Exploring the long-term safety of asenapine in adults with schizophrenia in a double-blind, fixed-dose, extension study

Suresh Durgam,1 Ronald P Landbloom,2 Mary Mackle,2 Xiao Wu,1 Maju Mathews,3 Henry A Nasrallah4 1Allergan Inc, Jersey City, 2Merck, Whitehouse Station, 3Forest Research Institute (now Allergan), Jersey City, NJ, 4Saint Louis University School of Medicine, St Louis, MO, USA Purpose: The primary obje...

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Autores principales:	Durgam S, Landbloom RP, Mackle M, Wu X, Mathews M, Nasrallah HA
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2017
Materias:	asenapine schizophrenia long-term safety weight olanzapine Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/61d88f1532d9409397d0f30c92e39abd
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spelling	oai:doaj.org-article:61d88f1532d9409397d0f30c92e39abd2021-12-02T02:16:05ZExploring the long-term safety of asenapine in adults with schizophrenia in a double-blind, fixed-dose, extension study1178-2021https://doaj.org/article/61d88f1532d9409397d0f30c92e39abd2017-07-01T00:00:00Zhttps://www.dovepress.com/exploring-the-long-term-safety-of-asenapine-in-adults-with-schizophren-peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Suresh Durgam,1 Ronald P Landbloom,2 Mary Mackle,2 Xiao Wu,1 Maju Mathews,3 Henry A Nasrallah4 1Allergan Inc, Jersey City, 2Merck, Whitehouse Station, 3Forest Research Institute (now Allergan), Jersey City, NJ, 4Saint Louis University School of Medicine, St Louis, MO, USA Purpose: The primary objective of this study was to assess long-term safety with sublingual asenapine 2.5 or 5 mg twice daily (BID) in patients with schizophrenia.Patients and methods: Actively treated patients on asenapine 2.5 mg BID, asenapine 5 mg BID, or olanzapine 15 mg once daily (QD) who completed a 6-week randomized, double-blind, placebo- and olanzapine-controlled study continued lead-in treatment in this 26-week, multicenter, double-blind, double-dummy, olanzapine-controlled Phase IIIB extension study; placebo patients were assigned to asenapine 2.5 mg BID treatment. Safety analyses were based on the all treated set (patients who received one or more doses of extension trial medication); change from baseline analyses used the acute study baseline. Treatment-emergent adverse events (TEAEs) and changes in laboratory parameters were monitored; weight change for asenapine versus olanzapine was the key secondary objective. Descriptive statistics were used; weight change was analyzed using a mixed-model repeated-measure approach.Results: Of the 120 patients in the all-treated set, 60% completed treatment (asenapine 2.5 mg BID 66.1% overall, asenapine 5 mg BID 52.4%, olanzapine 15 mg QD 56.3%). The incidence of TEAEs was higher for placebo patients from the lead-in study who switched to asenapine 2.5 mg BID for extension treatment (71.0%) versus patients continuing asenapine 2.5 mg BID (38.7%), asenapine 5 mg BID (38.1%), or olanzapine 15 mg QD (25.0%). The most common TEAE (≥5% in every group) was worsening of schizophrenia. Least squares mean change in body weight from the acute study baseline to week 26 was +0.6 kg for overall asenapine 2.5 mg BID, +0.8 kg for asenapine 5 mg BID, and +1.2 kg for olanzapine 15 mg QD. There were no clinically relevant changes in metabolic parameters; values were generally similar across treatment groups.Conclusion: Asenapine 2.5 mg BID and 5 mg BID were generally well tolerated in long-term treatment. Weight gain was less for overall asenapine 2.5 mg BID and 5 mg BID than for olanzapine 15 mg QD. Keywords: asenapine, schizophrenia, long-term, safety, weight, olanzapineDurgam SLandbloom RPMackle MWu XMathews MNasrallah HADove Medical Pressarticleasenapineschizophrenialong-termsafetyweightolanzapineNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol Volume 13, Pp 2021-2035 (2017)
institution	DOAJ
collection	DOAJ
language	EN
topic	asenapine schizophrenia long-term safety weight olanzapine Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	asenapine schizophrenia long-term safety weight olanzapine Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Durgam S Landbloom RP Mackle M Wu X Mathews M Nasrallah HA Exploring the long-term safety of asenapine in adults with schizophrenia in a double-blind, fixed-dose, extension study
description	Suresh Durgam,1 Ronald P Landbloom,2 Mary Mackle,2 Xiao Wu,1 Maju Mathews,3 Henry A Nasrallah4 1Allergan Inc, Jersey City, 2Merck, Whitehouse Station, 3Forest Research Institute (now Allergan), Jersey City, NJ, 4Saint Louis University School of Medicine, St Louis, MO, USA Purpose: The primary objective of this study was to assess long-term safety with sublingual asenapine 2.5 or 5 mg twice daily (BID) in patients with schizophrenia.Patients and methods: Actively treated patients on asenapine 2.5 mg BID, asenapine 5 mg BID, or olanzapine 15 mg once daily (QD) who completed a 6-week randomized, double-blind, placebo- and olanzapine-controlled study continued lead-in treatment in this 26-week, multicenter, double-blind, double-dummy, olanzapine-controlled Phase IIIB extension study; placebo patients were assigned to asenapine 2.5 mg BID treatment. Safety analyses were based on the all treated set (patients who received one or more doses of extension trial medication); change from baseline analyses used the acute study baseline. Treatment-emergent adverse events (TEAEs) and changes in laboratory parameters were monitored; weight change for asenapine versus olanzapine was the key secondary objective. Descriptive statistics were used; weight change was analyzed using a mixed-model repeated-measure approach.Results: Of the 120 patients in the all-treated set, 60% completed treatment (asenapine 2.5 mg BID 66.1% overall, asenapine 5 mg BID 52.4%, olanzapine 15 mg QD 56.3%). The incidence of TEAEs was higher for placebo patients from the lead-in study who switched to asenapine 2.5 mg BID for extension treatment (71.0%) versus patients continuing asenapine 2.5 mg BID (38.7%), asenapine 5 mg BID (38.1%), or olanzapine 15 mg QD (25.0%). The most common TEAE (≥5% in every group) was worsening of schizophrenia. Least squares mean change in body weight from the acute study baseline to week 26 was +0.6 kg for overall asenapine 2.5 mg BID, +0.8 kg for asenapine 5 mg BID, and +1.2 kg for olanzapine 15 mg QD. There were no clinically relevant changes in metabolic parameters; values were generally similar across treatment groups.Conclusion: Asenapine 2.5 mg BID and 5 mg BID were generally well tolerated in long-term treatment. Weight gain was less for overall asenapine 2.5 mg BID and 5 mg BID than for olanzapine 15 mg QD. Keywords: asenapine, schizophrenia, long-term, safety, weight, olanzapine
format	article
author	Durgam S Landbloom RP Mackle M Wu X Mathews M Nasrallah HA
author_facet	Durgam S Landbloom RP Mackle M Wu X Mathews M Nasrallah HA
author_sort	Durgam S
title	Exploring the long-term safety of asenapine in adults with schizophrenia in a double-blind, fixed-dose, extension study
title_short	Exploring the long-term safety of asenapine in adults with schizophrenia in a double-blind, fixed-dose, extension study
title_full	Exploring the long-term safety of asenapine in adults with schizophrenia in a double-blind, fixed-dose, extension study
title_fullStr	Exploring the long-term safety of asenapine in adults with schizophrenia in a double-blind, fixed-dose, extension study
title_full_unstemmed	Exploring the long-term safety of asenapine in adults with schizophrenia in a double-blind, fixed-dose, extension study
title_sort	exploring the long-term safety of asenapine in adults with schizophrenia in a double-blind, fixed-dose, extension study
publisher	Dove Medical Press
publishDate	2017
url	https://doaj.org/article/61d88f1532d9409397d0f30c92e39abd
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Exploring the long-term safety of asenapine in adults with schizophrenia in a double-blind, fixed-dose, extension study

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