scholarly journals Lusutrombopag as a substitute for platelet transfusion for thrombocytopenia associated with chronic liver disease in a patient undergoing endoscopic spinal surgery

Medicine ◽  
2021 ◽  
Vol 100 (2) ◽  
pp. e24094
Author(s):  
Takeshi Kaneko ◽  
Yuichi Takano ◽  
Katsuhiko Ishibashi
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Hiroaki Nomoto ◽  
Naoki Morimoto ◽  
Kouichi Miura ◽  
Shunji Watanabe ◽  
Yoshinari Takaoka ◽  
...  

Abstract Background Chronic liver disease (CLD) is often complicated by severe thrombocytopenia (platelet count < 50,000/µL). Platelet transfusion has been a gold standard for increasing the platelet count to prevent hemorrhagic events in such patients. Lusutrombopag, a thrombopoietin receptor agonist, can increase the platelet count in such patients when invasive procedures are scheduled. Former studies on lusutrombopag included patients with a platelet count of > 50,000/µL at baseline: the proportions of patients who did not require platelet transfusion were 84–96%, which might be overestimated. Methods The efficacy and safety of lusutrombopag were retrospectively investigated in CLD patients with platelet count of < 50,000/µL, a criterion for platelet transfusion, in real-world settings. We examined the proportion of patients who did not require platelet transfusion in 31 CLD patients, which exceeded a minimum required sample size (21 patients) calculated by 80% power at a significance level of 5%. Lusutrombopag, 3 mg once daily, was administered 8–18 days before scheduled invasive procedures. Results Among 31 patients who received lusutrombopag, 23 patients (74.2%) patients showed a platelet count of ≥ 50,000/µL (Group A) and did not require platelet transfusion. The remaining 8 patients (25.8%) did not reached platelet ≥ 50,000/µL (Group B). The means of platelet increase were 38,000/µL and 12,000/µL in groups A and B, respectively. A low platelet count at baseline was a characteristic of patients in group B. Among 13 patients who repeatedly used lusutrombopag, lusutrombopag significantly increased the platelet count as the initial treatment. When all repeated uses of lusutrombopag were counted among these 13 patients, platelet transfusion was not required in 82.1% (23/28) of treatments. Although one patient showed portal thrombosis after lusutrombopag treatment, the thrombosis was disappeared by anticoagulant treatment for 35 days. The degree of platelet increase with lusutrombopag was larger than that in their previous platelet transfusion. Conclusions The proportion of patients who did not require platelet transfusion was 74.2%, which is smaller than that in former studies which included CLD patients with a platelet count of > 50,000/µL. However, lusutrombopag is effective and safe for CLD patients with a platelet count of < 50,000/µL.


2018 ◽  
Vol 155 (3) ◽  
pp. 705-718 ◽  
Author(s):  
Norah Terrault ◽  
Yi-Cheng Chen ◽  
Namiki Izumi ◽  
Zeid Kayali ◽  
Paul Mitrut ◽  
...  

2013 ◽  
Vol 229 (3) ◽  
pp. 213-220 ◽  
Author(s):  
Takehito Maruyama ◽  
Soichiro Murata ◽  
Kazuhiro Takahashi ◽  
Takafumi Tamura ◽  
Reiji Nozaki ◽  
...  

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2108-2108
Author(s):  
Michael Jaglal ◽  
Damian A. Laber ◽  
Ankita K. Patel ◽  
Mintallah Haider ◽  
Jennifer Eatrides ◽  
...  

Introduction: Chronic liver disease (CLD) results in thrombocytopenia [1]. Depression of thrombopoietin (TPO) levels in CLD leads to thrombocytopenia. Thrombocytopenia increases the risk of bleeding in patients undergoing invasive diagnostic or therapeutic procedures [2]. TPO agonists have been depicted to be safe and efficacious in the treatment of thrombocytopenia due to idiopathic immune thrombocytopenia and aplastic anemia. Several studies have evaluated the use of TPO agonist versus placebo for pre-procedural treatment of thrombocytopenic patients with chronic liver disease. These studies were of limited sample sizes. We conducted a meta-analysis to determine if TPO agonists reduce the need of platelet transfusions before procedures in chronic liver disease patients. Methods: We performed a computerized search of Medline, Cochrane and Google Scholar databases through March 2019 for studies evaluating the efficacy of thrombopoietin (TPO) agonists versus placebo in the treatment of thrombocytopenia of chronic liver disease patients undergoing procedures. We screened 295 studies and only 5 of them met our inclusion and exclusion criteria. Inclusion criteria were studies with adults >18 years old, English literature, randomized controlled trials utilizing a TPO agonists in chronic liver disease patients. Exclusion criteria were studies with patients <18 years old, improper study design (e.g. abstract, commentary, editorials) and literature without available data. The primary study outcomes were proportion of patients responding to TPO agonists in comparison to placebo (an increase of 20000 of platelet count /ul and a value of more than 50000 count/ul). Our secondary outcomes were evaluating the proportion of patients not requiring platelet transfusion and evaluating the percentage of patients who developed a portal venous thrombosis (PVT) on study. Statistical analyses were calculated using Cumulative Meta-Analysis software (version 3.0) Results: The final analysis included 5 studies with a total of 1098 patients. Please see Image 1 for Individual Trial data. The proportion of responders for TPO agonists odds ratio was 0.060 (0.038-0.095) with P value <0.0001. The proportion of patients not requiring transfusion on TPO agonist odds ratio was 0.118 (0.077-0.182) with P value <0.0001. The portal vein thrombosis odds ratio while on TPO agonist was 0.631 (0.175-2.268) with P value of 0.480. All 5 trials demonstrated that TPO agonists compared to placebo significantly increased the platelet count and reduced the need of platelet transfusion pre-procedural with a P-value of <0.0001. The risk of developing PVT in patients receiving TPO agonists was not significantly increased when compared to those receiving placebo. Conclusion: Our analysis shows that TPO-agonists provide significant benefit compared to placebo in regard to increasing platelet count and reducing the need for platelet transfusions. The risk of developing PVT in patients receiving TPO agonists was not significantly increased when compared to those receiving placebo. More trials are needed to validate the comparison for PVT outcome. Figure Disclosures Jaglal: NOVARTIS: Consultancy.


2020 ◽  
Vol 2020 ◽  
pp. 1-11
Author(s):  
Fred Poordad ◽  
Norah A. Terrault ◽  
Naim Alkhouri ◽  
Wei Tian ◽  
Lee F. Allen ◽  
...  

Aims. Thrombocytopenia complicates the management of patients with chronic liver disease (CLD) undergoing invasive procedures with a bleeding risk. Until recently, prophylactic platelet transfusion was the only treatment option, but has significant safety and efficacy limitations. Phase 3 data demonstrated the superiority of avatrombopag to placebo in reducing platelet transfusions for bleeding, supporting its recent approval. Methods. Integrated analyses of pooled data (N=435) from two randomized, double-blind, placebo-controlled, phase 3 studies assessed the original efficacy endpoints. Additional analyses included subgroup analyses, alternate Baseline platelet count definitions, and another efficacy endpoint. Results. Avatrombopag was superior to placebo in increasing patients not requiring a platelet transfusion or rescue procedure, those achieving a platelet count ≥50 × 109/L on Procedure Day, and the change in platelet counts from Baseline. The avatrombopag treatment effect was consistently positive across clinically important disease and Baseline clinical characteristic subgroups, and using alternate Baseline platelet count cohort definitions. Similarly, more avatrombopag-treated patients achieved ≥50 × 109/L platelets with an increase of ≥20 × 109/L from Baseline. The incidence and severity of adverse events were similar between avatrombopag and placebo. Further, safety data demonstrated a low risk for thromboembolic events and hepatotoxicity. Conclusion. These integrated analyses confirmed the superiority of avatrombopag to placebo in reducing platelet transfusions or rescue procedures for bleeding in patients with thrombocytopenia and CLD scheduled to undergo an invasive procedure, and its tolerable safety profile. Importantly, these data warrant reconsideration of clinical decision making regarding the need to treat thrombocytopenia in patients with CLD. This trial was registered with NCT01972529 and NCT01976104.


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