Efficacy, Safety and Patient-Reported Outcomes of Mirogabalin in Diabetic Peripheral Neuropathic Pain

Diabetic Peripheral Neuropathic Pain (DPNP) is pain arising from abnormalities of the somatosensory system due to diabetes. It commonly manifests as burning or shooting pain, allodynia, and hyperalgesia, which interfere with sleep, mood, and daily activities. Pathophysiology involves hyperglycemia-induced nerve injury, sodium channel dysregulation, and central sensitization, resulting in complex pain states often resistant to standard analgesics.

Current first-line therapies for DPNP include pregabalin, duloxetine, and gabapentin. However, fewer than 50% of patients achieve adequate pain relief, and adverse effects such as somnolence and dizziness contribute to high discontinuation rates. Second- and third-line treatments, including tramadol, tapentadol, topical capsaicin, or lidocaine infusion, provide limited relief and are associated with safety or tolerability concerns.

Mirogabalin, a selective α₂δ-1 ligand, offers a potential improvement in the management of DPNP by targeting pain pathways while reducing CNS adverse effects. Its high-affinity binding to the α₂δ-1 subunit of voltage-gated calcium channels prolongs analgesia, while reduced activity at the α₂δ-2 subunit mitigates somnolence and dizziness. Phase III studies in Asian populations indicate comparable pain reduction to pregabalin, with fewer CNS side effects.

This study aims to evaluate and compare the efficacy, safety, and patient-reported outcomes of mirogabalin and pregabalin in patients with DPNP. The trial will provide robust data on pain reduction, adverse events, quality of life, and treatment satisfaction to guide optimal therapeutic strategies.