Expert opinion on pharmacotherapy · 2026
Efficacy and safety of mirogabalin + opioids vs opioids alone for neuropathic cancer pain: Miro-Canp.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Hashiguchi Saori, Matsumoto Yoshihisa, Kessoku Takaomi, Kajiura Shinya, Honma Hideyuki, Yamaguchi Takashi, Hasuo Hideaki, Takahashi Hiroshi, Yamamoto Shuhei, Satomi Eriko
Аннотация
BACKGROUND: Opioids are a treatment for cancer pain, but may be less effective for neuropathic than nociceptive pain. However, evidence supporting opioid - neuropathic drug combinations for neuropathic cancer pain (NCP) remains limited.
RESEARCH DESIGN AND METHODS: This randomized, open-label, parallel-group study, conducted across Japan, evaluated the efficacy and safety of mirogabalin + opioids (M+O) versus opioid monotherapy (O) in patients with NCP. Change in the numerical rating scale (NRS) pain score from baseline at Week 4 was the primary endpoint.
RESULTS: Of 142 patients, 141 were randomized (M+O, N = 71; O, N = 70). The M+O group achieved a greater reduction in NRS pain scores from baseline at Week 4 than the O group (intergroup difference in least squares mean changes: -1.5, 95% confidence interval: -2.4, -0.6; P = 0.0017) and higher NRS responder (≥30% reduction) rates (72.3% vs. 42.0%; P = 0.0039). Treatment-emergent adverse event incidences were 60.9% (42/69) and 27.1% (19/70) in the M+O and O groups, respectively. Somnolence (20.3%) and dizziness (8.7%) were the most common adverse drug events for mirogabalin.
CONCLUSIONS: Mirogabalin, as an opioid add-on, improved neuropathic pain vs opioid monotherapy in patients with NCP. Concomitant use of mirogabalin could be a novel treatment option for NCP.
CLINICAL TRIAL REGISTRATION: Japan Registry of Clinical Trials (https://jrct.mhlw.go.jp/) identifier is jRCTs031220569.
RESEARCH DESIGN AND METHODS: This randomized, open-label, parallel-group study, conducted across Japan, evaluated the efficacy and safety of mirogabalin + opioids (M+O) versus opioid monotherapy (O) in patients with NCP. Change in the numerical rating scale (NRS) pain score from baseline at Week 4 was the primary endpoint.
RESULTS: Of 142 patients, 141 were randomized (M+O, N = 71; O, N = 70). The M+O group achieved a greater reduction in NRS pain scores from baseline at Week 4 than the O group (intergroup difference in least squares mean changes: -1.5, 95% confidence interval: -2.4, -0.6; P = 0.0017) and higher NRS responder (≥30% reduction) rates (72.3% vs. 42.0%; P = 0.0039). Treatment-emergent adverse event incidences were 60.9% (42/69) and 27.1% (19/70) in the M+O and O groups, respectively. Somnolence (20.3%) and dizziness (8.7%) were the most common adverse drug events for mirogabalin.
CONCLUSIONS: Mirogabalin, as an opioid add-on, improved neuropathic pain vs opioid monotherapy in patients with NCP. Concomitant use of mirogabalin could be a novel treatment option for NCP.
CLINICAL TRIAL REGISTRATION: Japan Registry of Clinical Trials (https://jrct.mhlw.go.jp/) identifier is jRCTs031220569.