title: Effects of the abrupt switch from solution to modified-release granule formulation of valproate.
abstract: BACKGROUND
  A new modified-release (MR) granule formulation of valproate (VPA) has been recently developed for the treatment of children with epilepsy. It consists of tasteless microspheres that can be sprinkled on soft foods and easily swallowed. There are no data on the effectiveness of this formulation in pediatric age.
  
  
  OBJECTIVE
  To evaluate the effects of the abrupt switch from solution to VPA MR granules in children undergoing chronic treatment.
  
  
  METHODS
  We enrolled children receiving VPA solution as sole or adjunctive therapy and switched them to MR granules at identical dosages. VPA blood level, treatment efficacy (clinical and EEG data), tolerability (adverse reactions), palatability, ease of administration, and compliance were evaluated before switching (T0) and after 4 weeks (T1).
  
  
  RESULTS
  Out of 112 enrolled children, 108 (96.4%) completed the evaluation. We observed no significant differences between the patients at T0 and T1 in VPA blood levels, treatment efficacy, tolerability, and compliance. MR granules were judged more palatable (P < 0.05) and easier to administer (P < 0.05) than solution by children and parents. At 6-month follow-up, all patients continued to use MR granules.
  
  
  CONCLUSIONS
  Modified-release granule formulation of VPA may be a reliable alternative to solution for its convenience of use.
authors.affiliation: Department of Pediatrics, University of Chieti, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Verrotti
authors.forename: G
authors.initials: G
authors.lastname: Nanni
authors.forename: S
authors.initials: S
authors.lastname: Agostinelli
authors.forename: E T
authors.initials: ET
authors.lastname: Alleva
authors.forename: P
authors.initials: P
authors.lastname: Aloisi
authors.forename: E
authors.initials: E
authors.lastname: Franzoni
authors.forename: A
authors.initials: A
authors.lastname: Spalice
authors.forename: F
authors.initials: F
authors.lastname: Chiarelli
authors.forename: G
authors.initials: G
authors.lastname: Coppola
mesh_terms: D000927:Anticonvulsants / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D002648:Child; D002675:Child, Preschool; D003692:Delayed-Action Preparations / Q000008:administration & dosage* / Q000009:adverse effects; D004827:Epilepsy / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D011446:Prospective Studies; D014635:Valproic Acid / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood
chemical_list: D000927:Anticonvulsants; D003692:Delayed-Action Preparations; D014635:Valproic Acid