메뉴 건너뛰기




Volumn 11, Issue 7, 2012, Pages 579-588

Efficacy and tolerability of zonisamide versus controlled-release carbamazepine for newly diagnosed partial epilepsy: A phase 3, randomised, double-blind, non-inferiority trial

Author keywords

[No Author keywords available]

Indexed keywords

BICARBONATE; CARBAMAZEPINE; ZONISAMIDE;

EID: 84862311867     PISSN: 14744422     EISSN: 14744465     Source Type: Journal    
DOI: 10.1016/S1474-4422(12)70105-9     Document Type: Article
Times cited : (126)

References (38)
  • 1
    • 0034598762 scopus 로고    scopus 로고
    • Early identification of refractory epilepsy
    • Kwan P, Brodie MJ Early identification of refractory epilepsy. N Engl J Med 2000, 342:314-319.
    • (2000) N Engl J Med , vol.342 , pp. 314-319
    • Kwan, P.1    Brodie, M.J.2
  • 2
    • 0038679502 scopus 로고    scopus 로고
    • Clinical trials of antiepileptic medications in newly diagnosed patients with epilepsy
    • Kwan P, Brodie MJ Clinical trials of antiepileptic medications in newly diagnosed patients with epilepsy. Neurology 2003, 60(suppl 4):S2-12.
    • (2003) Neurology , vol.60 , Issue.SUPPL. 4
    • Kwan, P.1    Brodie, M.J.2
  • 3
    • 77951299278 scopus 로고    scopus 로고
    • Clinical development of drugs for epilepsy: a review of approaches in the United States and Europe
    • Porter RJ, Baulac M, Nohria V Clinical development of drugs for epilepsy: a review of approaches in the United States and Europe. Epilepsy Res 2010, 89:163-175.
    • (2010) Epilepsy Res , vol.89 , pp. 163-175
    • Porter, R.J.1    Baulac, M.2    Nohria, V.3
  • 4
    • 34548431717 scopus 로고    scopus 로고
    • Clinical pharmacology and mechanism of action of zonisamide
    • Biton V Clinical pharmacology and mechanism of action of zonisamide. Clin Neuropharmacol 2007, 30:230-240.
    • (2007) Clin Neuropharmacol , vol.30 , pp. 230-240
    • Biton, V.1
  • 5
    • 84873074570 scopus 로고    scopus 로고
    • Zonegran Summary of Product Characteristics, (accessed Feb 8, 2012).
    • Zonegran Summary of Product Characteristics, (accessed Feb 8, 2012). http://www.medicines.org.uk/emc/medicine/16240/SPC/Zonegran%20capsules.
  • 6
    • 84873069865 scopus 로고    scopus 로고
    • Zonegran Prescribing Information, (accessed Feb 8, 2012).
    • Zonegran Prescribing Information, (accessed Feb 8, 2012). http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020789s022s025lbl.pdf.
  • 7
    • 0027180811 scopus 로고
    • Zonisamide for add-on treatment of refractory partial epilepsy: a European double-blind trial
    • Schmidt D, Jacob R, Loiseau P, et al. Zonisamide for add-on treatment of refractory partial epilepsy: a European double-blind trial. Epilepsy Res 1993, 15:67-73.
    • (1993) Epilepsy Res , vol.15 , pp. 67-73
    • Schmidt, D.1    Jacob, R.2    Loiseau, P.3
  • 8
    • 0035960602 scopus 로고    scopus 로고
    • Randomized controlled trial of zonisamide for the treatment of refractory partial-onset seizures
    • Zonisamide 922 Trial Group
    • Faught E, Ayala R, Montouris GG, Leppik IE Randomized controlled trial of zonisamide for the treatment of refractory partial-onset seizures. Neurology 2001, 57:1774-1779. Zonisamide 922 Trial Group.
    • (2001) Neurology , vol.57 , pp. 1774-1779
    • Faught, E.1    Ayala, R.2    Montouris, G.G.3    Leppik, I.E.4
  • 9
    • 3042636758 scopus 로고    scopus 로고
    • Randomized, controlled clinical trial of zonisamide as adjunctive treatment for refractory partial seizures
    • Sackellares JC, Ramsay RE, Wilder BJ, Browne TR, Shellenberger MK Randomized, controlled clinical trial of zonisamide as adjunctive treatment for refractory partial seizures. Epilepsia 2004, 45:610-617.
    • (2004) Epilepsia , vol.45 , pp. 610-617
    • Sackellares, J.C.1    Ramsay, R.E.2    Wilder, B.J.3    Browne, T.R.4    Shellenberger, M.K.5
  • 10
    • 13144306049 scopus 로고    scopus 로고
    • Dose-dependent safety and efficacy of zonisamide: a randomized, double-blind, placebo-controlled study in patients with refractory partial seizures
    • Brodie MJ, Duncan R, Vespignani H, Solyom A, Bitenskyy V, Lucas C Dose-dependent safety and efficacy of zonisamide: a randomized, double-blind, placebo-controlled study in patients with refractory partial seizures. Epilepsia 2005, 46:31-41.
    • (2005) Epilepsia , vol.46 , pp. 31-41
    • Brodie, M.J.1    Duncan, R.2    Vespignani, H.3    Solyom, A.4    Bitenskyy, V.5    Lucas, C.6
  • 11
    • 55949103811 scopus 로고    scopus 로고
    • Long-term safety and efficacy of zonisamide in patients with refractory partial-onset epilepsy
    • Wroe SJ, Yeates AB, Marshall A Long-term safety and efficacy of zonisamide in patients with refractory partial-onset epilepsy. Acta Neurol Scand 2008, 118:87-93.
    • (2008) Acta Neurol Scand , vol.118 , pp. 87-93
    • Wroe, S.J.1    Yeates, A.B.2    Marshall, A.3
  • 12
    • 32644476871 scopus 로고    scopus 로고
    • Zonisamide in the management of epilepsy: Japanese experience
    • Ohtahara S Zonisamide in the management of epilepsy: Japanese experience. Epilepsy Res 2006, 68(suppl 2):S25-S33.
    • (2006) Epilepsy Res , vol.68 , Issue.SUPPL. 2
    • Ohtahara, S.1
  • 13
    • 76249106175 scopus 로고    scopus 로고
    • Flexible dosing of adjunctive zonisamide in the treatment of adult partial-onset seizures: a non-comparative, open-label study (ZEUS)
    • Dupont S, Striano S, Trinka E, et al. Flexible dosing of adjunctive zonisamide in the treatment of adult partial-onset seizures: a non-comparative, open-label study (ZEUS). Acta Neurol Scand 2010, 121:141-148.
    • (2010) Acta Neurol Scand , vol.121 , pp. 141-148
    • Dupont, S.1    Striano, S.2    Trinka, E.3
  • 14
    • 77952239895 scopus 로고    scopus 로고
    • A prospective audit of adjunctive zonisamide in an everyday clinical setting
    • Stephen LJ, Kelly K, Wilson EA, Parker P, Brodie MJ A prospective audit of adjunctive zonisamide in an everyday clinical setting. Epilepsy Behav 2010, 17:455-460.
    • (2010) Epilepsy Behav , vol.17 , pp. 455-460
    • Stephen, L.J.1    Kelly, K.2    Wilson, E.A.3    Parker, P.4    Brodie, M.J.5
  • 15
    • 72849124489 scopus 로고    scopus 로고
    • Zonisamide in the treatment of epilepsy
    • Schulze-Bonhage A Zonisamide in the treatment of epilepsy. Expert Opin Pharmacother 2010, 11:115-126.
    • (2010) Expert Opin Pharmacother , vol.11 , pp. 115-126
    • Schulze-Bonhage, A.1
  • 16
    • 80052845510 scopus 로고    scopus 로고
    • The long-term retention of zonisamide in a large cohort of people with epilepsy at a tertiary referral centre
    • Catarino CB, Bartolini E, Bell GS, Yuen AW, Duncan JS, Sander JW The long-term retention of zonisamide in a large cohort of people with epilepsy at a tertiary referral centre. Epilepsy Res 2011, 96:39-44.
    • (2011) Epilepsy Res , vol.96 , pp. 39-44
    • Catarino, C.B.1    Bartolini, E.2    Bell, G.S.3    Yuen, A.W.4    Duncan, J.S.5    Sander, J.W.6
  • 17
    • 84883073854 scopus 로고    scopus 로고
    • European Medicines Agency Committee for Proprietary Medicinal Products (CPMP), CHMP, London, (accessed Feb 8, 2012).
    • CHMP Guideline on clinical investigation of medicinal products in the treatment of epileptic disorders 2009, European Medicines Agency Committee for Proprietary Medicinal Products (CPMP), CHMP, London, (accessed Feb 8, 2012). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003531.pdf.
    • (2009) CHMP Guideline on clinical investigation of medicinal products in the treatment of epileptic disorders
  • 18
    • 33746124186 scopus 로고    scopus 로고
    • ILAE treatment guidelines: evidence-based analysis of antiepileptic drug efficacy and effectiveness as initial monotherapy for epileptic seizures and syndromes
    • Glauser T, Ben-Menachem E, Bourgeois B, et al. ILAE treatment guidelines: evidence-based analysis of antiepileptic drug efficacy and effectiveness as initial monotherapy for epileptic seizures and syndromes. Epilepsia 2006, 47:1094-1120.
    • (2006) Epilepsia , vol.47 , pp. 1094-1120
    • Glauser, T.1    Ben-Menachem, E.2    Bourgeois, B.3
  • 20
    • 0032991290 scopus 로고    scopus 로고
    • The medical dictionary for regulatory activities (MedDRA)
    • Brown EG, Wood L, Wood S The medical dictionary for regulatory activities (MedDRA). Drug Saf 1999, 20:109-117.
    • (1999) Drug Saf , vol.20 , pp. 109-117
    • Brown, E.G.1    Wood, L.2    Wood, S.3
  • 21
    • 33846850154 scopus 로고    scopus 로고
    • Comparison of levetiracetam and controlled-release carbamazepine in newly diagnosed epilepsy
    • Levetiracetam Monotherapy Study Group
    • Brodie MJ, Perucca E, Ryvlin P, Ben-Menachem E, Meencke HJ Comparison of levetiracetam and controlled-release carbamazepine in newly diagnosed epilepsy. Neurology 2007, 68:402-408. Levetiracetam Monotherapy Study Group.
    • (2007) Neurology , vol.68 , pp. 402-408
    • Brodie, M.J.1    Perucca, E.2    Ryvlin, P.3    Ben-Menachem, E.4    Meencke, H.J.5
  • 22
    • 80052967975 scopus 로고    scopus 로고
    • Efficacy and safety of pregabalin versus lamotrigine in patients with newly diagnosed partial seizures: a phase 3, double-blind, randomised, parallel-group trial
    • Kwan P, Brodie MJ, Kälviäinen R, Yurkewicz L, Weaver J, Knapp LE Efficacy and safety of pregabalin versus lamotrigine in patients with newly diagnosed partial seizures: a phase 3, double-blind, randomised, parallel-group trial. Lancet Neurol 2011, 10:881-890.
    • (2011) Lancet Neurol , vol.10 , pp. 881-890
    • Kwan, P.1    Brodie, M.J.2    Kälviäinen, R.3    Yurkewicz, L.4    Weaver, J.5    Knapp, L.E.6
  • 23
    • 68849091880 scopus 로고    scopus 로고
    • Interpreting regulatory trials in epilepsy
    • Marson AG, Williamson PR Interpreting regulatory trials in epilepsy. Curr Opin Neurol 2009, 22:167-173.
    • (2009) Curr Opin Neurol , vol.22 , pp. 167-173
    • Marson, A.G.1    Williamson, P.R.2
  • 24
    • 80052962453 scopus 로고    scopus 로고
    • What is a fair comparison in head-to-head trials of antiepileptic drugs?
    • French J What is a fair comparison in head-to-head trials of antiepileptic drugs?. Lancet Neurol 2011, 10:866-867.
    • (2011) Lancet Neurol , vol.10 , pp. 866-867
    • French, J.1
  • 25
    • 0032569514 scopus 로고    scopus 로고
    • Epileptology of the first-seizure presentation: a clinical, electroencephalographic, and magnetic resonance imaging study of 300 consecutive patients
    • King MA, Newton MR, Jackson GD, et al. Epileptology of the first-seizure presentation: a clinical, electroencephalographic, and magnetic resonance imaging study of 300 consecutive patients. Lancet 1998, 352:1007-1011.
    • (1998) Lancet , vol.352 , pp. 1007-1011
    • King, M.A.1    Newton, M.R.2    Jackson, G.D.3
  • 26
    • 0031883148 scopus 로고    scopus 로고
    • Antiepileptic drugs as a cause of worsening seizures
    • Perucca E, Gram L, Avanzini G, Dulac O Antiepileptic drugs as a cause of worsening seizures. Epilepsia 1998, 39:5-17.
    • (1998) Epilepsia , vol.39 , pp. 5-17
    • Perucca, E.1    Gram, L.2    Avanzini, G.3    Dulac, O.4
  • 27
    • 53549106359 scopus 로고    scopus 로고
    • Designing clinical trials to assess antiepileptic drugs as monotherapy: difficulties and solutions
    • Perucca E Designing clinical trials to assess antiepileptic drugs as monotherapy: difficulties and solutions. CNS Drugs 2008, 22:917-938.
    • (2008) CNS Drugs , vol.22 , pp. 917-938
    • Perucca, E.1
  • 28
    • 84862326815 scopus 로고    scopus 로고
    • Dose responsive efficacy of zonisamide monotherapy during 40 weeks treatment of partial seizures in patients with newly diagnosed epilepsy
    • Naritoku D Dose responsive efficacy of zonisamide monotherapy during 40 weeks treatment of partial seizures in patients with newly diagnosed epilepsy. Epilepsia 2006, 47(suppl 3):138-139.
    • (2006) Epilepsia , vol.47 , Issue.SUPPL. 3 , pp. 138-139
    • Naritoku, D.1
  • 29
    • 0029651761 scopus 로고
    • Double-blind comparison of lamotrigine and carbamazepine in newly diagnosed epilepsy. UK Lamotrigine/Carbamazepine Monotherapy Trial Group
    • Brodie MJ, Richens A, Yuen AW Double-blind comparison of lamotrigine and carbamazepine in newly diagnosed epilepsy. UK Lamotrigine/Carbamazepine Monotherapy Trial Group. Lancet 1995, 345:476-479.
    • (1995) Lancet , vol.345 , pp. 476-479
    • Brodie, M.J.1    Richens, A.2    Yuen, A.W.3
  • 30
    • 0033519964 scopus 로고    scopus 로고
    • Safety and efficacy of vigabatrin and carbamazepine in newly diagnosed epilepsy: a multicentre randomised double-blind study. Vigabatrin European Monotherapy Study Group
    • Chadwick D Safety and efficacy of vigabatrin and carbamazepine in newly diagnosed epilepsy: a multicentre randomised double-blind study. Vigabatrin European Monotherapy Study Group. Lancet 1999, 354:13-19.
    • (1999) Lancet , vol.354 , pp. 13-19
    • Chadwick, D.1
  • 31
    • 0036554690 scopus 로고    scopus 로고
    • Efficacy and safety of remacemide versus carbamazepine in newly diagnosed epilepsy: comparison by sequential analysis
    • Brodie MJ, Wroe SJ, Dean AD, Holdich TA, Whitehead J, Stevens JW Efficacy and safety of remacemide versus carbamazepine in newly diagnosed epilepsy: comparison by sequential analysis. Epilepsy Behav 2002, 3:140-146.
    • (2002) Epilepsy Behav , vol.3 , pp. 140-146
    • Brodie, M.J.1    Wroe, S.J.2    Dean, A.D.3    Holdich, T.A.4    Whitehead, J.5    Stevens, J.W.6
  • 32
    • 0037354372 scopus 로고    scopus 로고
    • Topiramate, carbamazepine and valproate monotherapy: double-blind comparison in newly diagnosed epilepsy
    • EPMN 105 Study Group
    • Privitera MD, Brodie MJ, Mattson RH, Chadwick DW, Neto W, Wang S Topiramate, carbamazepine and valproate monotherapy: double-blind comparison in newly diagnosed epilepsy. Acta Neurol Scand 2003, 107:165-175. EPMN 105 Study Group.
    • (2003) Acta Neurol Scand , vol.107 , pp. 165-175
    • Privitera, M.D.1    Brodie, M.J.2    Mattson, R.H.3    Chadwick, D.W.4    Neto, W.5    Wang, S.6
  • 33
    • 20444407159 scopus 로고    scopus 로고
    • New onset geriatric epilepsy: a randomized study of gabapentin, lamotrigine, and carbamazepine
    • VA Cooperative Study 428 Group
    • Rowan AJ, Ramsay RE, Collins JF, et al. New onset geriatric epilepsy: a randomized study of gabapentin, lamotrigine, and carbamazepine. Neurology 2005, 64:1868-1873. VA Cooperative Study 428 Group.
    • (2005) Neurology , vol.64 , pp. 1868-1873
    • Rowan, A.J.1    Ramsay, R.E.2    Collins, J.F.3
  • 34
    • 0021887675 scopus 로고
    • Comparison of carbamazepine, phenobarbital, phenytoin, and primidone in partial and secondarily generalized tonic-clonic seizures
    • Mattson RH, Cramer JA, Collins JF, et al. Comparison of carbamazepine, phenobarbital, phenytoin, and primidone in partial and secondarily generalized tonic-clonic seizures. N Engl J Med 1985, 313:145-151.
    • (1985) N Engl J Med , vol.313 , pp. 145-151
    • Mattson, R.H.1    Cramer, J.A.2    Collins, J.F.3
  • 35
    • 0026794763 scopus 로고
    • A comparison of valproate with carbamazepine for the treatment of complex partial seizures and secondarily generalized tonic-clonic seizures in adults. The Department of Veterans Affairs Epilepsy Cooperative Study No. 264 Group
    • Mattson RH, Cramer JA, Collins JF A comparison of valproate with carbamazepine for the treatment of complex partial seizures and secondarily generalized tonic-clonic seizures in adults. The Department of Veterans Affairs Epilepsy Cooperative Study No. 264 Group. N Engl J Med 1992, 327:765-771.
    • (1992) N Engl J Med , vol.327 , pp. 765-771
    • Mattson, R.H.1    Cramer, J.A.2    Collins, J.F.3
  • 36
    • 79952010199 scopus 로고    scopus 로고
    • Pharmacogenetics of cutaneous adverse drug reactions
    • Aihara M Pharmacogenetics of cutaneous adverse drug reactions. J Dermatol 2011, 38:246-254.
    • (2011) J Dermatol , vol.38 , pp. 246-254
    • Aihara, M.1
  • 37
    • 61849129452 scopus 로고    scopus 로고
    • The impact of zonisamide on weight. A clinical study in 103 patients with epilepsy
    • Wellmer J, Wellmer S, Bauer J The impact of zonisamide on weight. A clinical study in 103 patients with epilepsy. Acta Neurol Scand 2009, 119:233-238.
    • (2009) Acta Neurol Scand , vol.119 , pp. 233-238
    • Wellmer, J.1    Wellmer, S.2    Bauer, J.3
  • 38
    • 14844361792 scopus 로고    scopus 로고
    • Effect of zonisamide on the pharmacokinetics and pharmacodynamics of a combination ethinyl estradiol-norethindrone oral contraceptive in healthy women
    • Griffith SG, Dai Y Effect of zonisamide on the pharmacokinetics and pharmacodynamics of a combination ethinyl estradiol-norethindrone oral contraceptive in healthy women. Clin Ther 2004, 26:2056-2065.
    • (2004) Clin Ther , vol.26 , pp. 2056-2065
    • Griffith, S.G.1    Dai, Y.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.