הרצאתו
של פרופ' Soheyl Noachter מתוך מפגש הליגה למניעת אפילפסיה, 23/01/08
Keppra: The first and the only AED with Class I evidence in the treatment of myoclonic seizures in patients with JME
- Broad-spectrum efficacy as adjunctive therapy 1
- Documented seizure freedom in patients with myoclonic seizures
1
- Documented seizure freedom in patients with partial-onset
seizures 13, 14
- In adults: 9%(23/269) achieved seizure freedom with Keppra
(levetiracetam)
tablets vs 1% (3/367) for placebo 13
- In pediatric patients 4-16 years of age 7% (7/101) achieved seizure freedom with Keppra Oral solution vs 1% (1/97) for placebo 14
- No worsening of typical absence or PGTCS occurred 1
- Rapid onset of action-seizure freedom documented at day 1 1
- No known clinically significant drug interactions 7-10
- Long-term favourable tolerability with no Black Box warning 11,12
Juvenile Myoclonic Epilepsy (JME): A common seizure syndrome affecting millions of patients
- JME affects approximately 7% of all people with epilepsy2
- True prevalence remains unclear since many cases are under diagnosed or misdiagnosed3,4
- IGE seizure syndromes, such as JME, can be difficult to identify
because features from one syndrome overlap with another2,5
- GTCS occurs in over 90% of patients with JME
- Up to one third of patients with JME also experience absence seizures
- Establishing a correct diagnosis and prescribing effective therapy right from the start is critical to reduce patient morbidity6
- Usually requires lifelong treatment2
Effective as adjunctive therapy in adults (12-65)
- The effectiveness of Keppra as adjunctive therapy was established in a phase III, double-blind, randomized, placebo-controlled, parallel-group, multicentre study of patients with myoclonic seizures who were not controlled on a stable dose of 1 AED for at least 4 weeks before the study began.
- Study population: history of seizure subtypes

Seizure control with Lev. in JME
Significant seizure freedom achieved.1
- Percent of refractory patients with myoclonic seizures achieving seizure freedom with Keppra as adjunctive therapy (during 12-week evaluation period)
- Percent of refractory patients achieving seizure freedom
from all seizures*
with Keppra as adjunctive therapy (during 12-week evaluation period)

Freedom vs Placebo
- Effect of LEV treatment on Quality-of-life
Tolerability
- LEV was well tolerated
- During the treatment period (titration+evaluation), 75% (45/60) LEV patients and 66.7 (40/60) placebo patients experienced > AE(s) (Table 2)
- One LEV patient and 2 placebo patients experienced severe undesirable effects (LEV:headache; placebo: syncope, vomiting)
- 2 LEV patients and 1 placebo patient prematurely discontinued treatment because of >1 AE(s)
Summary of AEs

- Data on life. UCB S.A.
- Nordli DR Jr. Idiopathic generalized epilepsies recognized by the International League against Epilepsy. Epilepsia. 2005;46(suppl):48-56.
- Diagnosing juvenile myoclonic epilepsy (editorial). Lancet. 1992;340:759-760.
- Zifkin B, Andermann E.,Andermann F. Mechanisms, genetics, and pathogenesis of juvenile myoclonic epilepsy. Curr Opin Neurol. 2005;18:147-153.
- Gardiner M. Genetics of idiopathic generalized epilepsies. Epilepsia. 2005;46(suppl):15-20.
- Renganathan R. Delanty N. Juvenile myoclonic epilepsy: under-appreciated and under-diagnosed. Postgrad Med J. 2003;79:78-80.
- Perucca E. Gidal BE, Baltes E. Effects of antiepileptic comedication on levetiracetam pharmacokinetics: a pooled analysis of data from randomized adjunctive therapy trials. Epilepsy res. 2003;53:47-56.
- Regueneau-Majlessi i. levy RH. Meyerhoff C. Lack of effect of repeated administration of levetiracetam on the pharmacodynamic and pharmacokinetic profiles of warfarin. Epilepsy res. 2001;47:55-63.
- Ragueneau-Majlessi I, Levy RH, janik F. Levetiracetem does not alter the pharmacokinetics of an oral contraceptive in healthy women. Epilepsia. Pharmacokinetics and pharmacodynamics in healthy volunteers. Epilepsy res. 2001;46:93-99.
- Keppra Summary of Product Characteristics (smpc), UCB S.A.
- Ben-Menachem E, Edrich p, Van Vleymen B,et al. Evidence for sustained efficacy of levetiracetam as add-on epilepsy therapy. Epilepsy res. 2003;53:57-64.
- Meencke H-J, Buyle s. Assessment of a dose-response relationship of levetiracetam. Eur j neurol. In press.
- Glauser TA, Gauer, Lu Z, et
al. Short-and long-term efficacy of levetiracetam
adjunctive therapy in children with refractory
partial epilepsy.
Poster presented at: EFNS; September 14, 2005;Athens, Greece.

Broad spectrum efficacy