EFFICACY, SAFETY AND RESOURCE USE IN PATIENTS SWITCHED DIRECTLY TO RISPERIDONE MICROSPHERES- EVIDENCE FROM CHINESE SAMPLES
Author(s)
Hong chao Li, MS, Assistant1, Niu fan Gu, MD, Professor2, Peng Dong, PhD, Assistant31China Pharmaceutical University, Nanjing, Jiangsu, China; 2 Shanghai Mental Health Center, Shanghai, Shanghai, China; 3 Xi'an-Janssen Pharmaceutical Ltd, Beijing, Beijing, China
OBJECTIVES: This study was carried out to evaluate the efficacy, safety and resource use of Risperidone Microspheres in China. METHODS: We evaluated the impact in patients after switched to Risperidone Microspheres at baseline, and after 4, 12, 24 and 36 weeks’ treatment. Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression-Disease Severity (CGI-S) and Personal and Social Performance scale (PSP) are used to measure the efficacy. Extrapyramidal symptoms were assessed by means of the Extrapyramidal Symptom Rating Scale (ESRS) and adverse events were reported at the same visits. Outpatient, inpatient and emergency care use were also investigated both 36 weeks before and after the first visit. RESULTS: Total PANSS scores on average for the patients in this study decreased from 67.93 at baseline to 47.25 at endpoint (p<0.001) and 63.0% patients showed a reduction rate of at least 20%. CGI-S score on average reduced from 3.87 to 2.49(p<0.001) and the proportion of patients considered to be "not ill" or "borderline ill" increased from 13.5% to 59.1% (p<0.001). PSP total score on average improved from 55.27 to 70.79 (p<0.001). Significant decreases in total ESRS scores from 5.72 at baseline to 3.66 at endpoint (p<0.001), was found in the study. The EPS incidence rate was also dropped significantly, from 22.0% to 8.7% (p<0.001). The adverse event rate related to Risperidone Microspheres was 19.0% during the 36 weeks treatment, but only 1.5% of all patients stopped the medicine treatment because of it. The hospitalization rate declined from 35% to 4.3% (p<0.001) and the outpatient use declined from 6.26 to 3.65 times per patient on average. Emergency care use did not change significantly. CONCLUSIONS:The efficacy, safety and resource saving of treatment with Risperidone Microspheres in patients was proved to be significantly improved compared to baseline during the trial period.
Conference/Value in Health Info
2008-09, ISPOR Asia Pacific 2008, Seoul, South Korea
Value in Health, Vol. 11, No. 6 (November 2008)
Code
PMH1
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Mental Health