The efficacy and safety of once-daily quetiapine extended release in patients with schizophrenia switched from other antipsychotics: an open-label study in Chinese population

BMC Psychiatry

Chin-Bin Yeh²  Meei-Shyuan Lee¹  Pei-Yin Pan² 

[1] School of Public Health, National Defense Medical Center, No.161, Sec. 6, Minquan E. Rd., Neihu Dist., Taipei City 114, Taiwan;Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, No.325, Sec.2,Chenggong Rd., Neihu Dist., Taipei City 114, Taiwan

关键词: Chinese population;    Drug switching;    Antipsychotic agents;    Quetiapine XR;    Schizophrenia;   

Others  :  1090489
DOI  :  10.1186/s12888-014-0378-5

 received in 2014-08-09, accepted in 2014-12-20,  发布年份 2015

【 摘 要 】

Background

Non-adherence to antipsychotic medication in schizophrenic patients is common and associated with symptom relapse and poorer long-term outcomes. The risk factors for treatment non-adherence include dosing frequency and complexity. Besides, slower dose titration in an acute schizophrenic episode may lead to attenuated efficacy. Therefore, the convenient dosage regimen and rapid initiation scheme of quetiapine extended release (XR) were expected to provide better effectiveness and promote adherence in patients with schizophrenia. This study was implemented to assess the efficacy and safety of once-daily quetiapine XR in schizophrenic patients with switched from other antipsychotics which were suboptimal due to insufficient efficacy or tolerability.

Methods

This was a 12-week, open-label study conducted in the Chinese population in Taiwan.

Patients who had a score of 4 (moderate) or greater on any of the 7 items of the Positive and Negative Syndrome Scale (PANSS) Positive Symptom Subscale and needed to switch from previous antipsychotics were recruited. Quetiapine XR was administered at 300 mg on day 1, 600 mg on day 2 and up to 800 mg after day 2. From day 8 until the end of the study, the dose of quetiapine XR was adjusted within 400-800 mg per day, depending on the clinical response and tolerance of the patients. The variable of the primary outcome was the change from baseline to Week 12 in PANSS total and subscale scores. Secondary outcome was the baseline-to-endpoint difference in the Clinical Global Impression-Severity (CGI-S) scores of the participants.

Results

Sixty-one patients were recruited and 55.7% of them completed the study. The mean changes in the PANSS total score and CGI-S score showed significant improvement (−18.4, p < .001 and −1.0, p < .001, respectively). Four patients (6.7%) experienced adverse events including headache, exacerbation of psychosis and dysuria. The use of concomitant anticholinergics decreased from 15.0% to 8.3%.

Conclusions

The results of our investigation implicated that quetiapine XR was an effective and well tolerated alternative for Chinese schizophrenic patients with previous suboptimal treatment. Future large-scale studies are warranted to validate our results.

Trial registration

ClinicalTrials.gov ID NCT02142556. Registered 15 May 2014.

【 授权许可】

   
2015 Pan et al.; licensee BioMed Central.

【 图 表 】

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【 参考文献 】

• [1]Hasan A, Falkai P, Wobrock T, Lieberman J, Glenthoj B, Gattaz WF, et al.: World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines for Biological Treatment of Schizophrenia, part 1: update 2012 on the acute treatment of schizophrenia and the management of treatment resistance. World J Biol Psychiatry 2012, 13(5):318-78.
• [2]Hasan A, Falkai P, Wobrock T, Lieberman J, Glenthoj B, Gattaz WF, 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 2013, 14(1):2-44.
• [3]Buchanan RW, Kreyenbuhl J, Kelly DL, Noel JM, Boggs DL, Fischer BA, et al.: The 2009 schizophrenia PORT psychopharmacological treatment recommendations and summary statements. Schizophr Bull 2010, 36(1):71-93.
• [4]National Institute for Health and Clinical Excellence. Psychosis and schizophrenia in adults: treatment and management, NICE clinical guideline 178. In: NICE. National Institute for Health and Clinical Excellence. 2014. http://www.nice.org.uk/guidance/CG178. Accessed Feb 2014.
• [5]Ascher-Svanum H, Faries DE, Zhu B, Ernst FR, Swartz MS, Swanson JW: Medication adherence and long-term functional outcomes in the treatment of schizophrenia in usual care. J Clin Psychiatry 2006, 67(3):453-60.
• [6]Llorca PM: Partial compliance in schizophrenia and the impact on patient outcomes. Psychiatry Res 2008, 161(2):235-47.
• [7]Lindström E, Bingefors K: Patient compliance with drug therapy in schizophrenia. Economic and clinical issues. Pharmacoeconomics 2000, 18(2):106-24.
• [8]Valenstein M, Ganoczy D, McCarthy JF, Myra Kim H, Lee TA, Blow FC: Antipsychotic adherence over time among patients receiving treatment for schizophrenia: a retrospective review. J Clin Psychiatry 2006, 67(10):1542-50.
• [9]Lacro JP, Dunn LB, Dolder CR, Leckband SG, Jeste DV: Prevalence of and risk factors for medication nonadherence in patients with schizophrenia: a comprehensive review of recent literature. J Clin Psychiatry 2002, 63(10):892-909.
• [10]Chang CM, Wu KY, Liang HY, Wu EC, Chen CY, Wu CS, et al.: Adherence patterns with first- versus second-generation antipsychotics for newly diagnosed schizophrenia in Taiwan. Psychiatr Serv 2012, 63(5):504-7.
• [11]Goff DC, Hill M, Freudenreich O: Strategies for improving treatment adherence in schizophrenia and schizoaffective disorder. J Clin Psychiatry 2010, 71(Suppl 2):20-6.
• [12]Perkins DO, Gu H, Weiden PJ, McEvoy JP, Hamer RM, Lieberman JA, et al.: Predictors of treatment discontinuation and medication nonadherence in patients recovering from a first episode of schizophrenia, schizophreniform disorder, or schizoaffective disorder: a randomized, double-blind, flexible-dose, multicenter study. J Clin Psychiatry 2008, 69(1):106-13.
• [13]Masand PS, Narasimhan M: Improving adherence to antipsychotic pharmacotherapy. Curr Clin Pharmacol 2006, 1(1):47-56.
• [14]Claxton AJ, Cramer J, Pierce C: A systematic review of the associations between dose regimens and medication compliance. Clin Ther 2001, 23(8):1296-310.
• [15]Leucht S, Zhao J: Early improvement as a predictor of treatment response and remission in patients with schizophrenia: a pooled, post-hoc analysis from the asenapine development program. J Psychopharmacol 2014, 28(4):387-94.
• [16]Arango C, Bobes J: Managing acute exacerbations of schizophrenia: focus on quetiapine. Curr Med Res Opin 2004, 20(5):619-26.
• [17]Levine SZ, Leucht S: Early symptom response to antipsychotic medication as a marker of subsequent symptom change: an eighteen-month follow-up study of recent episode schizophrenia. Schizophr Res 2012, 141(2–3):168-72.
• [18]Schennach-Wolff R, Meyer S, Seemüller F, Jäger M, Schmauss M, Laux G, et al.: Influencing factors and predictors of early improvement in the acute treatment of schizophrenia and schizophrenia spectrum disorder. J Psychiatr Res 2011, 45(12):1639-47.
• [19]Pajonk FG, Schwertner AK, Seelig MA: Rapid dose titration of quetiapine for the treatment of acute schizophrenia and acute mania: a case series. J Psychopharmacol 2006, 20(1):119-24.
• [20]Ganesan S, Levy M, Bilsker D, Khanbhai I: Effectiveness of quetiapine for the management of aggressive psychosis in the emergency psychiatric setting: a naturalistic uncontrolled trial. Int J Psychiatry Clin Pract 2005, 9(3):199-203.
• [21]Smith MA, McCoy R, Hamer-Maansson J, Brecher M: Rapid dose escalation with quetiapine: a pilot study. J Clin Psychopharmacol 2005, 25(4):331-5.
• [22]Keks NA, Tonso M, Tabone K, McHugh M, Thomas R, Tune P, et al.: Clinical experience with atypical antipsychotics in an acute inpatient unit: focus on quetiapine. Int J Psychiatry Clin Pract 2006, 10(2):138-41.
• [23]Kinon BJ, Ahl J, Rotelli MD, McMullen E: Efficacy of accelerated dose titration of olanzapine with adjunctive lorazepam to treat acute agitation in schizophrenia. Am J Emerg Med 2004, 22(3):181-6.
• [24]Lindenmayer JP, Brown D, Liu S, Brecher M, Meulien D: The efficacy and tolerability of once-daily extended release quetiapine fumarate in hospitalized patients with acute schizophrenia: a 6-week randomized, double-blind, placebo-controlled study. Psychopharmacol Bull 2008, 41(3):11-35.
• [25]Peuskens J: The management of schizophrenia: focus on extended-release quetiapine fumarate. Neuropsychiatr Dis Treat 2011, 7:549-64.
• [26]Figueroa C, Brecher M, Hamer-Maansson JE, Winter H: Pharmacokinetic profiles of extended release quetiapine fumarate compared with quetiapine immediate release. Prog Neuropsychopharmacol Biol Psychiatry 2009, 33(2):199-204.
• [27]Datto C, Berggren L, Patel JB, Eriksson H: Self-reported sedation profile of immediate-release quetiapine fumarate compared with extended-release quetiapine fumarate during dose initiation: a randomized, double-blind, crossover study in healthy adult subjects. Clin Ther 2009, 31(3):492-502.
• [28]Boidi G, Ferro M: Rapid dose initiation of quetiapine for the treatment of acute schizophrenia and schizoaffective disorder: a randomised, multicentre, parallel-group, open study. Hum Psychopharmacol 2007, 22(5):299-306.
• [29]Chue PS, MacKenzie EM, Chue JA, Baker GB: The pharmacology and formulation of paliperidone extended release. Expert Rev Neurother 2012, 12(12):1399-410.
• [30]Diaz E, Neuse E, Sullivan MC, Pearsall HR, Woods SW: Adherence to conventional and atypical antipsychotics after hospital discharge. J Clin Psychiatry 2004, 65(3):354-60.
• [31]Meulien D, Huizar K, Brecher M: Safety and tolerability of once-daily extended release quetiapine fumarate in acute schizophrenia: pooled data from randomised, double-blind, placebo-controlled studies. Hum Psychopharmacol 2010, 25(2):103-15.
• [32]Kahn RS, Schulz SC, Palazov VD, Reyes EB, Brecher M, Svensson O, et al.: Efficacy and tolerability of once-daily extended release quetiapine fumarate in acute schizophrenia: a randomized, double-blind, placebo-controlled study. J Clin Psychiatry 2007, 68(6):832-42.
• [33]Peuskens J, Trivedi J, Malyarov S, Brecher M, Svensson O, Miller F, et al.: Prevention of schizophrenia relapse with extended release quetiapine fumarate dosed once daily: a randomized, placebo-controlled trial in clinically stable patients. Psychiatry (Edgmont) 2007, 4(11):34-50.
• [34]Peuskens J, Trivedi JK, Brecher M, Miller F: Study 4 Investigators: Long-term symptomatic remission of schizophrenia with once-daily extended release quetiapine fumarate: post-hoc analysis of data from a randomized withdrawal, placebo-controlled study. Int Clin Psychopharmacol 2010, 25(3):183-7.
• [35]Ganesan S, Agambaram V, Randeree F, Eggens I, Huizar K, Meulien D, et al.: Switching from other antipsychotics to once-daily extended release quetiapine fumarate in patients with schizophrenia. Curr Med Res Opin 2008, 24(1):21-32.
• [36]Chue P, Malla A, Bouchard RH, Lessard S, Ganesan S, Stip E, et al.: The long-term clinical benefit and effectiveness of switching to once-daily quetiapine extended release in patients with schizophrenia. Curr Med Res Opin 2013, 29(3):227-39.
• [37]Compton WM 3rd, Helzer JE, Hwu HG, Yeh EK, McEvoy L, Tipp JE, et al.: New methods in cross-cultural psychiatry: psychiatric illness in Taiwan and the United States. Am J Psychiatry 1991, 148(12):1697-704.
• [38]Hwu HG, Yeh EK, Chang LY: Prevalence of psychiatric disorders in Taiwan defined by the Chinese Diagnostic Interview Schedule. Acta Psychiatr Scand 1989, 79(2):136-47.
• [39]Jann MW, Chang WH, Davis CM, Chen TY, Deng HC, Lung FW, et al.: Haloperidol and reduced haloperidol plasma levels in Chinese vs. non-Chinese psychiatric patients. Psychiatry Res 1989, 30(1):45-52.
• [40]Jann MW, Chang WH, Lam YW, Hwu HG, Lin HN, Chen H, et al.: Comparison of haloperidol and reduced haloperidol plasma levels in four different ethnic populations. Prog Neuropsychopharmacol Biol Psychiatry 1992, 16(2):193-202.
• [41]Chou YH, Chiu NM, Yang TT, Feng J, Chan CC, Lee HK, et al.: An early improvement in depressive symptoms predicts symptomatic remission of schizophrenia treated with quetiapine: a multicenter, 4-week case-control study. Int Clin Psychopharmacol 2013, 28(5):255-60.
• [42]Giegling I, Porcelli S, Balzarro B, Andrisano C, Schäfer M, Möller HJ, et al.: Antipsychotic response in the first week predicts later efficacy. Neuropsychobiology 2012, 66(2):100-5.
• [43]Chue P, Stip E, Remington G, Kopala L: Switching atypical antipsychotics: a review. Acta Neuropsychiatr 2004, 16:301-13.
• [44]Coleman CI, Limone B, Sobieraj DM, Lee S, Roberts MS, Kaur R, et al.: Dosing frequency and medication adherence in chronic disease. J Manag Care Pharm 2012, 18(7):527-39.
• [45]Medic G, Higashi K, Littlewood KJ, Diez T, Granström O, Kahn RS: Dosing frequency and adherence in chronic psychiatric disease: systematic review and meta-analysis. Neuropsychiatr Dis Treat 2013, 9:119-31.
• [46]Barkhof E, Meijer CJ, de Sonneville LMJ, Linszen DH, de Haan L: Interventions to improve adherence to antipsychotic medication in patients with schizophrenia–a review of the past decade. Eur Psychiatry 2012, 27(1):9-18.
• [47]Cheer SM, Wagstaff AJ: Quetiapine. A review of its use in the management of schizophrenia. CNS Drugs 2004, 18(3):173-99.
• [48]Evans SR: Clinical trial structures. J Exp Stroke Transl Med 2010, 3(1):8-18.
• [49]Jüni P, Altman DG, Egger M: Systematic reviews in health care: assessing the quality of controlled clinical trials. BMJ 2001, 323(7303):42-6.
• [50]Furberg CD, Soliman EZ: Double-blindness protects scientific validity. J Thromb Haemost 2008, 6(2):230-1.
• [51]Tschoner A, Engl J, Laimer M, Kaser S, Rettenbacher M, Fleischhacker WW, et al.: Metabolic side effects of antipsychotic medication. Int J Clin Pract 2007, 61(8):1356-70.