Mirogabalin for the treatment of diabetic peripheral neuropathic pain: A randomized, double‐blind, placebo‐controlled phase III study in Asian patients. Issue 5 (28th February 2019)

• Record Type: Journal Article
• Authors: Baba, Masayuki; Matsui, Norimitsu; Kuroha, Masanori; Wasaki, Yosuke; Ohwada, Shoichi
• Is Part Of: Journal of diabetes investigation. Volume 10:Issue 5(2019)
• Page Start: 1299
• Page End: 1306
• Publication Date: 2019-02-28
• Subjects: Diabetic peripheral neuropathic pain -- Mirogabalin -- Pain; Diabetes -- Periodicals; Diabetes -- Research -- Periodicals; Diabetes Mellitus -- Periodicals; 616.462005
• DOI: 10.1111/jdi.13013
• Languages: English
• ISSNs: 2040-1116

Abstract

Abstract: Aims/Introduction: This study evaluated the efficacy and safety of mirogabalin, a novel, potent, selective ligand of the α2 δ subunit of voltage‐dependent Ca 2+ channels, for the treatment of diabetic peripheral neuropathic pain (DPNP). Materials and Methods: During this double‐blind, multisite, placebo‐controlled phase III study, Asian patients aged ≥20 years with type 1 or 2 diabetes and DPNP were randomized 2:1:1:1 to a placebo, mirogabalin 15, 20 or 30 mg/day for up to 14 weeks, with a 1‐ to 2‐week titration (NCT02318706). The primary endpoint was the change from baseline in average daily pain score (ADPS) at week 14, defined as a weekly average of daily pain (0 = no pain to 10 = worst possible pain, for the past 24 h). Results: Of 834 randomized patients, 330, 164, 165 and 165 received placebo, mirogabalin 15, 20 or 30 mg/day, respectively, and were included in analyses (modified intention‐to‐treat population, n = 824); 755 (90.5%) completed the study. At week 14, the least squares mean average daily pain score change from baseline was −1.31, −1.34, −1.47 and −1.81, respectively, showing statistical significance for mirogabalin 30 mg/day versus placebo ( P = 0.0027). The treatment‐emergent adverse events observed were mostly mild‐to‐moderate in all mirogabalin doses, and the most frequent treatment‐emergent adverse events were nasopharyngitis, somnolence, dizziness, peripheral edema and weight increase. Conclusions: Mirogabalin relieved DPNP in a dose‐dependent manner; mirogabalin 30 mg/day showed statistically significant pain relief (vs placebo) in Asian DPNP patients. All doses of mirogabalin tested were well tolerated. Abstract : Approximately 20–30% of patients with diabetes mellitus experience diabetic peripheral neuropathic pain. This phase 3, randomized, double‐blind, placebo‐controlled study evaluated the efficacy, tolerability, and safety of mirogabalin, a ligand of the alpha2delta subunit, in Asian patients with diabetic peripheral neuropathic pain.