Peng Men and Zhanmiao Yi contributed equally to this work.
Amisulpride was introduced into China in 2010 as a second-generation atypical antipsychotic, while olanzapine has been on the market since 1999 as one of the leading treatments for schizophrenia in China. Since more Chinese patients are gaining access to amisulpride, the study aims to compare the efficacy, safety, and costs between amisulpride and olanzapine for schizophrenia treatment in China.
PubMed, Embase, the Cochrane library, China National Knowledge Infrastructure (CNKI) and WanFang database were systematically searched for randomized controlled trials (RCTs) up to July 2018. The Cochrane Risk of Bias tool was utilized to assess the quality of included studies. A meta-analysis was performed to compare the efficacy and safety of amisulpride and olanzapine, followed by a cost-minimization analysis using local drug and medical costs reported in China.
Twenty RCTs with 2000 patients were included in the systematic review. There were no significant differences between amisulpride and olanzapine on efficacy measures based on scores from the Positive and Negative Syndrome Scale, the Scale for the Assessment of Negative Symptoms, the Brief Psychiatric Rating Scale and the Clinical Global Impressions-Severity or Improvement. For safety outcomes, amisulpride was associated with lower fasting blood glucose and less abnormal liver functions as well as significantly lower risks of weight gain, constipation, and somnolence; olanzapine was associated with significantly lower risks of insomnia and lactation/amenorrhea/sexual hormone disorder. No significant differences were found in risks of extrapyramidal symptoms (EPS), tremor, akathisia, abnormal corrected QT interval. Cost-minimization analysis showed that amisulpride was likely to be a cost-saving alternative in China, with potential savings of 1358 Chinese Yuan (CNY) per patient for a three-month schizophrenia treatment compared with olanzapine.
As the first meta-analysis and cost-minimization analysis comparing the efficacy, safety and cost of amisulpride and olanzapine within a Chinese setting, the study suggests that amisulpride may be an effective, well-tolerated, and cost-saving antipsychotic drug alternative in China.
Schizophrenia overview. https://www.nimh.nih.gov/health/topics/schizophrenia/index.shtml. Accessed 26 Apr 2018.
GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the global burden of disease study 2015. Lancet. 2016;388:1545–602. https://doi.org/10.1016/S0140-6736(16)31678-6. PMID: 27733282 CrossRef
Montgomery W, Liu L, Stensland MD, Xue HB, Treuer T, Ascher-Svanum H. The personal, societal, and economic burden of schizophrenia in the People’s Republic of China: implications for antipsychotic therapy. Clinicoecon Outcomes Res. 2013;5:407–18. https://doi.org/10.2147/CEOR.S44325. PMID: 23983478 CrossRefPubMedPubMedCentral
Chong HY, Teoh SL, DB-C W, Kotirum S, Chiou C-F, Chaiyakunapruk N. Global economic burden of schizophrenia: a systematic review. Neuropsychiatr Dis Treat. 2016; https://doi.org/10.2147/NDT.S96649.
Wu J, He X, Liu L, Ye W, Montgomery W, Xue H, et al. Health care resource use and direct medical costs for patients with schizophrenia in Tianjin, People’s Republic of China. Neuropsychiatr Dis Treat. 2015;11:983–90. https://doi.org/10.2147/NDT.S76231. PMID: 25897235 CrossRefPubMedPubMedCentral
Zhao J, Shi S. Chinese guidelines for the prevention and treatment of schizophrenia (version 2). 2015.
Research and Markets. Investigation Report on China’s Olanzapine Market 2015–2019. 2015. https://www.prnewswire.com/news-releases/investigation-report-on-chinas-olanzapine-market-2015-2019-300125449.html. Accessed 26 Apr 2018.
Komossa K, Rummel-Kluge C, Hunger H, Schmid F, Schwarz S, Silveira da Mota Neto JI, et al. Amisulpride versus other atypical antipsychotics for schizophrenia. Cochrane Database Syst Rev. 2010;1:CD006624. https://doi.org/10.1002/14651858.CD006624.pub2. PMID: 20091599 CrossRef
Lin L, Zhao YJ, Zhou HJ, Khoo AL, Teng M, Soh LB, et al. Comparative cost-effectiveness of 11 oral antipsychotics for relapse prevention in schizophrenia within Singapore using effectiveness estimates from a network meta-analysis. Int Clin Psychopharmacol. 2016;31:84–92. https://doi.org/10.1097/YIC.0000000000000111. PMID: 26619182 CrossRefPubMed
Obradovic M, Mrhar A, Kos M. Cost-effectiveness of antipsychotics for outpatients with chronic schizophrenia. Int J Clin Pract. 2007;61:1979–88. https://doi.org/10.1111/j.1742-1241.2007.01431.x. CrossRefPubMed
Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from: http://handbook.cochrane.org. Accessed 26 Apr 2018.
The guidelines manual | Guidance and guidelines | NICE. https://www.nice.org.uk/process/pmg6/chapter/introduction. Accessed 26 Apr 2018.
Lecrubier Y, Quintin P, Bouhassira M, Perrin E, Lancrenon S. The treatment of negative symptoms and deficit states of chronic schizophrenia: olanzapine compared to amisulpride and placebo in a 6-month double-blind controlled clinical trial. Acta Psychiatr Scand. 2006;114:319–27. https://doi.org/10.1111/j.1600-0447.2006.00887.x. PMID: 17022791 CrossRefPubMed
Praharaj SK, Jana AK, Goyal N, Sinha VK. Metformin for olanzapine-induced weight gain: a systematic review and meta-analysis. Br J Clin Pharmacol. 2011;71:377–82. https://doi.org/10.1111/j.1365-2125.2010.03783.x. PMID: 21284696 CrossRefPubMedPubMedCentral
Chu W, Chen Y, Zhao Y, Zhao B, Xu Z, Qiu R, et al. A comparison of six kinds of antipsychotic drugs′effects on the cognitive function in patients with first episode schizophrenia. J Clin Psychiatry. 2015;25:197–9. https://bit.ly/2KdKgFX. Accessed 26 Apr 2018
Guo W, Xu H, Zhang X. A randomized and comparative study of amisulpride and olanzapine in treatment of schizophrenia. J Neurosci Ment Health. 2012;12:284–6. https://doi.org/10.3969/j.issn.1009-6574.2012.03.022. CrossRef
Kahn RS, Fleischhacker WW, Boter H, Davidson M, Vergouwe Y, Keet IPM, et al. Effectiveness of antipsychotic drugs in first-episode schizophrenia and schizophreniform disorder: an open randomised clinical trial. Lancet. 2008;371:1085–97. https://doi.org/10.1016/S0140-6736(08)60486-9. PMID: 18374841 CrossRefPubMed
Kong Y, Song Y. A control study of amisulpride vs.olanzapine in the treatment of first-episode schizophrenia. J Cli Psychosom Dis. 2014;20:34–35,40. https://doi.org/10.3969/j.issn.1672-187X.2014.06.014-0034-03. CrossRef
Li B, Chi Z, Chen B, Yan C. Effects of amisulpride, paliperidone extendedrelease tablets, olanzapine on cognitive and memory function of patients with first-episode schizophrenia and without medication. J Inte Tional Psychiatry. 2015;42:14–7. https://bit.ly/2JrAMWn. Accessed 26 Apr 2018.
Li F, Zheng X, Feng W. A control study on amisulpride and olanzapine in first episode patients with schizophrenia. 2014;24:121–2. https://bit.ly/2FeQDFm. Accessed 26 Apr 2018.
Lin H, Miao H. Clinical observation of amoxicillin and olanzapine in the treatment of acute schizophrenia. J Mod Clin Med. 2015;41:130–1. https://doi.org/10.11851/j.issn.1673-1557.2015.02.018. CrossRef
Liu X, Jin S, Li W. A control study of amisulpride vs olanzapine in the treatment of female schizophrenia. J Clin Psychosom Dis. 2015;21 https://doi.org/10.3969/j.issn.1672-187X.2015.02.012-0035-03.
Lv Z, Zhou Z, Zhang Y. The treatment of female schizophrenia using Amisulpride and olanzapine. China J Health Psychol. 2014;22:499–501. https://doi.org/10.13342/j.cnki.cjhp.2014.04.009. CrossRef
Pawar GR, Phadnis P, Paliwal A. Evaluation of efficacy, safety, and cognitive profile of amisulpride per se and its comparison with olanzapine in newly diagnosed schizophrenic patients in an 8-week, double-blind, single-centre, prospective clinical trial. ISRN Psychiatry. 2012;2012:703751. https://doi.org/10.5402/2012/703751. PMID: 23738210 CrossRefPubMedPubMedCentral
Sun X, Yang J. The curative effects of amisulpride and olanzapine on acute schizophrenia. Chin J Prev Contr Chron Dis. 2013;21:292–3. 296. https://doi.org/10.16386/j.cjpccd.issn.1004-6194.2013.03.048. CrossRef
Vanelle J-M, Douki S. A double-blind randomised comparative trial of amisulpride versus olanzapine for 2 months in the treatment of subjects with schizophrenia and comorbid depression. Eur Psychiatry. 2006;21:523–30. https://doi.org/10.1016/j.eurpsy.2006.09.003. PMID: 17113759 CrossRefPubMed
Wagner M, Quednow BB, Westheide J, Schlaepfer TE, Maier W, Kühn K-U. Cognitive improvement in schizophrenic patients does not require a serotonergic mechanism: randomized controlled trial of olanzapine vs amisulpride. Neuropsychopharmacology. 2005;30:381–90. https://doi.org/10.1038/sj.npp.1300626. PMID: 15578006 CrossRefPubMed
Yang D, Chen J, Chen Y, Peng H. Comparative study of Amisulpride vs .Olanzapine for the treatment of schizophrenia. J Clin Res. 2014;31:479–480,483. https://doi.org/10.3969/j.issn.1671-7171.2014.03.022. CrossRef
Yang F, Zhang C, Wen L. A control study of amisulpride vs olanzapine in the treatment of schizophrenia characterized by negative symptoms. J Clin Psychosom Dis. 2015;21:32–34,48. https://doi.org/10.3969/j.issn.1672-187X.2015.02.011-0032-04. CrossRef
Yao K, Zhou Q, Sui Y. A comparative study of sulforam and olanzapine on first - episode schizophrenia. Anhui Med J. 2016;37:80–2. https://doi.org/10.3969/j.issn.1000-0399.2016.01.026. CrossRef
Yi J, Hu Y, Wan Q. Comparative study on effects of amisulpride and olanzapine on glucose and lipid metabolism in patients with aged schizophrenia. J Neurosci Ment Health. 2014;14:400–402,405. https://doi.org/10.3969/j.issn.1009-6574.2014.04.022. CrossRef
- Comparative efficacy and safety between amisulpride and olanzapine in schizophrenia treatment and a cost analysis in China: a systematic review, meta-analysis, and cost-minimization analysis
- BioMed Central