Systematic Review with Meta-Analysis: Efficacy and Safety of Lusutrombopag for Severe Thrombocytopenia in Patients with Chronic Liver Disease Undergoing Invasive Procedures.
Chronic liver disease
Invasive procedure
Lusutrombopag
Meta-analysis
Severe thrombocytopenia
Thrombopoietin receptor agonist
Journal
Advances in therapy
ISSN: 1865-8652
Titre abrégé: Adv Ther
Pays: United States
ID NLM: 8611864
Informations de publication
Date de publication:
09 2022
09 2022
Historique:
received:
06
05
2022
accepted:
17
06
2022
pubmed:
15
7
2022
medline:
27
8
2022
entrez:
14
7
2022
Statut:
ppublish
Résumé
Lusutrombopag is an oral thrombopoietin receptor agonist (TPO-RA). Clinical trials have shown lusutrombopag's efficacy in reducing need for preoperative platelet transfusion in patients with chronic liver disease (CLD) and severe thrombocytopenia. This analysis assessed efficacy and safety of lusutrombopag in patients with severe thrombocytopenia and CLD undergoing planned invasive procedures. An electronic database search (through 1 December 2020) identified three randomised, placebo-controlled, double-blind clinical trials comparing lusutrombopag with placebo in patients with CLD and platelet count below 50 × 10 The meta-analysis included 343 (lusutrombopag 3 mg, n = 173; placebo, n = 170) patients. More patients met the criteria for treatment response (platelet count at least 50 × 10 This meta-analysis showed that treatment of severe thrombocytopenia with lusutrombopag in patients with CLD prior to a planned invasive procedure was efficacious and safe in increasing platelet counts, avoiding the need for platelet transfusions, and reducing risk of bleeding, thereby enhancing the certainty of evidence supporting the efficacy and safety of lusutrombopag.
Identifiants
pubmed: 35836089
doi: 10.1007/s12325-022-02235-w
pii: 10.1007/s12325-022-02235-w
pmc: PMC9402754
doi:
Substances chimiques
Cinnamates
0
Thiazoles
0
lusutrombopag
6LL5JFU42F
Types de publication
Journal Article
Meta-Analysis
Systematic Review
Langues
eng
Pagination
4169-4188Informations de copyright
© 2022. The Author(s).
Références
Afdhal N, McHutchison J, Brown R, et al. Thrombocytopenia associated with chronic liver disease. J Hepatol. 2008;48:1000–7.
pubmed: 18433919
doi: 10.1016/j.jhep.2008.03.009
Poordad F. Review article: thrombocytopenia in chronic liver disease. Aliment Pharmacol Ther. 2007;26(Suppl 1):5–11.
pubmed: 17958514
doi: 10.1111/j.1365-2036.2007.03510.x
Buckley MF, James JW, Brown DE, et al. A novel approach to the assessment of variations in the human platelet count. Thromb Haemost. 2000;83:480–4.
pubmed: 10744157
doi: 10.1055/s-0037-1613840
Giannini EG. Review article: thrombocytopenia in chronic liver disease and pharmacologic treatment options. Aliment Pharmacol Ther. 2006;23:1055–65.
pubmed: 16611265
doi: 10.1111/j.1365-2036.2006.02889.x
Bashour FN, Teran JC, Mullen KD. Prevalence of peripheral blood cytopenias (hypersplenism) in patients with nonalcoholic chronic liver disease. Am J Gastroenterol. 2000;95:2936–9.
pubmed: 11051371
doi: 10.1111/j.1572-0241.2000.02325.x
Mitchell O, Feldman DM, Diakow M, Sigal SH. The pathophysiology of thrombocytopenia in chronic liver disease. Hepat Med. 2016;8:39–50.
pubmed: 27186144
pmcid: 4847598
Berzigotti A, Seijo S, Arena U, et al. Elastography, spleen size, and platelet count identify portal hypertension in patients with compensated cirrhosis. Gastroenterology. 2013;144:102-111.e101.
pubmed: 23058320
doi: 10.1053/j.gastro.2012.10.001
Giannini EG, Greco A, Marenco S, Andorno E, Valente U, Savarino V. Incidence of bleeding following invasive procedures in patients with thrombocytopenia and advanced liver disease. Clin Gastroenterol Hepatol. 2010;8:899–902.
pubmed: 20601131
doi: 10.1016/j.cgh.2010.06.018
Hayashi H, Beppu T, Shirabe K, Maehara Y, Baba H. Management of thrombocytopenia due to liver cirrhosis: a review. World J Gastroenterol. 2014;20:2595–605.
pubmed: 24627595
pmcid: 3949268
doi: 10.3748/wjg.v20.i10.2595
Seeff LB, Everson GT, Morgan TR, et al. Complication rate of percutaneous liver biopsies among persons with advanced chronic liver disease in the HALT-C trial. Clin Gastroenterol Hepatol. 2010;8:877–83.
pubmed: 20362695
pmcid: 3771318
doi: 10.1016/j.cgh.2010.03.025
Estcourt L, Birchall J, Allard S, et al. Guidelines for the use of platelet transfusions. Br J Haematol. 2017;176:365–94.
pubmed: 28009056
doi: 10.1111/bjh.14423
National Clinical Guideline Centre (UK). Blood Transfusion. London: National Institute for Health and Care Excellence (NICE); 2015 Nov. PMID: 26632625.
Kaufman RM, Djulbegovic B, Gernsheimer T, et al. Platelet transfusion: a clinical practice guideline from the AABB. Ann Intern Med. 2015;162:205–13.
pubmed: 25383671
doi: 10.7326/M14-1589
Liumbruno GM, Bennardello F, Lattanzio A, Piccoli P, Rossetti G. Recommendations for the transfusion management of patients in the peri-operative period. I. The pre-operative period. Blood Transfus. 2011;9:19–40.
pubmed: 21235852
pmcid: 3021395
Samama CM, Djoudi R, Lecompte T, Nathan N, Schved JF. Perioperative platelet transfusion. Recommendations of the French Health Products Safety Agency (AFSSAPS) 2003. Minerva Anestesiol. 2006;72:447–52.
pubmed: 16682914
Bachowski G, Borge D, Brunker PAR, et al. A compendium of transfusion practice guidelines. 3rd ed. Chicago: American National Red Cross; 2017.
American Society of Anesthesiologists. Practice guidelines for perioperative blood management: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Blood Management. Anesthesiology. 2015;122:241–75.
doi: 10.1097/ALN.0000000000000463
Schepis F, Turco L, Bianchini M, Villa E. Prevention and management of bleeding risk related to invasive procedures in cirrhosis. Semin Liver Dis. 2018;38:215–29.
pubmed: 30041274
doi: 10.1055/s-0038-1660523
Northup PG, Garcia-Pagan JC, Garcia-Tsao G, et al. Vascular liver disorders, portal vein thrombosis, and procedural bleeding in patients with liver disease: 2020 Practice Guidance by the American Association for the Study of Liver Diseases. Hepatology. 2021;73:366–413.
pubmed: 33219529
doi: 10.1002/hep.31646
European Association for the Study of the Liver. EASL Clinical Practice Guidelines for the management of patients with decompensated cirrhosis. J Hepatol. 2018;69:406–60.
doi: 10.1016/j.jhep.2018.03.024
Savinkina AA, Haass KA, Sapiano MRP, et al. Transfusion-associated adverse events and implementation of blood safety measures - findings from the 2017 National Blood Collection and Utilization Survey. Transfusion. 2020;60(Suppl 2):S10-s16.
pubmed: 32134123
pmcid: 7908682
Schiffer CA, Anderson KC, Bennett CL, et al. Platelet transfusion for patients with cancer: clinical practice guidelines of the American Society of Clinical Oncology. J Clin Oncol. 2001;19:1519–38.
pubmed: 11230498
doi: 10.1200/JCO.2001.19.5.1519
Chen BZ, Xia R. Pro-inflammatory effects after platelet transfusion: a review. Vox Sang. 2020;115:349–57.
pubmed: 32293034
doi: 10.1111/vox.12879
Murphy MF, Waters AH. Clinical aspects of platelet transfusions. Blood Coagul Fibrinolysis. 1991;2:389–96.
pubmed: 1893071
doi: 10.1097/00001721-199104000-00026
O’Leary JG, Greenberg CS, Patton HM, Caldwell SH. AGA clinical practice update: coagulation in cirrhosis. Gastroenterology. 2019;157:34-43.e31.
pubmed: 30986390
doi: 10.1053/j.gastro.2019.03.070
Noetzli LJ, French SL, Machlus KR. New Insights Into the differentiation of megakaryocytes from hematopoietic progenitors. Arterioscler Thromb Vasc Biol. 2019;39:1288–300.
pubmed: 31043076
pmcid: 6594866
doi: 10.1161/ATVBAHA.119.312129
MULPLETA
Katsube T, Ishibashi T, Kano T, Wajima T. Population pharmacokinetic and pharmacodynamic modeling of lusutrombopag, a newly developed oral thrombopoietin receptor agonist, in healthy subjects. Clin Pharmacokinet. 2016;55:1423–33.
pubmed: 27209291
doi: 10.1007/s40262-016-0411-6
Shionogi & Co., Ltd. Shionogi launches MULPLETA
European Commission. Lusutrombopag [product information]. 2019. https://www.ema.europa.eu/en/medicines/human/EPAR/mulpleo . Accessed 3 May 2022.
Peck-Radosavljevic M, Simon K, Iacobellis A, et al. Lusutrombopag for the treatment of thrombocytopenia in patients with chronic liver disease undergoing invasive procedures (L-PLUS 2). Hepatology. 2019;70:1336–48.
pubmed: 30762895
doi: 10.1002/hep.30561
Hidaka H, Kurosaki M, Tanaka H, et al. Lusutrombopag reduces need for platelet transfusion in patients with thrombocytopenia undergoing invasive procedures. Clin Gastroenterol Hepatol. 2019;17:1192–200.
pubmed: 30502505
doi: 10.1016/j.cgh.2018.11.047
Tateishi R, Seike M, Kudo M, et al. A randomized controlled trial of lusutrombopag in Japanese patients with chronic liver disease undergoing radiofrequency ablation. J Gastroenterol. 2019;54:171–81.
pubmed: 30105510
doi: 10.1007/s00535-018-1499-2
Royle P, Waugh N. Literature searching for clinical and cost-effectiveness studies used in health technology assessment reports carried out for the National Institute for Clinical Excellence appraisal system. Health Technol Assess. 2003; 7:iii, ix-x, 1–51.
Stata MP 16.1 for Windows. www.stata.com [computer program]. 2016.
Harris R, Bradburn M, Deeks J, Harbord R, Altman D, Sterne J. metan: fixed- and random-effects meta-analysis. Stata Journal. 2008;8:3–28.
doi: 10.1177/1536867X0800800102
Palmer TM, Sterne JAC. Meta-analysis in stata: an updated collection from the Stata Journal. 2nd ed. College Station: Stata; 2016.
Berkey CS, Hoaglin DC, Mosteller F, Colditz GA. A random-effects regression model for meta-analysis. Stat Med. 1995;14:395–411.
pubmed: 7746979
doi: 10.1002/sim.4780140406
Paule RC, Mandel J. Consensus values and weighting factors. J Res Natl Bur Stand. 1982;87:377–85.
doi: 10.6028/jres.087.022
Borenstein M, Hedges L, Higgins J, Rothstein H. Introduction to meta-analysis: Chapter 13: fixed-effect versus random-effects models. Chichester: Wiley; 2009.
The Cochrane Collaboration. Section 9.5.2: Identifying and measuring heterogeneity. In: Higgins J, Green S, editors. The Cochrane Handbook. vol 5.1.02011. http://handbook.cochrane.org/ . Accessed 3 May 2022.
Thompson SG, Sharp SJ. Explaining heterogeneity in meta-analysis: a comparison of methods. Stat Med. 1999;18:2693–708.
pubmed: 10521860
doi: 10.1002/(SICI)1097-0258(19991030)18:20<2693::AID-SIM235>3.0.CO;2-V
The Cochrane Collaboration. Section 16.9.2: Special topics in statistics: Rare events. Studies with zero-cell counts. In: Higgins J, Green S, editors. The Cochrane Handbook. vol 5.1.02011. http://handbook.cochrane.org/ . Accessed 3 May 2022.
Sauro J, Lewis J. Estimating completion rates from small samples using binomial confidence intervals: comparisons and Recommendations. Proc Hum Factors Ergon Soc Ann Meet. 2005;49:2100–3.
doi: 10.1177/154193120504902407
Knol MJ, Duijnhoven RG, Grobbee DE, Moons KG, Groenwold RH. Potential misinterpretation of treatment effects due to use of odds ratios and logistic regression in randomized controlled trials. PLoS ONE. 2011;6: e21248.
pubmed: 21698176
pmcid: 3116891
doi: 10.1371/journal.pone.0021248
National Institute for Health and Care Excellence. Process and methods guides. The guidelines manual: Appendix C Methodology checklist: randomised controlled trials. https://www.nice.org.uk/process/pmg6/resources/the-guidelines-manual-appendices-bi-2549703709/chapter/appendix-c-methodology-checklist-randomised-controlled-trials . Accessed 6 July 2022.
The Cochrane Collaboration. Section 8.5: The Cochrane collaboration’s tool for assessing risk of bias. In: Higgins J, Green S, editors. The Cochrane Handbook. vol 5.1.02011. http://handbook.cochrane.org/ . Accessed 3 May 2022.
Handbook for grading the quality of evidence and the strength of recommendations using the GRADE approach. In: Schünemann H, Brożek J, Guyatt G, Oxman A, editors. GRADE Handbook. http://gdt.guidelinedevelopment.org/app/handbook/handbook.html . Accessed 3 May 2022.
Armstrong N, Büyükkaramikli N, Penton H, 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;24:1–220.
pubmed: 33292924
pmcid: 7750869
doi: 10.3310/hta24510
Lindquist I, Olson SR, Li A, et al. The efficacy and safety of thrombopoietin receptor agonists in patients with chronic liver disease undergoing elective procedures: a systematic review and meta-analysis. Platelets. 2021. https://doi.org/10.1080/09537104.2020.1859102 .
doi: 10.1080/09537104.2020.1859102
pubmed: 33459573
Brown RS Jr, Bentley R, Cai B, et al. The clinical and economic burden of patients with chronic liver disease and thrombocytopaenia receiving platelet transfusions during planned invasive procedures. GastroHep. 2019;1:236–48.
doi: 10.1002/ygh2.357
Toner RW, Pizzi L, Leas B, Ballas SK, Quigley A, Goldfarb NI. Costs to hospitals of acquiring and processing blood in the US: a survey of hospital-based blood banks and transfusion services. Appl Health Econ Health Policy. 2011;9:29–37.
pubmed: 21174480
doi: 10.2165/11530740-000000000-00000
Under the auspices of the Italian Association for the Study of Liver Diseases (AISF) and the Italian Society of Internal Medicine (SIMI). Hemostatic balance in patients with liver cirrhosis: report of a consensus conference. Dig Liver Dis. 2016;48:455–67.
doi: 10.1016/j.dld.2016.02.008
Intagliata NM, Argo CK, Stine JG, et al. Concepts and controversies in haemostasis and thrombosis associated with liver disease: proceedings of the 7th International Coagulation in Liver Disease Conference. Thromb Haemost. 2018;118:1491–506.
pubmed: 30060258
pmcid: 6202935
doi: 10.1055/s-0038-1666861
Giannini EG, Kano T, Ochiai T, Bentley R, Shrestha P, Afdhal N. Bleeding events in lusutrombopag-treated thrombocytopenic patients. Eur J Clin Invest. 2021;51: e13503.
pubmed: 33523482
pmcid: 8243945
doi: 10.1111/eci.13503
Terrault N, Chen YC, Izumi N, et al. Avatrombopag before procedures reduces need for platelet transfusion in patients with chronic liver disease and thrombocytopenia. Gastroenterology. 2018;155:705–18.
pubmed: 29778606
doi: 10.1053/j.gastro.2018.05.025
Treatment of thrombocytopenia in patients with chronic liver diseaseundergoing an elective procedure. https://clinicaltrials.gov/ct2/show/results/NCT01972529?term=NCT01972529&draw=2&rank=1 . Accessed 26 May 2022.
Loffredo L, Violi F. Thrombopoietin receptor agonists and risk of portal vein thrombosis in patients with liver disease and thrombocytopenia: a meta-analysis. Dig Liver Dis. 2019;51:24–7.
pubmed: 29958825
doi: 10.1016/j.dld.2018.06.005
Afdhal NH, Giannini EG, Tayyab G, et al. Eltrombopag before procedures in patients with cirrhosis and thrombocytopenia. N Engl J Med. 2012;367:716–24.
pubmed: 22913681
doi: 10.1056/NEJMoa1110709
Wojciechowski P, Wilson K, Pochopień M, et al. PDB34 Comparative efficacy and safety of avatrombopag versus lusutrombopag in patients with chronic liver disease and severe thrombocytopenia undergoing invasive procedures: a systematic literature review and network meta-analysis. Value Health. 2021;24:S84.
doi: 10.1016/j.jval.2021.04.431
De Pietri L, Bianchini M, Montalti R, et al. Thrombelastography-guided blood product use before invasive procedures in cirrhosis with severe coagulopathy: a randomized, controlled trial. Hepatology. 2016;63:566–73.
pubmed: 26340411
doi: 10.1002/hep.28148
Alvaro D, Caporaso N, Giannini EG, et al. Procedure-related bleeding risk in patients with cirrhosis and severe thrombocytopenia. Eur J Clin Invest. 2021;51: e13508.
pubmed: 33539542
pmcid: 8244048
doi: 10.1111/eci.13508