Mirogabalin for the treatment of diabetic peripheral neuropathic pain: A randomized, double-blind, placebo-controlled phase 3 study in Asian patients
Journal of Diabetes Investigation Jan 26, 2019
Baba M, et al. - In this double-blind, multisite, placebo-controlled, phase 3 study, researchers assessed the safety and effectiveness of mirogabalin for the treatment of diabetic peripheral neuropathic pain (DPNP). For this investigation, Asian patients (aged ≥ 20 years) with type 1 or 2 diabetes and DPNP were randomized 2:1:1:1 to placebo, mirogabalin 15, 20, or 30 mg/day for up to 14 weeks, with a 1- to 2-week titration. According to findings, mirogabalin relieved DPNP in a dose-dependent manner; mirogabalin 30 mg/day in Asian DPNP patients showed statistically significant pain relief compared with placebo. Data reported that all mirogabalin doses tested were well tolerated. The treatment-emergent adverse events (TEAEs) observed in all mirogabalin doses were mostly mild to moderate in severity. Nasopharyngitis, somnolence, dizziness, peripheral edema, and weight increase were the most frequent TEAE.
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