Efficacy of gabapentin enacarbil in adult patients with severe primary restless legs syndrome
| Autor: | William G. Ondo, Ryan Hays, Mansoor Ahmed, Alon Y. Avidan, Mark J. Jaros, Daniel O. Lee, Gwendoline Shang, Mark J. Buchfuhrer, Richard Kim, Diego Garcia-Borreguero |
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| Rok vydání: | 2016 |
| Předmět: |
Male
medicine.medical_specialty Placebo law.invention 03 medical and health sciences 0302 clinical medicine Double-Blind Method Randomized controlled trial law Restless Legs Syndrome Internal medicine mental disorders medicine Humans 030212 general & internal medicine Restless legs syndrome gamma-Aminobutyric Acid Randomized Controlled Trials as Topic Intention-to-treat analysis Dose-Response Relationship Drug business.industry General Medicine Middle Aged medicine.disease Tolerability Quality of Life Clinical Global Impression Physical therapy Female Carbamates medicine.symptom Gabapentin enacarbil business 030217 neurology & neurosurgery Somnolence medicine.drug |
| Zdroj: | Sleep Medicine. 19:50-56 |
| ISSN: | 1389-9457 |
| Popis: | Aim Assess efficacy and tolerability of gabapentin enacarbil (GEn) in adults with severe primary restless legs syndrome (RLS). Methods We pooled data from three 12-week, double-blind, placebo-controlled, randomized trials (NCT00298623, NCT00365352, NCT01332305) across GEn 600-mg, GEn 1200-mg, and placebo treatment groups for severe primary RLS (baseline International Restless Legs Scale (IRLS) total score ≥24). Co-primary end points at week 12 were mean change from baseline in IRLS total score and proportion of responders ("much"/very much" improved) on the investigator-rated Clinical Global Impression – Improvement (CGI-I) Scale. Outcomes for individual IRLS items (eg, sleep, mood, quality of life, pain, safety) were assessed. Results A total of 309 patients had severe primary RLS (placebo, n = 110; GEn 600 mg, n = 80; GEn 1200 mg, n = 119). GEn 600 mg and 1200 mg significantly improved least-squares mean IRLS total scores versus placebo at week 12 (placebo, −12.3; GEn 600 mg, −16.3; GEn 1200 mg, −18.0; treatment difference vs. placebo, both p 0.01). Significantly more patients with severe primary RLS treated with GEn 600 mg (64%) and 1200 mg (74%) were CGI-I responders at week 12 versus placebo (42%; p 0.01 for both GEn doses). Both GEn doses led to significant improvements in the other outcomes explored versus placebo at week 12. The most frequent treatment-emergent adverse events (TEAEs) were somnolence (GEn, 21–24%; placebo, 3%) and dizziness (GEn, 14–19%; placebo, 3%). Conclusions GEn (600 mg or 1200 mg) once daily significantly improved RLS symptoms and consequences of these symptoms in severe primary RLS. The most frequent TEAEs were somnolence and dizziness. |
| Databáze: | OpenAIRE |
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