Year: 2026 | Month: August | Volume: 16 | Issue: 8 | Pages: 120-127
DOI: https://doi.org/10.52403/ijhsr.20260813
Retrospective Analysis of the Effectiveness and Safety of Pregabalin and Duloxetine Fixed-Dose Combination Therapy in the Management of Neuropathic Pain (RESET Study)
Nitin Kapure1, Mayur Mayabhate2, Akhilesh Sharma3
1,2,3Department of Medical Affairs, Alkem Laboratories, Senapati Bapat Marg, Lower Parel, Mumbai, Maharashtra 400013
Corresponding Author: Nitin Kapure
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