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Review

Gabapentin enacarbil for the treatment of moderate to severe primary restless legs syndrome (Willis-Ekbom disease): 600 or 1,200 mg dose?

Pages 249-262 | Published online: 03 Feb 2014

References

  • EkbomKARestless legsActa Med Scand1945158Suppl1123
  • AllenRPPicchiettiDHeningWATrenkwalderCWaltersASMontplaisiJRestless Legs Syndrome Diagnosis and Epidemiology workshop at the National Institutes of Health; International Restless Legs Syndrome Study GroupRestless legs syndrome: diagnostic criteria, special considerations, and epidemiology. A report from the restless legs syndrome diagnosis and epidemiology workshop at the National Institutes of HealthSleep Med20034210111914592341
  • TunçTKaradağYSDoğuluFInanLEPredisposing factors of restless legs syndrome in pregnancyMov Disord200722562763117285614
  • AllenRPEarleyCJThe role of iron in restless legs syndromeMov Disord200722Suppl 18S440S44817566122
  • GigliGLAdoratiMDolsoPRestless legs syndrome in end-stage renal diseaseSleep Med20045330931515165541
  • GemignaniFBrindaniFNegrottiAVitettaFAlfieriSMarbiniARestless legs syndrome and polyneuropathyMov Disord20062181254125716685701
  • ManconiMGovoniVDe VitoARestless legs syndrome and pregnancyNeurology20046361065106915452299
  • AllenRPWaltersASMontplaisirJRestless legs syndrome prevalence and impact: REST general population studyArch Intern Med2005165111286129215956009
  • HeningWWaltersASAllenRPMontplaisirJMyersAFerini-StrambiLImpact, diagnosis and treatment of restless legs syndrome (RLS) in a primary care population: the REST (RLS epidemiology, symptoms, and treatment) primary care studySleep Med20045323724615165529
  • OhayonMMO’HaraRVitielloMVEpidemiology of restless legs syndrome: a synthesis of the literatureSleep Med Rev201216428329521795081
  • InnesKESelfeTKAgarwalPPrevalence of restless legs syndrome in North American and Western European populations: a systematic reviewSleep Med201112762363421752711
  • AllenRPBharmalMCallowayMPrevalence and disease burden of primary restless legs syndrome: results of a general population survey in the United StatesMov Disord201126111412021322022
  • AllenRPStillmanPMyersAJPhysician-diagnosed restless legs syndrome in a large sample of primary medical care patients in western Europe: Prevalence and characteristicsSleep Med2010111313719464949
  • NomuraTInoueYKusumiMEmail-based epidemiological surveys on restless legs syndrome in JapanSleep Biol Rhythm20086139145
  • NomuraTInoueYKusumiMUemuraYNakashimaKPrevalence of restless legs syndrome in a rural community in JapanMov Disord200823162363236918973260
  • MizunoSMiyaokaTInagakiTHoriguchiJPrevalence of restless legs syndrome in non-institutionalized Japanese elderlyPsychiatry Clin Neurosci200559446146516048452
  • Garcia-BorregueroDKohnenRSilberMHThe long-term treatment of restless legs syndrome/Willis-Ekbom disease: evidence-based guidelines and clinical consensus best practice guidance: a report from the International Restless Legs Syndrome Study GroupSleep Med201314767568423859128
  • SilberMHEhrenbergBLAllenRPMedical Advisory Board of the Restless Legs Syndrome FoundationAn algorithm for the management of restless legs syndromeMayo Clin Proc200479791692215244390
  • OertelWHTrenkwalderCZucconiMState of the art in restless legs syndrome therapy: practice recommendations for treating restless legs syndromeMov Disord200722Suppl 18S466S47517516455
  • TrenkwalderCHeningWAMontagnaPTreatment of restless legs syndrome: an evidence-based review and implications for clinical practiceMov Disord200823162267230218925578
  • HeningWACurrent guidelines and standards of practice for restless legs syndromeAm J Med20071201 Suppl 1S22S2717198767
  • VignatelliLBilliardMClarenbachPEFNS Task ForceEFNS guidelines on management of restless legs syndrome and periodic limb movement disorder in sleepEur J Neurol200613101049106516987157
  • BliwiseDLFreemanAIngramCDRyeDBChakravortySWattsRLRandomized, double-blind, placebo-controlled, short-term trial of ropinirole in restless legs syndromeSleep Med20056214114715716217
  • AllenRBeckerPMBoganRRopinirole decreases periodic leg movements and improves sleep parameters in patients with restless legs syndromeSleep200427590791415453549
  • PartinenMHirvonenKJamaLEfficacy and safety of pramipexole in idiopathic restless legs syndrome: a polysomnographic dose-finding study – the PRELUDE studySleep Med20067540741716815748
  • García-BorregueroDAllenRPBenesHAugmentation as a treatment complication of restless legs syndrome: concept and managementMov Disord200722Suppl 18S476S48417580331
  • García-BorregueroDWilliamsAMDopaminergic augmentation of restless legs syndromeSleep Med Rev201014533934620219397
  • Horizant® (gabapentin enacarbil) [prescribing information]Santa Clara, CAXenoPort, Inc. revised52013
  • HendrichJVan MinhATHeblichFPharmacological disruption of calcium channel trafficking by the alpha2delta ligand gabapentinProc Natl Acad Sci U S A200810593628363318299583
  • DooleyDJTaylorCPDonevanSFeltnerDCa2+ channel alpha2delta ligands: novel modulators of neurotransmissionTrends Pharmacol Sci2007282758217222465
  • Garcia-BorregueroDFerini-StrambiLKohnenREuropean Federation of Neurological SocietiesEuropean Neurological SocietyEuropean Sleep Research SocietyEuropean guidelines on management of restless legs syndrome: report of a joint task force by the European Federation of Neurological Societies, the European Neurological Society and the European Sleep Research SocietyEur J Neurol201219111385139622937989
  • ThorpMLMorrisCDBagbySPA crossover study of gabapentin in treatment of restless legs syndrome among hemodialysis patientsAm J Kidney Dis200138110410811431189
  • HappeSSauterCKlöschGSaletuBZeitlhoferJGabapentin versus ropinirole in the treatment of idiopathic restless legs syndromeNeuropsychobiology2003482828614504416
  • MicozkadiogluHOzdemirFNKutASezerSSaatciUHaberalMGabapentin versus levodopa for the treatment of Restless Legs Syndrome in hemodialysis patients: an open-label studyRen Fail200426439339715462107
  • Garcia-BorregueroDLarrosaOde la LlaveYVergerKMasramonXHernandezGTreatment of restless legs syndrome with gabapentin: a double-blind, cross-over studyNeurology200259101573157912451200
  • Neurontin® (gabapentin) [prescribing information]New YorkPfizer, Inc. revised122012
  • GidalBERadulovicLLKrugerSRuteckiPPitterleMBockbraderHNInter- and intra-subject variability in gabapentin absorption and absolute bioavailabilityEpilepsy Res2000402–312312710863139
  • StewartBHKuglerARThompsonPRBockbraderHNA saturable transport mechanism in the intestinal absorption of gabapentin is the underlying cause of the lack of proportionality between increasing dose and drug levels in plasmaPharm Res19931022762818456077
  • LalRSukbuntherngJLuoWPharmacokinetics and tolerability of single escalating doses of gabapentin enacarbil: a randomized-sequence, double-blind, placebo-controlled crossover study in healthy volunteersClin Ther20093181776178619808136
  • XenoPort, IncGabapentin Enacarbil (GSK1838262) Adult Restless Legs Syndrome Post Marketing Commitment Study (CONCORD) Available from: http://clinicaltrials.gov/ct2/show/NCT01668667?term=concord&rank=1Accessed: January 6, 2014
  • LalRSukbuntherngJLuoWClinical pharmacokinetics of gabapentin after administration of gabapentin enacarbil extended-release tablets in patients with varying degrees of renal function using data from an open-label, single-dose pharmacokinetic studyClin Ther201234120121322206794
  • CundyKCSastrySLuoWZouJMoorsTLCanafaxDMClinical pharmacokinetics of XP13512, a novel transported prodrug of gabapentinJ Clin Pharmacol200848121378138818827074
  • LalREllenbogenAChenDA randomized, double-blind, placebo-controlled, dose-response study to assess the pharmacokinetics, efficacy, and safety of gabapentin enacarbil in subjects with restless legs syndromeClin Neuropharmacol201235416517322664749
  • CundyKCAnnamalaiTBuLXP13512 [(±)-1-([(alpha-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 monkeysJ Pharmacol Exp Ther2004311132433315146029
  • CundyKCBranchRChernov-RoganTXP13512 [(±)-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 transportersJ Pharmacol Exp Ther2004311131532315146028
  • LalRSukbuntherngJLuoWHuffFJZouJCundyKCThe effect of food with varying fat content on the clinical pharmacokinetics of gabapentin after oral administration of gabapentin enacarbilInt J Clin Pharmacol Ther201048212012820137764
  • LalRSukbuntherngJHoJCundyKCA phase I, single-dose study of the disposition of 14C-radiolabeled gabapentin enacarbil in healthy male volunteersInt J Clin Pharmacol Ther201149210911521255527
  • LalRSukbuntherngJLuoWClinical pharmacokinetics of gabapentin after administration of gabapentin enacarbil extended-release tablets in patients with varying degrees of renal function using data from an open-label, single-dose pharmacokinetic studyClin Ther201234120121322206794
  • ChenCMeta-analyses of dose-exposure relationships for gabapentin following oral administration of gabapentin and gabapentin enacarbilEur J Clin Pharmacol201369101809181723743781
  • KushidaCAWaltersASBeckerPXP021 Study GroupA randomized, double-blind, placebo-controlled, crossover study of XP13512/GSK1838262 in the treatment of patients with primary restless legs syndromeSleep200932215916819238802
  • WaltersASOndoWGKushidaCAXP045 Study GroupGabapentin enacarbil in restless legs syndrome: a phase 2b, 2-week, randomized, double-blind, placebo-controlled trialClin Neuropharmacol200932631132019667976
  • KushidaCABeckerPMEllenbogenALCanafaxDMBarrettRWXP052 Study GroupRandomized, double-blind, placebo-controlled study of XP13512/GSK1838262 in patients with RLSNeurology200972543944619188575
  • LeeDOZimanRBPerkinsATPocetaJSWaltersASBarrettRWXP053 Study GroupA randomized, double-blind, placebo-controlled study to assess the efficacy and tolerability of gabapentin enacarbil in subjects with restless legs syndromeJ Clin Sleep Med20117328229221677899
  • BoganRKBornemannMAKushidaCATrânPVBarrettRWXP060 Study GroupLong-term maintenance treatment of restless legs syndrome with gabapentin enacarbil: a randomized controlled studyMayo Clin Proc201085651252120511481
  • EllenbogenALTheinSGWinslowDHA 52-week study of gabapentin enacarbil in restless legs syndromeClin Neuropharmacol201134181621242741
  • WinkelmanJWBoganRKSchmidtMHHudsonJDDeRossettSEHill-ZabalaCERandomized polysomnography study of gabapentin enacarbil in subjects with restless legs syndromeMov Disord201126112065207221611981
  • VanMeterSAKavanaghSTWarrenSBarrettRWDose response of Gabapentin Enacarbil versus placebo in subjects with moderate-to-severe primary restless legs syndrome: an integrated analysis of three 12-week studiesCNS Drugs201226977378022849331
  • LalRSukbuntherngJLuoWToveraJLassauzetMLCundyKCPopulation pharmacokinetics and pharmacodynamics of gabapentin after administration of gabapentin enacarbilJ Clin Pharmacol2013531294023400741
  • BoganRKEllenbogenABeckerPMGabapentin enacarbil in subjects with moderate to severe primary restless legs syndrome with and without severe sleep disturbance: an integrated analysis of subjective and novel sleep endpoints from two studiesJ Parkinsonism Restless Legs Syndrome201333140
  • InoueYUchimuraNKurodaKHirataKHattoriNLong-term efficacy and safety of gabapentin enacarbil in Japanese restless legs syndrome patientsProg Neuropsychopharmacol Biol Psychiatry201236225125722036917
  • InoueYHirataKUchimuraNKurodaKHattoriNTakeuchiMGabapentin enacarbil in Japanese patients with restless legs syndrome: a 12-week, randomized, double-blind, placebo-controlled, parallel-group studyCurr Med Res Opin2013291132123121149
  • Center for Drug Evaluation and ResearchApplication number: 022399Orig1s000 Medical Review Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022399Orig1s000MedR.pdfAccessed: January 6, 2014
  • Center for Drug Evaluation and ResearchApplication number: 022399Orig1s000 Summary Review Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022399Orig1s000SumR.pdfAccessed: January 6, 2014
  • IrizarryMCWebbDJBoudiafNRisk of cancer in patients exposed to gabapentin in two electronic medical record systemsPharmacoepidemiol Drug Saf201221221422522144034
  • KohnenRAllenRPBenesHAssessment of restless legs syndrome – methodological approaches for use in practice and clinical trialsMov Disord200722Suppl 18S485S49417534967
  • Stiasny-KolsterKBenesHPeglauIEffective cabergoline treatment in idiopathic restless legs syndromeNeurology200463122272227915623686
  • FuldaSWetterTCWhere dopamine meets opioids: a meta-analysis of the placebo effect in restless legs syndrome treatment studiesBrain2008131490291717932100
  • Center for Drug Evaluation and ResearchApplication number: 022399Orig1s000 Pharmacology Review Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022399Orig1s000PharmR.pdfAccessed: January 6, 2014
  • Center for Drug Evaluation and ResearchApplication number: 022399Orig1s000 Cross Discipline Team Leader Review Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022399Orig1s000CrossR.pdfAccessed: January 6, 2014
  • LiYWaltersASChiuveSERimmEBWinkelmanJWGaoXProspective study of restless legs syndrome and coronary heart disease among womenCirculation2012126141689169422967852
  • InnesKESelfeTKAgarwalPRestless legs syndrome and conditions associated with metabolic dysregulation, sympathoadrenal dysfunction, and cardiovascular disease risk: a systematic reviewSleep Med Rev201216430933921733722
  • Tippmann-PeikertMParkJGBoeveBFShepardJWSilberMHPathologic gambling in patients with restless legs syndrome treated with dopaminergic agonistsNeurology200768430130317242339
  • Driver-DunckleyEDNobleBNHentzJGGambling and increased sexual desire with dopaminergic medications in restless legs syndromeClin Neuropharmacol200730524925517909302
  • VoonVSchoerlingAWenzelSFrequency of impulse control behaviours associated with dopaminergic therapy in restless legs syndromeBMC Neurol20111111721955669