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Efficacy and safety of eltrombopag in Chinese patients with chronic immune thrombocytopenia: stage 2 results from a multicenter phase III study.
Liu, Xiaofan; Hou, Ming; Li, Junmin; Jin, Jie; Huang, Meijuan; Yu, Ziqiang; Xu, Xiaojun; Zhang, Xiaohui; Yang, Renchi.
Afiliação
  • Liu X; Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.
  • Hou M; Qilu Hospital, Shandong University, Ji'nan, China.
  • Li J; Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
  • Jin J; The First Affiliated Hospital, Zhejiang University College of Medicine, Hangzhou, China.
  • Huang M; Fujian Union Hospital, Fujian Medical University, Fuzhou, China.
  • Yu Z; The First Affiliated Hospital of Soochow University, Soochow University, Suzhou, China.
  • Xu X; The seventh Affiliated Hospital, Sun Yat-sen University, Shenzhen, China.
  • Zhang X; Peking University People's Hospital, Peking University, Beijing, China.
  • Yang R; Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.
Platelets ; 33(1): 82-88, 2022 Jan 02.
Article em En | MEDLINE | ID: mdl-33251910
This phase III, randomized, placebo-controlled study conducted in three stages (6-week, randomized, placebo-controlled stage 1; 24-week, open-label stage 2; and continuous extension stage 3) assessed the long-term efficacy and safety of eltrombopag use in Chinese patients with chronic immune thrombocytopenia (ITP). This article presents the results from stage 2. Overall, 150 patients (placebo-eltrombopag [P-E], 50; eltrombopag-eltrombopag [E-E], 100) received open-label eltrombopag. The median platelet count was maintained between 41 × 109/L and 80 × 109/L. Most patients in both groups (P-E, 90.0%; E-E, 81.8%) achieved platelet counts ≥30 × 109/L and ≥2 times the baseline platelet count at least once with eltrombopag treatment. Overall, 32% of patients achieved platelet counts ≥50 × 109/L in ≥75% of platelet count assessments. Both groups showed a decreased tendency to infrequent bleeding and clinically significant bleeding events during stage 2 compared with baseline. Among patients who received ≥1 ITP medication at baseline, 70.4% in the P-E group and 40.8% in the E-E group reduced or permanently stopped ≥1 of their ITP medications. The stage 2 results further demonstrated a sustainable long-term efficacy and good tolerability of eltrombopag with a favorable benefit-risk ratio in Chinese chronic ITP patients.Trial registration: Clinicaltrials.gov NCT01762761. Registered 8 January 2013, https://clinicaltrials.gov/ct2/show/NCT01762761.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Pirazóis / Benzoatos / Púrpura Trombocitopênica Idiopática / Hidrazinas Tipo de estudo: Clinical_trials Limite: Humans Idioma: En Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Pirazóis / Benzoatos / Púrpura Trombocitopênica Idiopática / Hidrazinas Tipo de estudo: Clinical_trials Limite: Humans Idioma: En Ano de publicação: 2022 Tipo de documento: Article