Takeda Pharmaceuticals International Co., Cambridge.
Acadia Pharmaceuticals, Princeton, NJ.
Clin J Pain. 2021 Jan;37(1):38-42. doi: 10.1097/AJP.0000000000000886.
In this study, patients with painful diabetic neuropathy were trained using an experimental pain paradigm in an attempt to enroll a subset of patients who are "pain connoisseurs" and therefore more able to discriminate between active and placebo treatments.
AZD5213, a novel histamine H3 receptor inverse agonist+pregabalin, pregabalin, and placebo were then tested in a 3-period cross-over.
The study did not provide any evidence of clinical efficacy for AZD5213 when combined with pregabalin in the treatment of painful diabetic neuropathy.
The training of study patients in pain reporting and subsequent enrichment with good pain reporters also did not enable the robust detection of the efficacy of pregabalin relative to placebo in a small sample size. Further work is required before recommending the use of "connoisseur" patients in future neuropathic pain studies.
在这项研究中，使用实验性疼痛范式对伴有痛性糖尿病周围神经病变的患者进行训练，试图纳入一部分“疼痛鉴赏家”患者，这些患者更能区分活性药物和安慰剂治疗。
然后对新型组胺 H3 受体反向激动剂+普瑞巴林、普瑞巴林和安慰剂进行 3 期交叉试验。
该研究未提供 AZD5213 与普瑞巴林联合治疗痛性糖尿病周围神经病变的临床疗效证据。
对研究患者进行疼痛报告的培训，以及随后对疼痛报告良好的患者进行富集，也未能在小样本量中可靠地检测出普瑞巴林相对于安慰剂的疗效。在推荐在未来的神经病理性疼痛研究中使用“鉴赏家”患者之前，还需要进一步开展工作。
