Efficacy and Safety of Lurasidone vs. Quetiapine XR in Acutely Psychotic Patients With Schizophrenia in Korea: A Randomized, Double-Blind, Active-Controlled Trial
- Author:
Se Hyun KIM
1
;
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
;
Euitae KIM
;
Won-Hyoung KIM
;
Chul Eung KIM
;
Doo-Heum PARK
;
Byung-Ook LEE
;
Jungsun LEE
;
Seung-Yup LEE
;
Nuree KANG
;
Hee Yeon JUNG
Author Information
- Publication Type:Original Article
- From:Psychiatry Investigation 2024;21(7):762-771
- CountryRepublic of Korea
- Language:EN
-
Abstract:
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.
