Abstract
BACKGROUND/OBJECTIVES: Gabapentinoids are first-line treatments for neuropathic pain (NP); however, real-world evidence regarding their safety and effectiveness in complex clinical populations remains limited. This study aimed to evaluate the effectiveness and safety profile of gabapentinoid therapy in patients managed within a specialized pain relief institution. METHODS: A retrospective cohort study (n = 109) was conducted (January 2024 to December 2024). Effectiveness was assessed via DN4 and VAS over one year. Time to improvement was analyzed using Kaplan-Meier curves. RESULTS: The cohort (mean age 66.2 ± 15.3 years) presented 100% comorbidity and polypharmacy (66.1% opioids; 67.9% antidepressants). Although all patients showed improvement, only 35.8% achieved "maximal improvement." Pregabalin demonstrated faster VAS reduction than gabapentin (p = 0.029), though long-term success was comparable (p = 0.30). Significantly, 100% of patients reported at least one adverse drug event (ADE), primarily somnolence (66.1%), though no serious ADEs occurred. Lower baseline pain scores were significant predictors of therapeutic success. CONCLUSIONS: Gabapentinoids are effective for long-term NP management; however, their use is consistently associated with non-serious ADEs. In specialized settings characterized by extensive CNS-active polypharmacy, proactive pharmacovigilance and multidisciplinary oversight are essential to balance analgesic effectiveness with medication safety.