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Neuropsychiatric Disease and Treatment Volume 15, 2019 - Issue
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Original Research

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

Leslie Citrome1 Psychiatry and Behavioral Sciences, New York Medical College, Valhalla, NY, USACorrespondence[email protected]
,
Yangchun Du2 Biostatistics, Alkermes, Inc., Waltham, MA, USA
&
Peter J Weiden3 Medical Affairs, Alkermes, Inc., Waltham, MA, USA
Pages 2639-2646 | Published online: 12 Sep 2019

References

  • Meltzer HY, Risinger R, Nasrallah HA, et al. A randomized, double-blind, placebo-controlled trial of aripiprazole lauroxil in acute exacerbation of schizophrenia. J Clin Psychiatry. 2015;76(8):1085–1090. doi:10.4088/JCP.14m0974126114240
  • Citrome L, Risinger R, Cutler AJ, et al. Effect of aripiprazole lauroxil in patients with acute schizophrenia as assessed by the positive and negative syndrome scale-supportive analyses from a Phase 3 study. CNS Spectr. 2018;23(4):284–290. doi:10.1017/S109285291700039628625204
  • Nasrallah HA, Newcomer JW, Risinger R, et al. Effect of aripiprazole lauroxil on metabolic and endocrine profiles and related safety considerations among patients with acute schizophrenia. J Clin Psychiatry. 2016;77(11):1519–1525. doi:10.4088/JCP.15m1046727574838
  • Aristada [package Insert]. Waltham, MA: Alkermes, Inc.; 2018.
  • Citrome L, Ketter TA. When does a difference make a difference? Interpretation of number needed to treat, number needed to harm, and likelihood to be helped or harmed. Int J Clin Pract. 2013;67(5):407–411. doi:10.1111/ijcp.1214223574101
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  • Straus SE. Individualizing treatment decisions. The likelihood of being helped or harmed. Eval Health Prof. 2002;25(2):210–224. doi:10.1177/01632787020250020612026754
  • Citrome L, Magnusson K. Paging Dr Cohen, Paging Dr Cohen…An effect size interpretation is required STAT!: visualising effect size and an interview with Kristoffer Magnusson. Int J Clin Pract. 2014;68(5):533–534. doi:10.1111/ijcp.1243524750523
  • Citrome L. Quantifying risk: the role of absolute and relative measures in interpreting risk of adverse reactions from product labels of antipsychotic medications. Curr Drug Saf. 2009;4(3):229–237.19534647
  • Kraemer HC, Kupfer DJ. Size of treatment effects and their importance to clinical research and practice. Biol Psychiatry. 2006;59(11):990–996. doi:10.1016/j.biopsych.2005.09.01416368078
  • Fusar-Poli P, Kempton MJ, Rosenheck RA. Efficacy and safety of second-generation long-acting injections in schizophrenia: a meta-analysis of randomized-controlled trials. Int Clin Psychopharmacol. 2013;28(2):57–66. doi:10.1097/YIC.0b013e32835b091f23165366
  • Citrome L. Paliperidone palmitate - review of the efficacy, safety and cost of a new second-generation depot antipsychotic medication. Int J Clin Pract. 2010;64(2):216–239. doi:10.1111/j.1742-1241.2009.02240.x19886879
  • Mathews M, Gopal S, Nuamah I, et al. Clinical relevance of paliperidone palmitate 3-monthly in treating schizophrenia. Neuropsychiatr Dis Treat. 2019;15:1365–1379. doi:10.2147/NDT.S19722531190840
  • Citrome L. Iloperidone for schizophrenia: a review of the efficacy and safety profile for this newly commercialised second-generation antipsychotic. Int J Clin Pract. 2009;63(8):1237–1248. doi:10.1111/j.1742-1241.2009.02142.x19624791
  • Citrome L. Cariprazine for the treatment of schizophrenia: a review of this dopamine D3-preferring D3/D2 receptor partial agonist. Clin Schizophr Relat Psychoses. 2016;10(2):109–119. doi:10.3371/1935-1232-10.2.10927440212
  • Citrome L. Schizophrenia relapse, patient considerations, and potential role of lurasidone. Patient Prefer Adherence. 2016;10:1529–1537. doi:10.2147/PPA.S4540127563237
  • Citrome L, Norton JC, Chi-Burris K, Demos G. Pimavanserin for the treatment of Parkinson’s disease psychosis: number needed to treat, number needed to harm, and likelihood to be helped or harmed. CNS Spectr. 2018;23(3):228–238. doi:10.1017/S109285291700073629098976
  • United States Food and Drug Administration. Aristada (aripiprazole lauroxil) drug approval package; 2015 Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207533Orig1s000TOC.cfm. Accessed August 21, 2019.
  • Citrome L, Du Y, Risinger R, et al. Effect of aripiprazole lauroxil on agitation and hostility in patients with schizophrenia. Int Clin Psychopharmacol. 2016;31(2):69–75. doi:10.1097/YIC.000000000000010626517202
  • Citrome L. Relative vs. absolute measures of benefit and risk: what’s the difference? Acta Psychiatr Scand. 2010;121(2):94–102. doi:10.1111/j.1600-0447.2009.01449.x19694632

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