Institute of Neurological Sciences, Nürnberg, Germany.
Grünenthal GmbH, Aachen, Germany.
BMJ Open Diabetes Res Care. 2022 Nov;10(6). doi: 10.1136/bmjdrc-2022-003062.
Painful diabetic peripheral neuropathy (PDPN), a common complication of diabetes mellitus, is challenging to treat. Efficacy and tolerability of the topical lidocaine 700 mg medicated plaster (LMP) and well-established first-line oral medications (OM) were compared in refractory PDPN patients.
This is a subgroup analysis of a non-interventional, retrospective 24-week cohort study using anonymized routine medical care data from the German Pain eRegistry. Propensity score matching provided 732 datasets per treatment group. Primary effectiveness endpoint was the absolute change in average 24-hour Pain Intensity Index (0-100 mm) from baseline after 4, 12 and 24 weeks of treatment and over the entire treatment period.
The majority of this multimorbid and polymedicated study population of patients with PDPN had suffered pain for more than a year and presented with a high pain burden despite a median of seven previous analgesic medications. LMP treatment resulted in significant reductions in pain intensity and improvements in daily functioning already after 4 treatment weeks. Effectiveness was maintained over the treatment period even when concomitant analgesics were reduced or discontinued and quality of life improved. Mean change in the primary effectiveness parameter over the 24-week treatment period was -30.2 mm (SE 0.38) and -17.0 mm (SE 0.51) in the LMP and OM groups, respectively. Improvements in all effectiveness parameters were significantly greater under LMP than under OM treatment (p<0.001). Significantly fewer patients under LMP than OM experienced drug-related adverse events (DRAEs; 9.6% vs 61.6%, p<0.001) and discontinued treatment due to DRAEs (4.4% vs 35.8%, p<0.001).
LMP was effective and well tolerated in routine clinical care of patients with PDPN. The more favorable benefit/risk profile and greater reduction in intake of concomitant analgesics compared with OM suggest LMP as a useful treatment option for PDPN.
EUPAS 32826.
痛性糖尿病周围神经病变（PDPN）是糖尿病的常见并发症，治疗具有挑战性。本研究比较了局部利多卡因 700mg 贴剂（LMP）和已确立的一线口服药物（OM）在难治性 PDPN 患者中的疗效和耐受性。
这是一项回顾性 24 周队列研究的亚组分析，使用德国疼痛登记处的匿名常规医疗数据。倾向评分匹配为每个治疗组提供了 732 个数据集。主要疗效终点是治疗 4、12 和 24 周以及整个治疗期间从基线开始的平均 24 小时疼痛强度指数（0-100mm）的绝对变化。
该研究人群为患有 PDPN 的多合并症和多药物治疗患者，大多数患者疼痛持续超过一年，尽管中位数接受了七种以前的镇痛药物治疗，但仍存在较高的疼痛负担。LMP 治疗可显著减轻疼痛强度并改善日常功能，在治疗 4 周后即可显现。即使减少或停止伴随的镇痛药物，治疗期间疗效仍能维持，生活质量也得到改善。在 24 周的治疗期间，主要疗效参数的平均变化值分别为 LMP 组和 OM 组的-30.2mm（SE 0.38）和-17.0mm（SE 0.51）。LMP 治疗在所有疗效参数方面的改善均显著优于 OM 治疗（p<0.001）。与 OM 治疗相比，LMP 治疗组报告药物相关不良事件（DRAEs；9.6% vs. 61.6%，p<0.001）和因 DRAEs 停药的患者明显更少（4.4% vs. 35.8%，p<0.001）。
LMP 在常规临床治疗 PDPN 患者中有效且耐受性良好。与 OM 相比，LMP 的获益/风险比更优，同时减少伴随镇痛药物的摄入，表明 LMP 是治疗 PDPN 的一种有用的治疗选择。
EUPAS 32826。
