1.2.2.1 Efficacy


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Proven seizure control with tolerability patients need

In a double-blind, active-control* study of 156 adult patients with partial seizures inadequately controlled on carbamazepine (CBZ) or phenytoin (PHT) (> 4 seizures/month)¹

Demonstrated efficacy with conversion to monotherapy from carbamazepine or phenytoin

• In the per-protocol analysis, more than twice as many patients (56%; 28/50) were successfully maintained on monotherapy with LAMICTAL for the 12-week monotherapy phase vs 20% (13/64) of patients receiving low-dose valproate (P=0.001)

• Intent-to-treat analysis results were similar (included all randomized patients): 37% (28/76) of patients taking LAMICTAL completed the monotherapy trial vs 16% (13/80) of patients receiving active control (P=0.0012)

Median time to meet escape criteria was significantly longer with LAMICTAL (168 days vs 57 days; P=0.001)¹

Escape Criteria:

doubling of average monthly seizure rate
doubling of the highest consecutive 2-day seizure rate
emergence of a new, more severe seizure type
clinically significant prolongation of tonic-clonic seizures

The data presented are protocol-specific secondary analyses. The per-protocol analysis included patients who either met escape criteria or completed the monotherapy phase. Those who withdrew due to adverse events were not counted.

Study Design

LAMICTAL or active control was titrated to 250 mg BID and 500 mg BID, respectively. CBZ or PHT was withdrawn over the next 4 weeks. LAMICTAL or control was maintained for 12 weeks at target doses. Note: In this study, titration of LAMICTAL was faster than currently recommended.

• 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

* This study employed a low-dose active control for ethical reasons, to provide some seizure protection. The study is not intended to imply the superiority of LAMICTAL to the active control, which was low-dose valproate.

More than 5 million patient exposures worldwide and growing²

More than 13 years of worldwide postmarketing experience

See the tolerability data for LAMICTAL.

References: 1. Gilliam F, Vazquez B, Sackellares JC, et al. An active-control trial of lamotrigine monotherapy for partial seizures. Neurology. 1998;51:1018-1025. 2. Data on file, GlaxoSmithKline. Based on kg of lamotrigine sold.

Important Safety Information

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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 and 0.3% (3/1000) in adults on adjunctive therapy. In a prospectively followed cohort of 1983 pediatric patients taking adjunctive LAMICTAL, there was 1 rash-related death

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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

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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 patients should be evaluated immediately. LAMICTAL should be discontinued if an alternative etiology cannot be established

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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

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To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations of LAMICTAL should not be exceeded

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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

Read the Frequently Asked Questions to learn more about LAMICTAL.

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