Safety and effectiveness of pregabalin controlled-release in Korean patients with peripheral neuropathic pain: A post-marketing surveillance data

Abstract

Chronic pain, including neuropathic pain (NP), significantly affects quality of life in 7% to 10% of the general population. The prevalence of NP is rising owing to factors such as aging, obesity, and enhanced cancer survival rates. Effective management of NP is essential to improve patient outcomes. This study aimed to assess the safety and effectiveness of controlled-release (CR) pregabalin in Korean patients with peripheral NP . An open-label, non-comparative, multicenter study was conducted with 623 participants across 18 institutions. The patients received pregabalin CR as part of their routine treatment. Safety and efficacy data were collected over 12 weeks. Pain severity was assessed using the 11-point numeric rating scale (0 = no pain, 10 = worst imaginable pain), and sleep interference was assessed using an 11-point Likert scale (0 = did not interfere, 10 = unable to sleep). Safety was evaluated through adverse event (AE) reporting. Among the 617 participants evaluated for safety, 6.32% reported AEs, primarily dizziness and somnolence. Serious AEs were rare (0.32%). The efficacy analysis included 363 participants, with significant reductions in daily pain (from 5.05 ± 2.41 to 3.16 ± 2.26, P < .0001) and sleep interference scores (from 2.32 ± 2.70 to 1.42 ± 2.18, P < .0001) at week 12. Both the patients' and clinicians' global impressions demonstrated meaningful improvements in over 26% of the participants. The efficacy was reduced in patients with a medical history and in those receiving high doses (>165 mg/d). Pregabalin CR effectively reduced NP and sleep interference, with a manageable safety profile. These findings support the use of this drug as first-line treatment for NP. Personalized treatment and continuous monitoring are recommended to optimize patient outcomes.