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Efficacy & Tolerability Overview> Efficacy in Pediatric Patients Tolerability in Pediatric Patients> Efficacy in Adult Patients> Tolerability in Adult Patients>		Efficacy in Pediatric Patients Think ahead—an AED profile for their years of development *Protocol-specific secondary analysis. Primary endpoint: Median reduction of all partial seizures over the entire treatment period was 36% for LAMICTAL vs 7% with placebo (P=0.008) RESULTS FROM: DUCHOWNY ET AL. Neurology. 1999;53:1724-1731. Study design: LAMICTAL or placebo was added to existing therapy of up to 2 concurrent AEDs in an 18-week, multicenter, double-blind, placebo-controlled trial of 199 pediatric patients (aged 2 to 16 years) with partial seizures inadequately controlled on existing therapy (>4 seizures/month). The maintenance dose of LAMICTAL was based on weight and concomitant medications. Click here for Interactive Pediatric Dosing Illustrator. Primary endpoint: Median percent decrease from baseline in PGTC seizure for the entire treatment period (escalation + maintenance phases) was 77% in the lamotrigine group and 40% in the placebo group (P= 0.044) RESULTS FROM: TREVATHAN ET AL, Pediatrics 2006; 118;371-378. Study design: Subanalysis of children and adolescents, aged 2 to 20 years (n=45) from a randomized, blinded, placebo-controlled clinical trial of 117 patients, aged 2 to 55 years with PGTC seizures inadequately controlled on 1 or 2 current antiepileptic drugs. †Protocol-specific secondary analysis. ‡Atonic, tonic, major myoclonic, and tonic-clonic. Median reduction in all drop attacks in patients with LGS was 34% for LAMICTAL versus 9% for placebo (P=0.01; treatment week 1 to 16)† Primary endpoint: Median reduction for all major seizures‡over the entire treatment period was 32% for LAMICTAL versus 9% for placebo (P=0.002) Tonic-clonic seizures were reduced by 36% in patients receiving LAMICTAL, but increased by 10% in patients receiving placebo (P=0.03) RESULTS FROM: MOTTE ET AL. N Engl J Med. 1997;337:1807-1812. Study design: Multicenter, double-blind, placebo-controlled trial of 169 patients (aged 3 to 25) with LGS inadequately controlled (average of >1 seizure every other day) on existing therapy. At baseline, frequency ranged from 3 to 249 major seizures/week for patients in the group taking LAMICTAL and from 2 to 593 major seizures/week for patients in the placebo group. After a 4-week placebo baseline, LAMICTAL or placebo was added to existing therapy of up to 3 concomitant AEDs for 16 weeks. The maintenance dose of LAMICTAL was based on weight and concomitant medications. References: 1. Duchowny M, Pellock JM, Graf WD, et al. A placebo-controlled trial of lamotrigine add-on therapy for partial seizures in children. Neurology. 1999;53:1724-1731. 2. Trevathan E, Kerls SP, Hammer AE, Vuong A, Messenheimer JA. LAMICTAL (lamotrigine) as adjunctive therapy among children and adolescents with primary generalized tonic-clonic seizures. Pediatrics. 2006; 118:e371-e378. 3. Motte J, Trevathan E, Arvidsson JFV, et al. Lamotrigine for generalized seizures associated with the Lennox-Gastaut syndrome. N Engl J Med. 1997;337:1807-1812.		EFFICACY AND TOLERABILITY Learn more about the efficacy and tolerability your adult patients need.
• Safety and effectiveness of LAMICTAL have not been established 1) as initial monotherapy, 2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate, or 3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs Important Safety Information • Serious rashes requiring hospitalization and discontinuation of treatment have been reported in association with the use of LAMICTAL, some of which have included Stevens-Johnson syndrome — Epilepsy clinical trials: The incidence of these rashes is approximately 0.8% (8/1000) in pediatric patients (age <16 years) receiving LAMICTAL as adjunctive therapy for epilepsy and 0.3% (3/1000) in adults on adjunctive therapy for epilepsy. In a prospectively followed cohort of 1983 pediatric patients with epilepsy taking adjunctive LAMICTAL, there was 1 rash-related death — Mood disorders: In clinical trials of bipolar and other mood disorders, the incidence of these rashes was 0.08% (0.8/1000) in adults receiving LAMICTAL as initial monotherapy and 0.13% (1.3/1000) in adult patients receiving LAMICTAL as adjunctive therapy • In worldwide postmarketing experience, rare cases of toxic epidermal necrolysis and/or rash-related death have been reported in adult and pediatric patients, but their numbers are too few to permit a precise estimate of the rate • Hypersensitivity reactions, some fatal or life-threatening, have occurred in association with the use of LAMICTAL. It is important to note that early manifestations of hypersensitivity (eg, fever, lymphadenopathy) may be present even though a rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately, and LAMICTAL should be discontinued if an alternative etiology cannot be established • Prior to initiation of treatment with LAMICTAL, the patient should be instructed that a rash or other signs or symptoms of hypersensitivity (eg, fever, lymphadenopathy) may herald a serious medical event and that the patient should report any such occurrence to a physician immediately • To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations of LAMICTAL should not be exceeded • LAMICTAL should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related Complete Prescribing Information for LAMICTAL® (lamotrigine) Tablets               This site is intended for US healthcare professionals only. © 1997-2008 GlaxoSmithKline. All Rights Reserved. Legal Notices | Privacy Statement | Medicine Savings | Contact Us