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Asenapine prescribing patterns in the treatment of manic in- and outpatients: Results from the MANACOR study

Published online by Cambridge University Press:  15 April 2020

I. Grande ,
D. Hidalgo-Mazzei ,
E. Nieto ,
M. Mur ,
C. Sàez ,
I. Forcada  and
E. Vieta
I. Grande
Affiliation:
Bipolar Disorders Unit, Clinical Institute of Neurosciences, Hospital Clinic, University of Barcelona, IDIBAPS, CIBERSAM, Villarroel 170, 08036Barcelona, Catalonia, Spain
D. Hidalgo-Mazzei
Affiliation:
Bipolar Disorders Unit, Clinical Institute of Neurosciences, Hospital Clinic, University of Barcelona, IDIBAPS, CIBERSAM, Villarroel 170, 08036Barcelona, Catalonia, Spain
E. Nieto
Affiliation:
Mental Health Division of Althaia, Xarxa Assistencial Universitária de Manresa, Catalonia, Spain
M. Mur
Affiliation:
Psychiatric Service, Santa Maria Hospital, IRB Lleida (Biomedicine Research Institute), University of Lleida, Lleida, Catalonia, Spain
C. Sàez
Affiliation:
University Psychiatric Hospital, Institut Pere Mata, IISPV, URV, CIBERSAM, Reus, Catalonia, Spain
I. Forcada
Affiliation:
Psychiatric Service, Santa Maria Hospital, IRB Lleida (Biomedicine Research Institute), University of Lleida, Lleida, Catalonia, Spain
E. Vieta*
Affiliation:
Bipolar Disorders Unit, Clinical Institute of Neurosciences, Hospital Clinic, University of Barcelona, IDIBAPS, CIBERSAM, Villarroel 170, 08036Barcelona, Catalonia, Spain
*
*Corresponding author. Bipolar Disorders Unit, Clinical Institute of Neurosciences, Hospital Clinic, Villarroel 170, 08036 Barcelona, Spain. Tel.: +34 93 22 75 40 0; fax: +34 93 22 79 22 8. E-mail address:evieta@clinic.ub.es (E. Vieta).
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Abstract

Background:

Asenapine is the most recent compound that has been FDA- and EMA-approved for treatment of mania. Its efficacy and safety have been assessed in placebo-controlled trials, but little is known about its performance in routine clinical conditions. In this study, we compared features of patients treated with adjunctive asenapine or other adjunctive antipsychotics and the costs of the treatment.

Methods:

A combined prospective and retrospective data collection and analysis was conducted from January 2011 to December 2013 following a clinical interview and assessment of manic and depressive symptoms (YMRS, HDRS-17), clinical state (CGI-BP-M), psychosocial functioning (FAST), sexual dysfunction (PRSexDQ) and health resource costs associated with treatment with adjunctive asenapine versus other adjunctive antipsychotics.

Results:

Hundred and fifty-two patients from different university hospitals were included. Fifty-three patients received adjunctive asenapine and 99 received other adjunctive antipsychotics concomitantly to mood stabilizers. Considering inpatients, those treated with adjunctive asenapine presented a significantly less severe manic episode (P = 0.001), less psychotic symptoms (P = 0.030) and more comorbid personality disorder (P = 0.002). Regarding outpatients, those treated with adjunctive asenapine showed significantly less severe manic episode (P = 0.046), more previous mixed episodes (P = 0.013) and more sexual dysfunction at baseline (P = 0.036). No significant differences were found in mean total costs per day.

Conclusion:

Clinicians tended to use adjunctive asenapine in patients with less severe manic symptoms but more complex clinical profile, including more mixed episodes in the past, concomitant personality disorder, and sexual problems. Treatment with adjunctive asenapine was not associated with higher costs when compared to other options.

Keywords

Bipolar disorderAntipsychoticAsenapineCostBurden
Type
Original article
Information
European Psychiatry , Volume 30 , Issue 4 , June 2015 , pp. 528 - 534
Copyright
Copyright © Elsevier Masson SAS 2015

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References

Alonso, J, Petukhova, M, Vilagut, G, Chatterji, S, Heeringa, S, Ustün, TBet al.Days out of role due to common physical and mental conditions: results from the WHO World Mental Health surveys. Mol Psychiatry 2011;16:1234–1246.CrossRefGoogle ScholarPubMed
American Psychiatric Association, Diagnostic and statistical manual for mental disorders, fourth edition, text revision, 4th ed, Arlington: American Psychiatric Press; 2000.CrossRefGoogle Scholar
Azorin, JM, Sapin, C, Weiller, EEffect of asenapine on manic and depressive symptoms in bipolar I patients with mixed episodes: results from post hoc analyses. J Affect Disord 2013;145:62–69.CrossRefGoogle ScholarPubMed
Buoli, M, Serati, M, Altamura, ACIs the combination of a mood stabilizer plus an antipsychotic more effective than mono-therapies in long-term treatment of bipolar disorder? A systematic review. J Affect Disord 2014;152–154:12–18.CrossRefGoogle ScholarPubMed
Caresano, C, Di Sciascio, G, Fagiolini, A, Maina, G, Perugi, G, Ripellino, Cet al.Cost-effectiveness of asenapine in the treatment of patients with bipolar I disorder with mixed episodes in an Italian context. Adv Ther 2014;31:873–890.CrossRefGoogle Scholar
Catalá-López, F, Gènova-Maleras, R, Vieta, E, Tabarés-Seisdedos, RThe increasing burden of mental and neurological disorders. Eur Neuropsychopharmacol 2013;23:1337–1339.CrossRefGoogle ScholarPubMed
Cipriani, A, Barbui, C, Salanti, G, Rendell, J, Brown, R, Stockton, Set al.Comparative efficacy and acceptability of antimanic drugs in acute mania: a multiple-treatments meta-analysis. Lancet 2011;378:1306–1315.CrossRefGoogle ScholarPubMed
Colom, F, Vieta, E, Martínez-Arán, A, Garcia-Garcia, M, Reinares, M, Torrent, Cet al.Spanish version of a scale for the assessment of mania: validity and reliability of the Young Mania Rating Scale. Med Clin (Barc) 2002;119:366–371.CrossRefGoogle ScholarPubMed
Colom, F, Vieta, E, Daban, C, Pacchiarotti, I, Sánchez-Moreno, JClinical and therapeutic implications of predominant polarity in bipolar disorder. J Affect Disord 2006;93:13–17.CrossRefGoogle ScholarPubMed
Cruz, N, Vieta, EAsenapine: a new focus on the treatment of mania. Rev Psiquiatr Salud Ment 2011;4:101–108.CrossRefGoogle ScholarPubMed
Das Gupta, R, Guest, JFAnnual cost of bipolar disorder to UK society. Br J Psychiatry 2002;180:227–233.CrossRefGoogle ScholarPubMed
Goikolea, JM, Colom, F, Capapey, J, Torres, I, Valenti, M, Grande, Iet al.Faster onset of antimanic action with haloperidol compared to second-generation antipsychotics. A meta-analysis of randomized clinical trials in acute mania. Eur Neuropsychopharmacol 2013;23:305–316.CrossRefGoogle ScholarPubMed
Gonzalez-Pinto, AM, Dardennes, R, de Zélicourt, M, López, P, Oliveros, RG, Vieta, Eet al.In-patient care costs of patients with bipolar I disorder: a comparison between two European centers. J Affect Disord 2010;121:152–155.CrossRefGoogle ScholarPubMed
Grande, I, Balanzá-Martínez, V, Jiménez-Arriero, M, Iglesias Lorenzo, FG, Franch Valverde, JI, de Arce, Ret al.Clinical factors leading to lamotrigine prescription in bipolar outpatients: subanalysis of the SIN-DEPRES study. J Affect Disord 2012;143:102–108.CrossRefGoogle ScholarPubMed
Grande, I, Goikolea, JM, de Dios, C, González-Pinto, A, Montes, JM, Saiz-Ruiz, Jet al.Occupational disability in bipolar disorder: analysis of predictors of being on severe disablement benefit (PREBIS study data). Acta Psychiatr Scand 2013;127:403–411.CrossRefGoogle Scholar
Grande, I, de Arce, R, Jiménez-Arriero MÁ, , Lorenzo, FGI, Valverde, JIF, Balanzá-Martínez, Vet al.Patterns of pharmacological maintenance treatment in a community mental health services bipolar disorder cohort study (SIN-DEPRES). Int J Neuropsychopharmacol 2013;16:513–523.CrossRefGoogle Scholar
Grande, I, Bernardo, M, Bobes, J, Saiz-Ruiz, J, Alamo, C, Vieta, Eet al.Antipsychotic switching in bipolar disorders: a systematic review. Int J Neuropsychopharmacol 2013;17:497–507.CrossRefGoogle ScholarPubMed
Hamilton, MA rating scale for depression. J Neurol Neurosurg Psychiatry 1960;23:56–62.CrossRefGoogle ScholarPubMed
Hidalgo-Mazzei, D, Undurraga, J, Reinares, M, Bonnin, CM, Saez, C, Mur, Met al.The real world cost and health resource utilization associated to manic episodes: the MANACOR study. Rev Psiquiatr Salud Ment 2015[in press].Google ScholarPubMed
Kemp, DE, Zhao, J, Cazorla, P, Landbloom, RP, Mackle, M, Snow-Adami, Let al.Weight change and metabolic effects of asenapine in patients with schizophrenia and bipolar disorder. J Clin Psychiatry 2014;75:238–245.CrossRefGoogle ScholarPubMed
Kendall, T, Morriss, R, Mayo-Wilson, E, Marcus, EAssessment and management of bipolar disorder: summary of updated NICE guidance. BMJ 2014;349:g5673.CrossRefGoogle ScholarPubMed
Kleinman, L, Lowin, A, Flood, E, Gandhi, G, Edgell, E, Revicki, DCosts of bipolar disorder. Pharmacoeconomics 2003;21:601–622.CrossRefGoogle ScholarPubMed
Lachaine, J, Beauchemin, C, Mathurin, K, Gilbert, D, Beillat, MCost-effectiveness of asenapine in the treatment of bipolar disorder in Canada. BMC Psychiatry 2014;14:16.CrossRefGoogle ScholarPubMed
Martín-Blanco, A, Patrizi, B, Villalta, L, Gasol, X, Soler, J, Gasol, Met al.Asenapine in the treatment of borderline personality disorder: an atypical antipsychotic alternative. Int Clin Psychopharmacol 2014;29:120–123.CrossRefGoogle ScholarPubMed
McIntyre, RS, Cohen, M, Zhao, J, Alphs, L, Macek, TA, Panagides, JA 3-week, randomized, placebo-controlled trial of asenapine in the treatment of acute mania in bipolar mania and mixed states. Bipolar Disord 2009;11:673–686.CrossRefGoogle ScholarPubMed
McIntyre, RS, Cohen, M, Zhao, J, Alphs, L, Macek, TA, Panagides, JAsenapine versus olanzapine in acute mania: a double-blind extension study. Bipolar Disord 2009;11:815–826.CrossRefGoogle ScholarPubMed
McIntyre, RS, Cohen, M, Zhao, J, Alphs, L, Macek, TA, Panagides, JAsenapine in the treatment of acute mania in bipolar I disorder: a randomized, double-blind, placebo-controlled trial. J Affect Disord 2010;122:27–38.CrossRefGoogle ScholarPubMed
McIntyre, RS, Cohen, M, Zhao, J, Alphs, L, Macek, TA, Panagides, JAsenapine for long-term treatment of bipolar disorder: a double-blind 40-week extension study. J Affect Disord 2010;126:358–365.CrossRefGoogle ScholarPubMed
McIntyre, RS, Tohen, M, Berk, M, Zhao, J, Weiller, EDSM-5 mixed specifier for manic episodes: evaluating the effect of depressive features on severity and treatment outcome using asenapine clinical trial data. J Affect Disord 2013;150:378–383.CrossRefGoogle ScholarPubMed
Montejo, AL, García, M, Espada, M, Rico-Villademoros, F, Llorca, G, Izquierdo, JAet al.Psychometric characteristics of the psychotropic-related sexual dysfunction questionnaire. Actas Esp Psiquiatr 2000;28:141–150.Google ScholarPubMed
Parker, G, Parker, K, Malhi, G, Wilhelm, K, Mitchell, PStudying personality characteristics in bipolar depressed subjects: how comparator group selection can dictate results. Acta Psychiatr Scand 2004;109:376–382.CrossRefGoogle ScholarPubMed
Ramos-Brieva, JA, Cordero-Villafafila, AA new validation of the Hamilton Rating Scale for Depression. J Psychiatr Res 1988;22:21–28.CrossRefGoogle ScholarPubMed
Rosa, AR, Sánchez-Moreno, J, Martínez-Aran, A, Salamero, M, Torrent, C, Reinares, Met al.Validity and reliability of the Functioning Assessment Short Test (FAST) in bipolar disorder. Clin Pract Epidemiol Ment Health 2007;3:5.CrossRefGoogle Scholar
Rosa, AR, Reinares, M, Amann, B, Popovic, D, Franco, C, Comes, Met al.Six-month functional outcome of a bipolar disorder cohort in the context of a specialized-care program. Bipolar Disord 2011;13:679–686.CrossRefGoogle ScholarPubMed
Sawyer, L, Azorin, J.-M., Chang, S, Rinciog, C, Guiraud-Diawara, A, Marre, Cet al.Cost-effectiveness of asenapine in the treatment of bipolar I disorder patients with mixed episodes. J Med Econ 2014;17:508–519.CrossRefGoogle ScholarPubMed
Spearing, MK, Post, RM, Leverich, GS, Brandt, D, Nolen, WModification of the Clinical Global Impressions (CGI) Scale for use in bipolar illness (BP): the CGI-BP. Psychiatry Res 1997;73:159–171.CrossRefGoogle ScholarPubMed
Tafalla, M, Salvador-Carulla, L, Saiz-Ruiz, J, Diez, T, Cordero, LPattern of healthcare resource utilization and direct costs associated with manic episodes in Spain. BMC Psychiatry 2010;10:31.CrossRefGoogle ScholarPubMed
Vieta, EPros and cons of specialised care in bipolar disorder: an international perspective. Br J Psychiatry 2013;202:170–171.CrossRefGoogle Scholar
Vieta, E, Valentí, MMixed states in DSM-5: implications for clinical care, education, and research. J Affect Disord 2013;148:28–36.CrossRefGoogle ScholarPubMed
Vieta, E, Colom, F, Corbella, B, Martínez-Arán, A, Reinares, M, Benabarre, Aet al.Clinical correlates of psychiatric comorbidity in bipolar I patients. Bipolar Disord 2001;3:253–258.CrossRefGoogle ScholarPubMed
Vieta, E, Torrent Font, C, Martínez-Arán, A, Colom Victoriano, F, Reinares Gabnepen, M, Benabarre Hernández, Aet al.A user-friendly scale for the short- and long-term outcome of bipolar disorder: the CGI-BP-M. Actas Esp Psiquiatr 2002;30:301–304.Google Scholar
Vieta, E, Günther, O, Locklear, J, Ekman, M, Miltenburger, C, Chatterton, MLet al.Effectiveness of psychotropic medications in the maintenance phase of bipolar disorder: a meta-analysis of randomized controlled trials. Int J Neuropsychopharmacol 2011;14:1029–1049.CrossRefGoogle ScholarPubMed
Vieta, E, Langosch, JM, Figueira, ML, Souery, D, Blasco-Colmenares, E, Medina, Eet al.Clinical management and burden of bipolar disorder: results from a multinational longitudinal study (WAVE-bd). Int J Neuropsychopharmacol 2013;13:1–14.Google Scholar
Vita, A, De Peri, L, Siracusano, A, Sacchetti, EEfficacy and tolerability of asenapine for acute mania in bipolar I disorder: meta-analyses of randomized-controlled trials. Int Clin Psychopharmacol 2013;28:219–227.CrossRefGoogle ScholarPubMed
Yildiz, A, Vieta, E, Leucht, S, Baldessarini, RJEfficacy of antimanic treatments: meta-analysis of randomized, controlled trials. Neuropsychopharmacology 2011;36:375–389.CrossRefGoogle ScholarPubMed
Young, RC, Biggs, JT, Ziegler, VE, Meyer, DAA rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry 1978;133:429–435.CrossRefGoogle ScholarPubMed
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