Schizophrenia relapse and the clinical usefulness of once-monthly aripiprazole depot injection

Sheng-Min Wang,1 Changsu Han,2 Soo-Jung Lee,5 Ashwin A Patkar,3 Prakash S Masand,4 Chi-Un Pae3,5 1International Health Care Center, Seoul St Mary’s Hospital, The Catholic University of Korea, College of Medicine, Seoul, Republic of Korea; 2Department of Psychiatry, College of Medicine, K...

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Autores principales: Wang SM, Han C, Lee SJ, Patkar AA, Mas, PS, Pae CU
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Publicado: Dove Medical Press 2014
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spelling oai:doaj.org-article:fbc5c543112948739d6e949e102522dc2021-12-02T01:59:12ZSchizophrenia relapse and the clinical usefulness of once-monthly aripiprazole depot injection1178-2021https://doaj.org/article/fbc5c543112948739d6e949e102522dc2014-08-01T00:00:00Zhttp://www.dovepress.com/schizophrenia-relapse-and-the-clinical-usefulness-of-once-monthly-arip-peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021 Sheng-Min Wang,1 Changsu Han,2 Soo-Jung Lee,5 Ashwin A Patkar,3 Prakash S Masand,4 Chi-Un Pae3,5 1International Health Care Center, Seoul St Mary’s Hospital, The Catholic University of Korea, College of Medicine, Seoul, Republic of Korea; 2Department of Psychiatry, College of Medicine, Korea University, Seoul, Republic of Korea; 3Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, 4Global Medical Education, New York, NY, USA; 5Department of Psychiatry, Bucheon St Mary’s Hospital, The Catholic University of Korea, College of Medicine, Seoul, Republic of Korea Abstract: Improving medication adherence is critical to improving outcomes in patients with schizophrenia. A long-acting injectable (depot) antipsychotic is one of the most effective methods for improving treatment adherence and decreasing rehospitalization rates in patients with schizophrenia. Until recently, only three second-generation antipsychotics were available in a long-acting injectable formulation (risperidone, paliperidone, and olanzapine). In this respect, the emergence of long-acting aripiprazole injection (ALAI), approved by the US Food and Drug Administration for the treatment of schizophrenia in 2013, is timely. ALAI is a lyophilized powder of aripiprazole, and the aripiprazole molecule is unmodified. The initial and target dosage of ALAI is 400 mg once monthly, but it could be reduced to 300 mg if adverse reactions occur with 400 mg. When first administering ALAI, it is recommended to continue treatment with oral aripiprazole (10–20 mg/day) or another oral antipsychotic for 2 weeks in order to maintain therapeutic antipsychotic concentrations. The primary clearance route for ALAI is hepatic, ie, cytochrome P450 (CYP)2D6 and CYP3A4, so dose adjustment is required in poor CYP2D6 metabolizers. The efficacy of ALAI was demonstrated in three studies. A randomized controlled trial that formed the basis for approval of ALAI in the treatment of schizophrenia showed that ALAI significantly delayed time to impending relapse when compared with placebo (P<0.0001, log-rank test). An open-label, mirror study demonstrated that total psychiatric hospitalization rates were significantly lower after switching from oral antipsychotics to ALAI. Another randomized controlled trial presented in poster form suggested that ALAI 400 mg was comparable with oral aripiprazole 10–30 mg in preventing relapse. ALAI was generally well tolerated during both short-term and long-term studies. Its tolerability profile, including extrapyramidal symptoms and clinically relevant metabolic parameters, was similar to placebo. However, insomnia, headache, anxiety, akathisia, weight gain, injection site pain, and tremor need clinical attention. These studies suggest that ALAI is a viable treatment option for patients with schizophrenia, but direct head-to-head comparisons between ALAI and other long-acting injectable antipsychotics are needed to elucidate its risk–benefit profile. Keywords: aripiprazole, schizophrenia, depot, long-acting injectable, relapse, treatmentWang SMHan CLee SJPatkar AAMasPSPae CUDove Medical PressarticleNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol 2014, Iss default, Pp 1605-1611 (2014)
institution DOAJ
collection DOAJ
language EN
topic Neurosciences. Biological psychiatry. Neuropsychiatry
RC321-571
Neurology. Diseases of the nervous system
RC346-429
spellingShingle Neurosciences. Biological psychiatry. Neuropsychiatry
RC321-571
Neurology. Diseases of the nervous system
RC346-429
Wang SM
Han C
Lee SJ
Patkar AA
Mas
PS
Pae CU
Schizophrenia relapse and the clinical usefulness of once-monthly aripiprazole depot injection
description Sheng-Min Wang,1 Changsu Han,2 Soo-Jung Lee,5 Ashwin A Patkar,3 Prakash S Masand,4 Chi-Un Pae3,5 1International Health Care Center, Seoul St Mary’s Hospital, The Catholic University of Korea, College of Medicine, Seoul, Republic of Korea; 2Department of Psychiatry, College of Medicine, Korea University, Seoul, Republic of Korea; 3Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, 4Global Medical Education, New York, NY, USA; 5Department of Psychiatry, Bucheon St Mary’s Hospital, The Catholic University of Korea, College of Medicine, Seoul, Republic of Korea Abstract: Improving medication adherence is critical to improving outcomes in patients with schizophrenia. A long-acting injectable (depot) antipsychotic is one of the most effective methods for improving treatment adherence and decreasing rehospitalization rates in patients with schizophrenia. Until recently, only three second-generation antipsychotics were available in a long-acting injectable formulation (risperidone, paliperidone, and olanzapine). In this respect, the emergence of long-acting aripiprazole injection (ALAI), approved by the US Food and Drug Administration for the treatment of schizophrenia in 2013, is timely. ALAI is a lyophilized powder of aripiprazole, and the aripiprazole molecule is unmodified. The initial and target dosage of ALAI is 400 mg once monthly, but it could be reduced to 300 mg if adverse reactions occur with 400 mg. When first administering ALAI, it is recommended to continue treatment with oral aripiprazole (10–20 mg/day) or another oral antipsychotic for 2 weeks in order to maintain therapeutic antipsychotic concentrations. The primary clearance route for ALAI is hepatic, ie, cytochrome P450 (CYP)2D6 and CYP3A4, so dose adjustment is required in poor CYP2D6 metabolizers. The efficacy of ALAI was demonstrated in three studies. A randomized controlled trial that formed the basis for approval of ALAI in the treatment of schizophrenia showed that ALAI significantly delayed time to impending relapse when compared with placebo (P<0.0001, log-rank test). An open-label, mirror study demonstrated that total psychiatric hospitalization rates were significantly lower after switching from oral antipsychotics to ALAI. Another randomized controlled trial presented in poster form suggested that ALAI 400 mg was comparable with oral aripiprazole 10–30 mg in preventing relapse. ALAI was generally well tolerated during both short-term and long-term studies. Its tolerability profile, including extrapyramidal symptoms and clinically relevant metabolic parameters, was similar to placebo. However, insomnia, headache, anxiety, akathisia, weight gain, injection site pain, and tremor need clinical attention. These studies suggest that ALAI is a viable treatment option for patients with schizophrenia, but direct head-to-head comparisons between ALAI and other long-acting injectable antipsychotics are needed to elucidate its risk–benefit profile. Keywords: aripiprazole, schizophrenia, depot, long-acting injectable, relapse, treatment
format article
author Wang SM
Han C
Lee SJ
Patkar AA
Mas
PS
Pae CU
author_facet Wang SM
Han C
Lee SJ
Patkar AA
Mas
PS
Pae CU
author_sort Wang SM
title Schizophrenia relapse and the clinical usefulness of once-monthly aripiprazole depot injection
title_short Schizophrenia relapse and the clinical usefulness of once-monthly aripiprazole depot injection
title_full Schizophrenia relapse and the clinical usefulness of once-monthly aripiprazole depot injection
title_fullStr Schizophrenia relapse and the clinical usefulness of once-monthly aripiprazole depot injection
title_full_unstemmed Schizophrenia relapse and the clinical usefulness of once-monthly aripiprazole depot injection
title_sort schizophrenia relapse and the clinical usefulness of once-monthly aripiprazole depot injection
publisher Dove Medical Press
publishDate 2014
url https://doaj.org/article/fbc5c543112948739d6e949e102522dc
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AT mas schizophreniarelapseandtheclinicalusefulnessofoncemonthlyaripiprazoledepotinjection
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