Combined Efficacy of Systemically Acting Diclofenac Sodium Patch and Alpha-2-Delta Calcium Channel Ligand in Chronic Low Back Pain: Subanalysis of a Phase III Study,Pain and Therapy

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Combined Efficacy of Systemically Acting Diclofenac Sodium Patch and Alpha-2-Delta Calcium Channel Ligand in Chronic Low Back Pain: Subanalysis of a Phase III Study
Pain and Therapy ( IF 4.1 ) Pub Date : 2023-10-20 , DOI: 10.1007/s40122-023-00558-2
Shigeki Yamaguchi ₁ , Takaaki Terahara ₂ , Koji Okawa ₂ , Hiroshi Inakura ₂

Affiliation

Introduction

Chronic low back pain often comprises mixed pain types and involves multiple factors. Therefore, we hypothesized that the systemic transdermal formulation of diclofenac sodium (DF systemic patch), which is effective for nociceptive pain, and an α2δ Ca²⁺ channel ligand, which is effective for neuropathic pain, would have additive effects in the treatment of chronic low back pain.

Methods

From among participants in a randomized, double-blind, placebo-controlled study of DF systemic patch (75 or 150 mg) applied once daily for 2 weeks in patients with chronic low back pain, we performed a subpopulation analysis of those who were concomitantly treated with an α2δ Ca²⁺ channel ligand during the study period. The efficacy endpoint was pain intensity score on a visual analog scale (VAS).

Results

The difference (95% confidence interval) in the least square mean pain VAS score between patients in the 150-mg combination group, who were treated with 150-mg DF systemic patch and an α2δ Ca²⁺ channel ligand (n = 11), and those in the non-combination group, who were treated with placebo patch and α2δ Ca²⁺ channel ligand (n = 22), was − 15.09 mm (− 26.45, − 3.73). Because the upper limit of the 95% confidence interval was less than zero, this result indicates that the pain VAS score improved more in the 150-mg combination group than in the non-combination group (placebo group).

Conclusions

The combination of the DF systemic patch and an α2δ Ca²⁺ channel ligand may be more effective than α2δ Ca²⁺ channel ligand monotherapy for controlling chronic low back pain.

Trial registration numbers: JPRN-JapicCTI-205134 and jRCT2080225040.

中文翻译：

双氯芬酸钠贴剂和 Alpha-2-Delta 钙通道配体对慢性腰痛的全身作用的联合疗效：III 期研究的子分析

介绍

慢性腰痛通常包括混合疼痛类型并涉及多种因素。因此，我们假设双氯芬酸钠全身透皮制剂（DF全身贴剂）对伤害性疼痛有效，而α2δ Ca ²⁺通道配体对神经性疼痛有效，在慢性疼痛的治疗中将具有附加效果。腰背疼痛。

方法

我们对慢性腰痛患者每天一次使用 DF 全身贴剂（75 或 150 毫克）持续两周的随机、双盲、安慰剂对照研究的参与者进行了亚群分析在研究期间与α2δ Ca ²⁺通道配体。疗效终点是视觉模拟量表（VAS）上的疼痛强度评分。

结果

使用 150 mg DF 全身贴片和 α2δ Ca ²⁺通道配体治疗的 150 mg 联合组患者之间最小二乘平均疼痛 VAS 评分的差异（95% 置信区间）（ n = 11），接受安慰剂贴片和 α2δ Ca ²⁺通道配体治疗的非联合组 ( n = 22) 的厚度为 − 15.09 mm (− 26.45, − 3.73)。由于95%置信区间的上限小于零，该结果表明150mg联合组的疼痛VAS评分比非联合组（安慰剂组）改善更多。