Document Detail

An active-control trial of lamotrigine monotherapy for partial seizures.
MedLine Citation:
PMID:  9781523     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: We report the results of a double-blind, double-dummy, active-control study designed to evaluate the efficacy and safety of lamotrigine (LTG) administered as monotherapy to adult outpatients with partial seizures.
BACKGROUND: The effectiveness of LTG as add-on therapy for partial seizures in adults has previously been established.
METHODS: After an 8-week baseline during which patients continued their baseline antiepileptic drug (carbamazepine or phenytoin monotherapy), 156 patients were randomly assigned to receive increasing doses of LTG (target 250 mg b.i.d.) or valproic acid (VPA; target low dose of 500 mg b.i.d.) during the first 4 weeks of an 8-week transition period. Carbamazepine or phenytoin was withdrawn over the next 4 weeks; then patients entered a 12-week monotherapy period. Study drug treatment was discontinued in patients who met predetermined escape criteria for seizure worsening.
RESULTS: More patients receiving LTG were successfully maintained on monotherapy compared with patients receiving VPA (56% versus 20%; p < 0.001). The time to meet the escape criteria was also significantly longer in LTG-treated patients (median = 168 days) than in VPA-treated patients (median = 57 days; p = 0.001). The incidence of adverse events during the monotherapy period was lower than during the transition period. Four LTG patients and five VPA patients reported serious adverse events. Two of those patients experienced a rash that led to withdrawal soon after adding LTG to carbamazepine.
CONCLUSIONS: We conclude that LTG is effective and well tolerated when administered as monotherapy in adult patients with partial seizures.
F Gilliam; B Vazquez; J C Sackellares; G Y Chang; J Messenheimer; J Nyberg; M E Risner; G D Rudd
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Neurology     Volume:  51     ISSN:  0028-3878     ISO Abbreviation:  Neurology     Publication Date:  1998 Oct 
Date Detail:
Created Date:  1998-10-30     Completed Date:  1998-10-30     Revised Date:  2013-08-21    
Medline Journal Info:
Nlm Unique ID:  0401060     Medline TA:  Neurology     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  1018-25     Citation Subset:  AIM; IM    
University of Alabama at Birmingham, 35294-0021, USA.
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MeSH Terms
Anticonvulsants / administration & dosage*,  adverse effects,  blood
Carbamazepine / administration & dosage
Double-Blind Method
Epilepsies, Partial / drug therapy*
Exanthema / chemically induced
Hydrogen Peroxide
Middle Aged
Phenytoin / administration & dosage
Triazines / administration & dosage*,  adverse effects,  blood
Valproic Acid / administration & dosage
Reg. No./Substance:
0/Anticonvulsants; 0/Triazines; 298-46-4/Carbamazepine; 57-41-0/Phenytoin; 7722-84-1/Hydrogen Peroxide; 99-66-1/Valproic Acid; U3H27498KS/lamotrigine
Comment In:
Neurology. 2000 Feb 8;54(3):777   [PMID:  10680834 ]
Neurology. 1998 Oct;51(4):940-2   [PMID:  9781508 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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