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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Bibliographic Details
Title:	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.
Authors:	Hermanowicz, Neal, Ellenbogen, Aaron, Irving, Gordon, Buchfuhrer, Mark, Jaros, Mark, Shang, Gwendoline, Kim, Richard, Jaros, Mark J (AUTHOR)
Source:	CNS Drugs. May2016, Vol. 30 Issue 5, p443-454. 12p. 5 Charts, 4 Graphs.
Subjects:	Restless legs syndrome, Gabapentin, Diseases in adults, Randomized controlled trials, Quality of life, Dopamine agonists, Acyclic acids, Clinical trials, Comparative studies, Dose-effect relationship in pharmacology, GABA, Research methodology, Medical cooperation, Pain, Research, Evaluation research, Treatment effectiveness, Blind experiment, Disease complications, Therapeutics
Abstract:	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. [ABSTRACT FROM AUTHOR]
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Database:	Psychology and Behavioral Sciences Collection

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