Relationship between serum aprindine concentration and neurologic side effects in Japanese

Abstract

The aim of this study was to evaluate the relationship between the neurologic side effects associated with serum aprindine concentrations and the safety range of aprindine for the prevention of neurologic side effects in 142 Japanese inpatients. Serum aprindine concentrations were determined by high-performance liquid chro- matography. A poor positive correlation was observed between dose and serum aprindine concentration(r2=0.0419, p=0.0114), and between age and ratio of serum aprindine concentration to the dose per body weight of aprindine(r2=0.0159, p=0.121). When aprindine concentration was <1 μg/ml, almost no patients showed neurologic side effects associated with aprindine. On the other hand, about 50% of the patients showed neurologic side effects when aprindine concentrations were >1 μg/ml. Here, the side effects associated with aprindine such as dizziness or intention tremors were observed in 15 patients, which later disappeared after discontinuance of aprindine therapy or a decrease in the dose. In conclusion, serum aprindine concentration should be maintained under approximately 1 μg/ml in Japanese patients to prevent neurologic side effects. © 2009 Pharmaceutical Society of Japan.