קפרה - Keppra K is for KidsBroad spectrum efficacy

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

efficasy - JME

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)


  • JME

  • Percent of refractory patients achieving seizure freedom from all seizures*
    with Keppra as adjunctive therapy (during 12-week evaluation period)

    JME

Freedom vs Placebo


  • Effect of LEV treatment on Quality-of-life

    JME


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

JME - Safety

 

cts
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