Difference between revisions of "Thrombocytopenia in liver disease"
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m (Text replacement - "style="background-color:#1a9851" |Phase III" to "style="background-color:#1a9851" |Phase 3") |
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|[https://www.gastrojournal.org/article/S0016-5085(18)34545-1/fulltext Terrault et al. 2018 (ADAPT-2)] | |[https://www.gastrojournal.org/article/S0016-5085(18)34545-1/fulltext Terrault et al. 2018 (ADAPT-2)] | ||
|2013-2017 | |2013-2017 | ||
| − | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (E-esc) |
|[[#Placebo|Placebo]] | |[[#Placebo|Placebo]] | ||
| style="background-color:#1a9850" |Superior primary endpoint | | style="background-color:#1a9850" |Superior primary endpoint | ||
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|[https://www.gastrojournal.org/article/S0016-5085(18)34545-1/fulltext Terrault et al. 2018 (ADAPT-1)] | |[https://www.gastrojournal.org/article/S0016-5085(18)34545-1/fulltext Terrault et al. 2018 (ADAPT-1)] | ||
|2014-2017 | |2014-2017 | ||
| − | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (E-esc) |
|[[#Placebo|Placebo]] | |[[#Placebo|Placebo]] | ||
| style="background-color:#1a9850" |Superior primary endpoint | | style="background-color:#1a9850" |Superior primary endpoint | ||
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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 | |2013-2014 | ||
| − | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (E-esc) |
|[[#Placebo|Placebo]] | |[[#Placebo|Placebo]] | ||
| style="background-color:#1a9850" |Superior primary endpoint | | style="background-color:#1a9850" |Superior primary endpoint | ||
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|[https://doi.org/10.1016/j.cgh.2020.03.032 Alkhouri et al. 2020 (L-PLUS 2)] | |[https://doi.org/10.1016/j.cgh.2020.03.032 Alkhouri et al. 2020 (L-PLUS 2)] | ||
|2015-2017 | |2015-2017 | ||
| − | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (E-esc) |
|[[#Placebo|Placebo]] | |[[#Placebo|Placebo]] | ||
| style="background-color:#1a9850" |Superior primary endpoint | | style="background-color:#1a9850" |Superior primary endpoint | ||
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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 | |2013-2014 | ||
| − | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
|[[#Lusutrombopag_monotherapy|Lusutrombopag]] | |[[#Lusutrombopag_monotherapy|Lusutrombopag]] | ||
| style="background-color:#d73027" |Inferior primary endpoint | | style="background-color:#d73027" |Inferior primary endpoint | ||
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|[https://www.gastrojournal.org/article/S0016-5085(18)34545-1/fulltext Terrault et al. 2018 (ADAPT-2)] | |[https://www.gastrojournal.org/article/S0016-5085(18)34545-1/fulltext Terrault et al. 2018 (ADAPT-2)] | ||
|2013-2017 | |2013-2017 | ||
| − | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
|[[#Avatrombopag_monotherapy|Avatrombopag]] | |[[#Avatrombopag_monotherapy|Avatrombopag]] | ||
| style="background-color:#d73027" |Inferior primary endpoint | | style="background-color:#d73027" |Inferior primary endpoint | ||
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|[https://www.gastrojournal.org/article/S0016-5085(18)34545-1/fulltext Terrault et al. 2018 (ADAPT-1)] | |[https://www.gastrojournal.org/article/S0016-5085(18)34545-1/fulltext Terrault et al. 2018 (ADAPT-1)] | ||
|2014-2017 | |2014-2017 | ||
| − | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
|[[#Avatrombopag_monotherapy|Avatrombopag]] | |[[#Avatrombopag_monotherapy|Avatrombopag]] | ||
| style="background-color:#d73027" |Inferior primary endpoint | | style="background-color:#d73027" |Inferior primary endpoint | ||
| Line 129: | Line 129: | ||
|[https://doi.org/10.1016/j.cgh.2020.03.032 Alkhouri et al. 2020 (L-PLUS 2)] | |[https://doi.org/10.1016/j.cgh.2020.03.032 Alkhouri et al. 2020 (L-PLUS 2)] | ||
|2015-2017 | |2015-2017 | ||
| − | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
|[[#Lusutrombopag_monotherapy|Lusutrombopag]] | |[[#Lusutrombopag_monotherapy|Lusutrombopag]] | ||
| style="background-color:#d73027" |Inferior primary endpoint | | style="background-color:#d73027" |Inferior primary endpoint | ||
Revision as of 02:15, 16 December 2021
| Page editor | Section editor | ||
|---|---|---|---|
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Ronak H. Mistry, DO Vanderbilt University Nashville, TN  @rmistry91
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Benjamin Tillman, MD Vanderbilt University Nashville, TN |
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
| back to top |
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) as follows:
- 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
| back to top |
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
| back to top |
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