Mirogabalin for Treatment of Neuropathic Pain and Associated Sleep Interference: An Updated Meta‐Analysis

ABSTRACT Background and Objective Neuropathic pain (NeP) is a common and debilitating consequence of several neurological conditions. Gabapentinoids are used on a large scale for the treatment of both central and peripheral NeP. Mirogabalin, a novel gabapentinoid, has been proposed as a promising treatment for this condition; however, its efficacy and safety profile still need to be determined in clinical practice. In this systematic review and meta‐analysis, we assessed the efficacy on pain intensity reduction, effects on sleep interference by pain, and safety of mirogabalin compared with placebo in patients affected by NeP. Databases and Data Treatment We searched PubMed, Cochrane Library, Embase, Web of Science, and ClinicalTrials.gov databases for randomised controlled trials (RCTs) comparing mirogabalin with placebo in patients experiencing central or peripheral NeP. We computed mean differences (MD) and pooled risk ratios (RR) for continuous and binary outcomes, respectively, with 95% confidence intervals (CI). Pain was measured on a 0 to 10 numerical rating scale. Results We included 6 RCTs involving 3048 patients. The mean age was 60.6 years, and 64.7% were male. When compared with placebo, patients treated with mirogabalin had a significant decrease in average daily pain (MD −0.60; 95% CI −0.75 to −0.45; p < 0.001) and in pain‐related sleep interference scores (MD −0.66; 95% CI −0.81 to −0.51; p < 0.001). The mirogabalin group showed a higher rate of substantial pain relief (≥ 50%) compared with the placebo group (RR 1.27; 95% CI 1.10 to 1.46; p = 0.001). Nonetheless, treatment with mirogabalin increased the risk of weight gain, peripheral oedema, somnolence and dizziness. Conclusion In this meta‐analysis of RCTs evaluating patients with central and peripheral NeP, mirogabalin significantly improved pain and decreased sleep interference by pain, as compared with placebo; however, there was an increased risk of adverse events. Significance This meta‐analysis refines the current understanding of mirogabalin by demonstrating modest yet consistent benefits in reducing pain and pain‐related sleep interference across neuropathic pain syndromes. The results contribute to ongoing efforts to optimise neuropathic pain management and provide more robust evidence to support clinical decision‐making and guideline development.