Mirogabalin May Be Safe for Postherpetic Neuralgia and Diabetic Peripheral Neuropathic Pain
The study’s primary efficacy endpoint was change in average daily pain score at 14 weeks.
|The following article is part of conference coverage from the IASP 2018 conference in Boston, Massachusetts. Clinical Pain Advisor's staff will be reporting breaking news associated with research conducted by leading experts in pain medicine. Check back for the latest news from IASP 2018.|
Mirogabalin may be efficacious and well tolerated in Asian individuals with postherpetic neuralgia or diabetic peripheral neuropathic pain, according to a study to be presented at the 2018 World Congress on Pain, held September 12-16 in Boston, Massachusetts.
This study included 1587 individuals, 824 of whom had diabetic peripheral neuropathic pain and 763 of whom had postherpetic neuralgia. Mirogabalin was administered to 954 individuals (at 15 mg once daily, 10 mg twice daily, or 15 mg twice daily for up to 15 weeks, including a 1-2 week titration period and with a follow-up of 1 week) and 633 participants received a placebo. Data used in this study were from two phase 3 studies. The primary efficacy endpoint was change in average daily pain score at 14 weeks, and the primary safety endpoints were treatment-related adverse events. These endpoints were analyzed both in the total population and in subpopulations based on age, weight, concomitant analgesic medicines or therapies, baseline average daily pain score, sex, creatinine clearance, and medication intake with food.
Least squares mean in average daily pain score were reduced at week 14 compared with baseline in all groups: placebo, -1.26; mirogabalin 15 mg once daily, -1.46; mirogabalin 10 mg twice daily, -1.57 (vs placebo, -0.31; 95% CI, -0.55 to -0.08); and mirogabalin 15 mg twice daily, -1.89 (vs placebo, -0.63; 95% CI, -0.86 to -0.40). Treatment-related adverse events were mostly mild to moderate, with somnolence and dizziness being the most common.
Subpopulation analysis revealed no one factor that markedly affected mirogabalin's safety and efficacy, with the exception of average daily pain score, which had a negative impact on efficacy. For participants receiving mirogabalin 15 mg twice daily, high baseline an average daily pain score ≥6 was associated with a greater least squares mean difference vs placebo (-1.09; 95% CI, -1.47 to -0.71) compared with a baseline average daily pain score <6 (-0.32; 95% CI, -0.61 to -0.03).
“[Mirogabalin] was efficacious and well tolerated for Asian patients with [diabetic peripheral neuropathic pain] or [postherpetic neuralgia]. Efficacy and adverse events appeared to be dose-dependent. In addition, these results demonstrate consistent efficacy and safety of [mirogabalin] across subpopulations of Asian patients defined by demographic and baseline features. Considering the pathophysiology of [postherpetic neuralgia] and the mechanism of action of [mirogabalin], it is expected that [mirogabalin] would be efficacious and well tolerated for patients with other types of [postherpetic neuralgia] as well,” concluded the study authors.
Kato J, Baba M, Matsui N, et al. Mirogabalin for the treatment of diabetic peripheral neuropathic pain and postherpetic neuralgia: A pooled analysis of Asian phase 3 results. Presented at: IASP World Congress on Pain; September 12-16, 2018; Boston, MA. Poster 64599.
For more coverage of IASP 2018, click here.