拉米地坦用于偏头痛患者及曲坦类药物禁忌者：一项事后分析
Lasmiditan for Patients with Migraine and Contraindications to Triptans: A Post Hoc Analysis.
作者信息
Krege John H, Lipton Richard B, Baygani Simin K, Komori Mika, Ryan Sinéad M, Vincent Maurice
机构信息
Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Albert Einstein College of Medicine, Bronx, NY, USA.
出版信息
Pain Ther. 2022 Jun;11(2):701-712. doi: 10.1007/s40122-022-00388-8. Epub 2022 Apr 26.
INTRODUCTION
As 5-HT receptor agonists, triptans produce vasoconstriction and have cardiovascular contraindications and precautions. Lasmiditan, a selective 5-HT receptor agonist, has a low affinity for 5-HT receptors, does not cause vasoconstriction, and is free of cardiovascular contraindications and precautions. The objective of this post hoc analysis was to evaluate the efficacy and safety of lasmiditan in patients with and without at least one triptan contraindication.
METHODS
Patient subgroups, with and without triptan contraindications, were analyzed from pooled patient data from four randomized, double-blind, placebo-controlled clinical trials (SAMURAI, SPARTAN, CENTURION, and MONONOFU). Patients experiencing a single migraine attack of moderate or severe intensity were treated with lasmiditan 50 mg (SPARTAN and MONONOFU only), 100 mg, 200 mg, or placebo, and efficacy data were recorded in an electronic diary.
RESULTS
Of 5704 patients, 207 (3.6%) patients had at least one contraindication to triptans. Overall subgroup analysis revealed that the effects of lasmiditan on pain freedom, pain relief, freedom from most bothersome symptom, disability freedom, and Patient Global Impression of Change at 2 h post-dose did not differ in patient groups with and without triptan contraindications. These outcomes generally showed a similar benefit pattern for lasmiditan in both subgroups, with all results being statistically significant in patients without contraindications, and pain relief being statistically significant in patients with contraindications. The safety and tolerability profiles of patients with triptan versus without triptan contraindications were similar, including dizziness in 18.3 to 22.8% and somnolence in 7.9 to 9.9% of patients at the highest dose of lasmiditan.
CONCLUSIONS
In pooled analyses from four trials, patients with and without triptan contraindications did not differ in their patterns of lasmiditan efficacy. Lasmiditan may be a treatment option in patients with contraindications to triptans.
TRIAL REGISTRATION NUMBERS
SAMURAI, NCT:02439320; SPARTAN, NCT:02605174; CENTURION, NCT:03670810; and MONONOFU, NCT:03962738.
引言
作为5-羟色胺（5-HT）受体激动剂，曲坦类药物可引起血管收缩，存在心血管方面的禁忌证和注意事项。拉米地坦是一种选择性5-HT受体激动剂，对5-HT受体的亲和力较低，不会引起血管收缩，且无心血管方面的禁忌证和注意事项。这项事后分析的目的是评估拉米地坦在有或没有至少一项曲坦类药物禁忌证的患者中的疗效和安全性。
方法
从四项随机、双盲、安慰剂对照临床试验（SAMURAI、SPARTAN、CENTURION和MONONOFU）的汇总患者数据中分析有和没有曲坦类药物禁忌证的患者亚组。经历中度或重度强度单次偏头痛发作的患者接受50毫克拉米地坦（仅SPARTAN和MONONOFU）、100毫克、200毫克或安慰剂治疗，并在电子日记中记录疗效数据。
结果
在5704名患者中，207名（3.6%）患者至少有一项曲坦类药物禁忌证。总体亚组分析显示，在给药后2小时，拉米地坦在疼痛缓解、疼痛减轻、最困扰症状缓解、功能障碍缓解以及患者总体变化印象方面对有和没有曲坦类药物禁忌证的患者组的影响没有差异。在两个亚组中，这些结果总体上显示拉米地坦具有相似的获益模式，在无禁忌证的患者中所有结果均具有统计学意义，在有禁忌证的患者中疼痛减轻具有统计学意义。有曲坦类药物禁忌证与无曲坦类药物禁忌证患者的安全性和耐受性概况相似，在拉米地坦最高剂量时，18.3%至22.8%的患者出现头晕，7.9%至9.9%的患者出现嗜睡。
结论
在四项试验的汇总分析中，有和没有曲坦类药物禁忌证的患者在拉米地坦疗效模式上没有差异。拉米地坦可能是有曲坦类药物禁忌证患者的一种治疗选择。
试验注册号
SAMURAI，NCT:02439320；SPARTAN，NCT:02605174；CENTURION，NCT:03670810；MONONOFU，NCT:03962738。
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