Department of Pharmacy Practice in Primary Care, Nihon University School of Pharmacy, Chiba, Japan.
Department of Pharmacoepidemiology, Nihon University School of Pharmacy, Chiba, Japan.
Expert Opin Drug Saf. 2023 Jul-Dec;22(9):841-848. doi: 10.1080/14740338.2023.2193395. Epub 2023 Mar 21.
Few studies have compared the safety risks between the gabapentinoids, pregabalin, and mirogabalin in post-marketing clinical settings. We assessed reported events associated with gabapentinoid use in patients with neuropathic pain.
We conducted a retrospective cohort study between September 2020 and December 2020 using the community pharmacies records in Japan. The pharmacists identified new vs. prevalent users of mirogabalin and pregabalin in September 2020 and reported data regarding baseline and adverse events to the Japan Pharmaceutical Association using web-based questionnaires. The incidence of events and hazard ratio (HR) were consequently compared.
New users of mirogabalin and pregabalin were identified (n = 1,650 and 2,244; mean age (SD): 69 (15) and 68 (16) years; women: 59% and 56%, respectively). Although serious events were not reported, a marked difference in HRs of common adverse events, including somnolence (1.6), dizziness (1.3), nausea (2.8), edema (3.1), and acetaminophen (2.0)/antidepressant (2.4) addition, was observed.
No new serious safety concerns were found for mirogabalin and pregabalin use in patients with neuropathic pain, although the HR of some events indicated increased risk among mirogabalin users. However, further studies are needed as estimates for events occurring in small numbers with wide confidence intervals.
在上市后临床环境中，很少有研究比较加巴喷丁类药物、普瑞巴林和米罗加巴林的安全性风险。我们评估了与神经性疼痛患者使用加巴喷丁类药物相关的报告事件。
我们于 2020 年 9 月至 12 月在日本的社区药房记录中进行了一项回顾性队列研究。药剂师在 2020 年 9 月确定了米罗加巴林和普瑞巴林的新使用者和现用者，并使用基于网络的问卷向日本制药协会报告了基线和不良事件的数据。随后比较了事件发生率和风险比（HR）。
确定了米罗加巴林和普瑞巴林的新使用者（n=1650 和 2244；平均年龄（标准差）：69（15）和 68（16）岁；女性：分别为 59%和 56%）。虽然没有报告严重事件，但常见不良事件（包括嗜睡、头晕、恶心、水肿和对乙酰氨基酚/抗抑郁药）的 HR 存在明显差异（分别为 1.6、1.3、2.8、3.1 和 2.0/2.4）。
在患有神经性疼痛的患者中使用米罗加巴林和普瑞巴林未发现新的严重安全问题，尽管米罗加巴林使用者的某些事件 HR 表明风险增加。然而，由于置信区间较宽，小数量事件的估计值需要进一步研究。
