Efficacy and safety of lurasidone in adolescents and young adults with schizophrenia: A pooled post hoc analysis of double-blind, placebo-controlled 6-week studies
Abstract Background The aim of this pooled analysis was to evaluate the efficacy and safety of lurasidone in the treatment of an acute exacerbation of schizophrenia in adolescents and young adults. Methods The six pooled studies in this analysis used similar study designs and outcome measures. P...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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Cambridge University Press
2021-01-01
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| Series: | European Psychiatry |
| Subjects: | |
| Online Access: | https://www.cambridge.org/core/product/identifier/S0924933821000304/type/journal_article |
| _version_ | 1811156374655074304 |
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| author | Isabella Costamagna Fabrizio Calisti Agnese Cattaneo Jay Hsu Michael Tocco Andrei Pikalov Robert Goldman |
| author_facet | Isabella Costamagna Fabrizio Calisti Agnese Cattaneo Jay Hsu Michael Tocco Andrei Pikalov Robert Goldman |
| author_sort | Isabella Costamagna |
| collection | DOAJ |
| description |
Abstract
Background
The aim of this pooled analysis was to evaluate the efficacy and safety of lurasidone in the treatment of an acute exacerbation of schizophrenia in adolescents and young adults.
Methods
The six pooled studies in this analysis used similar study designs and outcome measures. Patients (aged 13–25 years) were randomized to 6 weeks of double-blind, placebo-controlled treatment with lurasidone in fixed doses of 40, 80, 120, or 160 mg. The primary efficacy endpoint was Week 6 change in the Positive and Negative Syndrome Scale (PANSS) total score; secondary efficacy endpoints included Week 6 change in the Clinical Global Impression–Severity scale.
Results
The safety population consisted of 537 patients (mean age: 18.1 years); 82.6% of patients completed the studies. Treatment with lurasidone was significantly better than placebo at all doses (p < 0.001) for change in the PANSS total score at Week 6. Placebo-adjusted PANSS scores ranged from −9.4 to −16.1 (effect sizes: 0.53–0.90), with effect sizes increasing at higher doses. For lurasidone (combined doses), three adverse events occurred with a frequency of ≥5% (nausea: 13.5%; somnolence: 12.1%; akathisia: 10.1%). At last observation carried forward (LOCF)-endpoint weight gain of ≥7% was similar for lurasidone versus placebo (3.6 vs. 4.7%). Minimal median changes were observed at endpoint in cholesterol, −2.0 mg/dL; triglycerides, 0.0 mg/dL; and glucose, 0.0 mg/dL.
Conclusions
In adolescents and young adults with schizophrenia, treatment with lurasidone in doses of 40–160 mg/d was a safe, well-tolerated, and effective treatment. Short-term treatment with lurasidone was associated with minimal effects on weight and metabolic parameters.
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| first_indexed | 2024-04-10T04:49:20Z |
| format | Article |
| id | doaj.art-6d71dcd0347e4dfcabdaeece301ac3db |
| institution | Directory Open Access Journal |
| issn | 0924-9338 1778-3585 |
| language | English |
| last_indexed | 2024-04-10T04:49:20Z |
| publishDate | 2021-01-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | European Psychiatry |
| spelling | doaj.art-6d71dcd0347e4dfcabdaeece301ac3db2023-03-09T12:33:54ZengCambridge University PressEuropean Psychiatry0924-93381778-35852021-01-016410.1192/j.eurpsy.2021.30Efficacy and safety of lurasidone in adolescents and young adults with schizophrenia: A pooled post hoc analysis of double-blind, placebo-controlled 6-week studiesIsabella Costamagna0https://orcid.org/0000-0003-4212-8136Fabrizio Calisti1https://orcid.org/0000-0002-2063-6132Agnese Cattaneo2Jay Hsu3Michael Tocco4Andrei Pikalov5Robert Goldman6Angelini RR&D (Regulatory, Research, & Development), Angelini Pharma S.p.A., Viale Amelia, 70, 00181 Rome, ItalyAngelini RR&D (Regulatory, Research, & Development), Angelini Pharma S.p.A., Viale Amelia, 70, 00181 Rome, ItalyAngelini RR&D (Regulatory, Research, & Development), Angelini Pharma S.p.A., Viale Amelia, 70, 00181 Rome, ItalySunovion Pharmaceuticals Inc., Fort Lee, New Jersey, USASunovion Pharmaceuticals Inc., Marlborough, Massachusetts, USASunovion Pharmaceuticals Inc., Fort Lee, New Jersey, USASunovion Pharmaceuticals Inc., Marlborough, Massachusetts, USA Abstract Background The aim of this pooled analysis was to evaluate the efficacy and safety of lurasidone in the treatment of an acute exacerbation of schizophrenia in adolescents and young adults. Methods The six pooled studies in this analysis used similar study designs and outcome measures. Patients (aged 13–25 years) were randomized to 6 weeks of double-blind, placebo-controlled treatment with lurasidone in fixed doses of 40, 80, 120, or 160 mg. The primary efficacy endpoint was Week 6 change in the Positive and Negative Syndrome Scale (PANSS) total score; secondary efficacy endpoints included Week 6 change in the Clinical Global Impression–Severity scale. Results The safety population consisted of 537 patients (mean age: 18.1 years); 82.6% of patients completed the studies. Treatment with lurasidone was significantly better than placebo at all doses (p < 0.001) for change in the PANSS total score at Week 6. Placebo-adjusted PANSS scores ranged from −9.4 to −16.1 (effect sizes: 0.53–0.90), with effect sizes increasing at higher doses. For lurasidone (combined doses), three adverse events occurred with a frequency of ≥5% (nausea: 13.5%; somnolence: 12.1%; akathisia: 10.1%). At last observation carried forward (LOCF)-endpoint weight gain of ≥7% was similar for lurasidone versus placebo (3.6 vs. 4.7%). Minimal median changes were observed at endpoint in cholesterol, −2.0 mg/dL; triglycerides, 0.0 mg/dL; and glucose, 0.0 mg/dL. Conclusions In adolescents and young adults with schizophrenia, treatment with lurasidone in doses of 40–160 mg/d was a safe, well-tolerated, and effective treatment. Short-term treatment with lurasidone was associated with minimal effects on weight and metabolic parameters. https://www.cambridge.org/core/product/identifier/S0924933821000304/type/journal_articleadolescentatypical antipsychoticlurasidoneschizophreniatreatment-naïve |
| spellingShingle | Isabella Costamagna Fabrizio Calisti Agnese Cattaneo Jay Hsu Michael Tocco Andrei Pikalov Robert Goldman Efficacy and safety of lurasidone in adolescents and young adults with schizophrenia: A pooled post hoc analysis of double-blind, placebo-controlled 6-week studies European Psychiatry adolescent atypical antipsychotic lurasidone schizophrenia treatment-naïve |
| title | Efficacy and safety of lurasidone in adolescents and young adults with schizophrenia: A pooled post hoc analysis of double-blind, placebo-controlled 6-week studies |
| title_full | Efficacy and safety of lurasidone in adolescents and young adults with schizophrenia: A pooled post hoc analysis of double-blind, placebo-controlled 6-week studies |
| title_fullStr | Efficacy and safety of lurasidone in adolescents and young adults with schizophrenia: A pooled post hoc analysis of double-blind, placebo-controlled 6-week studies |
| title_full_unstemmed | Efficacy and safety of lurasidone in adolescents and young adults with schizophrenia: A pooled post hoc analysis of double-blind, placebo-controlled 6-week studies |
| title_short | Efficacy and safety of lurasidone in adolescents and young adults with schizophrenia: A pooled post hoc analysis of double-blind, placebo-controlled 6-week studies |
| title_sort | efficacy and safety of lurasidone in adolescents and young adults with schizophrenia a pooled post hoc analysis of double blind placebo controlled 6 week studies |
| topic | adolescent atypical antipsychotic lurasidone schizophrenia treatment-naïve |
| url | https://www.cambridge.org/core/product/identifier/S0924933821000304/type/journal_article |
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