Difference between revisions of "Thrombocytopenia in liver disease"
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|[https://doi.org/10.1016/j.cgh.2020.03.032 Alkhouri et al. 2020 (L-PLUS 1)] | |[https://doi.org/10.1016/j.cgh.2020.03.032 Alkhouri et al. 2020 (L-PLUS 1)] | ||
| − | |2013-2014 | + | |2013-10 to 2014-05 |
| style="background-color:#1a9851" |Phase 3 (E-esc) | | style="background-color:#1a9851" |Phase 3 (E-esc) | ||
|[[#Placebo|Placebo]] | |[[#Placebo|Placebo]] | ||
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# '''L-PLUS 1:''' Alkhouri N, Imawari M, Izumi N, Osaki Y, Ochiai T, Kano T, Bentley R, Trevisani F. Lusutrombopag Is Safe and Efficacious for Treatment of Thrombocytopenia in Patients With and Without Hepatocellular Carcinoma. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2600-2608.e1. Epub 2020 Mar 20. [https://doi.org/10.1016/j.cgh.2020.03.032 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32205226/ PubMed] JapicCTI-132323 | # '''L-PLUS 1:''' Alkhouri N, Imawari M, Izumi N, Osaki Y, Ochiai T, Kano T, Bentley R, Trevisani F. Lusutrombopag Is Safe and Efficacious for Treatment of Thrombocytopenia in Patients With and Without Hepatocellular Carcinoma. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2600-2608.e1. Epub 2020 Mar 20. [https://doi.org/10.1016/j.cgh.2020.03.032 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32205226/ PubMed] JapicCTI-132323 | ||
# '''L-PLUS 2:''' Alkhouri N, Imawari M, Izumi N, Osaki Y, Ochiai T, Kano T, Bentley R, Trevisani F. Lusutrombopag Is Safe and Efficacious for Treatment of Thrombocytopenia in Patients With and Without Hepatocellular Carcinoma. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2600-2608.e1. Epub 2020 Mar 20. [https://doi.org/10.1016/j.cgh.2020.03.032 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32205226/ PubMed] [https://clinicaltrials.gov/study/NCT02389621 NCT02389621] | # '''L-PLUS 2:''' Alkhouri N, Imawari M, Izumi N, Osaki Y, Ochiai T, Kano T, Bentley R, Trevisani F. Lusutrombopag Is Safe and Efficacious for Treatment of Thrombocytopenia in Patients With and Without Hepatocellular Carcinoma. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2600-2608.e1. Epub 2020 Mar 20. [https://doi.org/10.1016/j.cgh.2020.03.032 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32205226/ PubMed] [https://clinicaltrials.gov/study/NCT02389621 NCT02389621] | ||
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==Placebo== | ==Placebo== | ||
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
Revision as of 22:16, 29 January 2024
| Section editor | |
|---|---|
 |
Benjamin Tillman, MD Vanderbilt University Nashville, TN, USA |
See the thrombocytopenia reference page for general definitions and workup recommendations.
2 regimens on this page
2 variants on this page
|
Thrombocytopenia in liver disease with planned procedure
Avatrombopag monotherapy
Regimen
| FDA-recommended dose |
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Terrault et al. 2018 (ADAPT-2) | 2013-2017 | Phase 3 (E-esc) | Placebo | Superior primary endpoint |
| Terrault et al. 2018 (ADAPT-1) | 2014-2017 | Phase 3 (E-esc) | Placebo | Superior primary endpoint |
Growth factor therapy
- Avatrombopag (Doptelet) by the following laboratory-based criteria:
- Platelet count less than 40 x 109/L: 60 mg PO once per day on days 1 to 5
- Platelet count 40 up to 50 x 109/L: 40 mg PO once per day on days 1 to 5
Procedure days were days 10 to 13
References
- ADAPT-1: Terrault N, Chen YC, Izumi N, Kayali Z, Mitrut P, Tak WY, Allen LF, Hassanein T. Avatrombopag before procedures reduces need for platelet transfusion in patients with chronic liver disease and thrombocytopenia. Gastroenterology. 2018 Sep;155(3):705-718. Epub 2018 May 17. link to original article PubMed NCT01972529
- ADAPT-2: Terrault N, Chen YC, Izumi N, Kayali Z, Mitrut P, Tak WY, Allen LF, Hassanein T. Avatrombopag before procedures reduces need for platelet transfusion in patients with chronic liver disease and thrombocytopenia. Gastroenterology. 2018 Sep;155(3):705-718. Epub 2018 May 17. link to original article PubMed NCT01976104
Lusutrombopag monotherapy
Regimen
| FDA-recommended dose |
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Alkhouri et al. 2020 (L-PLUS 1) | 2013-10 to 2014-05 | Phase 3 (E-esc) | Placebo | Superior primary endpoint |
| Alkhouri et al. 2020 (L-PLUS 2) | 2015-2017 | Phase 3 (E-esc) | Placebo | Superior primary endpoint |
References
- L-PLUS 1: Alkhouri N, Imawari M, Izumi N, Osaki Y, Ochiai T, Kano T, Bentley R, Trevisani F. Lusutrombopag Is Safe and Efficacious for Treatment of Thrombocytopenia in Patients With and Without Hepatocellular Carcinoma. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2600-2608.e1. Epub 2020 Mar 20. link to original article PubMed JapicCTI-132323
- L-PLUS 2: Alkhouri N, Imawari M, Izumi N, Osaki Y, Ochiai T, Kano T, Bentley R, Trevisani F. Lusutrombopag Is Safe and Efficacious for Treatment of Thrombocytopenia in Patients With and Without Hepatocellular Carcinoma. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2600-2608.e1. Epub 2020 Mar 20. link to original article PubMed NCT02389621
Placebo
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Alkhouri et al. 2020 (L-PLUS 1) | 2013-2014 | Phase 3 (C) | Lusutrombopag | Inferior primary endpoint |
| Terrault et al. 2018 (ADAPT-2) | 2013-2017 | Phase 3 (C) | Avatrombopag | Inferior primary endpoint |
| Terrault et al. 2018 (ADAPT-1) | 2014-2017 | Phase 3 (C) | Avatrombopag | Inferior primary endpoint |
| Alkhouri et al. 2020 (L-PLUS 2) | 2015-2017 | Phase 3 (C) | Lusutrombopag | Inferior primary endpoint |
No active treatment.
References
- ADAPT-1: Terrault N, Chen YC, Izumi N, Kayali Z, Mitrut P, Tak WY, Allen LF, Hassanein T. Avatrombopag before procedures reduces need for platelet transfusion in patients with chronic liver disease and thrombocytopenia. Gastroenterology. 2018 Sep;155(3):705-718. Epub 2018 May 17. link to original article PubMed NCT01972529
- ADAPT-2: Terrault N, Chen YC, Izumi N, Kayali Z, Mitrut P, Tak WY, Allen LF, Hassanein T. Avatrombopag before procedures reduces need for platelet transfusion in patients with chronic liver disease and thrombocytopenia. Gastroenterology. 2018 Sep;155(3):705-718. Epub 2018 May 17. link to original article PubMed NCT01976104
- L-PLUS 1: Alkhouri N, Imawari M, Izumi N, Osaki Y, Ochiai T, Kano T, Bentley R, Trevisani F. Lusutrombopag Is Safe and Efficacious for Treatment of Thrombocytopenia in Patients With and Without Hepatocellular Carcinoma. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2600-2608.e1. Epub 2020 Mar 20. link to original article PubMed JapicCTI-132323
- L-PLUS 2: Alkhouri N, Imawari M, Izumi N, Osaki Y, Ochiai T, Kano T, Bentley R, Trevisani F. Lusutrombopag Is Safe and Efficacious for Treatment of Thrombocytopenia in Patients With and Without Hepatocellular Carcinoma. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2600-2608.e1. Epub 2020 Mar 20. link to original article PubMed NCT02389621