Comparative Study of the Efficacy and Side Effects of Brand-Name and Generic Clozapine for Long-Term Maintenance Treatment Among Korean Patients With Schizophrenia: A Retrospective Naturalistic Mirror-Image Study.

Abstract

Clozapine is considered the most reliable drug for treatment-resistant schizophrenia. In 2014, a generic formulation of clozapine (Clzapine) was introduced in Korea. This study was performed to provide clinical information regarding the use of clozapine and to compare efficacy and tolerability when converting from the brand-name formulation (Clozaril) to the generic formulation during longterm maintenance treatment among Korean patients with schizophrenia. This mirror-image study retrospectively investigated the electronic medical records of patients who had switched from Clozaril to Clzapine with a ≥1-year duration for each formulation. Clinical data were collected, including information regarding clozapine use, psychiatric hospitalization, co-medications, and blood test findings. Data before and after the switch were compared using paired t-tests. Among 332 patients, the mean 1-year dosages were 233.32±149.35 mg/day for Clozaril and 217.36±136.66 mg/day for Clzapine. The mean clozapine concentration-to-dose ratios were similar before and after the switch (Clozaril, 1.33±0.68; Clzapine, 1.26±0.80). Switching from Clozaril to Clzapine resulted in no significant differences in the hospitalization rate, hospitalization duration, or laboratory findings (liver function parameters, serum cholesterol level, and serum glucose level). Equivalent doses of co-prescribed antidepressants were decreased, but concomitant medications otherwise showed no significant differences. Clinical efficacy and tolerability appear comparable when switching to Clzapine during clozapine maintenance treatment. This study offers descriptive real-world clinical insights into clozapine maintenance treatment in Korea, thereby providing patients with more treatment options and contributing to the development of maintenance guidelines tailored to the Korean population.