Abstract
Purpose: Evaluation of daily clinical practice in prescribing lamotrigine in refractory epilepsy patients.Methods: A collaborative, retrospective, peri‐marketing study was performed in in‐ and out‐patients attending one of the three Dutch epilepsy centres. Analysis of both patients' and doctors' information was performed in 520 patients using questionnaires and medical files.Results:After one year of treatment 76% of patients maintained LTG treatment, an intention‐to‐treat analysis showed >= 50% seizure reduction in 23% of patients; 20‐50% seizure reduction in 23% of patients. Six percent of patients became at least three months seizure free. In about 20% of patients seizures became less severe and shorter of duration, while in 6% an increase was found.After three months a significant decrease in number of concomitant antiepileptic drugs was found (change from mean 1,8 to 1,5 AEDs) (p=< 0.01). After twelve months the mean number of AEDs was 1,4 per patient. Overall percentage of side effects appeared to be significantly higher if patients' questionnaire data were used. Epilepsy patients considered side effects as an important factor in the choice of medication and in withdrawal of medication. Future developments of new AEDs should take this into account. Conclusion: This perimarketing study gives insight information about long‐term daily use of lamotrigine, with emphasis on effectiveness. Patients complained in the questionnaires much more about side‐effects, than was known according to the medical file. Therefore, it seems necessary to perform perimarketing studies more systematically.
This is a preview of subscription content, log in via an institution to check access.
References
Leach, MJ., Marden, C.M., Miller, A.A. Pharmacological studies on lamotrigine, a novel potential antiepileptic drug. II Neurochemical studies on the mechanism of action. Epilepsia 1986;27:490-7.
Binnie, C.D., Van Emde Boas, W., Kasteleijn-NolstTrenité, DGA., De Korte, R.A., Meijer, J.W.A., Meindardi, H., Miller, A.A., Overweg, J., Peck, A.W., Van Wieringen, A. Acute effects of lamotrigine (BW430C) in persons with epilepsy. Epilepsia 1986;27:248-54.
Binnie, C.D., Debets, R.M.C., Engelsman, M. Double-blind cross-over trial of lamotrigine (Lamictal) as add-on therapy in intractable epilepsy. Epilepsy Res. 1989;4:222-9.
Motte, J., Trevathan, E., Arvidsson, J.F.V. Lamotrigine for generalized seizures associated with the Lennox-Gastaut syndrome. N Engl J Med 1997;337:1807-12.
Mikati, MA., Holmes, G.L. Lamotrigine in absence and primary generalized epilepsies. J.Child Neurol 1997;12:S29-37.
Stewart, J., Hughes, E., Reynolds, E.H. Lamotrigine for generalized epilepsies. Lancet 1992;340(14):122-3.
Eriksson, A-S., Nergardh, A., Hoppu, K. Efficacy of lamotrigine in children and adolescents with refractory generalized epilepsy: a randomized, double-blind, crossover study. Epilepsia 1998;39:495-501.
Dooley, J., Camfield, P., Gordon, K., Camfield, C., Wirrell, Z., Smith. Lamotrigine-induced rash in children. Neurology 1996;46:240-2.
Richens, A. Lamotrigine. Toxicity. In: Levy, R.H., Mattson, R.H., Meldrum, B.S. (Eds.), Antiepileptic Drugs. 4th edition. New York, Raven Press 1995;897-102.
Besag, P.M.C., Wallace, S.J., Dulac, O., Alving, J., Spencer, S.C., Hosking, G. Lamotrigine for the treatment of epilepsy in childhood. J. Pediatr 1995;127:991-7.
Sander, J.W., Patsalos, P.N. et al. A randomised double-blind placebo-controlled add-on trial of lamotrigine in patients with severe epilepsy. Epilepsy Res 1990;6(3):221-6
Loiseau, P., Yuen, A.W. et al. A randomised double-blind placebo-controlled crossover add-on trial of lamotrigine in patients with treatment-resistant partial seizures. Epilepsy Res 1990;7(2):136-45
Beran, R.G., Berkovic, S.F., Dunagan, F.M., Vajda, F.J.E., Danta, G., Black, A.B., Mackenzie., R. Double-blind, placebo-controlled, crossover study of lamotrigine in treatment-resistant generalised epilepsy. Epilepsia 1998;39(12):1329-33
Messenheimer, J., Ramsay, R.E. et al. Lamotrigine therapy for partial seizures: a multi-center, placebo-controlled, doubleblind, cross-over trial. Epilepsia 1994;35(1):113-21
Ramaratman, S., Marson, A.G. et al. Lamotrigine add-on for drug-resistant partial epilepsy (Cochrane Review). Cochrane database Syst. Rev 2000;(3):CD001909
Brodie, M.J., Richens, A. et al. Double-blind comparison of lamotrigine and carbamazepine in newly diagnosed epilepsy. Lancet 1995;345(8948):476-9
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Kasteleijn‐Nolst Trenité, D., Gilissen, K., Rentmeester, T.W. et al. Peri‐marketing surveillance of lamotrigine in the Netherlands: Doctors' and patients' viewpoints. Pharm World Sci 23, 1–5 (2001). https://doi.org/10.1023/A:1011258526637
Issue Date:
DOI: https://doi.org/10.1023/A:1011258526637