Data presented for the first time today by Elinor Ben-Menachem MD PhD, Professor at Sahlgrenska University Hospital, Gothenburg, Sweden, show that KEPPRA® was safe and well-tolerated when used for long-term treatment up to 7 .13 years (mean exposure was approximately 3 years). The data also showed that the anti-epileptic effect of KEPPRA® was sustained over the duration of the study. KEPPRA® showed a high retention rate of 54.3% (an estimation of efficacy and safety). The incidence of adverse events reported in this trial is very similar to the incidence described in previous studies, confirming the safety and tolerability profile for KEPPRA®.
Commenting on the data, Professor Ben-Menachem said, "Our study shows that long-term treatment with KEPPRA® gives sustained antiepileptic effect, with a high retention rate and an adverse event profile similar to that seen in the randomised controlled previous trials. This is good news for physicians, who can confidently choose KEPPRA® to treat their patients, without compromising their quality of life with increased risk of adverse events."
Commenting of the findings of the study, Professor José Serratosa, Chairman of the Scientific Advisory Committee of the 5th European Congress on Epileptology said, "The balance between efficacy and low incidence of adverse events is a difficult one to achieve in the treatment of epilepsy. Also, during 150,000 patient-years exposure, no serious safety issues have emerged with levetiracetam. These new and other data show that levetiracetam could help doctors and patients achieve that balance and continue to build confidence in the medical community that levetiracetam represents an advance in the treatment of many patients with epilepsy."
KEPPRA® received approval by the European Commission in September 2000. It is estimated that 50 million people world-wide have epilepsy2. The mean prevalence for active epilepsy (i.e. continuing seizures with the need for treatment) is approximately 8.2 per 1,000 of the general population – although this may be higher in developing countries.
KEPPRA® spokesperson Dr Peter Verdru, Global Medical Manager CNS said "We are very pleased to have been involved in the study presented today, which further support pre-marketing data for KEPPRA®, also conducted by UCB. We continue to be committed to investing in clinical research that may lead to the improvement of the quality of life of people with epilepsy".
KEPPRA® was discovered and developed in UCB's research laboratories. The Group, based in Brussels, Belgium, is a fast growing global pharmaceutical company. It is also committed to technically innovative products in films and fine chemicals for coatings. UCB employs 10,000 people around the world, of whom about half are in the Pharma Sector. Its pharmaceutical research division includes the following fields: respiratory, including allergy and asthma, and neurology. UCB Pharma's principle products include Zyrtec®, Xyzal® (anti-allergic), KEPPRA® (anti-epileptic), Nootropil® (cerebral function regulator) and Atarax® (tranquilliser).
® KEPPRA is a registered trademark of the UCB Group
References:
1. Jacobs A, et al. Long-term evaluation of the safety and tolerability of levetiracetam in patients with epilepsy. Poster presentation at 5th European Congress on Epileptology, Madrid , October 8, 2002.
2. WHO Factsheet number 165: Epilepsy: Etiology, Epidemiology and Prognosis.
http://www.who.int/inf-fs/en/fact165.html
Notes to editors: