Assessing effectiveness of aripiprazole lauroxil vs placebo for the treatment of schizophrenia using number needed to treat and number needed to harm

Leslie Citrome,1 Yangchun Du,2 Peter J Weiden3 1Psychiatry and Behavioral Sciences, New York Medical College, Valhalla, NY, USA; 2Biostatistics, Alkermes, Inc., Waltham, MA, USA; 3Medical Affairs, Alkermes, Inc., Waltham, MA, USACorrespondence: Leslie Citrome 11 Medical Park Drive, Suite 106, Pomona...

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Autores principales:	Citrome L, Du Y, Weiden PJ
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2019
Materias:	aripiprazole lauroxil long-acting injectable psychotic disorders antipsychotic agents number needed to treat effect size Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/c700ac7139d84a2abc3c65c982a94abc
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spelling	oai:doaj.org-article:c700ac7139d84a2abc3c65c982a94abc2021-12-02T03:14:09ZAssessing effectiveness of aripiprazole lauroxil vs placebo for the treatment of schizophrenia using number needed to treat and number needed to harm1178-2021https://doaj.org/article/c700ac7139d84a2abc3c65c982a94abc2019-09-01T00:00:00Zhttps://www.dovepress.com/assessing-effectiveness-of-aripiprazole-lauroxil-vs-placebo-for-the-tr-peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Leslie Citrome,1 Yangchun Du,2 Peter J Weiden3 1Psychiatry and Behavioral Sciences, New York Medical College, Valhalla, NY, USA; 2Biostatistics, Alkermes, Inc., Waltham, MA, USA; 3Medical Affairs, Alkermes, Inc., Waltham, MA, USACorrespondence: Leslie Citrome 11 Medical Park Drive, Suite 106, Pomona, NY 10970, USATel +1 845 362 2081Email citrome@cnsconsultant.comObjective: Schizophrenia clinical trials commonly measure observed changes in Positive and Negative Syndrome Scale (PANSS) total score. However, it is more intuitive to think of response vs nonresponse, a binary outcome. Assessing binary outcomes enables calculation of number needed to treat (NNT) for therapeutic outcomes, number needed to harm (NNH) for adverse outcomes, and likelihood to be helped or harmed (LHH) to demonstrate benefit/risk tradeoffs. Here, NNT, NNH, and LHH were used to evaluate the clinical usefulness of aripiprazole lauroxil in patients with an acute schizophrenia exacerbation.Methods: Categorical efficacy and tolerability data were taken from the pivotal Phase 3 trial evaluating aripiprazole lauroxil for treatment of an acute exacerbation of schizophrenia. NNT and NNH values, with 95% CIs, were calculated in this post hoc analysis.Results: Using the intent-to-treat population for the pooled doses of aripiprazole lauroxil (441 mg [n=196] and 882 mg [n=204] q4w), responder rates (≥30% improvement from baseline PANSS total score) were 35.3% for aripiprazole lauroxil arms vs 18.4% for placebo (n=196), yielding a NNT of 6 (95% CI: 5–11). Discontinuation rates due to adverse events (AEs) were higher among patients randomized to placebo than to either aripiprazole lauroxil dose. Akathisia was the only AE with an incidence ≥5% in each aripiprazole lauroxil group and at least twice that of placebo (11.6%, 11.5%, and 4.3% of the patients receiving aripiprazole lauroxil 441 mg, 882 mg, and placebo, respectively), producing a NNH of 14 (95% CI: 9–33) for pooled aripiprazole lauroxil doses vs placebo. Calculating LHH for therapeutic response vs akathisia, aripiprazole lauroxil was 2.3 times more likely to result in a therapeutic response than an incident of akathisia.Conclusion: Using metrics of NNT, NNH, and LHH, aripiprazole lauroxil was an efficacious and well-tolerated intervention in a pivotal study in patients with an acute schizophrenia exacerbation.Keywords: aripiprazole lauroxil, long-acting injectable, psychotic disorders, antipsychotic agents, number needed to treat, effect sizeCitrome LDu YWeiden PJDove Medical Pressarticlearipiprazole lauroxillong-acting injectablepsychotic disordersantipsychotic agentsnumber needed to treateffect sizeNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol Volume 15, Pp 2639-2646 (2019)
institution	DOAJ
collection	DOAJ
language	EN
topic	aripiprazole lauroxil long-acting injectable psychotic disorders antipsychotic agents number needed to treat effect size Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	aripiprazole lauroxil long-acting injectable psychotic disorders antipsychotic agents number needed to treat effect size Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Citrome L Du Y Weiden PJ Assessing effectiveness of aripiprazole lauroxil vs placebo for the treatment of schizophrenia using number needed to treat and number needed to harm
description	Leslie Citrome,1 Yangchun Du,2 Peter J Weiden3 1Psychiatry and Behavioral Sciences, New York Medical College, Valhalla, NY, USA; 2Biostatistics, Alkermes, Inc., Waltham, MA, USA; 3Medical Affairs, Alkermes, Inc., Waltham, MA, USACorrespondence: Leslie Citrome 11 Medical Park Drive, Suite 106, Pomona, NY 10970, USATel +1 845 362 2081Email citrome@cnsconsultant.comObjective: Schizophrenia clinical trials commonly measure observed changes in Positive and Negative Syndrome Scale (PANSS) total score. However, it is more intuitive to think of response vs nonresponse, a binary outcome. Assessing binary outcomes enables calculation of number needed to treat (NNT) for therapeutic outcomes, number needed to harm (NNH) for adverse outcomes, and likelihood to be helped or harmed (LHH) to demonstrate benefit/risk tradeoffs. Here, NNT, NNH, and LHH were used to evaluate the clinical usefulness of aripiprazole lauroxil in patients with an acute schizophrenia exacerbation.Methods: Categorical efficacy and tolerability data were taken from the pivotal Phase 3 trial evaluating aripiprazole lauroxil for treatment of an acute exacerbation of schizophrenia. NNT and NNH values, with 95% CIs, were calculated in this post hoc analysis.Results: Using the intent-to-treat population for the pooled doses of aripiprazole lauroxil (441 mg [n=196] and 882 mg [n=204] q4w), responder rates (≥30% improvement from baseline PANSS total score) were 35.3% for aripiprazole lauroxil arms vs 18.4% for placebo (n=196), yielding a NNT of 6 (95% CI: 5–11). Discontinuation rates due to adverse events (AEs) were higher among patients randomized to placebo than to either aripiprazole lauroxil dose. Akathisia was the only AE with an incidence ≥5% in each aripiprazole lauroxil group and at least twice that of placebo (11.6%, 11.5%, and 4.3% of the patients receiving aripiprazole lauroxil 441 mg, 882 mg, and placebo, respectively), producing a NNH of 14 (95% CI: 9–33) for pooled aripiprazole lauroxil doses vs placebo. Calculating LHH for therapeutic response vs akathisia, aripiprazole lauroxil was 2.3 times more likely to result in a therapeutic response than an incident of akathisia.Conclusion: Using metrics of NNT, NNH, and LHH, aripiprazole lauroxil was an efficacious and well-tolerated intervention in a pivotal study in patients with an acute schizophrenia exacerbation.Keywords: aripiprazole lauroxil, long-acting injectable, psychotic disorders, antipsychotic agents, number needed to treat, effect size
format	article
author	Citrome L Du Y Weiden PJ
author_facet	Citrome L Du Y Weiden PJ
author_sort	Citrome L
title	Assessing effectiveness of aripiprazole lauroxil vs placebo for the treatment of schizophrenia using number needed to treat and number needed to harm
title_short	Assessing effectiveness of aripiprazole lauroxil vs placebo for the treatment of schizophrenia using number needed to treat and number needed to harm
title_full	Assessing effectiveness of aripiprazole lauroxil vs placebo for the treatment of schizophrenia using number needed to treat and number needed to harm
title_fullStr	Assessing effectiveness of aripiprazole lauroxil vs placebo for the treatment of schizophrenia using number needed to treat and number needed to harm
title_full_unstemmed	Assessing effectiveness of aripiprazole lauroxil vs placebo for the treatment of schizophrenia using number needed to treat and number needed to harm
title_sort	assessing effectiveness of aripiprazole lauroxil vs placebo for the treatment of schizophrenia using number needed to treat and number needed to harm
publisher	Dove Medical Press
publishDate	2019
url	https://doaj.org/article/c700ac7139d84a2abc3c65c982a94abc
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Assessing effectiveness of aripiprazole lauroxil vs placebo for the treatment of schizophrenia using number needed to treat and number needed to harm

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