Difference between revisions of "Thrombocytopenia in liver disease"

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![[Levels_of_Evidence#Efficacy|Efficacy]]
 
![[Levels_of_Evidence#Efficacy|Efficacy]]
 
|-
 
|-
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|[https://www.sciencedirect.com/science/article/pii/S0016508518345451 Terrault et al. 2018 (ADAPT-1/ADAPT-2)]
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|[https://www.gastrojournal.org/article/S0016-5085(18)34545-1/fulltext Terrault et al. 2018 (ADAPT-1/ADAPT-2)]
 
| style="background-color:#1a9851" |Phase III (E)
 
| style="background-color:#1a9851" |Phase III (E)
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|Placebo
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|[[#Placebo|Placebo]]
 
| style="background-color:#1a9850" |Superior primary endpoint
 
| style="background-color:#1a9850" |Superior primary endpoint
 
|-
 
|-
 
|}
 
|}
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====Therapy====
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====Growth factor therapy====
 
*[[Avatrombopag (Doptelet)]] as follows:
 
*[[Avatrombopag (Doptelet)]] as follows:
 
**Platelet count less than 40 x 10<sup>9</sup>/L: 60 mg PO once per day on days 1 to 5
 
**Platelet count less than 40 x 10<sup>9</sup>/L: 60 mg PO once per day on days 1 to 5
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'''Procedure days were days 10 to 13'''
 
'''Procedure days were days 10 to 13'''
 
===References===
 
===References===
−
# 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 May 17. [Epub ahead of print] [https://www.sciencedirect.com/science/article/pii/S0016508518345451 link to SD article] [https://www.ncbi.nlm.nih.gov/pubmed/29778606 PubMed]
+
# '''ADAPT-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 May 17. [Epub ahead of print] [https://www.gastrojournal.org/article/S0016-5085(18)34545-1/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/29778606 PubMed]
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==Lusutrombopag monotherapy {{#subobject:8f4acd|Regimen=1}}==
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{| class="wikitable" style="float:right; margin-left: 5px;"
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|-
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|[[#top|back to top]]
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|}
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===Regimen {{#subobject:4c9447|Variant=1}}===
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{| class="wikitable" style="color:white; background-color:#404040"
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|<small>'''FDA-recommended dose'''</small>
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|-
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|}
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{| class="wikitable" style="width: 100%; text-align:center;"
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!Study
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![[Levels_of_Evidence#Evidence|Evidence]]
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!Comparator
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![[Levels_of_Evidence#Efficacy|Efficacy]]
 +
|-
 +
|(L-PLUS 1/L-PLUS 2)
 +
| style="background-color:#1a9851" |Phase III (E)
 +
|[[#Placebo|Placebo]]
 +
| style="background-color:#1a9850" |Superior primary endpoint
 +
|-
 +
|}
 +
''Note: there are no apparent publications of these trials, to date.''
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====Growth factor therapy====
 +
*[[Lusutrombopag (Mulpleta)]] 3 mg PO once per day on days 1 to 7
 +
 
 +
'''7-day course'''
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===References===
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# [https://clinicaltrials.gov/ct2/show/NCT02389621 CT.gov]
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==Placebo==
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{| class="wikitable" style="float:right; margin-left: 5px;"
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|-
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|[[#top|back to top]]
 +
|}
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===Regimen===
 +
{| class="wikitable" style="width: 100%; text-align:center;"
 +
!Study
 +
![[Levels_of_Evidence#Evidence|Evidence]]
 +
!Comparator
 +
![[Levels_of_Evidence#Efficacy|Efficacy]]
 +
|-
 +
|[https://www.gastrojournal.org/article/S0016-5085(18)34545-1/fulltext Terrault et al. 2018 (ADAPT-1/ADAPT-2)]
 +
| style="background-color:#1a9851" |Phase III (C)
 +
|[[#Avatrombopag_monotherapy|Avatrombopag]]
 +
| style="background-color:#d73027" |Inferior primary endpoint
 +
|-
 +
|(L-PLUS 1/L-PLUS 2)
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| style="background-color:#1a9851" |Phase III (C)
 +
|[[#Lusutrombopag_monotherapy|Lusutrombopag]]
 +
| style="background-color:#d73027" |Inferior primary endpoint
 +
|-
 +
|}
 +
''No active treatment.''
 +
===References===
 +
# '''ADAPT-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 May 17. [Epub ahead of print] [https://www.gastrojournal.org/article/S0016-5085(18)34545-1/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/29778606 PubMed]
  
 
[[Category:Thrombocytopenia in liver disease regimens]]
 
[[Category:Thrombocytopenia in liver disease regimens]]
 
[[Category:Disease-specific pages]]
 
[[Category:Disease-specific pages]]
 
[[Category:Cytopenias]]
 
[[Category:Cytopenias]]

Revision as of 02:21, 5 August 2018

Section editors
Shruti.jpg
 Shruti Chaturvedi, MBBS, MSCI
Baltimore, MD
LinkedIn
Tillman Benjamin-2.jpg
 Benjamin Tillman, MD
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 Evidence Comparator Efficacy
Terrault et al. 2018 (ADAPT-1/ADAPT-2) Phase III (E) 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

  1. ADAPT-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 May 17. [Epub ahead of print] link to original article PubMed

Lusutrombopag monotherapy

back to top

Regimen

FDA-recommended dose
Study Evidence Comparator Efficacy
(L-PLUS 1/L-PLUS 2) Phase III (E) Placebo Superior primary endpoint

Note: there are no apparent publications of these trials, to date.

Growth factor therapy

7-day course

References

  1. CT.gov

Placebo

back to top

Regimen

Study Evidence Comparator Efficacy
Terrault et al. 2018 (ADAPT-1/ADAPT-2) Phase III (C) Avatrombopag Inferior primary endpoint
(L-PLUS 1/L-PLUS 2) Phase III (C) Lusutrombopag Inferior primary endpoint

No active treatment.

References

  1. ADAPT-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 May 17. [Epub ahead of print] link to original article PubMed
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