Long-Term Safety and Efficacy of Crisugabalin for Diabetic Peripheral Neuropathic Pain: A 52-Week, Multicenter, Single-Arm Trial - PubMed
6 hours ago
- #Crisugabalin
- #Diabetic Neuropathy
- #Pain Management
- The study evaluated the long-term safety and efficacy of crisugabalin (80 mg/day) for diabetic peripheral neuropathic pain over 52 weeks.
- 301 patients (mean age 59.7 years, 58.1% male) from previous trials were enrolled in this single-arm extension study.
- Treatment-related adverse events (TRAEs) occurred in 38.9% of patients, with dizziness (27.2%), somnolence (8.3%), and peripheral edema (3.0%) being most common.
- Severe TRAEs (Grade 3 or higher) were rare (1.7%), and few patients required dose adjustments or discontinuation due to side effects.
- Significant pain reduction was observed, with SF-MPQ scores improving by -2.5 (PRI) and -23.4 (VAS) from baseline (p < 0.0001).
- 19.0% more patients achieved low pain scores (SF-MPQ PPI ≤ 1) compared to baseline, indicating sustained analgesic efficacy.
- Crisugabalin was well-tolerated and maintained effective pain relief in diabetic neuropathy patients over one year.