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Long-term tolerability and efficacy of lamotrigine in infants 1 to 24 months old

Show simple item record Pina-Garza J.E. Elterman R.D. Ayala R. Corral M. Mikati M.A. Pina-Garza M.J. Warnock C.R. Conklin H.S. Messenheimer J.A.
dc.contributor.editor 2008 2017-10-05T16:01:01Z 2017-10-05T16:01:01Z 2008
dc.identifier 10.1177/0883073808317348
dc.identifier.issn 08830738
dc.description.abstract This open-label study was designed to evaluate the long-term tolerability and efficacy of lamotrigine in 1- to 24-month-old infants with partial seizures. The study enrolled both lamotrigine-naïve patients and patients who had been previously exposed to lamotrigine in a randomized, double-blind, placebo-controlled study. Patients (n = 204) received lamotrigine according to a dosing schedule that depended on prior experience with lamotrigine and concurrent antiepileptic drug therapy for up to 48 weeks or their second birthday, whichever occurred last. Total duration of lamotrigine exposure (which included exposure during the placebo-controlled study in lamotrigine-experienced patients) was ≥24 weeks in 92percent of patients, ≥48 weeks in 70percent of patients, and ≥72 weeks in 20percent of patients. A total of 20 (10percent) patients (8 lamotrigine-naïve patients and 12 lamotrigine-experienced patients) transitioned to lamotrigine monotherapy. The most common adverse events were pyrexia (45percent of patients), upper-respiratory tract infection (28percent), and ear infection (22percent). The only adverse event considered reasonably attributable to study medication in 2percent of patients was irritability (n = 10; 5percent of patients). No cases of serious rash were reported. The median percent reduction from baseline in partial seizure frequency in the sample as a whole was 74percent. Seizure frequency was reduced by ≥50percent from pre-lamotrigine baseline in 62percent of patients in the sample as a whole, 60percent of the lamotrigine-naïve subgroup, and 63percent of the lamotrigine-experienced subgroup. In the sample as a whole, 13percent of patients were seizure free during the Treatment Phase. Investigators considered clinical status at the last clinic visit to be improved (mildly, moderately, or markedly) relative to prelamotrigine clinical status in 76percent of patients (150-197) and to be unchanged in 19percent (37-197). In this study-the first large prospective investigation of the long-term tolerability and efficacy of an antiepileptic drug in a patient population 2 years and younger-lamotrigine administered for up to approximately 72 weeks was well tolerated and associated with good seizure control. © 2008 Sage Publications.
dc.format.extent Pages: (853-861)
dc.language English
dc.publisher THOUSAND OAKS
dc.relation.ispartof Publication Name: Journal of Child Neurology; Publication Year: 2008; Volume: 23; no. 8; Pages: (853-861);
dc.source Scopus
dc.title Long-term tolerability and efficacy of lamotrigine in infants 1 to 24 months old
dc.type Article
dc.contributor.affiliation Piña-Garza, J.E., Vanderbilt University, Nashville, TN 37232-9559, United States, Children's Hospital at Vanderbilt, 2200 Children's Way, Nashville, TN 37232-9559, United States
dc.contributor.affiliation Elterman, R.D., Dallas Pediatric Neurology Associates, Dallas, TX, United States
dc.contributor.affiliation Ayala, R., Tallahassee Neurological Clinic, Florida, FL, United States
dc.contributor.affiliation Corral, M., Hospital de Niños Ricardo Gutiérrez, Buenos Aires, Argentina
dc.contributor.affiliation Mikati, M.A., American University Medical Center, Beirut, Lebanon
dc.contributor.affiliation Piña-Garza, M.J., Vanderbilt University, Nashville, TN 37232-9559, United States
dc.contributor.affiliation Warnock, C.R., Neuroscience Medicine Development Center, GlaxoSmithKline, Research Triangle Park, NC, United States
dc.contributor.affiliation Conklin, H.S., Neuroscience Medicine Development Center, GlaxoSmithKline, Research Triangle Park, NC, United States
dc.contributor.affiliation Messenheimer, J.A., Neuroscience Medicine Development Center, GlaxoSmithKline, Research Triangle Park, NC, United States
dc.contributor.authorAddress Piña-Garza, J.E.; Children's Hospital at Vanderbilt, 2200 Children's Way, Nashville, TN 37232-9559, United States; email:
dc.contributor.authorCorporate University: American University of Beirut Medical Center; Faculty: Faculty of Medicine; Department: Pediatrics and Adolescent Medicine;
dc.contributor.authorDepartment Pediatrics and Adolescent Medicine
dc.contributor.authorFaculty Faculty of Medicine
dc.contributor.authorInitials Pina-Garza, JE
dc.contributor.authorInitials Elterman, RD
dc.contributor.authorInitials Ayala, R
dc.contributor.authorInitials Corral, M
dc.contributor.authorInitials Mikati, MA
dc.contributor.authorInitials Pina-Garza, MJ
dc.contributor.authorInitials Warnock, CR
dc.contributor.authorInitials Conklin, HS
dc.contributor.authorInitials Messenheimer, JA
dc.contributor.authorReprintAddress Pina-Garza, JE (reprint author), Childrens Hosp Vanderbilt, 11210 Doctors Off Tower,2200 Childrens Way, Nashville, TN 37232 USA.
dc.contributor.authorUniversity American University of Beirut Medical Center
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dc.description.citedCount 6
dc.description.citedTotWOSCount 4
dc.description.citedWOSCount 4
dc.format.extentCount 9
dc.identifier.coden JOCNE
dc.identifier.pubmedID 18660469
dc.identifier.scopusID 48449093885
dc.publisher.address 2455 TELLER RD, THOUSAND OAKS, CA 91320 USA
dc.relation.ispartOfISOAbbr J. Child Neurol.
dc.relation.ispartOfIssue 8
dc.relation.ispartofPubTitle Journal of Child Neurology
dc.relation.ispartofPubTitleAbbr J. Child Neurol.
dc.relation.ispartOfVolume 23
dc.source.ID WOS:000257956300001
dc.type.publication Journal
dc.subject.otherAuthKeyword Clinical trial
dc.subject.otherAuthKeyword Epilepsy
dc.subject.otherAuthKeyword Lamotrigine
dc.subject.otherAuthKeyword Partial seizures
dc.subject.otherChemCAS amoxicillin, 26787-78-0, 34642-77-8, 61336-70-7
dc.subject.otherChemCAS azithromycin, 83905-01-5
dc.subject.otherChemCAS clavulanate potassium, 61177-45-5
dc.subject.otherChemCAS ibuprofen, 15687-27-1
dc.subject.otherChemCAS lamotrigine, 84057-84-1
dc.subject.otherChemCAS paracetamol, 103-90-2
dc.subject.otherChemCAS pseudoephedrine, 345-78-8, 7460-12-0, 90-82-4
dc.subject.otherChemCAS salbutamol, 18559-94-9
dc.subject.otherChemCAS valproic acid, 1069-66-5, 99-66-1
dc.subject.otherChemCAS Anticonvulsants
dc.subject.otherChemCAS lamotrigine, 84057-84-1
dc.subject.otherChemCAS Triazines
dc.subject.otherIndex amoxicillin
dc.subject.otherIndex anticonvulsive agent
dc.subject.otherIndex azithromycin
dc.subject.otherIndex clavulanate potassium
dc.subject.otherIndex ibuprofen
dc.subject.otherIndex lamotrigine
dc.subject.otherIndex paracetamol
dc.subject.otherIndex placebo
dc.subject.otherIndex pseudoephedrine
dc.subject.otherIndex salbutamol
dc.subject.otherIndex valproic acid
dc.subject.otherIndex vitamin
dc.subject.otherIndex adjuvant therapy
dc.subject.otherIndex article
dc.subject.otherIndex clinical trial
dc.subject.otherIndex complex partial seizure
dc.subject.otherIndex constipation
dc.subject.otherIndex controlled clinical trial
dc.subject.otherIndex controlled study
dc.subject.otherIndex decreased appetite
dc.subject.otherIndex double blind procedure
dc.subject.otherIndex drug dose escalation
dc.subject.otherIndex drug dose increase
dc.subject.otherIndex drug dose titration
dc.subject.otherIndex drug efficacy
dc.subject.otherIndex drug eruption
dc.subject.otherIndex drug tolerability
dc.subject.otherIndex drug withdrawal
dc.subject.otherIndex epileptic state
dc.subject.otherIndex female
dc.subject.otherIndex focal epilepsy
dc.subject.otherIndex follow up
dc.subject.otherIndex grand mal seizure
dc.subject.otherIndex human
dc.subject.otherIndex infant
dc.subject.otherIndex insomnia
dc.subject.otherIndex irritability
dc.subject.otherIndex major clinical study
dc.subject.otherIndex male
dc.subject.otherIndex monotherapy
dc.subject.otherIndex multicenter study
dc.subject.otherIndex open study
dc.subject.otherIndex optimal drug dose
dc.subject.otherIndex preschool child
dc.subject.otherIndex priority journal
dc.subject.otherIndex prospective study
dc.subject.otherIndex randomized controlled trial
dc.subject.otherIndex seizure
dc.subject.otherIndex side effect
dc.subject.otherIndex simple partial seizure
dc.subject.otherIndex somnolence
dc.subject.otherIndex Anticonvulsants
dc.subject.otherIndex Dose-Response Relationship, Drug
dc.subject.otherIndex Double-Blind Method
dc.subject.otherIndex Drug Administration Schedule
dc.subject.otherIndex Drug Therapy, Combination
dc.subject.otherIndex Epilepsies, Partial
dc.subject.otherIndex Female
dc.subject.otherIndex Humans
dc.subject.otherIndex Infant
dc.subject.otherIndex Long-Term Care
dc.subject.otherIndex Male
dc.subject.otherIndex Prospective Studies
dc.subject.otherIndex Recurrence
dc.subject.otherIndex Treatment Outcome
dc.subject.otherIndex Triazines
dc.subject.otherKeywordPlus LENNOX-GASTAUT-SYNDROME
dc.subject.otherKeywordPlus ADD-ON
dc.subject.otherKeywordPlus CHILDHOOD EPILEPSY
dc.subject.otherKeywordPlus PEDIATRIC-PATIENTS
dc.subject.otherKeywordPlus PARTIAL SEIZURES
dc.subject.otherKeywordPlus RETT-SYNDROME
dc.subject.otherKeywordPlus CHILDREN
dc.subject.otherKeywordPlus MONOTHERAPY
dc.subject.otherKeywordPlus PROGNOSIS
dc.subject.otherKeywordPlus ONSET
dc.subject.otherWOS Clinical Neurology
dc.subject.otherWOS Pediatrics

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