Aim The aim of the present study was to evaluate the efficacy and safety of lurasidone for the treatment of Chinese schizophrenic patients. Methods Hospitalized schizophrenia patients aged 18-65 were randomized to 6 weeks of double-blind, double-dummy, flexible-dose treatment with lurasidone (40 or 80 mg/day) or risperidone (2, 4 or 6 mg/day). Efficacy was evaluated using a non-inferiority comparison of lurasidone relative to risperidone based on week 6 change in the Positive and Negative Syndrome Scale (PANSS) total score. Safety assessments included adverse events, clinical laboratory measures, and electrocardiograms. Results Four hundred and forty-four patients were screened to obtain an intent-to-treat sample of 384 patients, of whom 54 patients discontinued treatment prior to 6 weeks. Lurasidone met the criteria for non-inferiority versus risperidone on the PANSS total score. Adjusted mean (SE) change at week 6 on the PANSS total score was -31.2 (1.0) and -34.9 (1.0) in the lurasidone and risperidone group, respectively. The mean difference score was 3.7, and the upper boundary of the 95%-confidence interval (1.0-6.3) was less than the prespecified margin of 7.0. No clinically meaningful between-treatment group differences were evident on secondary efficacy measures, including PANSS positive, PANSS negative, Clinical Global Impression scale - Severity, and Calgary Depression Scale for Schizophrenia scales. The incidence of adverse events was lower for lurasidone vs risperidone for extrapyramidal symptoms (17.0% vs 38.2%), akathisia (7.2% vs 13.6%), prolactin increase (3.1% vs 14.1%), and weight increase (0.5% vs 5.2%). Conclusion Lurasidone was found to be non-inferior to risperidone on the primary endpoint with minimal effects on weight, metabolic parameters, or prolactin levels.
第一作者机构:[1]Capital Med Univ, Beijing Anding Hosp, Dept Psychiat, Natl Clin Res Ctr Mental Disorders, Beijing, Peoples R China
通讯作者:
通讯机构:[1]Capital Med Univ, Beijing Anding Hosp, Dept Psychiat, Natl Clin Res Ctr Mental Disorders, Beijing, Peoples R China
推荐引用方式(GB/T 7714):
Feng Yuan,Shi Jianguo,Wang Lili,et al.Randomized, double-blind, 6-week non-inferiority study of lurasidone and risperidone for the treatment of schizophrenia[J].PSYCHIATRY AND CLINICAL NEUROSCIENCES.2020,74(6):336-343.doi:10.1111/pcn.12965.
APA:
Feng, Yuan,Shi, Jianguo,Wang, Lili,Zhang, Xia,Tan, Yunlong...&Wang, Gang.(2020).Randomized, double-blind, 6-week non-inferiority study of lurasidone and risperidone for the treatment of schizophrenia.PSYCHIATRY AND CLINICAL NEUROSCIENCES,74,(6)
MLA:
Feng, Yuan,et al."Randomized, double-blind, 6-week non-inferiority study of lurasidone and risperidone for the treatment of schizophrenia".PSYCHIATRY AND CLINICAL NEUROSCIENCES 74..6(2020):336-343