Difference between revisions of "Thrombocytopenia in liver disease"
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!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
| − | |[https://www.gastrojournal.org/article/S0016-5085(18)34545-1 | + | |[https://www.gastrojournal.org/article/S0016-5085(18)34545-1 Terrault et al. 2018 (ADAPT-2)] |
|2013-2017 | |2013-2017 | ||
| style="background-color:#1a9851" |Phase 3 (E-esc) | | style="background-color:#1a9851" |Phase 3 (E-esc) | ||
| Line 33: | Line 33: | ||
| style="background-color:#1a9850" |Superior primary endpoint | | style="background-color:#1a9850" |Superior primary endpoint | ||
|- | |- | ||
| − | |[https://www.gastrojournal.org/article/S0016-5085(18)34545-1 | + | |[https://www.gastrojournal.org/article/S0016-5085(18)34545-1 Terrault et al. 2018 (ADAPT-1)] |
|2014-2017 | |2014-2017 | ||
| style="background-color:#1a9851" |Phase 3 (E-esc) | | style="background-color:#1a9851" |Phase 3 (E-esc) | ||
| Line 48: | Line 48: | ||
===References=== | ===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. [https://www.gastrojournal.org/article/S0016-5085(18)34545-1 | + | # '''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. [https://www.gastrojournal.org/article/S0016-5085(18)34545-1 link to original article] [https://pubmed.ncbi.nlm.nih.gov/29778606 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. [https://www.gastrojournal.org/article/S0016-5085(18)34545-1 | + | # '''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. [https://www.gastrojournal.org/article/S0016-5085(18)34545-1 link to original article] [https://pubmed.ncbi.nlm.nih.gov/29778606 PubMed] NCT01976104 |
==Lusutrombopag monotherapy {{#subobject:8f4acd|Regimen=1}}== | ==Lusutrombopag monotherapy {{#subobject:8f4acd|Regimen=1}}== | ||
| Line 102: | Line 102: | ||
| style="background-color:#d73027" |Inferior primary endpoint | | style="background-color:#d73027" |Inferior primary endpoint | ||
|- | |- | ||
| − | |[https://www.gastrojournal.org/article/S0016-5085(18)34545-1 | + | |[https://www.gastrojournal.org/article/S0016-5085(18)34545-1 Terrault et al. 2018 (ADAPT-2)] |
|2013-2017 | |2013-2017 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
| Line 108: | Line 108: | ||
| style="background-color:#d73027" |Inferior primary endpoint | | style="background-color:#d73027" |Inferior primary endpoint | ||
|- | |- | ||
| − | |[https://www.gastrojournal.org/article/S0016-5085(18)34545-1 | + | |[https://www.gastrojournal.org/article/S0016-5085(18)34545-1 Terrault et al. 2018 (ADAPT-1)] |
|2014-2017 | |2014-2017 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
| Line 123: | Line 123: | ||
''No active treatment.'' | ''No active treatment.'' | ||
===References=== | ===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. [https://www.gastrojournal.org/article/S0016-5085(18)34545-1 | + | # '''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. [https://www.gastrojournal.org/article/S0016-5085(18)34545-1 link to original article] [https://pubmed.ncbi.nlm.nih.gov/29778606 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. [https://www.gastrojournal.org/article/S0016-5085(18)34545-1 | + | # '''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. [https://www.gastrojournal.org/article/S0016-5085(18)34545-1 link to original article] [https://pubmed.ncbi.nlm.nih.gov/29778606 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. [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] 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] NCT02389621 | ||
Revision as of 11:27, 16 September 2022
Section editor transclusions 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 | Years 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 at least 40 and less than 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 | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Alkhouri et al. 2020 (L-PLUS 1) | 2013-2014 | 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 |
Growth factor therapy
- Lusutrombopag (Mulpleta) 3 mg PO once per day on days 1 to 7
7-day course
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 | Years 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