A recent study published in CNS Drugs concluded that gabapentin enacarbil (GEn) taken once daily significantly improved quality of life in adults with moderate-to-severe primary restless legs syndrome (RLS) across all study time points.
Study authors aimed to assess the effects of GEn treatment on quality of life and mood by pooling data from 3 placebo-controlled, randomized, double-blind, 12-week trials that studied adults with primary RLS receiving GEn 600mg or 1200mg or placebo once daily. Quality of life was measured with the RLS Quality of Life questionnaire for 2 studies. Mood was assessed with the Profile of Mood States Brief Form (POMS-B) and as an exploratory analysis with International Restless Legs (IRLS) item 9 (daily affairs) and item 10 (mood disturbance) across all 3 studies. Secondary outcomes in each of the clinical trials were mood and quality of life.
In the QOL analysis modified intent-to-treat (MITT) population of 541 adults, 204 received placebo, 114 received GEn 600mg, and 223 received GEn 1200mg. The analysis showed both doses of GEn significantly improved quality of life vs. placebo (Week 12; P<0.01).
In the mood analysis MITT population of 671 adults, 244 received placebo, 161 received GEn 600mg, and 266 received GEn 1200mg. The analysis showed that GEn 600mg significantly improved POMS vigor-activity vs. placebo (Week 12; P<0.05). However, other POMS criteria were not significantly affected. The GEn 1200mg dose was found to significantly improve POMS scores for: total mood disturbance, depression-dejection, fatigue-inertia, vigor-activity, and confusion-bewilderment vs. placebo (Week 12; P<0.05). However, tension-anxiety and anger-hostility were not significantly affected.
Overall, treatment with both GEn doses significantly improved IRLS items 9 and 10 vs. placebo at Week 12 (P<0.05). Numerically, GEn 1200mg had greater quality of life and mood improvements than GEn 600mg.
For all time points examined, GEn 600mg and 1200mg once daily significantly improved quality of life in adults with moderate-to-severe primary RLS. GEn 600mg significantly improved only POMS vigor-activity but the 1200mg dose significantly improved total mood disturbance and other POMS items compared to placebo at Week 12.
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