小児てんかん患者に対するトピラマートの治療継続率と安全性の検討；成人を対照とした後ろ向きコホート研究

概要

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This study was designed to evaluate the persistence and safety of topiramate therapy in children and adults with epilepsy. It was a retrospective cohort study undertaken from October 2007 in which we analyzed the clinical records of 726 patients (216 children and 510 adults) who received topiramate for the treatment of epilepsy at the National Epilepsy Center, Shizuoka Institute of Epilepsy and Neurological Disorders. Factors associated with discontinuation of topiramate therapy determined from the results of the log-rank test (p<0.1) were subjected to multivariate Cox regression analysis in order to calculate hazard ratios and 95% confidence intervals (95% CI).Suspension (Discontinuation) or dose reduction of topiramate were necessary due to adverse effects in 85 children (39%), of which the major ones were drowsiness (16.2%), anorexia (10.7%), hypohidrosis (4.7%), and irritability (4.2%). There was a higher incidence of hypohidrosis and a lower incidence of speech disorders in children as compared with adults (both p < 0.05). According to Cox proportional hazards analysis, the adjusted hazard ratio for discontinuation of topiramate therapy in children was 0.92 (95% CI : 0.75-1.23 ; p=0.76). In conclusion, this comparative study showed that the persistence and safety of topiramate therapy were similar in children and adults.
日本医療薬学会の論文