EMA401,口头管理高度选择性血管紧张素ⅱ2型受体拮抗剂,小说postherpetic神经痛治疗:一个随机,双盲,安慰剂对照第二阶段的临床试验。

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大米ASC,德沃金RH,麦卡锡TD,阿南德•P Bountra C, McCloudπ,希尔J,刀G,凯特森G, Desem N,拉夫米

EMA401,口头管理高度选择性血管紧张素ⅱ2型受体拮抗剂,小说postherpetic神经痛治疗:一个随机,双盲,安慰剂对照第二阶段的临床试验。

柳叶刀》。2014年5月10日,383 (9929):1637 - 1647。doi: 10.1016 / s0140 - 6736 (13) 62337 - 5。Epub 2014 2月5。

PubMed ID

24507377 (在PubMed

]

文摘

背景:现有治疗postherpetic神经痛、神经性疼痛一般来说,受限于适度的功效和不利的副作用。血管紧张素ⅱ2型受体(AT2R)是神经性疼痛的新目标。高度选择性AT2R拮抗剂,EMA401正在开发为小说神经性疼痛治疗的代理。我们评估的治疗潜力EMA401 postherpetic神经痛患者。方法:在这个多中心、安慰剂对照、双盲、随机、2期临床试验,我们登记患者(22 - 89岁)postherpetic神经痛至少6个月的时间从六个国家的29中心中。我们随机分配的183名参与者接受口服EMA401(100毫克每日两次)或安慰剂为28天。随机是根据中央随机安排,被研究的网站,这是由一个独立的生成,揭露了统计学家。病人和医护人员在每个站点被蒙面的治疗任务。我们评估疗效,安全性,和EMA401的药物动力学。主要疗效终点是改变意味着基线之间的疼痛强度和剂量的最后一周(22天),测量了11个数字评定量表。 The primary efficacy analysis was intention to treat. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12611000822987. FINDINGS: 92 patients were assigned to EMA401 and 91 were assigned to placebo. The patients given EMA401 reported significantly less pain compared with baseline values in the final week of treatment than did those given placebo (mean reductions in pain scores -2.29 [SD 1.75] vs -1.60 [1.66]; difference of adjusted least square means -0.69 [SE 0.25]; 95% CI -1.19 to -0.20; p=0.0066). No serious adverse events related to EMA401 occurred. Overall, 32 patients reported 56 treatment-emergent adverse events in the EMA401 group compared with 45 such events reported by 29 patients given placebo. INTERPRETATION: EMA401 (100 mg twice daily) provides superior relief of postherpetic neuralgia compared with placebo at the end of 28 days of treatment. EMA401 was well tolerated by patients. FUNDING: Spinifex Pharmaceuticals.

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药物靶点

药物	目标	类	生物	药理作用	行动
Olodanrigan	2型血管紧张素ⅱ受体	蛋白质	人类	是的	拮抗剂	细节