Comparison of twice- and three times daily tiagabine for the adjunctive treatment of partial seizures in refractory patients with epilepsy: an open label, randomised, parallel-group study.

UNLABELLED: A multicentre, open label, randomised, parallel group study compared the efficacy, tolerability and safety of two dosing regimens, t.i.d. and b.i.d., of tiagabine as an adjunctive therapy for the treatment of refractory patients with partial seizures. A total of 347 patients were randomised and treated (175 t.i.d. and 172 b.i.d.). Each group was administered the same daily dose of tiagabine incremented stepwise during a 12-week fixed-schedule titration period to a target dose of 40 mg/day. The patients were followed for a further 12-week flexible continuation phase. A significantly greater number of patients in the t.i.d. group completed the fixed schedule titration period (81.4% versus 73.1%; 95% CI of odds ratio = 0.331, 0.970; p = 0.038). The proportion of responders (patients showing at least a 50% decrease in all-seizure frequency from baseline) was similar for both groups (42.3% for b.i.d. and 47.1% for t.i.d.) during the last 8 weeks of the flexible phase and seven (4.0%) patients in the b.i.d. group were seizure-free compared to 14 (8.1%) patients in the t.i.d. group. Adverse events were of similar incidence in both groups, and mainly occurred during the fixed schedule titration period; they were mainly mild and CNS-related with somnolence being the most frequently reported. CONCLUSION: Tiagabine was effective as add-on treatment of refractory partial seizures. Although both regimens appear to offer a similar efficacy and safety profile, significantly more patients completed the study in the t.i.d. group compared to b.i.d., probably as a consequence of a lesser tolerability when high doses are given undivided. These results confirm that a slow titration and appropriate adjustment of dosing are essential conditions to ensure optimal use of tiagabine.

Epileptic drivers--a study of 1,089 patients.

A longitudinal study of 1,089 epileptic patients followed up by the same specialist between 1965-1991, allowed close observation of the seizures occurring to the patient at the wheel and their consequences and to relate them to detailed epileptological criteria. The results show road accidents caused by epileptic seizures are few and most of them are minor. The repatriation of risks between patients is very uneven. The quality of the neuro-psychic inter-critical state as well as the patients' degree of compliance seem to be more reliable risk indicators than some more traditional criteria like the length of remission between seizures. Although seizures occur more frequently in patients suffering from Complex Partial seizures as opposed to other forms of epileptic seizures, the differences between patients with epilepsy lies mostly in their behaviour and in their own representation of the risks. There is a need for a body of rules and regulations serving as an official framework regulating the driving test. This widely circulated document should take into account the multiplicity of cases, including the small number of patients thought to be dangerous. Its mode of application should allow doctors as well as patients to opt for a realistic attitude based on decision-making criteria involving a thorough knowledge of epilepsy as well as a thorough knowledge of the psychological characteristics of the patient concerned.

[Epileptic seizures after recovery from an epilepsy with rolandic paroxysms (author's transl)]. / Crises epileptiques apres guerison d'une EPR (epilepsie a paroxysmes rolandiques).

154 subjects over 13 years of age were examined who had suffered from RPE (epilepsy with rolandic paroxysmal foci) in infancy (87 subjects were 20 years old). Seizures had reappeared 5 times, four of them being apparently, primary generalized motor seizures. Treatment was not resumed in 3 cases which had not had another seizure for 11, 13 and 2 years, respectively. All patients have shown a good social adaptation. Repetition of seizures seems very rare and only in predisposed subjects. The highly favourable prognosis for RPE is not disputed.

Epilepsy and driving: an international perspective. Joint Commission on Drivers' Licensing of the International Bureau for Epilepsy and the International League Against Epilepsy.

Individuals with a history of seizures may be granted driving privileges if the risks of future seizure while driving are relatively low. Different nations have defined these risks in a wide variety of ways. Some countries, e.g., Japan, Greece, Brazil, India, and Russia, preclude driving after a single seizure. Other countries, such as Canada and the United States, allow driving < or = 3 months after certain types of seizures. A Joint Commission of the International Bureau for Epilepsy/International League Against Epilepsy has summarized regulations in several countries. From a consideration of medical literature and existing practices, a series of proposed guidelines for driving and epilepsy is recommended. In general, these guidelines suggest use of a seizure-free interval, generally 1-2 years but less in particular instances, to determine fitness to drive. Required physician reporting is discouraged, but physicians should report patients whom they believe pose a danger to themselves and to public safety. Individualized consideration should be given to special circumstances that may modify a general driving prohibition. Education and information programs are necessary for medical and regulatory authorities to develop a rational approach to driving and epilepsy worldwide.

Long-term treatment of epilepsy: open multicenter trial with progabide in epileptic patients.

A long-term open multicenter trial was carried out in 15 European centers with therapy-resistant epileptics to evaluate the efficacy and safety of progabide, a new antiepileptic GABA receptor agonist; 187 patients, suffering from partial epilepsy (57%), primary generalized epilepsy (20%), secondary generalized epilepsy (21%), and unclassified generalized epilepsy (2%), participated in the study. All patients had a total seizure frequency higher than one per month in spite of standard antiepileptic medication; 46% had a mean partial seizure frequency from daily to weekly. Progabide was administered at a mean daily dose of 30.5 mg/kg/day as an add-on to the standard antiepileptic drugs up to one year in 115 patients; 37 patients (19.8%) dropped out because of reasons which were not drug-related (bad compliance, lost to follow-up); in 12 patients (6.5%) progabide was withdrawn for side effects and in 20 (10.7%) for lack of efficacy. 71.3% of patients treated for one year (62% considering the 'cumulative' number of patients) experienced more than a 50% reduction in seizure frequency. This reduction was equally present in patients with partial epilepsy (63.9%) and with generalized epilepsy (62.2% of patients with primary and 57.1% with secondary generalized epilepsy). No signs of tolerance phenomena to the antiepileptic effect of progabide were observed. No side effects were reported in 56.7% of the patients. Clinical side effects were mild and transient, leading to progabide discontinuation in 6.5% of the patients only; an increase in SGPT was observed in 5.7% of the patients, these increases were transient and without any clinical symptom.(ABSTRACT TRUNCATED AT 250 WORDS)