Long-term health-related quality of life improvements among patients treated with lurasidone: results from the open-label extension of a switch trial in schizophrenia

George Awad, Daisy Ng-Mak, Krithika Rajagopalan, Jay Hsu, Andrei Pikalov, Antony Loebel, George Awad, Daisy Ng-Mak, Krithika Rajagopalan, Jay Hsu, Andrei Pikalov, Antony Loebel

Abstract

Background: Long-term improvement of health-related quality of life (HRQoL) in schizophrenia may improve adherence and reduce relapse and rehospitalization. This analysis examines long-term changes in HRQoL among patients with schizophrenia switched to lurasidone from other antipsychotics.

Methods: Patients who completed an open-label 6-week switch study continued on lurasidone for an additional 24-weeks. HRQoL was measured using the self-reported Personal Evaluation of Transitions in Treatment (PETiT) scale and Short-Form 12 (SF-12) questionnaire. The PETiT assessed HRQoL via total and domain scores (adherence-related attitude and psychosocial functioning). The SF-12 assessed patients' mental and physical component summary scores (MCS and PCS). Mean changes from the initial baseline were calculated at extension baseline and extension endpoint using analysis of covariance models. Analyses were further stratified by prior antipsychotic medication and responder status; responders were defined as having a ≥20 % improvement in Positive and Negative Syndrome Scale during the first 6-weeks of treatment.

Results: The analysis included 144 patients with PETIT or SF-12 data who received ≥1 dose of lurasidone. Mean (standard deviation) PETiT total score improved significantly from 34.9 (9.3) at baseline to 39.5 (8.9) at extension baseline and 39.1 (9.0) at extension endpoint, representing improvements of 4.5 (7.9) and 5.1 (7.2) points, respectively (both p < 0.001). Significant improvements in adherence-related attitude and psychosocial functioning were observed at extension baseline and extension endpoint (all p < 0.001). Improvement in SF-12 MCS score was observed at extension baseline and endpoint, and PCS score at extension endpoint (all p < 0.01). Patients who switched from quetiapine and aripiprazole showed significant improvement of PETiT total score and adherence-related attitude at extension baseline and extension endpoint. In addition, patients who switched from quetiapine, risperidone, aripiprazole, or ziprasidone showed significant improvement in MCS scores from baseline to extension endpoint. Responders to lurasidone demonstrated greater improvement in PETiT total, psychosocial functioning, and MCS scores at extension baseline than nonresponders.

Conclusions: After switching to lurasidone, patients with schizophrenia experienced HRQoL improvements that were sustained for an additional 24 weeks of treatment. Further study is warranted to understand the implications of these improvements in terms of employment, adherence, relapse, and rehospitalization.

Trial registration: Clinical trials.gov identifier NCT01143090 (June 10th, 2010).

Keywords: Antipsychotic; Health-related quality of life; Long-term; Lurasidone; PETiT; SF-12.

Figures

Fig. 1
Fig. 1
Design of the lurasidone open-label core and extension switch studies.* 144 of the 235 (61 %) patients included in the core 6-week study of HRQoL were included
Fig. 2
Fig. 2
Mean Changes in PETiT total and domain scores in patients switched to long-term lurasidone therapy

References

    1. Mangalore R, Knapp M. Cost of schizophrenia in England. J Ment Health Policy Econ. 2007;10:23–41.
    1. Schennach R, Musil R, Moller HJ, Riedel M. Functional outcomes in schizophrenia: employment status as a metric of treatment outcome. Curr Psychiatry Rep. 2012;14:229–36. doi: 10.1007/s11920-012-0261-3.
    1. Karow A, Moritz S, Lambert M, Schottle D, Naber D. Remitted but still impaired? symptomatic versus functional remission in patients with schizophrenia. Eur Psychiatry. 2012;27:401–5. doi: 10.1016/j.eurpsy.2011.01.012.
    1. Palmer BW, Heaton RK, Gladsjo JA, Evans JD, Patterson TL, Golshan S, et al. Heterogeneity in functional status among older outpatients with schizophrenia: employment history, living situation, and driving. Schizophr Res. 2002;55:205–15. doi: 10.1016/S0920-9964(01)00218-3.
    1. Ucok A, Gorwood P, Karadayi G. Employment and its relationship with functionality and quality of life in patients with schizophrenia: EGOFORS Study. Eur Psychiatry. 2012;27:422–5. doi: 10.1016/j.eurpsy.2011.01.014.
    1. Rabinowitz J, Berardo CG, Bugarski-Kirola D, Marder S. Association of prominent positive and prominent negative symptoms and functional health, well-being, healthcare-related quality of life and family burden: a CATIE analysis. Schizophr Res. 2013;150:339–42. doi: 10.1016/j.schres.2013.07.014.
    1. Law CW, Chen EY, Cheung EF, Chan RC, Wong JG, Lam CL, et al. Impact of untreated psychosis on quality of life in patients with first-episode schizophrenia. Qual Life Res. 2005;14:1803–11. doi: 10.1007/s11136-005-3236-6.
    1. Cella D. Measuring quality of life in palliative care. Semin Oncol. 1995;22:73–81.
    1. Schipper H, Clinch JJ, Olweny CLM. Quality of life studies: definitions and conceptual issues. In: Spilker B, editor. Quality of life and pharmacoeconomics in clinical trials. Philadelphia: Lippincott-Raven Publishers; 1996. pp. 11–23.
    1. International Society for Quality of Life Research. Health-related Quality of Life Research. (2016). Accessed 11 Jan 2016.
    1. Guyatt GH, Feeny DH, Patrick DL. Measuring health-related quality of life. Ann Intern Med. 1993;118:622–9. doi: 10.7326/0003-4819-118-8-199304150-00009.
    1. Bobes J, Garcia-Portilla P, Saiz PA, Bascaran T, Bousono M. Quality of life measures in schizophrenia. Eur Psychiatry. 2005;20:S313–7. doi: 10.1016/S0924-9338(05)80182-8.
    1. Boyer L, Millier A, Perthame E, Aballea S, Auquier P, Toumi M. Quality of life is predictive of relapse in schizophrenia. BMC Psychiatry. 2013;13:15. doi: 10.1186/1471-244X-13-15.
    1. Hayhurst KP, Drake RJ, Massie JA, Dunn G, Barnes TR, Jones PB, et al. Improved quality of life over one year is associated with improved adherence in patients with schizophrenia. Eur Psychiatry. 2014;29:191–6. doi: 10.1016/j.eurpsy.2013.03.002.
    1. Haynes VS, Zhu B, Stauffer VL, Kinon BJ, Stensland MD, Xu L, Ascher-Svanum H. Long-term healthcare costs and functional outcomes associated with lack of remission in schizophrenia: a post-hoc analysis of a prospective observational study. BMC Psychiatry. 2012;12:222. doi: 10.1186/1471-244X-12-222.
    1. Adelufosi AO, Adebowale TO, Abayomi O, Mosanya JT. Medication adherence and quality of life among Nigerian outpatients with schizophrenia. Gen Hosp Psychiatry. 2012;34:72–9. doi: 10.1016/j.genhosppsych.2011.09.001.
    1. Sarlon E, Heider D, Millier A, Azorin JM, König HH, Hansen K, Angermeyer MC, Aballéa S, Toumi M. A prospective study of health care resourse utilisation and selected costs of schizophrenia in France. BMC Health Serv Res. 2012;12:269–76. doi: 10.1186/1472-6963-12-269.
    1. Haro JM, Novick D, Perrin E, Bertsch J, Knapp M. Symptomatic remission and patient quality of life in an observational study of schizophrenia: is there a relationship? Psychiatry Res. 2014;220:163–9. doi: 10.1016/j.psychres.2014.07.034.
    1. Guo X, Zhang Z, Zhai J, Fang M, Hu M, Wu R, et al. Effects of antipsychotic medications on quality of life and psychosocial functioning in patients with early-stage schizophrenia: 1-year follow-up naturalistic study. Compr Psychiatry. 2012;53:1006–12. doi: 10.1016/j.comppsych.2012.03.003.
    1. Osborne RH, Dalton A, Hertel J, Schrover R, Smith DK. Health-related quality of life advantage of long-acting injectable antipsychotic treatment for schizophrenia: a time trade-off study. Health Qual Life Outcomes. 2012;10:35. doi: 10.1186/1477-7525-10-35.
    1. Nuss P, Tessier C. Antipsychotic medication, functional outcome and quality of life in schizophrenia: focus on amisulpride. Curr Med Res Opin. 2010;26:787–801. doi: 10.1185/03007990903576953.
    1. Alonso J, Croudace T, Brown J, Gasquet I, Knapp MR, Suarez D, et al. Health-related quality of life (HRQL) and continuous antipsychotic treatment: 3-year results from the schizophrenia health outcomes (SOHO) study. Value Health. 2009;12:536–43. doi: 10.1111/j.1524-4733.2008.00495.x.
    1. Ritchie CW, Chiu E, Harrigan S, MacFarlane S, Mastwyk M, Halliday G, et al. A comparison of the efficacy and safety of olanzapine and risperidone in the treatment of elderly patients with schizophrenia: an open study of six months duration. Int J Geriatr Psychiatry. 2006;21:171–9. doi: 10.1002/gps.1446.
    1. De Araujo AA, De Araujo Dantas D, Do Nascimento GG, Ribeiro SB, Chaves KM, De Lima Silva V, et al. Quality of life in patients with schizophrenia: the impact of socio-economic factors and adverse effects of atypical antipsychotic drugs. Psychiatr Q. 2014;85:357–67. doi: 10.1007/s11126-014-9290-x.
    1. Cerovecki A, Musil R, Klimke A, Seemuller F, Haen E, Schennach R, et al. Withdrawal symptoms and rebound syndromes associated with switching and discontinuing atypical antipsychotics: theoretical background and practical recommendations. CNS Drugs. 2013;27:545–72. doi: 10.1007/s40263-013-0079-5.
    1. Lieberman JA, Stroup TS, McEvoy JP, Swartz MS, Rosenheck RA, Perkins DO, et al. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med. 2005;353:1209–23. doi: 10.1056/NEJMoa051688.
    1. Nyhuis AW, Faries DE, Ascher-Svanum H, Stauffer VL, Kinon BJ. Predictors of switching antipsychotic medications in the treatment of schizophrenia. BMC Psychiatry. 2010;10:75. doi: 10.1186/1471-244X-10-75.
    1. Ye W, Fujikoshi S, Nakahara N, Takahashi M, Ascher-Svanum H, Ohmori T. Improved outcomes following a switch to olanzapine treatment from risperidone treatment in a 1-year naturalistic study of schizophrenia patients in Japan. Psychiatry Clin Neurosci. 2012;66:313–21. doi: 10.1111/j.1440-1819.2012.02351.x.
    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;24:21–32. doi: 10.1185/030079908X253384.
    1. Kim CY, Chung S, Lee JN, Kwon JS, Kim Do H, Kim CE, et al. A 12-week, naturalistic switch study of the efficacy and tolerability of aripiprazole in stable outpatients with schizophrenia or schizoaffective disorder. Int Clin Psychopharmacol. 2009;24:181–8. doi: 10.1097/YIC.0b013e32832c25d7.
    1. Jabrink K, Kreif N, Benedict A, Locklear J. Quailty of life and drug costs associated with switching antipsychotic medication to once-daily extended release quetiapine fumarate in patients with schizophrenia. Curr Med Res Opin. 2009;25:709–16. doi: 10.1185/03007990902738810.
    1. Lloyd K, Latif MA, Simpson S, Shrestha KL. Switching stable patients with schizophrenia from depot and oral antipsychotics to long-acting injectable risperidone: efficacy, quality of life and functional outcome. Hum Psychopharmacol. 2010;25:243–52. doi: 10.1002/hup.1108.
    1. Gutierrez Fraile M, de la Gandara Martin JJ, Bobes GJ. Switching to ziprasidone in the clinical practice setting: an open-label study. Int J Psychiatry Med. 2013;45:125–42. doi: 10.2190/PM.45.2.c.
    1. Hashimoto N, Toyomaki A, Honda M, Miyano S, Nitta N, Sawayama H, et al. Long-term efficacy and tolerability of quetiapine in patients with schizophrenia who switched from other antipsychotics because of inadequate therapeutic response-a prospective open-label study. Ann Gen Psychiatry. 2015;14:1. doi: 10.1186/s12991-014-0039-6.
    1. Montgomery W, Kadziola Z, Ye W, Xue HB, Liu L, Treuer T. Correlation between changes in quality of life and symptomatic improvement in Chinese patients switched from typical antipsychtoics to olazapine. Neuropsychiatr Dis Treat. 2015;11:177–83. doi: 10.2147/NDT.S73992.
    1. Gattaz WF, Campos JA, Lacerda AL, Henna E, Ruschel SI, Bressan RA, et al. Switching from oral risperidone to flexibly dosed oral paliperidone extended-release: core symptoms, satisfaction, and quality of life in patients with stable but symptomatic schizophrenia: the RISPALI study. Curr Med Res Opin. 2014;30(4):695–709. doi: 10.1185/03007995.2013.869201.
    1. Nakamura M, Ogasa M, Guarino J, Phillips D, Severs J, Cucchiaro J, et al. Lurasidone in the treatment of acute schizophrenia: a double-blind, placebo-controlled trial. J Clin Psychiatry. 2009;70:829–36. doi: 10.4088/JCP.08m04905.
    1. Meltzer HY, Cucchiaro J, Silva R, Ogasa M, Phillips D, Xu J, et al. Lurasidone in the treatment of schizophrenia: a randomized, double-blind, placebo- and olanzapine-controlled study. Am J Psychiatry. 2011;168:957–67. doi: 10.1176/appi.ajp.2011.10060907.
    1. Ogasa M, Kimura T, Nakamura M, Guarino J. Lurasidone in the treatment of schizophrenia: a 6-week, placebo-controlled study. Psychopharmacology (Berl) 2013;225:519–30. doi: 10.1007/s00213-012-2838-2.
    1. Citrome L, Cucchiaro J, Sarma K, Phillips D, Silva R, Tsuchiya S, et al. Long-term safety and tolerability of lurasidone in schizophrenia: a 12-month, double-blind, active-controlled study. Int Clin Psychopharmacol. 2012;27:165–76. doi: 10.1097/YIC.0b013e32835281ef.
    1. Loebel A, Cucchiaro J, Xu J, Sarma K, Pikalov A, Kane JM. Effectiveness of lurasidone vs. quetiapine XR for relapse prevention in schizophrenia: a 12-month, double-blind, noninferiority study. Schizophr Res. 2013;147:95–102. doi: 10.1016/j.schres.2013.03.013.
    1. Citrome L. Lurasidone in schizophrenia: new information about dosage and place in therapy. Adv Ther. 2012;29:815–25. doi: 10.1007/s12325-012-0052-6.
    1. Citrome L. Lurasidone for schizophrenia: a review of the efficacy and safety profile for this newly approved second-generation antipsychotic. Int J Clin Pract. 2011;65:189–210. doi: 10.1111/j.1742-1241.2010.02587.x.
    1. McEvoy JP, Citrome L, Hernandez D, Cucchiaro J, Hsu J, Pikalov A, et al. Effectiveness of lurasidone in patients with schizophrenia or schizoaffective disorder switched from other antipsychotics: a randomized, 6-week, open-label study. J Clin Psychiatry. 2013;74:170–9. doi: 10.4088/JCP.12m07992.
    1. Awad G, Hassan M, Loebel A, Hsu J, Pikalov A, Rajagopalan K. Health-related quality of life among patients treated with lurasidone: results from a switch trial in patients with schizophrenia. BMC Psychiatry. 2014;14:53. doi: 10.1186/1471-244X-14-53.
    1. Voruganti LN, Awad AG. Personal evaluation of transitions in treatment (PETiT):a scale to measure subjective aspects of antipsychotic drug therapy in schizophrenia. Schizophr Res. 2002;56(1–2):37–46. doi: 10.1016/S0920-9964(01)00161-X.
    1. Ware J, Jr, Kosinski M, Keller SD. A 12-item short-form health survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34:220–33. doi: 10.1097/00005650-199603000-00003.
    1. Citrome L, Weiden PJ, McEvoy JP, Correll CU, Cucchiaro J, Hsu J, et al. Effectiveness of lurasidone in schizophrenia or schizoaffective patients switched from other antipsychotics: a 6-month, open-label, extension study. CNS Spectr. 2014;18:330–39. doi: 10.1017/S109285291300093X.
    1. Kawata AK, Revicki DA. Psychometric properties of the personal and social performance scale (PSP) among individuals with schizophrenia. Qual Life Res. 2008;17(10):1247–56. doi: 10.1007/s11136-008-9400-z.
    1. Rouillon F, Eriksson L, Burba B, Raboch J, Kaprinis G, Schreiner A. Functional recovery results from the risperidone long-atcing injectable versus quetiapine relapse prevention trial (ConstaTRE) Acta Neuropsychiatr. 2013;25(5):297–306. doi: 10.1017/neu.2013.7.
    1. Schreiner A, Hargarter L, Hitschfield K, Lee JI, Lenskara I, Sulaiman AH, Diels J. PILAR study group. clinical effectiveness and resource utilization of paliperidone ER for schizophrenia: Pharmacoepidemiologic International Longitudinal Antipsychotic Registry (PILAR) Curr Med Res Opin. 2014;30(7):1279–89. doi: 10.1185/03007995.2014.898630.
    1. Ascher-Svanum H, Zhu B, Faries DE, Salkever D, Slade EP, Peng X, et al. The cost of relapse and the predictors of relapse in the treatment of schizophrenia. BMC Psychiatry. 2010;10:2. doi: 10.1186/1471-244X-10-2.
    1. Brazier J, Connell J, Papaioannou D, Mukuria C, Mulhern B, Peasgood T, et al. A systematic review, psychometric analysis and qualitative assessment of generic preference-based measures of health in mental health populations and the estimation of mapping functions from widely used specific measures. Health Technol Assess. 2014;18(34):1–188. doi: 10.3310/hta18340.
    1. Leucht S. Measurements of response, remission, and recovery in schizophrenia and examples for their clinical application. J Clin Psychiatry. 2014;75(suppl 1):8–14. doi: 10.4088/JCP.13049su1c.02.
    1. Kinon BJ, Chen L, Ascher-Svanum H, Stauffer VL, Kollack-Walker S, Zhou W, Kapur S, Kane JM. Early response to antipsychotic drug therapy as a clinical marker of subsequent response in the treatment of schizophrenia. Neuropsychopharmacol. 2010;35:581–90. doi: 10.1038/npp.2009.164.
    1. Kinon BJ, Chen L, Ascher-Svanum H, Stauffer VL, Kollack-Walker S, Sniadecki JL, Kane JM. Predicting response to atypical antipsychotics based on early response in the treatment of schizophrenia. Schizophr Res. 2008;102:230–40. doi: 10.1016/j.schres.2008.02.021.
    1. Awad AG, Voruganti LN. The impact of newer atypical antipsychotics on patient-reported outcomes in schizophrenia. CNS Drugs. 2013;27:625–36. doi: 10.1007/s40263-013-0070-1.
    1. Loebel AD, Siu CO, Cucchiaro JB, Pikalov AA, Harvey PD. Daytime sleepiness associated with lurasidone and quetiapine XR: results from a randomized double-blind, placebo-controlled trial in patients with schizophrenia. CNS Spectr. 2014;19:197–205. doi: 10.1017/S1092852913000904.
    1. Hermes ED, Sernyak M, Rosenheck R. Use of second-generation antipsychotic agents for sleep and sedation: a provider survey. Sleep. 2013;36:597–600.
    1. Lea JW, Stoner SC, Lafollette J. Agitation associated with aripiprazole initiation. Pharmacotherapy. 2007;27:1339–42. doi: 10.1592/phco.27.9.1339.
    1. Takeuchi H, Remington G. A systematic review of reported cases involving psychotic symptoms worsened by aripiprazole in schizophrenia or schizoaffective disorder. Psychopharmacology (Berl) 2013;228:175–85. doi: 10.1007/s00213-013-3154-1.
    1. Kuipers E, Yesufu-Udechuku A, Taylor C, Kendall T. Management of psychosis and schizophrenia in adults: summary of updated NICE guidance. BMJ. 2014;348:g1173. doi: 10.1136/bmj.g1173.
    1. Lehman AF, Lieberman J, Dixon LB, McGlashan TH, Miller A, Perkins D, et al. Practice guideline for the treatment of patients with schizophrenia. American Psychiatric Association. 2010. . Accessed 30 Sep 2015.
    1. Morken G, Widen JH, Grawe RW. Non-adherence to antipsychotic medication, relapse and rehospitalisation in recent-onset schizophrenia. BMC Psychiatry. 2008;8:32. doi: 10.1186/1471-244X-8-32.
    1. Newcomer JW, Weiden PJ, Buchanan RW. Switching antipsychotic medications to reduce adverse event burden in schizophrenia: establishing evidence-based practice. J Clin Psychiatry. 2013;74:1108–20. doi: 10.4088/JCP.12028ah1.
    1. Awad AG, Voruganti LN, Heslegrave RJ, Hogan TP. Assessment of the patient’s subjective experience in acute neuroleptic treatment: implications for compliance and outcome. Int Clin Psychopharmacol. 1996;11(Suppl 2):55–9. doi: 10.1097/00004850-199605002-00009.
    1. Schennach-Wolff R, Jager M, Seemuller F, Obermeier M, Messer T, Laux G, et al. Attitude towards adherence in patients with schizophrenia at discharge. J Psychiatr Res. 2009;43:1294–301. doi: 10.1016/j.jpsychires.2009.05.003.
    1. Freudenreich O, Cather C, Evins AE, Henderson DC, Goff DC. Attitudes of schizophrenia outpatients toward psychiatric medications: relationship to clinical variables and insight. J Clin Psychiatry. 2004;65:1372–6. doi: 10.4088/JCP.v65n1012.
    1. Santone G, Rucci P, Muratori ML, Monaci A, Ciarafoni C, Borsetti G. Attitudes toward medication in inpatients with schizophrenia: a cluster analytic approach. Psychiatry Res. 2008;158:324–34. doi: 10.1016/j.psychres.2006.12.010.
    1. Hellewell JS. Patients’ subjective experiences of antipsychotics: clinical relevance. CNS Drugs. 2002;16:457–71. doi: 10.2165/00023210-200216070-00003.
    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;63:892–909. doi: 10.4088/JCP.v63n1007.
    1. Awad AG, Voruganti LN. New antipsychotics, compliance, quality of life, and subjective tolerability--are patients better off? Can J Psychiatry. 2004;49:297–302.
    1. San L, Bernardo M, Gomez A, Martinez P, Gonzalez B, Pena M. Socio-demographic, clinical and treatment characteristics of relapsing schizophrenic patients. Nord J Psychiatry. 2013;67:22–9. doi: 10.3109/08039488.2012.667150.
    1. Roussidis A, Kalkavoura C, Dimelis D, Theodorou A, Ioannidou I, Mellos E, et al. Reasons and clinical outcomes of antipsychotic treatment switch in outpatients with schizophrenia in real-life clinical settings: the ETOS observational study. Ann Gen Psychiatry. 2013;12:42. doi: 10.1186/1744-859X-12-42.
    1. Weiden PJ, Simpson GM, Potkin SG, O’Sullivan RL. Effectiveness of switching to ziprasidone for stable but symptomatic outpatients with schizophrenia. J Clin Psychiatry. 2003;64:580–8. doi: 10.4088/JCP.v64n0514.
    1. Kim SW, Shin IS, Kim JM, Lee JH, Lee YH, Yang SJ, et al. Effectiveness of switching to aripiprazole from atypical antipsychotics in patients with schizophrenia. Clin Neuropharmacol. 2009;32:243–9. doi: 10.1097/WNF.0b013e31819a68b5.
    1. Kim SW, Shin IS, Kim JM, Lee SH, Lee YH, Yang SJ, et al. Effects of switching to long-acting injectable risperidone from oral atypical antipsychotics on cognitive function in patients with schizophrenia. Hum Psychopharmacol. 2009;24:565–73. doi: 10.1002/hup.1057.

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