Makito Kanako, Okada Akira, Yasunaga Hideo
Department of Biostatistics, School of Public Health, The University of Tokyo, Japan.
Department of Prevention of Diabetes and Lifestyle-Related Diseases, Graduate School of Medicine, The University of Tokyo, Japan.
Ann Clin Epidemiol. 2025 Jan 24;7(2):61-68. doi: 10.37737/ace.25008. eCollection 2025 Apr 1.
Mirogabalin has a mechanism similar to that of pregabalin in the treatment of neuropathic pain. However, it remains unclear whether these drugs differ in terms of serious side effects, such as fall-related fractures, in older patients. This study aimed to investigate whether mirogabalin is associated with a decrease in adverse events, including fall-related fractures, compared with pregabalin.
We performed a retrospective cohort study using the DeSC database, a large administrative claims database in Japan. This study included 130,244 patients ≥65 years taking mirogabalin or pregabalin between April 2019 and May 2021. The primary outcome was defined as the occurrence of fractures or switching to other medications and was compared between those receiving mirogabalin and pregabalin using Kaplan-Meier curves and multivariable Cox proportional hazards models. A sensitivity analysis was performed regarding patients who received mirogabalin or pregabalin without other analgesic medications at the initial dose.
During a median follow-up of 2.8 months, 29,686 (22.8%) and 100,558 (77.2%) received mirogabalin and pregabalin, respectively. The rates of the outcome in the mirogabalin and pregabalin groups were 50.1 and 42.8 per 100 person-years. Cox regression analysis showed that mirogabalin was associated with a lower risk of the outcome (hazard ratio, 0.93; 95% confidence interval, 0.87-1.00). However, sensitivity analysis did not demonstrate a difference in the outcome between the mirogabalin and pregabalin groups without other analgesic medications (hazard ratio, 0.93; 95% confidence interval, 0.86-1.01).
Our analyses suggest that the outcome may be less likely in the mirogabalin group; however, the difference appears to be clinically insignificant. Further studies are warranted to confirm these findings.
在治疗神经性疼痛方面，米罗加巴林具有与普瑞巴林相似的作用机制。然而，在老年患者中，这些药物在严重副作用（如与跌倒相关的骨折）方面是否存在差异仍不清楚。本研究旨在调查与普瑞巴林相比，米罗加巴林是否与不良事件（包括与跌倒相关的骨折）的减少有关。
我们使用日本一个大型行政索赔数据库DeSC数据库进行了一项回顾性队列研究。本研究纳入了2019年4月至2021年5月期间130244名年龄≥65岁服用米罗加巴林或普瑞巴林的患者。主要结局定义为骨折的发生或改用其他药物，并使用Kaplan-Meier曲线和多变量Cox比例风险模型对接受米罗加巴林和普瑞巴林的患者进行比较。对初始剂量时未使用其他镇痛药而接受米罗加巴林或普瑞巴林的患者进行了敏感性分析。
在中位随访2.8个月期间，分别有29686名（22.8%）和100558名（77.2%）患者接受了米罗加巴林和普瑞巴林治疗。米罗加巴林组和普瑞巴林组的结局发生率分别为每100人年50.1例和42.8例。Cox回归分析显示，米罗加巴林与较低的结局风险相关（风险比，0.93；95%置信区间，0.87-1.00）。然而，敏感性分析未显示在未使用其他镇痛药的米罗加巴林组和普瑞巴林组之间结局存在差异（风险比，0.93；95%置信区间，0.86-1.01）。
我们的分析表明，米罗加巴林组出现结局的可能性可能较小；然而，这种差异在临床上似乎不显著。需要进一步的研究来证实这些发现。
