaluation Editorial Board. Published October 2020 DOI: 10.3310/hta24510 This report should be referenced as follows: Armstrong N, Büyükkaramikli N, Penton H, Riemsma R, Wetzelaer P, Huertas Carrera V, et al. Avatrombopag and lusutrombopag for thrombocytopenia in people with chronic liver disease needing an elective procedure: a systematic review and cost-effectiveness analysis. Health Technol Assess 2020;24(51). Health Technology Assessment is indexed and abstracted in Index Medicus/MEDLINE, Excerpta Medica/EMBASE, Science Citation Index Expanded (SciSearch®) and Current Contents®/ Clinical Medicine.
    [Show full text]
  • New Drug Evaluation Monograph Template
    © Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 | Fax 503-947-2596 Drug Class Review: Thrombocytopenia Date of Review: January 2019 End Date of Literature Search: 11/05/2018 Purpose for Class Review: Treatments for thrombocytopenia are being reviewed for the first time, prompted by the recent approval of three new drugs; avatrombopag (Doptelet®), fostamatinib (Tavalisse™) and lusutrombopag (Mulpleta®). Research Questions: 1. What is the evidence for efficacy and harms of thrombocytopenia treatments (avatrombopag, eltrombopag, lusutrombopag, fostamatinib, and romiplostim)? 2. Is there any comparative evidence for therapies for thrombocytopenia pertaining to important outcomes such as mortality, bleeding rates, and platelet transfusions? 3. Is there any comparative evidence based on the harms outcomes of thrombocytopenia treatments? 4. Are there subpopulations of patients for which specific thrombocytopenia therapies may be more effective or associated with less harm? Conclusions: Three guidelines, six randomized clinical trials and five high-quality systematic reviews and meta-analyses met inclusion criteria for this review. There was insufficient direct comparative evidence between different therapies to treat thrombocytopenia. A majority of trials were small and of short duration. Guidelines recommend corticosteroids and intravenous immunoglobulin (IVIg) as first-line therapy for most adults with idiopathic thrombocytopenia (ITP). Thrombopoietin receptor agonists (TPOs) and the tyrosine kinase inhibitor, fostamatinib, are recommended as second-line treatments after failure of at least one other treatment.1–3 Avatrombopag and lusutrombopag are only approved for short-term use before procedures in patients with chronic liver failure.
    [Show full text]
  • Informationen Zur
    Kriterien zur Bestimmung der zweckmäßigen Vergleichstherapie und Recherche und Synopse der Evidenz zur Bestimmung der zweckmäßigen Vergleichstherapie nach § 35a SGB V Vorgang: 2017-B-074 Damoctocog alfa pegol Stand: Juni 2017 I. Zweckmäßige Vergleichstherapie: Kriterien gemäß 5. Kapitel § 6 VerfO G-BA Damoctocog alfa pegol_2017-B-074 [Behandlung und Prophylaxe der Hämophilie A] Kriterien gemäß 5. Kapitel § 6 VerfO Sofern als Vergleichstherapie eine Arzneimittelanwendung in Betracht kommt, muss das Siehe Tabelle „II. Zugelassene Arzneimittel im Anwendungsgebiet“ Arzneimittel grundsätzlich eine Zulassung für das Anwendungsgebiet haben. Sofern als Vergleichstherapie eine nicht- medikamentöse Behandlung in Betracht kommt, muss nicht angezeigt diese im Rahmen der GKV erbringbar sein. Beschlüsse/Bewertungen/Empfehlungen des - Richtlinie Ambulante Behandlung im Krankenhaus nach § 116b des Fünften Gemeinsamen Bundesausschusses zu im Buches Sozialgesetzbuch (SGB V) (Anlage 2, Nr. 2: Diagnostik und Versorgung Anwendungsgebiet zugelassenen Arzneimitteln/nicht- von Patienten mit Gerinnungsstörungen (Hämophilie)) medikamentösen Behandlungen - Beschluss zur Nutzenbewertung nach § 35a SGB V zum Wirkstoff Turoctocog alfa vom 3. Juli 2014 - Beschluss zur Nutzenbewertung nach § 35a SGB V zum Wirkstoff Simoctocog alfa vom 7. Mai 2015 - Beschluss zur Nutzenbewertung nach § 35a SGB V zum Wirkstoff Efmoroctocog alfa vom 16. Juni 2016 Die Vergleichstherapie soll nach dem allgemein anerkannten Stand der medizinischen Erkenntnisse zur Siehe systematische Literaturrecherche
    [Show full text]
  • Clinical Pharmacology of Aminocaproic and Tranexamic Acids
    J Clin Pathol: first published as 10.1136/jcp.s3-14.1.41 on 1 January 1980. Downloaded from J Clin Pathol, 33, Suppl (Roy Coll Path), 14, 41-47 Clinical pharmacology of aminocaproic and tranexamic acids INGA MARIE NILSSON From the Coagulation Laboratory, University ofLund, Allmdnna Sjukhuset, Malmo, Sweden In a systematic search for a substance with anti- arbitrary urokinase units by reference to a standard fibrinolytic properties Okamoto and his group in urokinase preparation.'0 11 Japan found that several mercapto- and amino- Intravenous administration of 10 g EACA or carbonic acids were active. Of these substances 100 mg EACA/kg bodyweight produces an initial epsilon-aminocaproic acid (EACA) had the strong- serum concentration of about 150 mg/100 ml which est antifibrinolytic effect.1 2 The Japanese workers falls to 3 5 mg/100 ml within 3-4 hours (Fig. 1). described it as a plasmin inhibitor in vitro and The biological half life was calculated to be about 77 useful in inhibiting proteolytic enzymes in vivo. They minutes. Andersson et al.8 found that about 70 % of gave EACA in a dose of 10-20 g a day by mouth or the dose given intravenously was excreted in the intravenously to over 100 patients and observed no urine within 24 hours (Fig. 2). McNicol et al.7 toxic effects. Their investigation did not include any found 80-100I% of the given dose in the urine metabolic studies. EACA has since been widely used within 4-6 hours. The EACA is thus concentrated and its mode of action and pharmacokinetics intensively studied.
    [Show full text]
  • Novel T 2019 Vol 3 2.0.Indd
    Novel Treatments in Haemophilia & Other Bleeding Disorders: A Periodic Review 2019 - Issue 2 Irish Haemophilia Society haemophilia.ie October 2019 Contents Foreword Page 03 Abbreviations Page 04 An update on novel treatments for haemophilia A Page 05 Replacement therapies Page 05 Non-replacement therapies Page 08 Gene therapy Page 11 A comment on gene therapy Page 14 An update on novel treatments in haemophilia B Page 15 Replacement therapies Page 15 Non-replacement therapies Page 16 Gene therapy Page 16 A comment on PEG: Same data, same discussion, different regulatory decisions Page 18 An update on novel therapies for inhibitor treatment Page 20 By-passing therapies Page 20 Non-replacement therapies Page 20 Gene therapy Page 22 An update on novel therapies for von Willebrand disease Page 22 An update on novel therapies for rare bleeding disorders Page 23 Disclaimer: This publication is produced by the European Haemophilia Consortium (EHC) primarily as an educational tool for National Member Organisations (NMOs). With the constantly changing therapeutic environment, it is our intention to publish updates on a periodic basis. The information contained, and the views expressed herein constitute the collective input of the EHC New Products Working Group. The EHC does not engage in medical practice and under no circumstances recommends particular treatment for specifi c individuals. The EHC makes no representation, express or implied, that drug doses or other treatment recommendations in this publication are correct. For these reasons it is strongly recommended that individuals seek the advice of a medical adviser and/or consult printed instructions provided by the pharmaceutical company before administering any of the drugs referred to in this publication.
    [Show full text]
  • Tranexamic Acid (4.2) These Highlights Do Not Include All the Information Needed to Use LYSTEDA Safely and Effectively
    HIGHLIGHTS OF PRESCRIBING INFORMATION Hypersensitivity to tranexamic acid (4.2) These highlights do not include all the information needed to use LYSTEDA safely and effectively. See full prescribing information for -----------------------WARNINGS AND PRECAUTIONS------------------------ LYSTEDA. Concomitant use of LYSTEDA with Factor IX complex concentrates, anti-inhibitor coagulant concentrates or all-trans retinoic acid (oral LYSTEDA™ (tranexamic acid) Tablets tretinoin) may increase the risk of thrombosis. (5.1) Initial U.S. Approval: 1986 Visual or ocular adverse effects may occur with LYSTEDA. Immediately discontinue use if visual or ocular symptoms occur. (5.1) ---------------------------------RECENT MAJOR CHANGES--------------------- In case of severe allergic reaction, discontinue LYSTEDA and seek Contraindications (4.1) 10/2013 immediate medical attention. (5.2) Warnings and Precautions (5.1) 10/2013 Cerebral edema and cerebral infarction may be caused by use of LYSTEDA in women with subarachnoid hemorrhage. (5.3) Ligneous conjunctivitis has been reported in patients taking tranexamic ----------------------------INDICATIONS AND USAGE--------------------------- acid. (5.4) LYSTEDA (tranexamic acid) Tablets is an antifibrinolytic indicated for the treatment of cyclic heavy menstrual bleeding. (1) ------------------------------ADVERSE REACTIONS------------------------------- Most common adverse reactions in clinical trials (≥ 5%, and more frequent in ----------------------DOSAGE AND ADMINISTRATION----------------------- LYSTEDA
    [Show full text]