Mirogabalin in Japanese Patients with Renal Impairment and Pain Associated with Diabetic Peripheral Neuropathy or Post-Herpetic Neuralgia: A Phase III, Open-Label, 14-Week Study

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Main idea: Mirogabalin was well tolerated and significantly reduced pain levels in diabetic peripheral neuropathic pain and post-herpetic neuralgia treatment. The dose of 7.5 mg once or twice daily was efficient in patients with renal impairment..

Abstract: Overall, 35 patients were enrolled (30 with moderate and 5 with severe renal impairment). Mirogabalin was well tolerated and significantly reduced pain levels in diabetic peripheral neuropathic pain and post-herpetic neuralgia treatment. Most TEAEs were mild or moderate in severity; the most commonly reported were nasopharyngitis (22.9%) and somnolence (11.4%). Secondary efficacy endpoints included change in ADPS from baseline to Week 14. The primary endpoint was the safety and tolerability of mirogabalin, evaluated via treatment-emergent adverse events (TEAEs). Mirogabalin significantly decreased ADPS from baseline in patients with renal impairment least-squares mean change from baseline at Week 14 was -1.9. Only 4 patients (11.4%) discontinued treatment due to TEAEs. Mirogabalin dosage was titrated for 2 weeks, followed by a fixed-dose for 12 weeks according to a degree of renal impairment: 7.5 mg twice daily for moderate impairment and 7.5 mg once daily for severe impairment.

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