The Effect of Gabapentin Enacarbil (GEn) on Quality-of-Life (QoL) Outcomes in Adult Patients With Moderate-to-Severe and Severe Primary Restless Legs Syndrome (RLS): Pooled Analyses From Two 12-Week Trials (P7.299)

OBJECTIVE: To determine the effect of GEn on QoL in adults with moderate-to-severe and severe primary RLS. BACKGROUND: Poor QoL is pervasive among patients with RLS, yet data for QoL response to treatment are limited. GEn significantly improved RLS symptoms vs placebo in adults with moderate-to-severe primary RLS in XP052 and XP053. DESIGN/METHODS: Trial data were pooled. Patients with moderate-to-severe primary RLS received GEn (600 mg or 1200 mg) or placebo once daily. QoL was evaluated with the RLS QoL questionnaire (RLSQoL). Here we evaluated the modified intent-to-treat population with moderate-to-severe and severe (International RLS Rating Scale score 蠅24) primary RLS. RESULTS: 541 patients were randomized (placebo, n=204; GEn 600 mg, n=114; GEn 1200 mg, n=223). In the moderate-to-severe primary RLS population, least squares (LS) mean changes from baseline in RLSQoL score at week 12 were significantly greater for GEn 600 mg (20.6) and 1200 mg (22.3) vs placebo (15.5). LS mean treatment differences were 5.1 ( P P P =.047) for GEn 600 mg and 10.1 ( P <.001) for GEn 1200 mg. RLSQoL scores significantly improved at weeks 4 and 8 with both GEn doses vs placebo in patients with moderate-to-severe and severe primary RLS. RLSQoL scores were generally similar for both GEn doses. CONCLUSIONS: GEn 600 mg and 1200 mg significantly improved RLSQoL vs placebo at all time points assessed in this analysis of patients with moderate-to-severe and severe primary RLS. Within each study, the most common treatment-emergent adverse events were somnolence and dizziness. Disclosure: Dr. Avidan has received personal compensation for activities with Teva Pharmaceuticals, Xenoport, Merck, Vanda, and Best Doctors. Dr. Isaacson has received personal compensation for activities with Acadia Pharmaceuticals, Allergan, Inc., Brittania Pharmaceuticals, Chelsea Therapeutics, General Electric, GlaxoSmithKline, Impax Laboratories, Ipsen, Lundbeck USA Research, Inc., Medtron Dr. Jaros has received personal compensation for activities with XenoPort, Inc. as an employee. Dr. Kim has received personal compensation for activities with XenoPort, Inc. as an employee. Dr. Shang has received personal compensation for activities with XenoPort, Inc. as an employee.