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Post-marketing Survey of Risperidone in the Treatment of Outpatients with Behavioral and Psychological Symptoms of Dementia

Chun-Lin Chu, M.D.1,2,3, Yeong-Yu Juang, M.D. 1,2 Shih-Chieh Hsu, M.D. 1,2,3 , Mei-Chun Hsiao, M.D. 1,2,4

Objective: The aims of this study were to evaluate the optimal dosing and possible adverse effects of risperidone in Taiwanese outpatients with behavioral and psychological symptoms of dementia (BPSD). Methods: This was a phase IV, multi-center, 12-week, post-marketing surveillance study. We enrolled 558 patients with BPSD from an outpatient drugs surveillance system (risperidone postmarketing surveillance, RPMS) in Taiwan. The study patients were scheduled to return to the clinic fi ve times during the 12-week course of the study. Dosage of risperidone was titrated according to the patient's clinical condition at each visit. We evaluated the safety and tolerability of risperidone on the basis of adverse events reported in response to a questionnaire. Results: The initial dose of risperidone was from 0.5 to 1.0 mg daily, with a mean + standard deviation (0.65+ 0.31 mg). The mean dose + SD during the 12 weeks was 1.31 + 0.89 mg. Most patients received a fi nal dosage from 0.5 to 4.0 mg daily. Only three patients were prescribed more than 4 mg daily. Younger patients needed higher dose of rispeirdone than older patients, and the dosage was decreased with age. The most common adverse event was extrapyramidal symptoms (9.2%). Conclusion: The mean dose of riperidone prescribed for BPSD dementic outpatients in Taiwan was slightly higher than that for Caucasians. Risperidone is safe and well-tolerated by Taiwanese BPSD outpatients.
Key Word risperidone, behavioral and psychological symptoms, dementia
Editorial Committe, Taiwanese Journal of Psychiatry
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