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Eltrombopag for chronic immune thrombocytopenia.

机译:Eltompopag用于慢性免疫血小板减少症。

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Gregory Cheng and colleagues (Jan 29, p 393) report the results of a randomised, double-blind, placebo-controlled trial in patients with chronic immune thrombocytopenic purpura. They show that eltrombopag can maintain durable platelet counts and reduce risk of bleeding during a 6-month period. Since this study was done as a global clinical trial, the distribution of participants' ethnic origins warrants further consideration. In the eltrombopag group, 75% of the patients were white, 16% were Asian, and 10% were of other ethnic origins. All patients were treated with the standard starting regimen of 50 mg eltrombopag once daily with 25 mg dose adjustments (to a maximum of 75 mg) irrespective of ethnic origin. However, east Asian patients have a greater response to eltrombopag exposure, and thus require a lower dose, than do non-Asians. Indeed, according to the US Food and Drug Administration and the European Medicines Agency, the recommended dose for east Asian patients is a lower, 25 mg once-daily starting regimen. The recommended dose according to the Pharmaceuticals and Medical Devices Agency of Japan is a 12.5 mg once-daily starting regimen with 12.5 mg dose adjustments (to a maximum of 50 mg). Without these dose reductions, the incidence of adverse events might have been higher in east Asian patients in Cheng and colleagues'trial.
机译:格雷戈里程和他的同事(01月29日,第393)报道在慢性免疫性血小板减少性紫癜一项随机,双盲,安慰剂对照试验的结果。它们表明,波帕能保持持久的血小板计数和降低在6个月内的出血风险。由于本研究是一个全球性的临床试验完成后,参与者分布的种族起源值得进一步考虑。在波帕组的患者75%是白人,16%是亚裔,10%是其他种族的。所有患者均具有50毫克艾曲波帕,不论人种的标准起始方案每日一次用25次毫克的剂量调整(至最高75毫克)处理。然而,东亚病人要波帕曝光较大的反响,因此需要较低的剂量,不是做非亚洲人。事实上,根据美国食品和药品管理局和欧洲药品管理局,东亚患者的推荐剂量是较低的,25毫克,每日一次启动方案。根据日本的药品和医疗器械局的推荐剂量是12.5毫克剂量调整(最大为50毫克),12.5毫克每日一次启动方案。如果没有这些剂量减少,不良事件的发生率可能会在东亚患者在郑和colleagues'trial更高。

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