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Treatment response to sleep, pain, and mood disturbance and their correlation with sleep disturbance in adult patients with moderate-to-severe primary restless legs syndrome: Pooled analyses from 3 trials of gabapentin enacarbil
How sleep, pain, and mood improve and relate to sleep problems in adults with moderate-to-severe restless legs syndrome treated with gabapentin enacarbil
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Abstract
GEn significantly improved the International Restless Legs Scale total score by 12.3 points for the no-to-moderate sleep disturbance group.
- GEn 600 mg and 1200 mg both showed significant improvements in IRLS total scores compared to placebo for adults with moderate-to-severe primary restless legs syndrome.
- In the severe-to-very severe sleep disturbance group, GEn led to a mean change of -16.6 and -17.0 points, respectively, compared to -12.7 with placebo.
- A higher proportion of patients treated with GEn met the criteria for 'much'/'very much' improved on the Clinical Global Impression-Improvement scale compared to those on placebo.
- GEn also resulted in notable improvements in mood and pain scores for both sleep disturbance subgroups when compared to placebo.
- The most common side effects reported were somnolence and dizziness.
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