The Effect of Gabapentin Enacarbil on Pain Associated with Moderate-to-Severe Primary Restless Legs Syndrome in Adults: Pooled Analyses from Three Randomized Controlled Trials

Apr 21, 2016CNS drugs

Gabapentin Enacarbil's effects on pain in adults with moderate-to-severe restless legs syndrome: combined results from three clinical trials

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Abstract

Gabapentin enacarbil (GEn) significantly improved average daily pain scores in 671 adults with moderate-to-severe primary restless legs syndrome (RLS).

Both doses of GEn (600 mg and 1200 mg) reduced average daily RLS pain scores at week 12 compared to placebo (p < 0.001).
In a subanalysis, 70% of patients receiving GEn 600 mg and 67% receiving GEn 1200 mg were responders on the combined IRLS-pain scale, compared to 40% in the placebo group.
Moderate to strong correlations were observed between changes in total IRLS scores and pain scores from baseline to week 12.
Common adverse events included somnolence (20% for GEn 600 mg; 23% for GEn 1200 mg) and dizziness (13% for GEn 600 mg; 22% for GEn 1200 mg).
The study was not designed to determine significant differences between the two GEn doses.

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BACKGROUND: Adults with moderate-to-severe primary restless legs syndrome (RLS) often experience painful dysesthesias, which may lead to impaired quality of life.

OBJECTIVES: The aim of this study was to assess the effects of gabapentin enacarbil (GEn) on pain associated with moderate-to-severe primary RLS in adults.

METHODS: Data were pooled from three double-blind, randomized, placebo-controlled, 12-week trials (NCT00298623, NCT00365352, NCT01332305) for adults receiving GEn or placebo once daily. Change in average daily RLS pain score and a combined International Restless Legs Scale (IRLS)-pain response were examined.

RESULTS: The modified intention-to-treat population included 671 adults (placebo, n = 244; GEn 600 mg, n = 161; GEn 1200 mg, n = 266). Both GEn doses significantly improved average daily RLS pain score at week 12 (p < 0.001 for GEn 600 mg vs. placebo and GEn 1200 mg vs. placebo). The combined IRLS-pain response subanalysis included 366 patients with a baseline IRLS total score ≥15 and pain score ≥4 (placebo, n = 133; GEn 600 mg, n = 86; GEn 1200 mg, n = 147). Most patients were both IRLS and pain responders (placebo, 40 %; GEn 600 mg, 70 %; GEn 1200 mg, 67 %). Spearman rank correlations between IRLS total and pain score (change from baseline to week 12) were moderate or strong. The most frequent treatment-emergent adverse events were somnolence (placebo, 5 %; GEn 600 mg, 20 %; GEn 1200 mg, 23 %) and dizziness (placebo, 4 %; GEn 600 mg, 13 %; GEn 1200 mg, 22 %).

CONCLUSIONS: This post hoc pooled analysis suggests that GEn (600 and 1200 mg) once daily significantly improved pain associated with moderate-to-severe primary RLS in adults; however, the analysis was not powered to detect statistical differences between the two GEn doses. Numerically, more GEn-treated patients had a combined IRLS-pain response than placebo-treated patients.

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The Effect of Gabapentin Enacarbil on Pain Associated with Moderate-to-Severe Primary Restless Legs Syndrome in Adults: Pooled Analyses from Three Randomized Controlled Trials

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