Symptomatic stability with aripiprazole once-monthly: efficacy analyses from acute and long-term studies

Jessica J Madera,1 Pedro Such,2 Cathy Zhao,3 Ross A Baker11Global Medical Affairs, Otsuka Pharmaceutical Development & Commercialization, Inc, Princeton, NJ, USA; 2Medical Affairs Psychiatry, H. Lundbeck A/S, Valby, Denmark; 3Biostatistics, Otsuka Pharmaceutical Development & Commerc...

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Autores principales:	Madera JJ, Such P, Zhao C, Baker RA
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2019
Materias:	aripiprazole long-acting injectable antipsychotics schizophrenia Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/ac66f4f443d1457484217f752a6d9952
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spelling	oai:doaj.org-article:ac66f4f443d1457484217f752a6d99522021-12-02T06:48:54ZSymptomatic stability with aripiprazole once-monthly: efficacy analyses from acute and long-term studies1178-2021https://doaj.org/article/ac66f4f443d1457484217f752a6d99522019-06-01T00:00:00Zhttps://www.dovepress.com/symptomatic-stability-with-aripiprazole-once-monthly-efficacy-analyses-peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Jessica J Madera,1 Pedro Such,2 Cathy Zhao,3 Ross A Baker11Global Medical Affairs, Otsuka Pharmaceutical Development & Commercialization, Inc, Princeton, NJ, USA; 2Medical Affairs Psychiatry, H. Lundbeck A/S, Valby, Denmark; 3Biostatistics, Otsuka Pharmaceutical Development & Commercialization, Inc, Princeton, NJ, USAObjective: To evaluate the effect of aripiprazole once-monthly 400 mg (AOM 400; Abilify Maintena®) on symptom stability in acute treatment and maintenance therapy settings in patients with schizophrenia.Methods: Results were analyzed from two pivotal maintenance studies (Studies 246 and 247), a long-term (52 weeks), open-label extension of these studies (Study 248), an open-label, mirror-image study in patients switching from oral to long-acting injectable antipsychotic therapy (Study 283), and a study of AOM 400 in the acute setting (Study 291). Symptom stability was assessed using the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impression (CGI) scale (CGI-Severity of Illness and CGI-Improvement). Results are reported for the total study population and in subgroups stratified by age.Results: In Study 246, AOM 400 resulted in significantly greater improvements from baseline vs placebo on all measures of symptom stability, with improvements maintained through 52 weeks. In Study 247, a non-inferiority study, AOM 400 resulted in improvements in PANSS and CGI scores comparable or significantly greater at all timepoints vs oral aripiprazole. In Study 248, AOM 400 resulted in the long-term stability of symptom improvements from the earlier studies. In Study 283, AOM 400 resulted in significant improvements from baseline in PANSS and CGI scores over 24 weeks. In Study 291, AOM 400 resulted in significantly greater improvements from baseline in PANSS and CGI scores vs placebo at all post-baseline timepoints. In post hoc analyses, AOM 400 showed similar efficacy in symptom improvement in adult patients aged ≤35 years and >35 years, with some evidence of a larger treatment effect on PANSS negative symptoms among younger patients in the acute treatment setting.Conclusion: In acute treatment and maintenance therapy settings, AOM 400 was effective in the rapid stabilization and long-term maintenance of symptoms in patients with schizophrenia.Keywords: aripiprazole, long-acting injectable, antipsychotics, schizophreniaMadera JJSuch PZhao CBaker RADove Medical Pressarticlearipiprazolelong-acting injectableantipsychoticsschizophreniaNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol Volume 15, Pp 1593-1604 (2019)
institution	DOAJ
collection	DOAJ
language	EN
topic	aripiprazole long-acting injectable antipsychotics schizophrenia Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	aripiprazole long-acting injectable antipsychotics schizophrenia Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Madera JJ Such P Zhao C Baker RA Symptomatic stability with aripiprazole once-monthly: efficacy analyses from acute and long-term studies
description	Jessica J Madera,1 Pedro Such,2 Cathy Zhao,3 Ross A Baker11Global Medical Affairs, Otsuka Pharmaceutical Development & Commercialization, Inc, Princeton, NJ, USA; 2Medical Affairs Psychiatry, H. Lundbeck A/S, Valby, Denmark; 3Biostatistics, Otsuka Pharmaceutical Development & Commercialization, Inc, Princeton, NJ, USAObjective: To evaluate the effect of aripiprazole once-monthly 400 mg (AOM 400; Abilify Maintena®) on symptom stability in acute treatment and maintenance therapy settings in patients with schizophrenia.Methods: Results were analyzed from two pivotal maintenance studies (Studies 246 and 247), a long-term (52 weeks), open-label extension of these studies (Study 248), an open-label, mirror-image study in patients switching from oral to long-acting injectable antipsychotic therapy (Study 283), and a study of AOM 400 in the acute setting (Study 291). Symptom stability was assessed using the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impression (CGI) scale (CGI-Severity of Illness and CGI-Improvement). Results are reported for the total study population and in subgroups stratified by age.Results: In Study 246, AOM 400 resulted in significantly greater improvements from baseline vs placebo on all measures of symptom stability, with improvements maintained through 52 weeks. In Study 247, a non-inferiority study, AOM 400 resulted in improvements in PANSS and CGI scores comparable or significantly greater at all timepoints vs oral aripiprazole. In Study 248, AOM 400 resulted in the long-term stability of symptom improvements from the earlier studies. In Study 283, AOM 400 resulted in significant improvements from baseline in PANSS and CGI scores over 24 weeks. In Study 291, AOM 400 resulted in significantly greater improvements from baseline in PANSS and CGI scores vs placebo at all post-baseline timepoints. In post hoc analyses, AOM 400 showed similar efficacy in symptom improvement in adult patients aged ≤35 years and >35 years, with some evidence of a larger treatment effect on PANSS negative symptoms among younger patients in the acute treatment setting.Conclusion: In acute treatment and maintenance therapy settings, AOM 400 was effective in the rapid stabilization and long-term maintenance of symptoms in patients with schizophrenia.Keywords: aripiprazole, long-acting injectable, antipsychotics, schizophrenia
format	article
author	Madera JJ Such P Zhao C Baker RA
author_facet	Madera JJ Such P Zhao C Baker RA
author_sort	Madera JJ
title	Symptomatic stability with aripiprazole once-monthly: efficacy analyses from acute and long-term studies
title_short	Symptomatic stability with aripiprazole once-monthly: efficacy analyses from acute and long-term studies
title_full	Symptomatic stability with aripiprazole once-monthly: efficacy analyses from acute and long-term studies
title_fullStr	Symptomatic stability with aripiprazole once-monthly: efficacy analyses from acute and long-term studies
title_full_unstemmed	Symptomatic stability with aripiprazole once-monthly: efficacy analyses from acute and long-term studies
title_sort	symptomatic stability with aripiprazole once-monthly: efficacy analyses from acute and long-term studies
publisher	Dove Medical Press
publishDate	2019
url	https://doaj.org/article/ac66f4f443d1457484217f752a6d9952
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Symptomatic stability with aripiprazole once-monthly: efficacy analyses from acute and long-term studies

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