Drug updated on 12/11/2024
Dosage Form | Tablet (oral; 3 mg) |
Drug Class | Thrombopoietin receptor agonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.
Latest News
Summary
- This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
- Lusutrombopag significantly increased platelet counts in patients with chronic liver disease and severe thrombocytopenia compared to placebo, with an increase in patients achieving platelet counts of at least 50 x 10^9/L and an increase of at least 20 x 10^9/L (relative risk (RR) 6.39; 95% confidence interval (CI): 3.69, 11.07; p < 0.0001). Lusutrombopag also showed a favorable response compared to other treatments, though the advantage over avatrombopag was not statistically significant (odds ratio (OR) 1.91; 95% CI 0.52, 7.05).
- Lusutrombopag significantly reduced the need for platelet transfusions and rescue therapy for bleeding, with 68.0% of patients with hepatocellular carcinoma (HCC) and 77.0% of non-HCC patients avoiding transfusions and achieving the primary endpoint compared to 8.9% and 21.6%, respectively, on placebo (P < .0001). Additionally, lusutrombopag reduced the risk of bleeding events (RR 0.55; 95% CI 0.32, 0.95; p = 0.03).
- Lusutrombopag demonstrated a safety profile comparable to placebo, with similar thrombosis event rates between the two groups (RR 0.79; 95% CI 0.19, 3.24; p = 0.74), and did not increase the risk of bleeding or other serious adverse events compared to placebo in patients with chronic liver disease, including those with HCC.
- No specific adverse events were highlighted in one of the reviewed studies, but inconsistencies in data reporting were noted, suggesting the need for more detailed safety assessments in future studies.
- Lusutrombopag was evaluated in patients with chronic liver disease, including those with HCC. It was shown to be effective in increasing platelet counts, reducing the need for platelet transfusions, and lowering bleeding risks in both HCC and non-HCC populations. In patients with HCC, 68.0% achieved the primary endpoint compared to 8.9% on placebo, while in non-HCC patients, 77.0% reached the primary endpoint compared to 21.6% on placebo, with no significant differences in safety outcomes between the two groups.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Mulpleta (lusutrombopag) Prescribing Information. | 2020 | Shionogi Inc., Florham Park, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
NCCN Guidelines® insights: Hematopoietic growth factors, Version 1.2022. | 2022 | Journal of the National Comprehensive Cancer Network |
Practice guidelines of the central european hepatologic collaboration (CEHC) on the use of thrombopoietin receptor agonists in patients with chronic liver disease undergoing invasive procedures. | 2021 | Journal of Clinical Medicine |
ACG clinical guideline: Disorders of the hepatic and mesenteric circulation. | 2020 | American Journal of Gastroenterology |
Lusutrombopag for treating thrombocytopenia in people with chronic liver disease needing a planned invasive procedure. | 2020 | National Institute for Health and Care Excellence |