1432-P: Enhanced Efficacy of Crisugabalin 80 mg/day in Diabetic Peripheral Neuropathic Pain Patients with BMI ≥25 kg/m² or Longer Disease Duration: A Post Hoc Analysis

Introduction and Objective: Diabetic peripheral neuropathic pain (DPNP) poses significant clinical challenges, with suboptimal dosing contributing to inadequate pain control in practice. Crisugabalin, a third-generation calcium channel modulator approved in China for DPNP, offers rapid onset and no titration requirement. This post-hoc analysis aimed to explore the efficacy of crisugabalin 80 mg/d (40 mg bid) across different patient subgroups to inform personalized dosing strategies. Methods: This analysis utilized data from a multicenter, randomized, double-blind, placebo- and pregabalin-controlled phase II/III trial (13-week treatment, NCT04647773). The primary endpoint was the change from baseline in the Average Daily Pain Score (ADPS) at Week 13. Analyses were based on the Full Analysis Set (FAS). Results: A total of 326 patients were enrolled and divided into subgroups based on treatment and two criteria: baseline BMI (<25 vs. ≥25 kg/m²) and DPNP duration (≤1 vs. >1 year). BMI Subgroup: for patients treated with 80 mg crisugabalin, subgroup with a BMI ≥25 (mean ADPS change: -2.51 ± 1.78) achieved a significantly greater pain reduction comparing to those with a BMI <25 (-1.90 ± 1.75, p=0.037). The placebo group changes were -1.11 ± 1.63 (BMI ≥25) and -1.32 ± 1.73 (BMI <25). Disease Duration Subgroup: for 80 mg crisugabalin treatment, patients with a DPNP duration >1 year experienced significantly superior pain relief with the 80 mg/d dose (mean ADPS change: -2.44 ± 1.79, p=0.034) versus those with duration ≤1 year (-1.88 ± 1.75). The corresponding changes in the placebo group were -1.21 ± 1.69 and -1.25 ± 1.69, respectively. Most treatment-emergent adverse events (TEAEs) in crisugabalin groups were mild to moderate, which were always transient and needed no additional treatment. Conclusion: This analysis indicated that crisugabalin 80 mg/d (40 mg bid) may provide greater effective analgesia benefit for DPNP patients who are overweight (BMI ≥25) or have a longer disease duration (>1 year). Disclosure X. Wu: None. Y. Hu: None. X. Ye: None. Y. Xing: None. Y. Li: None. S. Yan: None. W. Chen: None. Q. Pan: None. X. Guo: None.