Parsons Bruce, Freynhagen Rainer, Schug Stephan, Whalen Ed, Ortiz Marie, Bhadra Brown Pritha, Knapp Lloyd
Pfizer Inc , New York, NY, USA.
Department of Anesthesiology, Critical Care Medicine, Pain Therapy & Palliative Care, Pain Center Lake Starnberg, Benedictus Hospital, Tutzing, Germany.
J Pain Res. 2019 Aug 22;12:2577-2587. doi: 10.2147/JPR.S199203. eCollection 2019.
Euphoria is a complex, multifactorial problem that is reported as an adverse event in clinical trials of analgesics including pregabalin. The relationship between the reporting of euphoria events and pregabalin early treatment responses was examined in this exploratory post-hoc analysis.
Data were from patients with neuropathic or non-neuropathic chronic pain enrolled in 40 randomized clinical trials, who received pregabalin (75-600 mg/day) or placebo. Reports of treatment-emergent euphoria events were based on the Medical Dictionary of Regulatory Activities preferred term "euphoric mood". Prevalence rates of euphoria events overall and by indication were assessed. Post-treatment endpoints included ≥30% improvements in pain and sleep scores up to 3 weeks as well as a ≥1-point improvement in daily pain score up to 11 days after treatment.
13,252 patients were analyzed; 8,501 (64.1%) and 4,751 (35.9%) received pregabalin and placebo, respectively. Overall, 1.7% (n=222) of patients reported euphoria events. Among pregabalin-treated patients, a larger proportion who reported euphoria events achieved an early pain response compared with those who did not report euphoria (30% pain responders in week 1 with euphoria events [43.0%], without euphoria events [24.2%]). Results were similar for weeks 2 and 3. For Days 2-11, a larger proportion of pregabalin-treated patients with (relative to without) euphoria events were 1-point pain responders. Findings were similar in pregabalin-treated patients for sleep endpoints (30% sleep responders in week 1 with euphoria events [50.7%], without euphoria events [36.1%]). Similar results were found for weeks 2 and 3. Patients who received placebo showed similar patterns, although the overall number of them who reported euphoria events was small (n=13).
In patients who received pregabalin for neuropathic or non-neuropathic chronic pain, those who experienced euphoria events may have better early treatment responses than those who did not report euphoria events.
欣快感是一个复杂的多因素问题，在包括普瑞巴林在内的镇痛药临床试验中被报告为不良事件。在这项探索性的事后分析中，研究了欣快感事件报告与普瑞巴林早期治疗反应之间的关系。
数据来自40项随机临床试验中纳入的神经性或非神经性慢性疼痛患者，他们接受了普瑞巴林（75 - 600毫克/天）或安慰剂治疗。治疗中出现的欣快感事件报告基于《医学监管活动词典》中的首选术语“欣快情绪”。评估了欣快感事件的总体患病率及按适应症的患病率。治疗后的终点包括疼痛和睡眠评分在3周内改善≥30%，以及治疗后11天内每日疼痛评分改善≥1分。
共分析了13252例患者；分别有8501例（64.1%）和4751例（35.9%）接受了普瑞巴林和安慰剂治疗。总体而言，1.7%（n = 222）的患者报告了欣快感事件。在接受普瑞巴林治疗的患者中，报告有欣快感事件的患者中，与未报告欣快感的患者相比，有更大比例的患者实现了早期疼痛缓解（第1周有欣快感事件的疼痛缓解者占30% [43.0%]，无欣快感事件的为[24.2%]）。第2周和第3周的结果相似。在第2 - 11天，接受普瑞巴林治疗且有（相对于无）欣快感事件的患者中，有更大比例的患者疼痛评分改善1分。在接受普瑞巴林治疗的患者中，睡眠终点的结果相似（第1周有欣快感事件的睡眠改善者占30% [50.7%]，无欣快感事件的为[36.1%]）。第2周和第3周也发现了类似结果。接受安慰剂治疗的患者也表现出类似模式，尽管报告有欣快感事件的患者总数较少（n = 13）。
在接受普瑞巴林治疗神经性或非神经性慢性疼痛的患者中，经历欣快感事件的患者可能比未报告欣快感事件的患者有更好的早期治疗反应。
