Retrospective Analysis of the Effectiveness and Safety of Pregabalin and Duloxetine Fixed-Dose Combination Therapy in the Management of Neuropathic Pain (RESET Study)
Year: 2026
Type: article
Study design: Observational Study
Abstract: Background: Neuropathic pain is a complex, chronic pain condition arising from somatosensory nervous system lesions or disease. Pregabalin and duloxetine are individually established pharmacological agents for neuropathic pain management; however, their combined efficacy as a fixed-dose combination (FDC) remains underexplored in real-world clinical settings. Objective: To retrospectively evaluate the effectiveness and safety of pregabalin–duloxetine FDC therapy in patients with neuropathic pain over a 3-month treatment period. Methods: A retrospective chart review was conducted enrolling 11,559 patients with confirmed neuropathic pain diagnoses receiving pregabalin/duloxetine FDC. Pain intensity was assessed using the Numeric Rating Scale (NRS, 0–10) and sleep interference using the Daily Sleep Interfering Rating Scale (DSIRS, 0–10) at baseline and 3 months post-treatment. Safety was evaluated by adverse drug reaction (ADR) monitoring and physician global assessment (PGA). Results: The mean NRS score decreased significantly from 6.79 ± 2.45 at baseline to 4.19 ± 2.32 post-3 months (mean reduction: 2.60 ± 3.24; p < 0.001). Similarly, DSIRS scores improved from 6.65 ± 2.38 to 4.15 ± 2.41 (mean reduction: 2.50 ± 3.31; p < 0.001). The treatment was well tolerated with 0.4% reported any ADR, predominantly mild in nature. PGA rated as Good or Excellent in 94.5% of patients. Conclusion: Pregabalin–duloxetine FDC therapy demonstrates statistically significant and clinically meaningful improvements in pain intensity and sleep quality in patients with neuropathic pain, with a favourable tolerability profile with low reported ADRs. These findings support its use as an effective therapeutic strategy in real-world clinical practice Key words: neuropathic pain, pregabalin, duloxetine, fixed-dose combination, NRS, DSIRS, retrospective analysis, RESET study
Authors: Nitin Kapure, Mayur Mayabhate, Akhilesh Sharma
Institution: Alkem (India)
Language: English
Subfield: Physiology (medical)
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W7203779404