Long-term efficacy and safety of gabapentin enacarbil in Japanese restless legs syndrome patients

Progress in Neuro-Psychopharmacology and Biological Psychiatry

Volumn 36, Issue 2, 2012, Pages 251-257

  Inoue, Yuichi ^a,b   Uchimura, Naohisa ^c   Kuroda, Kenji ^d   Hirata, Koichi ^e   Hattori, Nobutaka ^f  

^a NEUROPSYCHIATRIC RESEARCH INSTITUTE   (Japan)

^b TOKYO MEDICAL UNIVERSITY   (Japan)

^c KURUME UNIVERSITY   (Japan)

^d Hannan Hospital   (Japan)

^e DOKKYO MEDICAL UNIVERSITY   (Japan)

^f JUNTENDO UNIVERSITY   (Japan)

Author keywords

Efficacy; Gabapentin enacarbil (GEn); Long term open label study; Quality of life; Restless legs syndrome (RLS); Safety

Indexed keywords

GABAPENTIN ENACARBIL; GEN; UNCLASSIFIED DRUG;

ABDOMINAL DISCOMFORT; ABNORMAL SENSATION; ADULT; AGED; ARTICLE; BACKACHE; CLINICAL GLOBAL IMPRESSION SCALE; CONSTIPATION; CREATINE KINASE BLOOD LEVEL; DISEASE SEVERITY; DIZZINESS; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG WITHDRAWAL; EOSINOPHIL COUNT; FEMALE; GLUCOSE URINE LEVEL; HUMAN; INTERNATIONAL RESTLESS LEGS SYNDROME SCALE; JAPANESE; LONG TERM CARE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OPEN STUDY; PITTSBURGH SLEEP QUALITY INDEX; RATING SCALE; RESTLESS LEGS SYNDROME; RHINOPHARYNGITIS; SHORT FORM 36; SIDE EFFECT; SOMNOLENCE; URIC ACID BLOOD LEVEL; VERTIGO;

ADULT; AGED; AGED, 80 AND OVER; ANTICONVULSANTS; ASIAN CONTINENTAL ANCESTRY GROUP; CARBAMATES; FEMALE; GAMMA-AMINOBUTYRIC ACID; HUMANS; MALE; MIDDLE AGED; QUALITY OF LIFE; RESTLESS LEGS SYNDROME; SEVERITY OF ILLNESS INDEX; SLEEP DISORDERS; TIME FACTORS;

EID: 84855355900     PISSN: 02785846     EISSN: 18784216     Source Type: Journal    
DOI: 10.1016/j.pnpbp.2011.10.009     Document Type: Article

References (38)

1. Allen R.P., Picchietti D., Hening W.A., Trenkwalder C., Walters A.S., Montplaisi J. Restless legs syndrome diagnosis and epidemiology workshop at the National Institutes of Health 2003, International Restless Legs Syndrome Study Group.
2. Restless legs syndrome: diagnostic criteria, special considerations, and epidemiology: a report from the restless legs syndrome diagnosis and epidemiology workshop at the National Institutes of Health. Sleep Med 2003;4:101-19.
3. Allen R.P., Walters A.S., Montplaisir J., Hening W., Myers A., Bell T.J., et al. Restless legs syndrome prevalence and impact: REST general population study. Arch Intern Med 2005, 165:1286-1292.
4. American Academy of Sleep Medicine The International Classification of Sleep Disorders. Diagnostic and Coding Manual 2005, American Academy of Sleep Medicine, Westchester. 2nd edition.
5. Bogan R.K., Bornemann M.A., Kushida C.A., Trân P.V., Barrett R.W. Long-term maintenance treatment of restless legs syndrome with gabapentin enacarbil: a randomized controlled study. Mayo Clin Proc 2010, 85:512-521. XP060 Study Group.
6. Cundy K.C., Branch R., Chernov-Rogan T., Dias T., Estrada T., Hold K., et al. XP13512 [(+/-)-1-([(alpha-isobutanoyloxyethoxy)carbonyl] aminomethyl)-1-cyclohexane acetic acid], a novel gabapentin prodrug: I. design, synthesis, enzymatic conversion to gabapentin, and transport by intestinal solute transporters. J Pharmacol Exp Ther 2004, 311:315-323.
7. Cundy K.C., Sastry S., Luo W., Zou J., Moors T.L., Canafax D.M. Clinical pharmacokinetics of XP13512, a novel transported prodrug of gabapentin. J Clin Pharmacol 2008, 48:1378-1388.
8. Earley C.J., Silber M.H. Restless legs syndrome: understanding its consequences and the need for better treatment. Sleep Med 2010, 11:807-815.
9. Ellenbogen A.L., Thein S.G., Winslow D.H., Becker P.M., Tolson J.M., Lassauzet M.L., et al. A 52-week study of gabapentin enacarbil in restless legs syndrome. Clin Neuropharmacol 2011, 34:8-16.
10. Fulda S., Wetter T.C. Where dopamine meets opioids: a meta-analysis of the placebo effect in restless legs syndrome treatment studies. Brain 2008, 131:902-917.
11. Garcia-Borreguero D., Larrosa O., de la Llave Y., Verger K., Masramon X., Hernandez G. Treatment of restless legs syndrome with gabapentin: a double-blind, cross-over study. Neurology 2002, 59:1573-1579.
12. Garcia-Borreguero D., Grunstein R., Sridhar G., Dreykluft T., Montagna P., Dom R., et al. A 52-week open-label study of the long-term safety of ropinirole in patients with restless legs syndrome. Sleep Med 2007, 8:742-752.
13. Giorgi L., Ritchie S.Y., Kirsch J.M. Efficacy and tolerability of ropinirole in patients with restless legs syndrome and a baseline IRLS total score ≥ 24 points-data from the ropinirole clinical trial programme. Curr Med Res Opin 2006, 22:1867-1877.
14. Happe S., Sauter C., Klösch G., Saletu B., Zeitlhofer J. Gabapentin versus ropinirole in the treatment of idiopathic restless legs syndrome. Neuropsychobiology 2003, 48:82-86.
15. Högl B., García-Borreguero D., Kohnen R., Ferini-Strambi L., Hadjigeorgiou G., Hornyak M., et al. Progressive development of augmentation during long-term treatment with levodopa in restless legs syndrome: results of a prospective multi-center study. J Neurol 2010, 257:230-237.
16. Inoue Y., Kuroda K., Hirata K., Uchimura N., Kagimura T., Shimizu T. Long-term open-label study of pramipexole in patients with primary restless legs syndrome. J Neurol Sci 2010, 294:62-66.
17. Kushida C., Martin M., Nikam P., Blaisdell B., Wallenstein G., Ferini-Strambi L., et al. Burden of restless legs syndrome on health-related quality of life. Qual Life Res 2007, 16:617-624.
18. Kushida C.A., Becker P.M., Ellenbogen A.L., Canafax D.M., Barrett R.W. Randomized, double-blind, placebo-controlled study of XP13512/GSK1838262 in patients with RLS. Neurology 2009, 72:439-446. XP052 Study Group.
19. Merlino G., Serafini A., Young J.J., Robiony F., Gigli G.L., Valente M. Gabapentin enacarbil, a gabapentin prodrug for the treatment of the neurological symptoms associated with disorders such as restless legs syndrome. Curr Opin Investig Drugs 2009, 10:91-102.
20. Micozkadioglu H., Ozdemir F.N., Kut A., Sezer S., Saatci U., Haberal M. Gabapentin versus levodopa for the treatment of restless legs syndrome in hemodialysis patients: an open-label study. Ren Fail 2004, 26:393-397.
21. Montplaisir J., Fantini M.L., Desautels A., Michaud M., Petit D., Filipini D. Long-term treatment with pramipexole in restless legs syndrome. Eur J Neurol 2006, 13:1306-1311.
22. Montplaisir J., Karrasch J., Haan J., Volc D. Ropinirole is effective in the long-term management of restless legs syndrome: a randomized controlled trial. Mov Disord 2006, 21:1627-1635.
23. Nomura T., Inoue Y., Kusumi M., Oka Y., Nakashima K. Email-based epidemiological surveys on restless legs syndrome in Japan. Sleep Biol Rhythm 2008, 6:139-145.
24. Nomura T., Inoue Y., Kusumi M., Uemura Y., Nakashima K. Prevalence of restless legs syndrome in a rural community in Japan. Mov Disord 2008, 23:2363-2369.
25. Oertel W.H., Benes H., Garcia-Borreguero D., Geisler P., Högl B., Trenkwalder C., et al. One year open-label safety and efficacy trial with rotigotine transdermal patch in moderate to severe idiopathic restless legs syndrome. Sleep Med 2008, 9:865-873.
26. Ohayon M.M., Roth T. Prevalence of restless legs syndrome and periodic limb movement disorder in the general population. J Psychosom Res 2002, 53:547-554.
27. Partinen M., Hirvonen K., Jama L., Alakuijala A., Hublin C., Tamminen I., et al. Open-label study of the long-term efficacy and safety of pramipexole in patients with Restless Legs Syndrome (extension of the PRELUDE study). Sleep Med 2008, 9:537-541.
28. Rothdach A.J., Trenkwalder C., Haberstock J., Keil U., Berger K. Prevalence and risk factors of RLS in an elderly population: the MEMO study. Memory and Morbidity in Augsburg Elderly. Neurology 2000, 54:1064-1068.
29. Silber M.H., Ehrenberg B.L., Allen R.P., Buchfuhrer M.J., Earley C.J., Hening W.A., et al. Medical Advisory Board of the Restless Legs Syndrome Foundation 2004.
30. An algorithm for the management of restless legs syndrome. Mayo Clin Proc 2004;79:916-22.
31. Thorp M.L., Morris C.D., Bagby S.P. A crossover study of gabapentin in treatment of restless legs syndrome among hemodialysis patients. Am J Kidney Dis 2001, 38:104-108.
32. Trenkwalder C., Paulus W. Restless legs syndrome: pathophysiology, clinical presentation and management. Nat Rev Neurol 2010, 6:337-346.
33. Trenkwalder C., Hening W.A., Montagna P., Oertel W.H., Allen R.P., Walters A.S., et al. Treatment of restless legs syndrome: an evidence-based review and implications for clinical practice. Mov Disord 2008, 23:2267-2302.
34. Trenkwalder C., Benes H., Poewe W., Oertel W.H., Garcia-Borreguero D., de Weerd A.W., et al. Efficacy of rotigotine for treatment of moderate-to-severe restless legs syndrome: a randomised, double-blind, placebo-controlled trial. Lancet Neurol 2008, 7:595-604.
35. Walters A.S., Ondo W.G., Kushida C.A., Becker P.M., Ellenbogen A.L., Canafax D.M., et al. Gabapentin enacarbil in restless legs syndrome: a phase 2b, 2-week, randomized, double-blind, placebo-controlled trial. Clin Neuropharmacol 2009, 32:311-320.
36. Winkelman J.W., Johnston L. Augmentation and tolerance with long-term pramipexole treatment of restless legs syndrome (RLS). Sleep Med 2004, 5:9-14.
37. Winkelman J.W., Finn L., Young T. Prevalence and correlates of restless legs syndrome symptoms in the Wisconsin Sleep Cohort. Sleep Med 2006, 7:545-552.
38. Winkelman J.W., Sethi K.D., Kushida C.A., Becker P.M., Koester J., Cappola J.J., et al. Efficacy and safety of pramipexole in restless legs syndrome. Neurology 2006, 67:1034-1039.