Berman Gary, Thiry Alexandra, Croop Robert
Clinical Research Institute, Minneapolis, MN, USA.
Pfizer Inc., New York, NY, USA.
J Pain Res. 2024 May 21;17:1805-1814. doi: 10.2147/JPR.S453937. eCollection 2024.
To evaluate the safety and tolerability of rimegepant 75 mg for the acute treatment of migraine in participants concurrently using a preventive migraine medication.
This long-term, open-label safety study (NCT03266588) enrolled adults with a history of 2-14 moderate or severe migraine attacks per month. Participants self-administered rimegepant 75 mg (1) up to once daily as needed for 52 weeks to treat attacks of any pain intensity or (2) every other day plus as needed for 12 weeks. Preventive migraine medications were allowed if dosing was stable for ≥2 months prior to the baseline visit.
Of 1800 rimegepant-treated participants, 243 (13.5%) took a concomitant preventive medication. The most common preventive medication was topiramate (26.3%). Rimegepant exposure was comparable in both groups (mean [SD] number of doses per 4 weeks was 7.8 [4.5] in those taking preventives and 7.7 [4.7] in those not taking preventives). The proportion of participants experiencing ≥1 on-treatment adverse event (AE) was 68.7% among those using preventive medication and 59.2% among those not using preventives. Serious AEs occurred in 4.5% of those using preventive medication and 2.3% of those who were not using preventives. AEs leading to study drug discontinuation occurred in 4.5% of those taking preventive medication and 2.4% of those not taking preventives. AEs occurring in ≥5% of participants in either cohort (with preventives vs without preventives) were upper respiratory tract infection (7.4% vs 9.0%), nasopharyngitis (7.8% vs 6.6%), sinusitis (7.0% vs 4.8%), urinary tract infection (5.3% vs 3.6%), and back pain (5.3% vs 2.8%).
Acute treatment of migraine with rimegepant 75 mg for up to 52 weeks was well tolerated and had a favorable safety profile in adults who were concomitantly using preventive migraine medication.
评估75毫克瑞美吉泮用于正在同时使用偏头痛预防性药物的参与者急性治疗偏头痛的安全性和耐受性。
这项长期、开放标签的安全性研究（NCT03266588）纳入了每月有2 - 14次中度或重度偏头痛发作史的成年人。参与者自行服用75毫克瑞美吉泮：（1）根据需要每日最多服用1次，持续52周，以治疗任何疼痛强度的发作；或（2）每隔一天服用，并根据需要服用12周。如果在基线访视前给药稳定≥2个月，则允许使用偏头痛预防性药物。
在1800名接受瑞美吉泮治疗的参与者中，243名（13.5%）同时服用了预防性药物。最常用的预防性药物是托吡酯（26.3%）。两组的瑞美吉泮暴露量相当（服用预防性药物者每4周的平均[标准差]剂量数为7.8 [4.5]，未服用预防性药物者为7.7 [4.7]）。在服用预防性药物的参与者中，经历≥1次治疗期间不良事件（AE）的比例为68.7%，未服用预防性药物者为59.2%。严重不良事件发生在4.5%的服用预防性药物者和2.3%的未服用预防性药物者中。导致研究药物停用的不良事件发生在4.5%的服用预防性药物者和2.4%的未服用预防性药物者中。在任一队列（服用预防性药物与未服用预防性药物）中，≥5%的参与者发生的不良事件有上呼吸道感染（7.4%对9.0%）、鼻咽炎（7.8%对6.6%）、鼻窦炎（7.0%对4.8%）、尿路感染（5.3%对3.6%）和背痛（5.3%对2.8%）。
对于正在同时使用偏头痛预防性药物的成年人，使用75毫克瑞美吉泮急性治疗偏头痛长达52周耐受性良好，且安全性良好。
