Hospitalization rates in patients switched from oral anti-psychotics to aripiprazole once-monthly: final efficacy analysis

被引:40
作者
Kane, John M. [1 ,2 ]
Zhao, Cathy [3 ]
Johnson, Brian R. [4 ]
Baker, Ross A. [5 ]
Eramo, Anna [6 ]
McQuade, Robert D. [7 ]
Duca, Anna R. [4 ]
Sanchez, Raymond [8 ]
Peters-Strickland, Timothy [8 ]
机构
[1] Zucker Hillside Hosp, Glen Oaks, NY 11004 USA
[2] Hofstra North Shore LIJ Sch Med, Hempstead, NY USA
[3] Otsuka Pharmaceut Dev & Commercializat Inc, Biostat, Princeton, NJ USA
[4] Otsuka Pharmaceut Dev & Commercializat Inc, Clin Management, Princeton, NJ USA
[5] Otsuka Pharmaceut Dev & Commercializat Inc, CNS Global Med Affairs, Princeton, NJ USA
[6] Lundbeck LLC, Med Affairs & Phase Clin Affairs 4, Deerfield, IL USA
[7] Otsuka Pharmaceut Dev & Commercializat Inc, Global Med Regulatory Affairs & Alliances, Princeton, NJ USA
[8] Otsuka Pharmaceut Dev & Commercializat Inc, Global Clin Dev CNS, Princeton, NJ USA
关键词
Anti-psychotic agent; Aripiprazole once-monthly; Hospitalization; Long-acting injectable; Schizophrenia;
D O I
10.3111/13696998.2014.979936
中图分类号
F [经济];
学科分类号
02 ;
摘要
Objective: To compare hospitalization rates in patients with schizophrenia treated prospectively with aripiprazole once-monthly 400 mg (AOM 400; an extended-release injectable suspension) vs the same patients' retrospective rates with their prior oral anti-psychotic therapy. Research design and methods: Multi-center, open-label, mirror-image, naturalistic study in a community setting in North America. Patients who required a change in treatment and/or would benefit from long-acting injectable anti-psychotic therapy were treated prospectively for 6 months with AOM 400. Retrospective data on hospitalization rates were obtained. Clinical trial registration: ClinicalTrials. gov: NCT01432444. Main outcome measures: The proportion of patients with >= 1 psychiatric inpatient hospitalization with oral anti-psychotic therapy examined retrospectively (months -4 to -1 before oral conversion) and after switching to AOM 400 (months 4-6 after initiating AOM 400). Results: Psychiatric hospitalization rates were significantly lower when patients were treated with AOM 400 compared with oral anti-psychotic therapy both in the 3-month primary efficacy sample (2.7% [n = 9/ 336] vs 27.1% [n = 91/336], respectively; p50.0001) and in the total sample (6-month prospective rate: 8.8% [n = 38/433] vs 6-month retrospective rate: 38.1% [n = 165/433]; p50.0001). Discontinuations due to adverse events (AEs) during cross-titration were lower in patients cross-titrated on oral aripiprazole for >1 and <4 weeks (2.9% [n = 7/239]) compared with patients cross-titrated for = 1 week (10.4% [n = 5/48]). The most common treatment-emergent AEs during the prospective treatment phase were insomnia (6.7% [n = 29/431]) and akathisia (6.5% [n = 28/431]). Patient-rated injection-site pain decreased from the first injection to the last visit. Conclusions: In a community setting, patients with schizophrenia demonstrated significantly lower psychiatric hospitalization rates after switching from their prior oral anti-psychotic therapy to AOM 400. Patients served as their own control, and thus an active control group was not included in this study. Confounding factors, such as insurance coverage and availability of hospital beds, were not examined here and deserve further consideration.
引用
收藏
页码:145 / 154
页数:10
相关论文
共 36 条
[1]  
Schizophrenia, (2014)
[2]  
Wu E.Q., Birnbaum H.G., Shi L., Et al., The economic burden of schizophrenia in the United States in 2002, J Clin Psychiatry, 66, pp. 1122-1129, (2005)
[3]  
Gustavsson A., Svensson M., Jacobi F., Et al., Cost of disorders of the brain in Europe 2010, Eur Neuropsychopharmacol, 21, pp. 718-779, (2011)
[4]  
Hasan A., Falkai P., Wobrock T., Et al., World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for biological treatment of schizophrenia, part 2: Update 2012 on the long-term treatment of schizophrenia and management of antipsychotic-induced side effects, World J Biol Psychiatry, 14, pp. 2-44, (2013)
[5]  
Novick D., Haro J.M., Suarez D., Et al., Predictors and clinical consequences of non-adherence with antipsychotic medication in the outpatient treatment of schizophrenia, Psychiatry Res, 176, pp. 109-113, (2010)
[6]  
Offord S., Lin J., Mirski D., Et al., Impact of early nonadherence to oral anti-psychotics on clinical and economic outcomes among patients with schizophrenia, Adv Ther, 30, pp. 286-297, (2013)
[7]  
Gilmer T.P., Dolder C.R., Lacro J.P., Et al., Adherence to treatment with antipsych-otic medication and health care costs among Medicaid beneficiaries with schizophrenia, Am J Psychiatry, 161, pp. 692-699, (2004)
[8]  
Weiden P.J., Kozma C., Grogg A., Et al., Partial compliance and risk of rehos-pitalization among California Medicaid patients with schizophrenia, Psychiatr Serv, 55, pp. 886-891, (2004)
[9]  
Velligan D.I., Weiden P.J., Sajatovic M., Et al., The expert consensus guideline series: Adherence problems in patients with serious and persistent mental illness, J Clin Psychiatry, 70, pp. 1-46, (2009)
[10]  
Fleischhacker W.W., Sanchez R., Perry P.P., Et al., Aripiprazole once-monthly for treatment of schizophrenia: A double-blind, randomised, non-inferiority study, Br J Psychiatry, 205, pp. 135-144, (2014)