Abstract |
Eltrombopag, a thrombopoietin receptor agonist, raises platelet counts and reduces bleeding in patients with immune thrombocytopenia ( ITP). In Chinese patients, eltrombopag was evaluated at an initial dose of 25 mg, vs. 50 mg for non-Asians, because the plasma exposure of eltrombopag is higher in East Asians. A multicentre, double-blind, randomised, placebo-controlled, 8-week, phase III study enrolled 155 patients with chronic, previously treated ITP. Dosage could be adjusted (25-75 mg/day) to maintain platelet counts 50-250 × 109 /l. The primary efficacy endpoint was the proportion of patients with a platelet count ≥50 × 109 /l after Day 42. Pharmacokinetics and pharmacodynamics of eltrombopag were analysed in an open-label extension. After Day 42, 57·7% of eltrombopag-treated and 6·0% of placebo-treated patients achieved platelet counts ≥50 × 109 /l. Odds of achieving a platelet count ≥50 × 109 /l were 26·08 times greater with eltrombopag than placebo (P < 0·001). Compared with placebo, time to response and duration of response were better with eltrombopag (P < 0·001) and the odds of any bleeding were reduced by 72% (P = 0·001). Tolerability, pharmacokinetics, and pharmacokinetics/pharmacodynamics were similar to previous findings in East Asian patients. In conclusion, in Chinese patients with chronic ITP, eltrombopag 25 mg once daily, elevated platelet counts to a safe range and reduced bleeding.
|
Authors | Renchi Yang, Junmin Li, Jie Jin, Meijuan Huang, Ziqiang Yu, Xiaojun Xu, Xiaohui Zhang, Ming Hou |
Journal | British journal of haematology
(Br J Haematol)
Vol. 176
Issue 1
Pg. 101-110
(Jan 2017)
ISSN: 1365-2141 [Electronic] England |
PMID | 27734464
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
|
Copyright | © 2016 John Wiley & Sons Ltd. |
Chemical References |
- Benzoates
- Hydrazines
- Pyrazoles
- Receptors, Thrombopoietin
- eltrombopag
|
Topics |
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Asian People
- Benzoates
(administration & dosage, pharmacokinetics, therapeutic use)
- Double-Blind Method
- Female
- Hemorrhage
(etiology, prevention & control)
- Humans
- Hydrazines
(administration & dosage, pharmacokinetics, therapeutic use)
- Male
- Middle Aged
- Platelet Count
- Purpura, Thrombocytopenic, Idiopathic
(drug therapy)
- Pyrazoles
(administration & dosage, pharmacokinetics, therapeutic use)
- Receptors, Thrombopoietin
(agonists)
- Treatment Outcome
- Young Adult
|