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J Diabetes Investig. 2019 Jan 23. doi: 10.1111/jdi.13013. [Epub ahead of print]

Mirogabalin for the treatment of diabetic peripheral neuropathic pain: A randomized, double-blind, placebo-controlled phase III study in Asian patients.

Author information

1
Aomori Prefectural Central Hospital, Aomori, Japan.
2
Clinical Development Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
3
Asia Development Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
4
Biostatistics and Data Management Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.

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 Ca2+ 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.

KEYWORDS:

Diabetic peripheral neuropathic pain; Mirogabalin; Pain

PMID:
30672128
DOI:
10.1111/jdi.13013
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