A Prospective, Multicenter, Single-arm, Phase IV Study to Assess the Safety and Effectiveness of a Fixed-Dose Combination of Pregabalin Prolonged Release and Etoricoxib in Patients with Chronic Low Back Pain with a Neuropathic Component.

IF 1.9 Q3 PHARMACOLOGY & PHARMACY

Drugs - Real World Outcomes Pub Date : 2026-03-12 DOI:10.1007/s40801-026-00543-z

Sandesh Sahebrao Patil, Brijesh Jerambhai Patel, Bhavsar Neel Mahendrabhai, C L Nawal, B Valya, K Sanjeev Kumar, Pandurang Wattamwar, Rana Kaushikkumar Ramanlal, Swagat Shah, Mandodari Rajurkar, Supriya Sonowal, Dipak Patil, Pravin Ghadge, Suyog Mehta

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Abstract

Background and objective: Nearly two-thirds of patients with acute low back pain progress to chronic low back pain (CLBP). It is likely to be due to the involvement of both nociceptive and neuropathic pain mechanisms. Therefore, this study evaluated the safety and effectiveness of a fixed-dose combination (FDC) of pregabalin prolonged release (PR) and etoricoxib in patients with CLBP with a neuropathic component.

Methods: This single-arm, phase IV study was conducted at nine hospitals across India. Patients with CLBP received an FDC of pregabalin PR 75 mg and etoricoxib 60 mg. The primary endpoint was safety, evaluated by the incidence of adverse events (AEs) and serious AEs. The secondary endpoint was effectiveness, assessed by change in the numeric rating scale (NRS), Roland-Morris Disability Questionnaire (RDQ) and visual analog scale (VAS) scores, and proportion of patients using rescue medication.

Results: Of 231 screened patients, 185 met eligibility criteria and were enrolled. During the 8-week study, four patients were lost to follow-up, and one withdrew consent. Out of the 19 AEs reported, 18 were treatment-emergent AEs (TEAEs), which occurred in 13 (7.18%) patients. Dizziness, cough, pruritus, and rash were the most common TEAEs. All TEAEs were mild or moderate, and no serious TEAEs or discontinuations due to TEAEs occurred in the study. Statistically significant improvements were observed at week 8 compared with baseline in NRS scores (- 3.4 ± 1.69; p < 0.0001), RDQ scores (- 7.3 ± 3.42; p < 0.0001), and VAS scores (- 32.1 ± 15.33; p < 0.0001). The need for rescue medication decreased over time, with only 34 (18.89%) patients requiring it at week 8 compared with 121 (66.85%) at baseline.

Conclusion: The FDC of pregabalin PR and etoricoxib was found to be safe, well tolerated, and effective in reducing pain intensity and improving quality of life in patients with CLBP with a neuropathic component. Thus, this FDC can be a potential alternative for managing CLBP with a neuropathic component.

Trial registration number: CTRI/2022/05/042521 [Registered on: May 12, 2022] https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=Njg1ODg=&Enc=&userName.

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一项前瞻性、多中心、单臂、IV期研究，评估普瑞巴林缓释和依托昔布固定剂量联合治疗伴有神经性成分的慢性腰痛患者的安全性和有效性。

背景和目的：近三分之二的急性腰痛患者进展为慢性腰痛（CLBP）。这可能是由于伤害性和神经性疼痛机制的参与。因此，本研究评估了普瑞巴林缓释（PR）和依托昔布（etoricoxib）固定剂量联合（FDC）治疗伴有神经病变成分的CLBP患者的安全性和有效性。方法：这项单臂、IV期研究在印度的9家医院进行。CLBP患者接受普瑞巴林PR 75 mg和依托昔布60 mg的FDC治疗。主要终点是安全性，通过不良事件（ae）和严重ae的发生率来评估。次要终点是有效性，通过数值评定量表（NRS）、Roland-Morris残疾问卷（RDQ）和视觉模拟量表（VAS）评分的变化以及使用抢救药物的患者比例来评估。结果：在231名筛查患者中，185名符合资格标准并入组。在为期8周的研究中，4名患者未能随访，1名患者撤回同意。在报告的19例ae中，18例为治疗突发ae (teae)，发生在13例（7.18%）患者中。头晕、咳嗽、瘙痒和皮疹是最常见的teae。所有teae均为轻度或中度，研究中未发生严重teae或因teae而停药。与基线相比，第8周的NRS评分有统计学意义上的显著改善（- 3.4±1.69）；p结论：普瑞巴林PR和依托昔布的FDC被发现是安全的，耐受性良好，有效地减轻了伴有神经病变成分的CLBP患者的疼痛强度和改善了生活质量。因此，这种FDC可能是治疗伴有神经性成分的CLBP的潜在替代方法。试验报名号：CTRI/2022/05/042521[报名日期：2022年5月12日]https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=Njg1ODg=&Enc=&userName。

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来源期刊

Drugs - Real World Outcomes PHARMACOLOGY & PHARMACY-

CiteScore

3.60

自引率

5.00%

发文量

审稿时长

8 weeks

期刊介绍： Drugs - Real World Outcomes targets original research and definitive reviews regarding the use of real-world data to evaluate health outcomes and inform healthcare decision-making on drugs, devices and other interventions in clinical practice. The journal includes, but is not limited to, the following research areas: Using registries/databases/health records and other non-selected observational datasets to investigate: drug use and treatment outcomes prescription patterns drug safety signals adherence to treatment guidelines benefit : risk profiles comparative effectiveness economic analyses including cost-of-illness Data-driven research methodologies, including the capture, curation, search, sharing, analysis and interpretation of ‘big data’ Techniques and approaches to optimise real-world modelling.