GRAY M ATTERS RESEARCH COLLABORATION NOTIFICATION Invitation to participate in the EpiNet-First trials The EpiNet study group was established for investigator-led clinical research in epilepsy. EpiNet-First comprises a series of five closely related, multicenter, randomized controlled trials in which levetiracetam will be compared with standard antiepileptic drugs (AEDs) in patients with new-onset epilepsy. Trials will be unblinded, and will be conducted according to good clinical practice (GCP) principles. Patients will be allocated to the different trials according to seizure type. Primary end point is 12 months sustained seizure freedom. After giving consent, patients will be randomized online via the EpiNet platform. Data will be recorded into the EpiNet database. No separate case record forms (CRFs) will be utilized. Investigators must be accredited to confirm they diagnose epilepsy and seizures in a manner similar to that of other members of the EpiNet study group. EpiNet-First trials 1 EpiNet-First Trial 1: Patients with focal seizures will be randomized to receive either levetiracetam or lamotrigine or carbamazepine. 2 EpiNet-First Trial 2: Patients with generalized seizures will be randomized to receive either sodium valproate or levetiracetam. 3 EpiNet-First Trial 3: If sodium valproate is deemed unsuitable, then patients with generalized seizures will be randomized to either lamotrigine or levetiracetam. 4 EpiNet-First Trial 4: Patients with seizures of unknown nature will be randomized to receive either levetiracetam, lamotrigine, or sodium valproate. 5 EpiNet-First Trial 5: If sodium valproate is deemed unsuitable, then patients with seizures of unknown nature will be randomized to levetiracetam or lamotrigine. Trials will include people age 5 years or older with two or more spontaneous seizures. Patients with acute symptomatic seizures, or with progressive neurologic disease will not be included. All trial medication will be prescribed in a formulation and at a dose deemed suitable by the treating physicians. Investigators do not need to participate in all five trials. The EpiNet study group has received little external funding for this trial, and cannot supply the drugs or provide funding to centers to enroll or follow individual patients.
More information about the EpiNet study group is available at: www.epinet.co.nz. If you would like to participate in these trials, please contact the chairman of the EpiNet Study Group, Dr. Peter Bergin ([email protected]). Patients will be followed for a minimum of 2 years. DISCLOSURE None of the authors has any conflict of interest to disclose. We confirm that we have read the Journal’s position on issues involved in ethical publication and affirm that this report is consistent with those guidelines.
Peter S. Bergin1 [email protected] Ettore Beghi2 Manjari Tripathi3 Philip Smith4 Wendyl J. D’Souza5 1 Centre for Brain Research, Auckland City Hospital, University of Auckland, Auckland, New Zealand; 2 IRCCS – Mario Negri Institute Pharmacology Research Milan, Milan, Italy; 3 Neurosciences Centre, All India Institute of Medical Sciences, New Delhi, India; 4 University Hospital of Wales, Cardiff, United Kingdom; and 5 The Department of Medicine, St Vincent’s Hospital, The University of Melbourne, Melbourne, Victoria, Australia
LETTERS Long-term outcome in children with infantile spasms treated with vigabatrin: A cohort of 180 patients To the Editors: I have read with great interest the article of Djuric et al.,1 “Long-term outcome in children with infantile spasms treated with vigabatrin: A cohort of 180 patients.” They describe the largest reported cohort of patients with infantile spasms treated by vigabatrin followed for the longest period of time, and from a single tertiary epilepsy center. According to this report, the long-term outcome (at 2.4– 18, 9 [mean 10] years) is amazingly good: normal cognitive outcome (intelligence testing score [IQ] > 70) in 60
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GRAY MATTERS (40%) of 149 patients and freedom from seizures in 69 (46%) of 149 patients. It should be noted that IQ > 70 is not the same as IQ > 90, which is usually used for normal intelligence. These figures are seemingly much better than in the long-term follow-up in patients treated with adrenocorticotropic hormone (ACTH).2,3 The corresponding numbers in the latter study are 36 (24.5%) of 147 and 48 (33%) of 147, respectively. Because the results of Djuric et al. have been compared with my studies of long-term outcome of children treated for infantile spasms, I would like to correct some erroneous information presented about my study. 1) The numbers have been misquoted. In the Discussion “comparing the results of with ACTH-treated in a Finnish study, 51/88 patients (58%)1 versus 48/147 (33%) (48% is an error) were seizure-free,2,3 and 48/83 of patients (57.8%)1 versus 36/147 (24.5%)2,3 showed favorable intellectual outcome.” These figures presented in the article of Djuric et al. concerned responders (Table 4) and not the whole group. The Finnish numbers concerned the whole surviving group of infantile spasms. 2) In my study, children were treated with ACTH for 4–6 weeks, which is not considered to be long-term treatment as stated in the report of Djuric et al. It has not been the duration of the therapy but the large doses, 120–150 IU/day, which were associated with side effects (infections and hypertension).4 The large doses have not been used anymore in Finland. 3) The follow-up data from the study of Djuric et al. was much shorter than in the Finnish study: 10 and 25–35 years, respectively. In the Finnish study, all 162 patients (100%) could be traced and information from all 147 surviving patients obtained. Because most patients continue to have seizures, the cognitive outcome might be expected to be worse in patients surviving to adulthood. 4) In the study by Djuric et al., there are some concerns about the study population, as follows. (1) Onset of infantile spasms has ranged from 3 days to 25 months; 30 patients had an onset at
More information about the EpiNet study group is available at: www.epinet.co.nz. If you would like to participate in these trials, please contact the chairman of the EpiNet Study Group, Dr. Peter Bergin ([email protected]). Patients will be followed for a minimum of 2 years. DISCLOSURE None of the authors has any conflict of interest to disclose. We confirm that we have read the Journal’s position on issues involved in ethical publication and affirm that this report is consistent with those guidelines.
Peter S. Bergin1 [email protected] Ettore Beghi2 Manjari Tripathi3 Philip Smith4 Wendyl J. D’Souza5 1 Centre for Brain Research, Auckland City Hospital, University of Auckland, Auckland, New Zealand; 2 IRCCS – Mario Negri Institute Pharmacology Research Milan, Milan, Italy; 3 Neurosciences Centre, All India Institute of Medical Sciences, New Delhi, India; 4 University Hospital of Wales, Cardiff, United Kingdom; and 5 The Department of Medicine, St Vincent’s Hospital, The University of Melbourne, Melbourne, Victoria, Australia
LETTERS Long-term outcome in children with infantile spasms treated with vigabatrin: A cohort of 180 patients To the Editors: I have read with great interest the article of Djuric et al.,1 “Long-term outcome in children with infantile spasms treated with vigabatrin: A cohort of 180 patients.” They describe the largest reported cohort of patients with infantile spasms treated by vigabatrin followed for the longest period of time, and from a single tertiary epilepsy center. According to this report, the long-term outcome (at 2.4– 18, 9 [mean 10] years) is amazingly good: normal cognitive outcome (intelligence testing score [IQ] > 70) in 60
807
GRAY MATTERS (40%) of 149 patients and freedom from seizures in 69 (46%) of 149 patients. It should be noted that IQ > 70 is not the same as IQ > 90, which is usually used for normal intelligence. These figures are seemingly much better than in the long-term follow-up in patients treated with adrenocorticotropic hormone (ACTH).2,3 The corresponding numbers in the latter study are 36 (24.5%) of 147 and 48 (33%) of 147, respectively. Because the results of Djuric et al. have been compared with my studies of long-term outcome of children treated for infantile spasms, I would like to correct some erroneous information presented about my study. 1) The numbers have been misquoted. In the Discussion “comparing the results of with ACTH-treated in a Finnish study, 51/88 patients (58%)1 versus 48/147 (33%) (48% is an error) were seizure-free,2,3 and 48/83 of patients (57.8%)1 versus 36/147 (24.5%)2,3 showed favorable intellectual outcome.” These figures presented in the article of Djuric et al. concerned responders (Table 4) and not the whole group. The Finnish numbers concerned the whole surviving group of infantile spasms. 2) In my study, children were treated with ACTH for 4–6 weeks, which is not considered to be long-term treatment as stated in the report of Djuric et al. It has not been the duration of the therapy but the large doses, 120–150 IU/day, which were associated with side effects (infections and hypertension).4 The large doses have not been used anymore in Finland. 3) The follow-up data from the study of Djuric et al. was much shorter than in the Finnish study: 10 and 25–35 years, respectively. In the Finnish study, all 162 patients (100%) could be traced and information from all 147 surviving patients obtained. Because most patients continue to have seizures, the cognitive outcome might be expected to be worse in patients surviving to adulthood. 4) In the study by Djuric et al., there are some concerns about the study population, as follows. (1) Onset of infantile spasms has ranged from 3 days to 25 months; 30 patients had an onset at
