Efficacy of Lacosamide in Patients with Diabetic Neuropathy
Keywords:
Diabetic neuropathy, Diabetes mellitus, Small fiber neuropathy, Visual analog scale, LacosamideAbstract
Objective: To compare the efficacy of lacosamide versus placebo in patients with diabetic neuropathy in terms of reduction of the mean pain score.
Methodology: This randomized controlled trial (RCT) was conducted at the Department of Medicine, Nishtar Hospital, Multan from April to August 2025. After informed written consent, 60 patients with diabetic neuropathy were included and their baseline pain levels at recruitment were assessed using the visual analogue scale (VAS). The patients were enrolled using non-probability convenience sampling technique and subsequently randomized equally through a lottery method. Randomization was used to assign patients to either group A (lacosamide) or group B (placebo). Participants were administered either lacosamide (LCM; brand name atcomid) or a placebo that contained microcrystalline cellulose, which was commercially available and widely used in clinical trials involving diabetics. Both placebo & lacosamide were started at 100 mg daily and escalated to 400 mg/day over four weeks. Both were maintained at 400 mg for 12 weeks. The VAS was used to measure baseline and post-treatment pain scores. The variables of age, gender, duration of diabetes, obesity (body mass index ≥30 kg/m2), and diabetes control were documented. Statistical Package for the Social Sciences (SPSS) version 26 was used for the analysis of the data.
Results: The age distribution of the study population was statistically similar in the two groups (46.67±9.66 years vs. 49.30±8.38 years; p=0.264). Majority of the participants were males in both groups (66.7% vs. 56.7%). The baseline VAS values were almost similar across the groups (group A: 7.40±1.96 vs. group B: 6.87±2.01; p=0.31). The lacosamide group showed a notable decrease in post-treatment pain scores as compared to placebo (3.90±1.92 vs. 6.73±1.72; p <0.001).
Conclusion: Lacosamide provided a statistically and clinically significant reduction in pain intensity among patients with diabetic neuropathy compared to placebo. The marked decrease in post-treatment VAS scores highlighted its potential as an effective adjunctive option for managing neuropathic pain in this population.
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