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

Pei-Yin Pan, Meei-Shyuan Lee, Chin-Bin Yeh, Pei-Yin Pan, Meei-Shyuan Lee, Chin-Bin Yeh

Abstract

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.

Figures

Figure 1
Figure 1
The study design and schematic diagram of switching from other antipsychotics to quetiapine XR in this investigation.aAfter day 2, the dosage of quetiapine XR was allowed up to 800 mg. From day 8 until week 12, the dose of quetiapine XR was adjusted within the effective dose range of 400 mg to 800 mg per day.
Figure 2
Figure 2
Patient disposition during the study.
Figure 3
Figure 3
Changes in PANSS total and subscale scores from baseline to week 12 in patients with schizophrenia receiving the treatment of switching to quetiapine XR. The change in PANSS total and subscales score in all patients shown is based on estimated marginal means. *p < .05.
Figure 4
Figure 4
Changes in PANSS total score from baseline to W1, W4, W8 and W12 in patients with schizophrenia after switching to quetiapine XR. The change in PANSS total score in all patients shown is based on estimated marginal means. *p < .05.

References

    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. doi: 10.3109/15622975.2012.696143.
    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 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. doi: 10.3109/15622975.2012.739708.
    1. 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. doi: 10.1093/schbul/sbp116.
    1. 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. . Accessed Feb 2014.
    1. 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. doi: 10.4088/JCP.v67n0317.
    1. Llorca PM. Partial compliance in schizophrenia and the impact on patient outcomes. Psychiatry Res. 2008;161(2):235–47. doi: 10.1016/j.psychres.2007.07.012.
    1. Lindström E, Bingefors K. Patient compliance with drug therapy in schizophrenia. Economic and clinical issues. Pharmacoeconomics. 2000;18(2):106–24.
    1. 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. doi: 10.4088/JCP.v67n1008.
    1. 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. doi: 10.4088/JCP.v63n1007.
    1. 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. doi: 10.1176/appi.ps.201100011.
    1. 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. doi: 10.4088/JCP.9096su1cc.04.
    1. 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. doi: 10.4088/JCP.v69n0114.
    1. Masand PS, Narasimhan M. Improving adherence to antipsychotic pharmacotherapy. Curr Clin Pharmacol. 2006;1(1):47–56. doi: 10.2174/157488406775268255.
    1. 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. doi: 10.1016/S0149-2918(01)80109-0.
    1. 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. doi: 10.1177/0269881113517956.
    1. Arango C, Bobes J. Managing acute exacerbations of schizophrenia: focus on quetiapine. Curr Med Res Opin. 2004;20(5):619–26. doi: 10.1185/030079904125003430.
    1. 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. doi: 10.1016/j.schres.2012.08.030.
    1. 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. doi: 10.1016/j.jpsychires.2011.07.014.
    1. 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. doi: 10.1177/0269881105056665.
    1. 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. doi: 10.1080/13651500510029011.
    1. 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. doi: 10.1097/01.jcp.0000168486.14516.7c.
    1. 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. doi: 10.1080/13651500600579068.
    1. 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. doi: 10.1016/j.ajem.2004.02.021.
    1. 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.
    1. Peuskens J. The management of schizophrenia: focus on extended-release quetiapine fumarate. Neuropsychiatr Dis Treat. 2011;7:549–64. doi: 10.2147/NDT.S3380.
    1. 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. doi: 10.1016/j.pnpbp.2008.09.026.
    1. 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. doi: 10.1016/j.clinthera.2009.03.002.
    1. 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. doi: 10.1002/hup.844.
    1. Chue PS, MacKenzie EM, Chue JA, Baker GB. The pharmacology and formulation of paliperidone extended release. Expert Rev Neurother. 2012;12(12):1399–410. doi: 10.1586/ern.12.138.
    1. 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. doi: 10.4088/JCP.v65n0311.
    1. 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. doi: 10.1002/hup.1091.
    1. 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. doi: 10.4088/JCP.v68n0603.
    1. 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.
    1. 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. doi: 10.1097/YIC.0b013e328337789b.
    1. 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.
    1. 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. doi: 10.1185/03007995.2012.762903.
    1. 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. doi: 10.1176/ajp.148.12.1697.
    1. 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. doi: 10.1111/j.1600-0447.1989.tb08581.x.
    1. 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. doi: 10.1016/0165-1781(89)90170-4.
    1. 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. doi: 10.1016/0278-5846(92)90070-U.
    1. 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. doi: 10.1097/YIC.0b013e328363aa33.
    1. 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. doi: 10.1159/000337739.
    1. Chue P, Stip E, Remington G, Kopala L. Switching atypical antipsychotics: a review. Acta Neuropsychiatr. 2004;16:301–13. doi: 10.1111/j.0924-2708.2004.00098.x.
    1. 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.
    1. 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. doi: 10.2147/NDT.S39303.
    1. 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. doi: 10.1016/j.eurpsy.2011.02.005.
    1. Cheer SM, Wagstaff AJ. Quetiapine. A review of its use in the management of schizophrenia. CNS Drugs. 2004;18(3):173–99. doi: 10.2165/00023210-200418030-00004.
    1. Evans SR. Clinical trial structures. J Exp Stroke Transl Med. 2010;3(1):8–18. doi: 10.6030/1939-067X-3.1.8.
    1. Jüni P, Altman DG, Egger M. Systematic reviews in health care: assessing the quality of controlled clinical trials. BMJ. 2001;323(7303):42–6. doi: 10.1136/bmj.323.7303.42.
    1. Furberg CD, Soliman EZ. Double-blindness protects scientific validity. J Thromb Haemost. 2008;6(2):230–1. doi: 10.1111/j.1538-7836.2008.02836.x.
    1. 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. doi: 10.1111/j.1742-1241.2007.01416.x.

Source: PubMed

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir