J Korean Neuropsychiatr Assoc.
2002 Sep;41(5):890-904.
The Study for Switching Methods to Olanzapine in Korean Schizophrenic Patients Treated with Other Antipsychotics(II): Comparison of Safety
- Affiliations
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- 1Department of Psychiatry, Eulji University School of Medicine, Seoul, Korea.
- 2Department of Psychiatry Euijongbu St. Mary's Hospital The Catholic University of Korea College of Medicine, Euijongbu, Korea.
- 3Department of Psychiatry, Seoul National University College of Medicine, Seoul, Korea.
- 4Department of Psychiatry, Wonju Christian Hospital, Wonju Medical College, Yonsei University, Wonju, Korea.
- 5Department of Neuropsychiatry, Chung-Ang University College of Medicine, Seoul, Korea.
- 6Department of Neuropsychiatry, Our Lady of Mercy Hospital, The Catholic University of Korea, Incheon, Korea.
- 7Department of Psychiatry, College of Medicine, Yonsei University, Seoul, Korea.
- 8Ke Yo Hospital, Uiwang, Korea.
- 9Department of Neuropsychiatry, College of Medicine, Ewha Womans University, Seoul, Korea.
- 10Department of Psychiatry, Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.
- 11Department of Neuropsychiatry, Korea University Medical College, Seoul, Korea.
- 12Department of Neuropsychiatry, Soonchunhyang University Hospital, Seoul, Korea.
- 13Department of Neuropsychiatry, Kang-Dong Sacred Heart Hospital, College of Medicine, Hallym University, Chuncheon, Korea.
- 14Seoul National University Medical Research Center, Neuroscience Research Institute, Seoul, Korea.
Abstract
OBJECTIVES
This multicenter clinical trial involving 13 hospital sites compared the safety of switching to olanzapine between 'direct switching method' and 'start-tapering switching method'.
METHOD: This study included both inpatients and outpatients who fulfilled the criteria for schizophrenia as defined in the ICD-10, and were in need to be appropriate for switching antipsychotics. Subjects were randomly assigned to one of the two switching methods. For 'direct switching method' group, previous antipsychotics were abruptly discontinued and 10mg of olanzapine was administered, whereas for 'start-tapering switching method' group, initially 10mg of olanzapine was administered and previous antipsychotics was gradually tapered for 2 weeks. Olanzapine was used for 6 weeks and the dose was adjusted within the range of 5-20mg. The safety of switching to olanzapine was measured with vital signs including body weight, adverse events reported spontaneously, laboratory tests, and various scales such as Simpson-Angus Scale(SAS), Barnes Akathisia Rating Scale(BARS), Abnormal Involuntary Movement Scale(AIMS), and Liverpool University Neuroleptic Side Effect Rating Scale(LUNSERS).
RESULTS
103 patients were switched to olanzapine in this study. The comparison between two switching methods did not show any significant difference in the dosage of olanzapine used, the concomitant use of benzodiazepine, the rate and reasons of drop-out, the adverse events, vital signs, laboratory tests, and most scales for measuring side-effects. However, the decrease in AIMS scores was significantly lower in 'direct switching method' group, and the concomitant use of anticholinergics was comparatively greater in 'start-tapering switching method' group. At baseline, SAS and BARS scores were 3.5 and 1.8 points respectively, and more than 70% of the subjects showed hyperprolactinemia. After switching to olanzapine, SAS, BARS, and AIMS scores were significantly decreased and the proportion of the patients with hyperprolactinemia was also decreased to less than 30%. However significant weight gain after the treatment of olanzapine was observed regardless of switching method.
CONCLUSION
This study may suggest that switching to olanzapine can be done with relatively high safety regardless of switching methods and olanzapine can significantly decrease some side-effects induced by other antipsychotics.