title: Fluctuation of lacosamide serum concentrations during the day and occurrence of adverse drug reactions--first clinical experience.
abstract: OBJECTIVE
  To obtain better understanding of the effect of lacosamide (LCM) in clinical practice, laboratory and clinical data of 17 patients under treatment with LCM as an add-on antiepileptic drug (AED) were retrospectively evaluated.
  
  
  METHODS
  Total LCM serum concentrations were obtained at hourly intervals for up to 5h and 8h after morning dose. Adverse drug reactions (ADR) were assessed.
  
  
  RESULTS
  LCM serum concentrations showed high fluctuations during the day with a steep increase within the first 3h after intake (mean 87.8%; range: 44.4-149.0%) under b.i.d. Mean trough and peak concentrations of LCM were 5.0 μg/ml (range: 1.8-9.5 μg/ml) and 9.7 μg/ml (range: 4.0-18.3 μg/ml), respectively; mean dose 353 mg/d (range: 200-600mg/d). Twelve patients showed ADRs. After conversion to t.i.d. or dose reduction LCM serum concentration showed lower fluctuations during the day and a lower increase after intake (mean: 50.0%, range: 27.1-66.7%); peak LCM was 9.4 μg/ml (range: 4.7-11.6 μg/ml), mean dose 388 mg/d (range: 300-500 mg/d). These interventions led to amelioration of the ADR.
  
  
  CONCLUSIONS
  Changing the dose regimen from two to three times daily could reduce fluctuations of LCM during the day and improve tolerability of LCM in patients with ADR.
authors.affiliation: Epilepsiezentrum Bethel, Krankenhaus Mara gGmbH, D-33617 Bielefeld, Germany.
authors.forename: Annika
authors.initials: A
authors.lastname: Sattler
authors.forename: Marion
authors.initials: M
authors.lastname: Schaefer
authors.forename: Theodor W
authors.initials: TW
authors.lastname: May
authors.forename: Bernhard
authors.initials: B
authors.lastname: Rambeck
authors.forename: Christian
authors.initials: C
authors.lastname: Brandt
mesh_terms: D000081:Acetamides / Q000009:adverse effects / Q000097:blood*; D000328:Adult; D000927:Anticonvulsants / Q000009:adverse effects / Q000097:blood*; D002853:Chromatography, Liquid; D064420:Drug-Related Side Effects and Adverse Reactions / Q000097:blood* / Q000139:chemically induced; D004827:Epilepsy / Q000097:blood / Q000188:drug therapy; D005260:Female; D006801:Humans; D000078334:Lacosamide; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D055815:Young Adult
chemical_list: D000081:Acetamides; D000927:Anticonvulsants; D000078334:Lacosamide