Sao Paulo, Brazil
|Philip Patsalos, Secretary
To advise the ILAE Executive Committee on issues related to the treatment of epilepsy with emphasis on pharmacotherapy.
- To develop evidence-based guidelines for pharmacological treatment of epilepsy.
- To address the phenomenon of tolerance to antiepileptic drug effects and the problems in evaluating long-term efficacy.
- To address methodological problems related to the process of registration of new antiepileptic drugs for monotherapy.
- To update Practice Guidelines for Therapeutic Drug Monitoring.
Commission Activities from June 30, 2004 until August 31, 2005
- Commission meetings at the American Epilepsy Society in New Orleans, USA in December 2004 and at the IEC in Paris, France in August 2005.
- Workshop with the Subcommission on Evidence-based Treatment Guidelines in Göteborg, Sweden in August 2004.
- Presentation of the treatment guidelines during a symposium at the AES meeting, New Orleans, USA, December 2004.
- Session on the treatment guidelines in the scientific program of the IEC in Paris, August 2005.
Sessions and symposia at IEC organized by the Commission:
- Teratogenic Effects of Antiepileptic Drugs
- Surrogate Markers of AED Treatment Outcome
The ILAE Evidence-based Treatment Guidelines for Initial Monotherapy
Chaired by Santiago Arroyo, the Subcommission on Long-term Efficacy and Tolerance of AEDs arranged a workshop with 14 active international delegates in Milwaukee, USA on 31 January 2005. The topic was Long-Term Efficacy of AEDs and the Phenomenon of Tolerance. The result of the workshop has been summarized in a manuscript.
Chaired by Michel Baulac, the Subcommission on Monotherapy Trial Methodology organized a workshop on the possibility to use Historical Controls for Monotherapy Studies in San Servolo, Italy on 13 July 2003. Delegates included representatives from academia as well as regulatory bodies.
At the 7th Eilat Conference on New Antiepileptic Drugs in Sardinia, May 2004, the Subcommission presented a study proposal addressing the feasibility to synthesize and model existing data from randomized controlled trials to predict outcome of treatment vs. no treatment in newly diagnosed epilepsy. The ILAE Executive Committee has granted the project financial support to cover costs for statistical expertise in its initial phase. Results are underway.
Other activities in collaboration with the Commission on European Affairs and the European Epilepsy Academy. The Commission organized a 10-day course on pharmacological treatment, 10-19 July 2003. This international course, From Basic Knowledge to Rational Prescribing in Epilepsy, was the second in the Epilepsy Summer School series held at Venice International University in San Servolo Island, Venice, Italy. It attracted approximately 60 participants representing 47 different countries. The faculty was mainly formed by members of the organizing commissions.
The methodology as well as draft versions of the Evidence-based Treatment Guidelines have been presented and discussed by different members of the Subcommission at several international meetings including the Asian-Oceanian Epilepsy Congress in September 2004, the American Epilepsy Society Meeting in December 2004 and the 26th IEC in Paris 2005. The Subcommission has finalized a manuscript, Evidence Based Guideline: An Analysis of Antiepileptic Drug Efficacy and Effectiveness as Initial Monotherapy for Epileptic Seizures and Syndromes, which is intended for publication in Epilepsia.
A Subcommission on Therapeutic Drug Monitoring (TDM) has been established under the chairmanship of Philip Patsalos. Having first reviewed the old TDM ILAE guidelines from 1993, it was deemed important to provide an update. The group has thus developed a draft consensus document Antiepileptic Drugs – Best Practice Guidelines for Therapeutic Drug Monitoring. The final version is intended for publication in Epilepsia.
A project initiated by the previous Commission on Therapeutic Strategies has resulted in the publication in 2005 of a book Antiepileptic Drugs: Combination Therapy and Interactions, edited by Jerzy Majkowski, Blaise Bourgeois, Philip Patsalos and Richard Mattson.
The Commission has advised the ILAE and IBE concerning proposed changes in WHO Essential Drugs list and also submitted a report on the treatment of epilepsy in pregnancy for the ILAE Annual Report. On the request of the ILAE President, the Commission has reviewed and commented on the “Guide Your Journey” women’s initiative launched as part of the Global Campaign.
The Commission has endorsed EURAP, an International Antiepileptic Drugs and Pregnancy Registry, which subsequently has been presented at all three Regional Epilepsy Congresses in 2002 (Latin American, Asian-Oceanian and European). Information booths have been operational at these meetings to supplement and reinforce the information presented at the scientific sessions. As a consequence of these activities, the registry has now been implemented in more than 40 countries on four continents.
Recommendations for Future Work
It would be an important task for the ILAE to evaluate the impact of the recently developed treatment guidelines and to update them continuously. In addition there are other treatment areas that need guidelines. We suggest that the ILAE should take responsibility for developing guidelines for the treatment of status epilepticus. As discussed during one of the post main sessions at the IEC in Paris, it is also time for the ILAE to update its 1993 guidelines on the treatment of epilepsy in relation to pregnancy.
Treatment issues in the emerging economies would need more attention in the future, which among other things could include an analysis of the applicability of the developed treatment guidelines in this setting.
Torbjörn Tomson, Chair