Long-term safety and efficacy of mirogabalin in Asian patients with diabetic peripheral neuropathic pain
Journal of Diabetes Investigation Dec 13, 2019
Baba M, et al. - Since diabetic peripheral neuropathic pain (DPNP) influences the functionality, mood, and sleep patterns of patients with diabetes, researchers tested the long-term safety and effectiveness of mirogabalin in Asian patients with DPNP. This investigation was carried out in Japan, Korea, and Taiwan in DPNP patients. For this 52-week open-label extension study, individuals received mirogabalin, started at 5 mg twice daily and increased to a flexible maintenance dosage of 10 or 15 mg twice daily. Throughout the study, adverse events have been monitored. Using the Short-Form McGill Pain Questionnaire (SF-MPQ), patients provided a self-assessment of pain. The extension study was completed by 172 of 214 patients. Of the 172 patients who completed the study, 149 had the highest mirogabalin dose (15 mg twice daily). Nasopharyngitis, diabetic retinopathy, peripheral edema, somnolence, diarrhea, increased weight, and dizziness were the most common treatment-emergent adverse events (TEAEs). Most TEAEs in severity were mild or moderate. The incidence of TEAEs that contributed to the discontinuation of treatment was 13.1%. In patients with DPNP, the authors showed the effectiveness and safety of a long-term flexible dosing regimen of mirogabalin 10 mg or 15 mg twice daily.
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