EMA401 在周围神经病理性疼痛中的功效和安全性：两项随机、双盲、2 期研究的结果，研究对象为带状疱疹后神经痛和疼痛性糖尿病神经病患者。,Pain

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EMA401 在周围神经病理性疼痛中的功效和安全性：两项随机、双盲、2 期研究的结果，研究对象为带状疱疹后神经痛和疼痛性糖尿病神经病患者。
Pain ( IF 5.9 ) Pub Date : 2021-03-01 , DOI: 10.1097/j.pain.0000000000002252
Andrew S C Rice ₁ , Robert H Dworkin ₂ , Nanna B Finnerup ₃ , Nadine Attal _{4,

5} , Praveen Anand ₆ , Roy Freeman ₇ , Alessandro Piaia ₈ , Francesca Callegari ₉ , Christie Doerr ₁₀ , Subhayan Mondal ₁₁ , Nisha Narayanan ₁₁ , Laurent Ecochard ₉ , Yanina Flossbach ₉ , Shaloo Pandhi ₉

Affiliation

Department of Surgery and Cancer, Pain Research, Imperial College London, London, United Kingdom.
Department of Anesthesiology and Perioperative Medicine, University of Rochester Medical Center, Rochester, NY, United States.
Department of Clinical Medicine, Danish Pain Research Center, Aarhus University, Aarhus, Denmark.
INSERM U987, Ambroise Paré Hospital, APHP, Boulogne-Billancourt, Paris, France.
Université Versailles Saint Quentin- en Yvelines (UVSQ), Versailles, France.
Department of Brain Sciences, Imperial College London, London, United Kingdom.
Center for Autonomic and Peripheral Nerve Disorders, Beth Israel Deaconess Medical Center, Harvard Medical School Boston, Boston, MA, United States.
Novartis Institute for Biomedical Research, Basel, Switzerland.
Novartis Pharma AG, Basel, Switzerland.
Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States.
Novartis Healthcare Pvt. Ltd., Hyderabad, India.

两项 2b 期研究报告了 EMA401（一种高选择性血管紧张素 II 2 型受体拮抗剂）对带状疱疹后神经痛（PHN；EMPHENE）和疼痛性糖尿病神经病（EMPADINE）患者的镇痛功效和安全性。这些是多中心、随机、双盲治疗研究，对象是患有 PHN 或 I/II 型糖尿病并伴有疼痛性远端对称感觉运动神经病的参与者。参与者以 1:1:1 的比例随机分配至 EMPHENE 中的安慰剂、EMA401 25 mg 或 100 mg，每日两次（bid），以及以 1:1 的比例随机分配至 EMPADINE 中的安慰剂或 EMA401 100 mg bid。这两项研究的主要结果是使用数字评分量表（NRS）从基线到第 12 周的 24 小时平均疼痛评分的每周平均值的变化。由于长期临床前肝毒性，这两项研究都提前终止剂量，尽管在这些研究中没有观察到。在计划的参与者中，共有 129/360 (EMPHENE) 和 137/400 (EMPADINE) 参与者入组。NRS 疼痛评分的最小二乘均值降低在 EMPHENE（TD：-0.5 [95％CI：-1.6，0.6；p 值：0.35]）和 EMPADINE（治疗差异 [TD]）中均支持 EMA401 100 mg 组第 12 周结束时：-0.6 [95%CI：-1.4，0.1；p 值：0.10]）。然而，由于研究提前终止，无法得出明确的结论，但疼痛强度降低方面的临床改善一致这两项针对两个不同人群的研究值得注意。

"点击查看英文标题和摘要"

Efficacy and safety of EMA401 in peripheral neuropathic pain: results of two randomised, double-blind, phase 2 studies in patients with postherpetic neuralgia and painful diabetic neuropathy.

The analgesic efficacy and safety of two Phase 2b studies of EMA401 (a highly selective angiotensin II type 2 receptor antagonist), in patients with postherpetic neuralgia (PHN; EMPHENE) and painful diabetic neuropathy (EMPADINE) were reported. These were multicentre, randomised, double-blind treatment studies conducted in participants with PHN or type I/II diabetes mellitus with painful distal symmetrical sensorimotor neuropathy. Participants were randomised 1:1:1 to either placebo, EMA401 25 mg, or 100 mg twice daily (b.i.d) in the EMPHENE and 1:1 to placebo or EMA401 100 mg b.i.d. in the EMPADINE. The primary outcome for both the studies was change in weekly mean of the 24-hour average pain score, using a numeric rating scale (NRS), from baseline to Week 12. Both the studies were prematurely terminated due to preclinical hepatotoxicity on long-term dosing, although not observed in these studies. Out of the planned participants, a total of 129/360 (EMPHENE) and 137/400 (EMPADINE) participants were enrolled. The least square mean reduction in NRS pain score was numerically in favour of EMA401 100 mg arm in both EMPHENE (TD: -0.5 [95%CI: -1.6, 0.6; p value: 0.35]) and EMPADINE (treatment difference [TD]: -0.6 [95%CI: -1.4, 0.1; p value: 0.10]) at the end of Week 12. However, as the studies were terminated prematurely, no firm conclusion could be drawn but the consistent clinical improvement in pain intensity reduction across these two studies in two different populations is worth noting.

更新日期：2021-03-08

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