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Clinical Evidence

Efficacy, safety and tolerability profile of Lamictal

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Achieving seizure freedom1

The LAM-SAFE study showed that Lamictal is as effective as carbamazepine or valproate in achieving seizure freedom in newly diagnosed adolescents and adults with epilepsy.1

Lamictal Seizure Freedom Rates

Lamictal in patients with inadequate seizure control or with unacceptable adverse events2

  • In the large-scale SANAD study, lamotrigine was associated with a significantly longer time to treatment failure compared with carbamazepine (hazard ratio 0.78; 95% confidence interval [CI] 0.63–0.97), gabapentin (0.65; 95% CI 0.52–0.80) or topiramate (0.64; 95% CI 0.52–0.79)2
  • The benefits of lamotrigine were seen throughout the 4 years of study.2
Lamictal without treatment failure carbamazepine

Treatment failure defined as stopping the randomised drug due either to inadequate seizure control or to intolerable side effects, or both, or the addition of other antiepileptic drugs (AEDs), whichever was the earliest.2

Tolerability3

Lamotrigine is associated with lesser incidence of tremor, weight gain, confusion and hair loss compared to valproic acid.3

Lamictal Adverse Events

The risk of major malformations associated with first-trimester exposure to Lamictal is lower than with valproate, phenobarbital and topiramate4

Lamictal Risk of Foetal Malformations

Efficacy and tolerability in elderly patients with epilepsy56

  • 12 month seizure freedom data showed that monotherapy with lamotrigine is more effective than with other AEDs (carbamazepine, gabapentin, oxcarbazepine, phenytoin, topiramate;  sodium valproate, zonisamide).5
  • Significantly more patients on gabapentin had weight gain during the first 12 months than those on lamotrigine (p=0.001).6
  • More patients lost weight with lamotrigine than with gabapentin (p=0.002), but the proportion of patients who gained (47.5%) or lost weight (36.1%) while on lamotrigine was similar.6
  • Hypersensitivity (rash of any degree) occurred more frequently with carbamazepine than with lamotrigine (p=0.007).6

References

  1. Steinhoff BJ, Ueberall MA, Siemes H, Kurlemann G, Schmitz B, Bergmann L, et al. The LAM-SAFE Study: lamotrigine versus carbamazepine or valproic acid in newly diagnosed focal and generalised epilepsies in adolescents and adults. Seizure 2005;14(8):597–605.
  2. Marson AG, Al-Kharusi AM, Alwaidh M, Appleton R, Baker GA, Chadwick DW, et al. The SANAD study of effectiveness of carbamazepine, gabapentin, lamotrigine, oxcarbazepine, or topiramate for treatment of partial epilepsy: an unblinded randomised controlled trial. Lancet 2007;369(9566):1000–1015.
  3. Viteri C, Codina M, Cobaleda S, Lahuerta J, Barriga J, Morales MD, et al. Quality of life and treatment satisfaction in Spanish epilepsy patients on monotherapy with lamotrigine or valproic acid. Seizure 2010;19(7):432–438.
  4. Hernández-Díaz S, Smith CR, Shen A, Mittendorf R, Hauser WA, Yerby M, et al. North American AED Pregnancy Registry. Comparative safety of antiepileptic drugs during pregnancy. Neurology 2012;78(21):1692–1699.
  5. Arif H, Buchsbaum R, Pierro J, Whalen M, Sims J, Resor SR Jr, et al. Comparative effectiveness of 10 antiepileptic drugs in older adults with epilepsy. Arch Neurol 2010;67(4):408–415.
  6. Rowan AJ, Ramsay RE, Collins JF, Pryor F, Boardman KD, Uthman BM, et al. New onset geriatric epilepsy: a randomized study of gabapentin, lamotrigine, and carbamazepine. Neurology 2005;64(11):1868–1873.

Adverse events should be reported to the Health Products Regulatory Authority (HPRA) using an Adverse Reaction Report Form obtained either from the HPRA or electronically via the website at www.hpra.ie. Adverse reactions can also be reported to the HPRA by calling: (01) 6764971. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255

Lamictal is a registered trademark of the GlaxoSmithKline group of companies