title: Intravenous levetiracetam in clinical practice--Results from an independent registry.
abstract: OBJECTIVE
  Most common clinical studies with antiepileptic drugs do not reflect medical everyday practice due to their strict in- and exclusion criteria and specifications of treatment regimens. Here we present a large non-interventional registry with the intention to evaluate the spectrum of applications in daily use and the efficacy and tolerability of intravenously given levetiracetam (LEV-iv).
  
  
  METHODS
  In a prospective approach of 17 neurological and neuropediatric centres in Germany LEV-iv treated patients of all ages were included over a period of 10 months. The observational period was 10 days with daily documentation of LEV-iv administration, type and frequency of seizures, currently used drugs and doses, and adverse events (AEs). In addition, treatment efficacy and tolerability were assessed by patients and physicians at study end as well as practicability of LEV-iv using a five-step scale.
  
  
  RESULTS
  In 95 patients LEV-iv was administered, 93 were included into the analysis. The median LEV-iv dose was 1500 mg (range 110-6000 mg) per day. Median age was 66 years (range 0.7-90.3 years). The majority of patients (n=70, 75%) suffered from status epilepticus (SE, n=55, 59%) and acute seizure clusters (n=15, 16%). Of those with SE, 41 patients (75%) had SE for the first time. Acute seizure clusters and SE terminated in 83% after LEV-iv administration. A total of 29 adverse events were reported in 17 of the 95 patients from the safety set. Ten of these were at least possibly related to LEV-iv treatment. Slight decrease of blood pressure during the infusion (3 patients each) was captured most frequently. No serious side effect was observed. Physicians rated the efficacy and tolerability of LEV-iv treatment as good or very good in 78% and 82% of the cases, respectively.
  
  
  CONCLUSIONS
  In this large observational study of everyday practise the use of LEV-iv exhibited a remarkable good response and tolerability in patients with acute onset seizures (mostly SE). Further randomized controlled studies, like the established status epilepticus trial (ESET) are needed to confirm these findings.
authors.affiliation: Department of Neurology, University Hospital Schleswig-Holstein, Kiel, Germany.
authors.forename: N
authors.initials: N
authors.lastname: Lang
authors.affiliation: Department of Neurology, Städtisches Klinikum, Karlsruhe, Germany.
authors.forename: W
authors.initials: W
authors.lastname: Esser
authors.affiliation: Department of Neurology, Lindenbrunn Hospital, Coppenbrügge, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Evers
authors.affiliation: Department of Neurology, Klinikum, Osnabrück, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Kellinghaus
authors.affiliation: Department of Neurology, Asklepios Klinikum Uckermark, Schwedt, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Nguento
authors.affiliation: Department of Neurology, Ruhr University, Bochum, Germany.
authors.forename: U
authors.initials: U
authors.lastname: Schlegel
authors.affiliation: Department of Neurology, University Hospital, Greifswald, Germany.
authors.forename: B
authors.initials: B
authors.lastname: Gaida
authors.affiliation: Department of Neuropediatrics, University Hospital, Tübingen, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Gburek-Augustat
authors.affiliation: Epilepsy Centre, University Hospital, Freiburg, Germany.
authors.forename: D M
authors.initials: DM
authors.lastname: Altenmüller
authors.affiliation: Department of Neurology, University Hospital, Köln, Germany.
authors.forename: L
authors.initials: L
authors.lastname: Burghaus
authors.affiliation: Department of Neurology, Krankenhaus Martha-Maria, Halle, Germany.
authors.forename: F
authors.initials: F
authors.lastname: Hoffmann
authors.affiliation: Department of Neuropediatrics, University Hospital, Münster, Germany.
authors.forename: B
authors.initials: B
authors.lastname: Fiedler
authors.affiliation: University Children's Hopsital, Heidelberg, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Bast
authors.affiliation: Department of Neurology, Dietrich Bonhoeffer Klinikum, Neubrandenburg, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Rehfeld
authors.affiliation: Department of Neurology, Klinik Maria Frieden, Telgte, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Happe
authors.affiliation: Department of Neurology, University Hospital, Düsseldorf, Germany.
authors.forename: R J
authors.initials: RJ
authors.lastname: Seitz
authors.affiliation: Northern German Epilepsy Centre for Children and Adolescents, Raisdorf, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Boor
authors.affiliation: Department of Neuropediatrics, University Hospital Schleswig-Holstein, Kiel, Germany. Electronic address: stephani@pedneuro.uni-kiel.de.
authors.forename: U
authors.initials: U
authors.lastname: Stephani
mesh_terms: D061605:Administration, Intravenous; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000927:Anticonvulsants / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D005260:Female; D005858:Germany; D006801:Humans; D007223:Infant; D000077287:Levetiracetam; D008297:Male; D008875:Middle Aged; D010889:Piracetam / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D011446:Prospective Studies; D012042:Registries; D013226:Status Epilepticus / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D000927:Anticonvulsants; D000077287:Levetiracetam; D010889:Piracetam
keywords: Efficacy; Intravenous; Levetiracetam; Practicability; Status epilepticus; Tolerability