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Effects of the abrupt switch from solution to modified‐release granule formulation of valproate
Author(s) -
Verrotti A.,
Nanni G.,
Agostinelli S.,
Alleva E. T.,
Aloisi P.,
Franzoni E.,
Spalice A.,
Chiarelli F.,
Coppola G.
Publication year - 2012
Publication title -
acta neurologica scandinavica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.967
H-Index - 95
eISSN - 1600-0404
pISSN - 0001-6314
DOI - 10.1111/j.1600-0404.2011.01568.x
Subject(s) - tolerability , dose , medicine , adverse effect , granule (geology) , anesthesia , epilepsy , anticonvulsant , pharmacology , psychiatry , geomorphology , geology
Verrotti A, Nanni G, Agostinelli S, Tozzi Alleva E, Aloisi P, Franzoni E, Spalice A, Chiarelli F, Coppola G. Effects of the abrupt switch from solution to modified‐release granule formulation of valproate.
Acta Neurol Scand: 2012: 125: e14–e18.
© 2011 John Wiley & Sons A/S. 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. Aim of the study – 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. Conclusion – Modified‐release granule formulation of VPA may be a reliable alternative to solution for its convenience of use.