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Efficacy and safety of eltrombopag in Japanese patients with chronic liver disease and thrombocytopenia: a randomized, open-label, phase II study
Journal of Gastroenterology, 06/15/2012
Clinical Article
Kawaguchi T et al. – Eltrombopag ameliorated thrombocytopenia in Japanese patients with chronic liver disease (CLD) and thrombocytopenia. The recommended dose for these patients is 25 mg daily for 2 weeks.
Methods- Thirty–eight patients with CLD and thrombocytopenia (platelets <50,000/μL) were enrolled in this phase II, open–label, dose–ranging study that consisted of 2 parts.
- In the first part, 12 patients received 12.5 mg of eltrombopag once daily for 2 weeks.
- After the evaluation of safety, 26 patients were randomly assigned to receive either 25 or 37.5 mg of eltrombopag once daily for 2 weeks in the second part.
- Pharmacokinetics showed that the geometric means of the maximum plasma concentration (C max) and the area under the curve (AUC) in the 12.5 mg group were 3,413 ng/mL and 65,236 ng h/mL, respectively.
- At week 2, the mean increases from baseline in platelet counts were 24,800, 54,000, and 60,000/μL in the 12.5, 25, and 37.5 mg groups, respectively.
- The median platelet counts increased within 2 weeks of the beginning of administration in all groups, and remained at the same level throughout the 2–week post–treatment period in the 12.5 mg group, whereas the platelet counts peaked a week after the last treatment in both the 25 and 37.5 mg groups.
- Most adverse events reported were grade 1 or 2; 2 patients in the 37.5 mg group had drug–related serious adverse events.