Efficacy of gabapentin enacarbil in adult patients with severe primary restless legs syndrome

Daniel O. Lee, Mark J. Buchfuhrer, Diego Garcia-Borreguero, Alon Y. Avidan, Mansoor Ahmed, Ryan Hays, William G. Ondo, Mark J. Jaros, Richard Kim, Gwendoline Shang

Research output: Contribution to journalArticle

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)50-56
Number of pages7
JournalSleep Medicine
Volume19
DOIs
StatePublished - Mar 1 2016

Fingerprint

Restless Legs Syndrome
Placebos
Dizziness
1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid
Therapeutics
Least-Squares Analysis

Keywords

  • Clinical global impression - improvement
  • Gabapentin enacarbil
  • International restless legs scale
  • Mood
  • Restless legs syndrome
  • Sleep

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Lee, D. O., Buchfuhrer, M. J., Garcia-Borreguero, D., Avidan, A. Y., Ahmed, M., Hays, R., ... Shang, G. (2016). Efficacy of gabapentin enacarbil in adult patients with severe primary restless legs syndrome. Sleep Medicine, 19, 50-56. https://doi.org/10.1016/j.sleep.2015.11.002

Efficacy of gabapentin enacarbil in adult patients with severe primary restless legs syndrome. / Lee, Daniel O.; Buchfuhrer, Mark J.; Garcia-Borreguero, Diego; Avidan, Alon Y.; Ahmed, Mansoor; Hays, Ryan; Ondo, William G.; Jaros, Mark J.; Kim, Richard; Shang, Gwendoline.

In: Sleep Medicine, Vol. 19, 01.03.2016, p. 50-56.

Research output: Contribution to journalArticle

Lee, DO, Buchfuhrer, MJ, Garcia-Borreguero, D, Avidan, AY, Ahmed, M, Hays, R, Ondo, WG, Jaros, MJ, Kim, R & Shang, G 2016, 'Efficacy of gabapentin enacarbil in adult patients with severe primary restless legs syndrome', Sleep Medicine, vol. 19, pp. 50-56. https://doi.org/10.1016/j.sleep.2015.11.002
Lee, Daniel O. ; Buchfuhrer, Mark J. ; Garcia-Borreguero, Diego ; Avidan, Alon Y. ; Ahmed, Mansoor ; Hays, Ryan ; Ondo, William G. ; Jaros, Mark J. ; Kim, Richard ; Shang, Gwendoline. / Efficacy of gabapentin enacarbil in adult patients with severe primary restless legs syndrome. In: Sleep Medicine. 2016 ; Vol. 19. pp. 50-56.
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abstract = "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.",
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AU - Ahmed, Mansoor

AU - Hays, Ryan

AU - Ondo, William G.

AU - Jaros, Mark J.

AU - Kim, Richard

AU - Shang, Gwendoline

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N2 - 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.

AB - 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.

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