Gabapentin enacarbil in restless legs syndrome

Drugs of Today

Volumn 46, Issue 1, 2010, Pages 3-11

  Merlino, Giovanni ^a,b   Serafini, Anna ^a   Lorenzut, Simone ^a   Sommaro, Martina ^a   Gigli, Gian Luigi ^a,b   Valente, Mariarosaria ^a,b  

^a SANTA MARIA DELLA MISERICORDIA UNIVERSITY HOSPITAL   (Italy)

^b UNIVERSITY OF UDINE   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

DOPAMINE RECEPTOR STIMULATING AGENT; GABAPENTIN; GABAPENTIN ENACARBIL;

ARTICLE; CARDIOVASCULAR DISEASE; CLINICAL TRIAL; COGNITIVE DEFECT; COMORBIDITY; COMPULSION; DISTRESS SYNDROME; DIZZINESS; DRUG EFFICACY; DRUG SAFETY; HUMAN; PAIN; RESTLESS LEGS SYNDROME; SEIZURE; SOMNOLENCE; SUSTAINED RELEASE FORMULATION;

EID: 77951468743     PISSN: 16993993     EISSN: 16994019     Source Type: Journal    
DOI: 10.1358/dot.2010.46.1.1424766     Document Type: Article

References (54)

1. Allen, R.P., Picchietti, D., Hening W.A. et al. 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(2): 101-109
2. Benes, H., Walters, A.S., Allen, R.P., Hening, W.A., Kohnen, R. Definition of restless legs syndrome, how to diagnose it, and how to differentiate it from RLS mimics. Mov Disord 2007, 22(Suppl 18): S401-8.
3. Montplaisir, J., Boucher, S., Poirier, G., Lavigne, G., Lapierre, O., Lespérance, P. Clinical, polysomnographic, and genetic characteristics of restless legs syndrome: A study of 133 patients diagnosed with new standard criteria. Mov Disord 1997, 12(1): 61-65 (Pubitemid 27032881)
4. nd ed.: Diagnostic and coding manual. Westchester, Illinois: American Academy of Sleep Medicine, 2005.
5. Merlino, G., Valente, M., Serafini, A., Gigli, G.L. Restless legs syndrome: Diagnosis, epidemiology, classification and consequences. Neurol Sci 2007, 28(Suppl 1): S37-46.
6. Bassetti, C., Mauerhofer, D., Gugger, M., Mathis, J., Hess, C.W. Restless legs syndrome: A clinical study of 55 patients. Eur Neurol 2001, 45(2): 67-74. (Pubitemid 32215793)
7. Rottach, K.G., Schaner, B.M., Kirch, M.H., Zivotofsky, A.Z., Teufel, L.M., Gallwitz, T., Messer, T. Restless legs syndrome as side effect of second generation antidepressants. J Psychiatr Res 2008, 43(1): 70-75
8. Merlino, G., Fratticci, L., Valente, M. et al. Association of restless legs syndrome in type 2 diabetes: A case-control study. Sleep 2007, 30(7): 866-871 (Pubitemid 47044818)
9. Manconi, M., Ferini-Strambi, L., Filippi, M. et al. Multicenter case-control study on restless legs syndrome in multiple sclerosis: The REMS study. Sleep 2008, 31(7): 944-952 (Pubitemid 351956933)
10. Kaplan, Y., Inonu, H., Yilmaz, A., Ocal, S. Restless legs syndrome in patients with chronic obstructive pulmonary disease. Can J Neurol Sci 2008, 35(3): 352-357
11. Lo Coco, D., Mattaliano, A., Lo Coco, A., Randisi, B. Increased frequency of restless legs syndrome in chronic obstructive pulmonary disease patients. Sleep Med 2009, 10(5): 572-576
12. Weinstock, L.B., Bosworth, B.P., Schert, E.J. et al. Crohn's disease is associated with restless legs syndrome. Inflamm Bowel Dis 2010, 16(2): 275-279
13. Weinstock, L.B., Walters, A.S., Mullin, G.E., Duntley, S.P. Celiac Disease Is Associated with Restless Legs Syndrome. Dig Dis Sci 2009 in press.
14. Allen, R.P., Walters, A.S., Montplaisir, J., Hening, W., Myers, A., Bell, T.J., Ferini-Strambi, L. Restless legs syndrome prevalence and impact: REST general population study. Arch Intern Med 2005, 165(11): 1286-1292 (Pubitemid 40989594)
15. Kushida, C., Martin, M., Nikam, P., Blaisdell, B., Wallenstein, G., Ferini-Strambi, L., Ware, J.E. Jr. Burden of restless legs syndrome on health-related quality of life. Qual Life Res 2007, 16(4): 617-624 (Pubitemid 46474940)
16. Winkelmann, J., Prager, M., Lieb, R. et al. "Anxietas tibiarum". Depression and anxiety disorders in patients with restless legs syndrome. J Neurol 2005, 252(1): 67-71. (Pubitemid 40179020)
17. Pearson, V.E., Allen, R.P., Dean, T., Gamaldo, C.E., Lesage, S.R., Earley, C.J. Cognitive deficits associated with restless legs syndrome (RLS). Sleep Med 2006, 7(1): 25-30. (Pubitemid 43033541)
18. Winkelman, J.W., Shahar, E., Sharief, I., Gottlieb, D.J. Association of restless legs syndrome and cardiovascular disease in the Sleep Heart Health Study. Neurology 2008, 70(1): 35-42.
19. Akpinar, S. Treatment of restless legs syndrome with levodopa plus benserazide. Arch Neurol 1982, 39(11): 739. (Pubitemid 12003440)
20. Trenkwalder, C., Hening, W.A., Montagna, P. et al. Treatment of restless legs syndrome: An evidence-based review and implications for clinical practice. Mov Disord 2008, 23(16): 2267-2302
21. 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(Pt 4): 902-917 (Pubitemid 351499412)
22. Allen, R.P. Improving RLS diagnosis and severity assessment: Polysomnography, actigraphy and RLS-sleep log. Sleep Med 2007, 8 (Suppl 2): S13-8.
23. Evans, A.H., Butzkueven, H. Dopamine agonist-induced pathological gambling in restless legs syndrome due to multiple sclerosis. Mov Disord 2007, 22(4): 590-591 (Pubitemid 46608168)
24. Quickfall, J., Suchowersky, P. Pathological gambling associated with dopamine agonist use in restless legs syndrome. Parkinsonism Relat Disord 2007, 13(8): 535-536 (Pubitemid 350110554)
25. Tippmann-Peikert, M., Park, J.G., Boeve, B.F., Shepard, J.W., Silber, M.H. Pathologic gambling in patients with restless legs syndrome treated with dopaminergic agonists. Neurology 2007, 68(4): 301-303 (Pubitemid 46148346)
26. Ondo, W.G., Lai, D. Predictors of impulsivity and reward seeking behavior with dopamine agonists. Parkinsonism Relat Disord 2008, 14(1): 28-32.
27. Salas, R.E., Allen, R.P., Earley, C.J., Gamaldo, C.E. A case of compulsive behaviors observed in a restless legs syndrome patient treated with a dopamine agonist. Sleep 2009, 32(5): 587-588
28. Leu-Semenescu, S., Karroum, E., Brion, A., Konofal, E., Arnulf, I. Dopamine dysregulation syndrome in a patient with restless legs syndrome. Sleep Med 2009, 10(4): 494-496
29. Salas, R.E., Allen, R.P., Earley, C.J., Gamaldo, C.E. Drug hoarding: A case of atypical dopamine dysregulation syndrome in a RLS patient. Mov Disord 2009, 24(4): 627-628
30. Garcia-Borreguero, D., Allen, R.P., Kohnen, R. et al. Diagnostic standards for dopaminergic augmentation of restless legs syndrome: Report from a World Association of Sleep Medicine-International Restless Legs Syndrome Study Group consensus conference at the Max Planck Institute. Sleep Med 2007, 8(5): 520-530 (Pubitemid 46972001)
31. Garcia-Borreguero, D., Kohnen, R., Högl, B. et al. Validation of the Augmentation Severity Rating Scale (ASRS): A multi-centric, prospective study with levodopa on restless legs syndrome. Sleep Med 2007, 8(5): 455-463 (Pubitemid 46972002)
32. Earley, C.J., Allen, R.P. Pergolide and carbidopa/levodopa treatment of the restless legs syndrome and periodic leg movements in sleep in a consecutive series of patients. Sleep 1996, 19(10): 801-810 (Pubitemid 27131931)
33. Trenkwalder, C., Benes, H., Grote, L. et al. Cabergoline compared to levodopa in the treatment of patients with severe restless legs syndrome: Results from a multi-center, randomized, active controlled trial. Mov Disord 2007, 22(5): 696-703. (Pubitemid 46800141)
34. Paulus, W., Trenkwalder, C. Less is more: Pathophysiology of dopaminergic-therapy-related augmentation in restless legs syndrome. Lancet Neurol 2006, 5(10): 878-886 (Pubitemid 44715823)
35. Arnulf, I. Sleep and wakefulness disturbances in Parkinson's disease. J Neural Transm Suppl 2006, (70): 357-360
36. Möller, J.C., Körner, Y., Cassel, W., Meindorfner, C., Krüger, H.P., Oertel, W.H., Stiasny-Kolster, K. Sudden onset of sleep and dopaminergic therapy in patients with restless legs syndrome. Sleep Med 2006, 7(4): 333-339 (Pubitemid 43792897)
37. Bassetti, C., Clavadetscher, S., Gugger, M., Hess, C.W. Pergolide-associated 'sleep attacks' in a patient with Restless Legs Syndrome. Sleep Med 2002, 3(3): 275-277
38. Antonini, A., Poewe, W. Fibrotic heart-valve reactions to dopamine-agonist treatment in Parkinson's disease. Lancet Neurol 2007, 6(9): 826-829 (Pubitemid 47243713)
39. Smith, S.A., Waggoner, A.D., de las Fuentes, L., Davila-Roman, V.G. Role of serotoninergic pathways in drug-induced valvular heart disease and diagnostic features by echocardiography. J Am Soc Echocardiogr 2009, 22(8): 883-889
40. 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(1): 104-108
41. 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(10): 1573-1579 (Pubitemid 35387065)
42. 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(4): 393-397 (Pubitemid 39167616)
43. Happe, S., Sauter, C., Klosch, G., Saletu, B., Zeitlhofer, J. Gabapentin versus ropinirole in the treatment of idiopathic restless legs syndrome. Neuropsychobiology 2003, 48(2): 82-86 (Pubitemid 37176872)
44. Gidal, B.E., Radulovic, L.L., Kruger, S., Rutecki, P., Pitterle, M., Bockbrader, H.N. Inter- and intra-subject variability in gabapentin absorption and absolute bioavailability. Epilepsy Res 2000, 40(2-3): 123-127 (Pubitemid 30339403)
45. Cundy, K.C., Annamalai, T., Bu, L. et al. XP13512 [(+/-)-1-([(?- isobutanoyloxyethoxy)carbonyl] aminomethyl)-1-cyclohexane acetic acid], a novel gabapentin prodrug: II. Improved oral bioavailability, dose proportionality and colonic absorption compared with gabapentin in rats and monkeys. J Pharmacol Exp Ther 2004, 311(1): 324-333 (Pubitemid 39287812)
46. Cundy, K.C., Branch, R., Chernov-Rogan, T. et al. XP13512 [(±)-1-([(α-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(1):315-323
47. 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(12): 1378-1388
48. Kushida, C.A., Becker, P.M., Ellenbogen, A.L., Canafax, D.M., Berrett, R.W.; XP052 Study Group. Randomized, double-blind, placebo-controlled study of XP13512/GSK1838262 in patients with RLS. Neurology 2009, 72(5): 439-446
49. Kushida, C.A., Walters, A.S., Becker, P. et al. A randomized, double-blind, placebo-controlled, crossover study of XP13512/GSK1838262 in the treatment of patients with primary restless legs syndrome. Sleep 2009, 32(2): 159-168
50. Walters, A.S., Ondo, W.G., Kushida, C.A. et al. Gabapentin enacarbil in restless legs syndrome: A phase 2b, 2-week, randomized, double-blind, placebo-controlled trial. Clin Neuropharmacol 2009, 32(6): 311-320
51. Long-term study of XP13512 vs. placebo in patients with restless legs syndrome (NCT00311363). ClinicalTrials.gov Website, accessed 05 February 2010.
52. XP13512 extension study in patients with restless legs syndrome (NCT00333359). ClinicalTrials.gov Website, accessed 05 February 2010.
53. XP13512 versus placebo in patients with restless legs syndrome (NCT00365352). ClinicalTrials.gov Website, accessed 05 February 2010.
54. Polysomnography study of GSK1838262 (XP13512) extended release tablets versus placebo in Restless Legs Syndrome (RLS) and associated sleep disturbance (NCT00748098). ClinicalTrials.gov Website, accessed 05 February 2010.