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| Efficacy in Adult Patients |
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Efficacy in Adults
Approved for a broad spectrum of ages and seizure types including adjunctive therapy for partial and primary generalized tonic-clonic (PGTC) seizures and conversion to monotherapy for adults with partial seizures
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Adjunctive therapy |
Patient population |
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Simple and complex
partial seizures |
>2 years through adulthood |
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Primary generalized
tonic-clonic
seizures |
>2 years through adulthood |
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Generalized seizures* of
Lennox-Gastaut
syndrome (LGS) |
>2 years through adulthood |
| Conversion to monotherapy |
Patient population |
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Simple and complex
partial seizures |
>16 years through adulthood |
| *Atonic, tonic, major myoclonic, and tonic-clonic seizures. |
Proven efficacy as adjunctive therapy for partial seizures
- Approximately one third of patients receiving LAMICTAL 500 mg/day in combination with up to 3 AEDs experienced a >50% reduction in the number of seizures.1
- Primary endpoint: Median reduction in partial seizures was 8% for placebo, 20% for LAMICTAL 300 mg/day, and 36% for LAMICTAL 500 mg/day. Only LAMICTAL 500 mg/day was significant versus placebo.1
RESULTS FROM: MATSUO ET AL. Neurology. 1993;43:2284-2291.
Study design: In a double-blind, parallel-group study, 216 patients with refractory partial seizures were studied for 6 months, placebo-controlled, on the long-term efficacy and safety of LAMICTAL (300 or 500 mg/day) when added to up to 3 currently marketed AEDs.
In this study, initial dose was higher and rate of escalation was faster than recommended in the Prescribing Information for LAMICTAL.
Proven efficacy as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures
Reduced PGTC seizure frequency from baseline in patients > 2 years in both (escalation and maintenance phases).
- Primary endpoint: significant median reduction of PGTC seizure frequency over the entire treatment period (escalation plus maintenance phases) for LAMICTAL vs placebo (67% vs 34%, P=0.06)
- Protocol-specified secondary endpoint: Significantly more patients treated with LAMICTAL had a greater than 50% reduction of PGTC seizure frequency during maintenance phase vs placebo (72% vs 49%, P=0.014)
RESULTS FROM: BITON ET AL. Neurology. 2005, 65: 1737-1743. Study design: Double-blind, placebo-controlled evaluation of adjunctive therapy with LAMICTAL for PGTC seizures (with or without other idiopathic generalized seizure types, including absence, myoclonic, clonic, tonic, and atonic) in patients 2-55 years of age. Patients with partial seizures were excluded by screening and historical EEGs. After patients were screened, the study was divided into 3 phases: baseline (8 weeks), escalation (7 or 12 weeks, depending on patient's age), and maintenance (12 weeks). Fixed doses of LAMICTAL targeting 200-400 mg/day and 3-12 mg/kg/day based on age and concomitant AEDs (induced, non-induced, valproate [VPA]).
Convert with confidence—proven control with conversion to monotherapy
In adults with uncontrolled partial seizures (>4 seizures/month) converted from carbamazepine or phenytoin3*
The data presented here 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.
- More than twice as many patients in the group receiving LAMICTAL successfully completed the trial versus patients in the active control group
- Intent-to-treat analysis results, which included all randomized patients, were similar: 37% (28/76) versus 16% (13/80). (P=0.0012)
RESULTS FROM: GILLIAM ET AL. Neurology. 1998;51:1018-1025.
Study design: In a double-blind active-control study, 156 patients with partial seizures inadequately controlled on existing monotherapy [>4 seizures/month on carbamazepine (CBZ) or phenytoin (PHT)] were converted to monotherapy with LAMICTAL or valproate VPA 1000 mg/day titrated to 250 mg BID and 500 mg BID, respectively. CBZ or PHT was withdrawn over the next 4 weeks in 20% weekly decrements. LAMICTAL or VPA was maintained for 12 weeks at target dose. 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.
Click here for Adult Dosing.
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| EFFICACY AND TOLERABILITY |
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