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

Drugs Real World Outcomes. 2026 Mar 12. doi: 10.1007/s40801-026-00543-z. Online ahead of print.

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.

PMID:41813869 | DOI:10.1007/s40801-026-00543-z