Current medical research and opinion · 2026
Quality of life outcomes with a new sustained‑release pregabalin in a phase 3 trial of peripheral neuropathic pain.
Клиническое исследование III фазыEquivalence TrialСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Lee Seoungoh, An Taewon, Kim Sohee
Аннотация
BACKGROUND: Peripheral neuropathic pain (PNP) imposes substantial burdens on quality of life (QoL). A new sustained-release (SR) pregabalin formulation (YHD1119) was developed using gastroretentive technology to improve dosing convenience. This phase 3 trial evaluated QoL outcomes to compare the new SR pregabalin with immediate-release (IR) pregabalin in Korean patients with PNP.
METHODS: In this randomized, double-blind, active-controlled trial, adults with PNP due to diabetic peripheral neuropathy or postherpetic neuralgia received SR pregabalin or IR pregabalin for 12 weeks. The present analysis focused on health-related QoL outcomes, including the 12-item Short Form Health Survey (SF-12), the Weekly Sleep Interference Scale (WSIS), the Patient Global Impression of Change (PGIC), and the Clinician Global Impression of Change (CGIC).
RESULTS: A total of 296 participants were included in the per-protocol analysis. SF-12 Physical Component Summary increased by 2.50 with SR and 3.08 with IR (p = 0.5243), and Mental Component Summary increased by 2.57 and 0.89, respectively (p = 0.1157). WSIS scores improved significantly in both groups (mean change -2.12 for SR and -2.19 for IR), with no meaningful difference at week 12 (p = 0.3691). PGIC responder rates were 50.0% with SR and 56.0% with IR (p = 0.2456), and CGIC responders were 58.9% and 68.0% (p = 0.0880), indicating comparable perceived benefit between formulations.
CONCLUSION: Once-daily SR pregabalin (YHD1119) achieved QoL outcomes comparable to twice-daily IR pregabalin across general health status, sleep interference, and global impressions over 12 weeks. These findings support the new SR pregabalin as a practical alternative that maintains patient-reported therapeutic benefit while offering the convenience of once-daily dosing.
STUDY REGISTRATION: This study was registered at ClinicalTrials.gov (identifier NCT02985216).
METHODS: In this randomized, double-blind, active-controlled trial, adults with PNP due to diabetic peripheral neuropathy or postherpetic neuralgia received SR pregabalin or IR pregabalin for 12 weeks. The present analysis focused on health-related QoL outcomes, including the 12-item Short Form Health Survey (SF-12), the Weekly Sleep Interference Scale (WSIS), the Patient Global Impression of Change (PGIC), and the Clinician Global Impression of Change (CGIC).
RESULTS: A total of 296 participants were included in the per-protocol analysis. SF-12 Physical Component Summary increased by 2.50 with SR and 3.08 with IR (p = 0.5243), and Mental Component Summary increased by 2.57 and 0.89, respectively (p = 0.1157). WSIS scores improved significantly in both groups (mean change -2.12 for SR and -2.19 for IR), with no meaningful difference at week 12 (p = 0.3691). PGIC responder rates were 50.0% with SR and 56.0% with IR (p = 0.2456), and CGIC responders were 58.9% and 68.0% (p = 0.0880), indicating comparable perceived benefit between formulations.
CONCLUSION: Once-daily SR pregabalin (YHD1119) achieved QoL outcomes comparable to twice-daily IR pregabalin across general health status, sleep interference, and global impressions over 12 weeks. These findings support the new SR pregabalin as a practical alternative that maintains patient-reported therapeutic benefit while offering the convenience of once-daily dosing.
STUDY REGISTRATION: This study was registered at ClinicalTrials.gov (identifier NCT02985216).