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Recently Launched Antiepileptic, Levetiracetem 'is effective in the long term': Presented at ECE

By Mark Pownall
Special to DG News

BARCELONA, SPAIN -- October 9, 2002-- The antiepileptic drug levetiracetam is effective over several years as an add-on therapy with a high retention rate, results from the first large long-term study have found.

The study, presented here October 7 at the fifth European Congress on Epileptology (ECE), was carried out by Professor Elinor Ben-Menachem and researchers from the Sahlgrenska University Hospital, in Gothenburg, Sweden.

They found that well over half of the patients were still on levetiracetam treatment, at doses of between 1000 and 4000 mg/day, at the end of a mean of three years, up to a maximum of seven years. In all 54.3 percent of the 505 patients enrolled in the trial were still taking a mean of 3000 mg levetiracetam treatment at the end of the trial period.

The multicentre, non-comparative, open-label follow-up study administered levetiracetam -- launched in Europe and the US two years ago -- as adjunctive treatment. The patients were examined every 12 weeks using standard safety and efficacy procedures. The trial's aim was to look at the tolerability of long term treatment with levetiracetam using doses ranging from 1000 mg/day to 4000 mg/day.

No apparent tolerance to the effects of the drug developed; the antiepileptic effect of levetiracetam remained stable over the years of the study. The most common side effects were convulsions (30.5 percent of the adverse events reported), accidental injury (28.1 percent), infection (21 percent) and headache (20 percent). A total of 168 subjects (33.2 percent) experienced at least one serious adverse event and 11 (2.1 percent) subjects died.

Professor Ben-Menachem commented, "Our study shows that long-term treatment with levetiracetam gives sustained antiepileptic effect, with a high retention rate and an adverse event profile similar to that seen in the previous randomised controlled trials."

Professor José Serratosa, of the Fundacion Jimenez Diaz, in Madrid, Spain said, "The balance between efficacy and low incidence of adverse events is a difficult one to achieve in the treatment of epilepsy. During 150,000 patient-years exposure, no serious safety issues have emerged with levetiracetam."

Meanwhile, in a second study presented at the meeting, levetiracetam added on to other antiepileptic drugs was found to be helpful in children and adolescents with severe epilepsy that had not previously responded to treatment. Some patients in the study cut their dose of other antiepilepsy drugs while on add-on levetiracetam.

In a younger age group, 31 percent of 32 patients who ranged in age from birth to age 12, had more than a 50 percent reduction in seizures after six weeks, rising to a 50 percent or more reduction in 37 percent of the patients after 12 weeks. There was a lesser improvement -- a 25 percent reduction in seizures -- for a further 28 percent of the 0-12 year olds at six weeks and for 25 percent of this age group at 12 weeks.

In a group of 24 teenagers and young adults aged 13 to 20, there was a seizure reduction of more than 50 percent in 44 percent of the patients after six weeks of add-on treatment with levetiracetam, but the number of patients with this level of seizure reduction fell to 22 percent after 12 weeks, suggesting that efficacy may decline in this group of difficult to treat patients.

Twenty six percent of the adolescent/young adult patients reported agitation, and 11 percent reported diarrhoea. A third of the adolescents said they were more alert.

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