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Keppra (Levetiracetam) Well Tolerated in Elderly Patients with Epilepsy

Keppra's good safety and tolerability profile in the elderly confirmed in new analysis of patients with CNS disorders

BRUSSELS, BELGIUM -- December 9, 2003 -- New data published today1 in the international medical journal, Epilepsy Research, confirms that Keppra* (levetiracetam) is well tolerated in both young and elderly patient groups with various central nervous system (CNS) disorders. This new safety analysis of patients with either epilepsy, anxiety or cognitive disorders, in conjunction with the fact that Keppra has no known pharmacokinetic interactions with other medications, suggests that Keppra is well suited for use in elderly epilepsy patients.1

Longevity in the general population has increased the likelihood that a person will develop a CNS disorder during his/her lifetime, and this has focused attention on the need for information specific to the elderly population1. Information on the tolerability of Keppra in elderly patients with a variety of CNS disorders, including anxiety and cognitive disorders will aid physicians in making treatment decisions in clinical practice.

Lead author of the study, Joyce Cramer, Yale Medical School, New Haven, CT (USA), explained, "This analysis was a unique opportunity to compare adverse events across several populations, including many elderly patients. Finding that Keppra treatment not only had good tolerability for younger epilepsy patients, but also was well tolerated by elderly patients is reasonable evidence that Keppra will be safe for elderly epilepsy patients. The low incidence of adverse effects makes it more likely that patients will continue with long-term Keppra treatment and receive the benefit of this drug's high efficacy in controlling seizures."

Study design
A database with information on 2247 cases receiving Keppra and 1308 receiving placebo was examined to compare treatment-emergent adverse events (TEAE) related to the use of Keppra. The database includes reports of TEAE from double-blind trials of patients with diagnoses of either a cognitive disorder, an anxiety disorder, or epilepsy who participated in clinical trials lasting up to 16 weeks. Few elderly patients were included in the epilepsy trials. Therefore both young and elderly patients in the cognition and anxiety group were compared to the whole epilepsy group. Patients were grouped as young (<65 years) or elderly (>65 years) and the percent of patients taking Keppra or placebo who reported a TEAE were compared in a series of analyses. The incidences of TEAE observed for placebo were subtracted from those for Keppra to demonstrate the effect of Keppra over background placebo effect. The severity of each TEAE was based on the report with worst severity for that individual (mild, moderate or severe). 1

Study findings
Most of the TEAE were reported in equally large numbers by patients receiving placebo or were considered by the investigator to be unrelated to treatment. The data revealed that the most common TEAE (considered to be related to treatment and occurring more often in the Keppra treated groups) were abdominal pain, asthenia, headache, anorexia, weight loss, dizziness, insomnia, somnolence and tremor. The most common TEAE in the elderly cognition group was asthenia (7.1% higher than placebo). Somnolence (4.5% higher) and dizziness (3.3% higher) were the only other TEAE that were >3% more common in the Keppra than placebo groups. In the elderly anxiety group, headache and tremor (5.2% higher), dizziness (4.1% higher) weight-loss (4.0% higher) anorexia and abdominal pain (both 3.8% higher), and insomnia (3.0% higher) were the TEAE more common in the Keppra than placebo groups. The most common TEAE in the epilepsy group (>3% more common in the Keppra than placebo group) was somnolence (6.4% higher than placebo), asthenia (5.6% higher) and dizziness (4.7% higher). Overall, the proportion of Keppra and placebo treated patients discontinuing was low, and most patients reported only moderate severity of adverse events when they did occur1.

It is estimated that 50 million people worldwide have epilepsy3. The mean prevalence for active epilepsy is approximately 8.2 per 1000 of the general population3. Keppra one of the leading adjunctive (add-on) antiepileptic drugs4, is offering sustained efficacy over the long term at reducing seizure frequency in adult patients with difficult to treat seizures5.
Ends

* Keppra is a registered trademark of the UCB Group. Please consult your national product information and regulatory status as they may differ from one country to the other.

Keppra is UCB Pharma's new AED, currently indicated as adjunctive therapy in the treatment of partial onset seizures, with or without secondary generalisation, in adults with epilepsy. Keppra was discovered and developed in UCB Pharma's research laboratories.

References:
1. Cramer J.A et al. Tolerability of Levetiracetam in Elderly Patients with CNS Disorders. Epilepsy Research (2003) 56: 135-145
2. Kramer, G. Epilepsy in the elderly: some clinical and pharmacotherapeutic aspects. Epilepsia, 2001;42 suppl. 3:55-9
3. WHO (2003) Epilepsy fact sheet 165. www.who.int/inf-fs/en/fact165.html
4. IMS data MAT, Q II 2003
5. Ben Menachem et al. Evidence for sustained efficacy of levetiracetam as add-on epilepsy therapy. Epilepsy Research 2003, 53 (1-2): 57-64


SOURCE: Ketchum London

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