Efficacy and Safety of Lurasidone vs. Quetiapine XR in Acutely Psychotic Patients With Schizophrenia in Korea: A Randomized, Double-Blind, Active-Controlled Trial

• 발행기관: 대한신경정신의학회
• 저자명: Se Hyun Kim Do-Un Jung Do Hoon Kim Jung Sik Lee Kyoung-Uk Lee Seunghee Won Bong Ju Lee Sung-Gon Kim Sungwon Roh Jong-Ik Park Minah Kim Sung Won Jung Hong Seok Oh Han-yong Jung Sang Hoon Kim Hyun Seung Chee Jong-Woo Paik Kyu Young Lee Soo In Kim Seung-Hwan Lee Eun-Jin Cheon Hye-Geum Kim Heon-Jeong Lee In Won Chung Joonho Choi Min-Hyuk Kim Seong-Jin Cho HyunChul Youn Jhin-Goo Chang Hoo Rim Song Euit
• 간행물 정보: 『Psychiatry Investigation』제21권 제7호, 762~771쪽, 전체 10쪽
• 주제분류: 의약학 > 정신과학
• 파일형태: PDF
• 발행일자: 2024.07.30

국문 초록

Objective This study was performed to evaluate the efficacy and safety of lurasidone (160 mg/day) compared to quetiapine XR (QXR;600 mg/day) in the treatment of acutely psychotic patients with schizophrenia. Methods Patients were randomly assigned to 6 weeks of double-blind treatment with lurasidone 160 mg/day (n=105) or QXR 600 mg/ day (n=105). Primary efficacy measure was the change from baseline to week 6 in Positive and Negative Syndrome Scale (PANSS) total score and Clinical Global Impressions severity (CGI-S) score. Adverse events, body measurements, and laboratory parameters were assessed. Results Lurasidone demonstrated non-inferiority to QXR on the PANSS total score. Adjusted mean±standard error change at week 6 on the PANSS total score was -26.42±2.02 and -27.33±2.01 in the lurasidone and QXR group, respectively. The mean difference score was -0.91 (95% confidence interval -6.35–4.53). The lurasidone group showed a greater reduction in PANSS total and negative subscale on week 1 and a greater reduction in end-point CGI-S score compared to the QXR group. Body weight, body mass index, and waist circumference in the lurasidone group were reduced, with significantly lower mean change compared to QXR. Endpoint changes in glucose, cholesterol, triglycerides, and low-density lipoprotein levels were also significantly lower. The most common adverse drug reactions with lurasidone were akathisia and nausea. Conclusion Lurasidone 160 mg/day was found to be non-inferior to QXR 600 mg/day in the treatment of schizophrenia with comparable efficacy and tolerability. Adverse effects of lurasidone were generally tolerable, and beneficial effects on metabolic parameters can be expected.

목차

INTRODUCTION

METHODS

RESULTS

DISCUSSION

REFERENCES

키워드

Lurasidone Efficacy Safety Randomized clinical trial