OBJECTIVE: To examine the tolerability of topiramate (TPM) in paediatric practice. METHODOLOGY: A retrospective cohort study of patients aged less than 18 years commenced on TPM by paediatric neurologists. Patients were identified from the dispensing databases of two paediatric tertiary referral hospitals and from the authority prescription records of four paediatric neurologists. The clinical data were obtained from the patients' medical records. RESULTS: There were 159 patients who were identified as having been commenced on TPM and follow-up data were available for 127 (80%) patients. The median (range) age at commencement of TPM was 8.1 (0.5-17.9) years, with 12 patients aged less than 2 years. After 4 years, 60% of patients had ceased the medication. Treatment limiting adverse effects included aggression/psychosis (n = 10), cognitive impairment/sedation (n = 6), anorexia/weight loss (n = 4) and desquamation (n = 1). Prior aggression (hazard ratio 5.91 (2.12-16.44)) and female gender (hazard ratio 2.94 (1.02-8.41)) were risk factors for ceasing TPM because of an adverse event. Thirty percent of children commenced on TPM experienced a treatment limiting adverse effect within 2 years of commencement. CONCLUSIONS: The frequency of treatment limiting adverse events in children receiving topiramate is higher than previously reported.
OBJECTIVE: To examine the tolerability of topiramate (TPM) in paediatric practice. METHODOLOGY: A retrospective cohort study of patients aged less than 18 years commenced on TPM by paediatric neurologists. Patients were identified from the dispensing databases of two paediatric tertiary referral hospitals and from the authority prescription records of four paediatric neurologists. The clinical data were obtained from the patients' medical records. RESULTS: There were 159 patients who were identified as having been commenced on TPM and follow-up data were available for 127 (80%) patients. The median (range) age at commencement of TPM was 8.1 (0.5-17.9) years, with 12 patients aged less than 2 years. After 4 years, 60% of patients had ceased the medication. Treatment limiting adverse effects included aggression/psychosis (n = 10), cognitive impairment/sedation (n = 6), anorexia/weight loss (n = 4) and desquamation (n = 1). Prior aggression (hazard ratio 5.91 (2.12-16.44)) and female gender (hazard ratio 2.94 (1.02-8.41)) were risk factors for ceasing TPM because of an adverse event. Thirty percent of children commenced on TPM experienced a treatment limiting adverse effect within 2 years of commencement. CONCLUSIONS: The frequency of treatment limiting adverse events in children receiving topiramate is higher than previously reported.
Authors: Valentina G Dell'Orto; Eva A Belotti; Barbara Goeggel-Simonetti; Giacomo D Simonetti; Gian Paolo Ramelli; Mario G Bianchetti; Sebastiano A G Lava Journal: Br J Clin Pharmacol Date: 2014-06 Impact factor: 4.335
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