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Efficacy and safety of lurasidone 80 mg/day and 160 mg/day in the treatment of schizophrenia: a randomized, double-blind, placebo- and active-controlled trial.
Schizophr Res. 2013 Apr; 145(1-3):101-9.SR

Abstract

OBJECTIVE

This study was designed to evaluate the short-term efficacy and safety of once-daily lurasidone (80 mg/day and 160 mg/day) in the treatment of an acute exacerbation of schizophrenia.

METHODS

Participants, who were recently admitted inpatients with schizophrenia with an acute exacerbation of psychotic symptoms, were randomly assigned to 6 weeks of fixed-dose, double-blind treatment with lurasidone 80 mg (n=125), lurasidone 160 mg (n=121), quetiapine XR 600 mg (QXR-600 mg; n=119; active control included to test for assay sensitivity), or placebo (n=121), all dosed once daily in the evening. Efficacy was evaluated using a mixed-model repeated-measures analysis of the change from Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) total score (the primary efficacy measure) and Clinical Global Impressions severity (CGI-S) score (the key secondary efficacy measure).

RESULTS

Treatment with both doses of lurasidone or with QXR-600 mg was associated with significantly greater improvement at Week 6 on PANSS total score, PANSS positive and negative subscale scores, and CGI-S score compared with placebo. The endpoint responder rate (≥ 20% improvement in PANSS total score) was higher in subjects treated with lurasidone 80 mg (65%; p<0.001), lurasidone 160 mg (79%; p<0.001), and QXR-600 mg (79%; p<0.001) compared with placebo (41%). The proportion of patients experiencing ≥ 7% weight gain was 4% for each lurasidone group, 15% for the QXR-600 mg group, and 3% for the placebo group. Endpoint changes in levels of cholesterol, triglycerides, and low-density lipoprotein (LDL) cholesterol were comparable for both lurasidone groups and placebo, while the QXR-600 mg group showed a significant median increase compared with the placebo group in levels of cholesterol (p<0.001), LDL cholesterol (p<0.01), and triglycerides (p<0.05).

CONCLUSIONS

Lurasidone 80 mg and 160 mg doses administered once-daily in the evening, were safe and effective treatments for subjects with acute schizophrenia, with increased response rates observed at the higher dose. Dose-related adverse effects were limited, and both doses were generally well-tolerated.

Authors+Show Affiliations

Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23415311

Citation

Loebel, Antony, et al. "Efficacy and Safety of Lurasidone 80 Mg/day and 160 Mg/day in the Treatment of Schizophrenia: a Randomized, Double-blind, Placebo- and Active-controlled Trial." Schizophrenia Research, vol. 145, no. 1-3, 2013, pp. 101-9.
Loebel A, Cucchiaro J, Sarma K, et al. Efficacy and safety of lurasidone 80 mg/day and 160 mg/day in the treatment of schizophrenia: a randomized, double-blind, placebo- and active-controlled trial. Schizophr Res. 2013;145(1-3):101-9.
Loebel, A., Cucchiaro, J., Sarma, K., Xu, L., Hsu, C., Kalali, A. H., Pikalov, A., & Potkin, S. G. (2013). Efficacy and safety of lurasidone 80 mg/day and 160 mg/day in the treatment of schizophrenia: a randomized, double-blind, placebo- and active-controlled trial. Schizophrenia Research, 145(1-3), 101-9. https://doi.org/10.1016/j.schres.2013.01.009
Loebel A, et al. Efficacy and Safety of Lurasidone 80 Mg/day and 160 Mg/day in the Treatment of Schizophrenia: a Randomized, Double-blind, Placebo- and Active-controlled Trial. Schizophr Res. 2013;145(1-3):101-9. PubMed PMID: 23415311.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of lurasidone 80 mg/day and 160 mg/day in the treatment of schizophrenia: a randomized, double-blind, placebo- and active-controlled trial. AU - Loebel,Antony, AU - Cucchiaro,Josephine, AU - Sarma,Kaushik, AU - Xu,Lei, AU - Hsu,Chuanchieh, AU - Kalali,Amir H, AU - Pikalov,Andrei, AU - Potkin,Steven G, Y1 - 2013/02/13/ PY - 2012/10/23/received PY - 2013/01/09/revised PY - 2013/01/11/accepted PY - 2013/2/19/entrez PY - 2013/2/19/pubmed PY - 2013/9/11/medline SP - 101 EP - 9 JF - Schizophrenia research JO - Schizophr Res VL - 145 IS - 1-3 N2 - OBJECTIVE: This study was designed to evaluate the short-term efficacy and safety of once-daily lurasidone (80 mg/day and 160 mg/day) in the treatment of an acute exacerbation of schizophrenia. METHODS: Participants, who were recently admitted inpatients with schizophrenia with an acute exacerbation of psychotic symptoms, were randomly assigned to 6 weeks of fixed-dose, double-blind treatment with lurasidone 80 mg (n=125), lurasidone 160 mg (n=121), quetiapine XR 600 mg (QXR-600 mg; n=119; active control included to test for assay sensitivity), or placebo (n=121), all dosed once daily in the evening. Efficacy was evaluated using a mixed-model repeated-measures analysis of the change from Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) total score (the primary efficacy measure) and Clinical Global Impressions severity (CGI-S) score (the key secondary efficacy measure). RESULTS: Treatment with both doses of lurasidone or with QXR-600 mg was associated with significantly greater improvement at Week 6 on PANSS total score, PANSS positive and negative subscale scores, and CGI-S score compared with placebo. The endpoint responder rate (≥ 20% improvement in PANSS total score) was higher in subjects treated with lurasidone 80 mg (65%; p<0.001), lurasidone 160 mg (79%; p<0.001), and QXR-600 mg (79%; p<0.001) compared with placebo (41%). The proportion of patients experiencing ≥ 7% weight gain was 4% for each lurasidone group, 15% for the QXR-600 mg group, and 3% for the placebo group. Endpoint changes in levels of cholesterol, triglycerides, and low-density lipoprotein (LDL) cholesterol were comparable for both lurasidone groups and placebo, while the QXR-600 mg group showed a significant median increase compared with the placebo group in levels of cholesterol (p<0.001), LDL cholesterol (p<0.01), and triglycerides (p<0.05). CONCLUSIONS: Lurasidone 80 mg and 160 mg doses administered once-daily in the evening, were safe and effective treatments for subjects with acute schizophrenia, with increased response rates observed at the higher dose. Dose-related adverse effects were limited, and both doses were generally well-tolerated. SN - 1573-2509 UR - https://www.unboundmedicine.com/medline/citation/23415311/Efficacy_and_safety_of_lurasidone_80_mg/day_and_160_mg/day_in_the_treatment_of_schizophrenia:_a_randomized_double_blind_placebo__and_active_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0920-9964(13)00047-9 DB - PRIME DP - Unbound Medicine ER -