Long-Term Efficacy and Safety of Asenapine or Olanzapine in Patients with Schizophrenia or Schizoaffective Disorder: An Extension Study

Abstract

Introduction:

Safety and efficacy results, collected in schizophrenia and schizoaffective disorder patients treated for up to nearly 3 years, are presented for asenapine and olanzapine.

Methods:

Patients completing a 52-week randomized double-blind core study on flexible-dose asenapine (5 or 10 mg BID) or olanzapine (10 or 20 mg QD) could continue treatment until study blind was broken.

Results:

290 patients on asenapine and 150 on olanzapine continued treatment for variable lengths of time [mean±SD (range) 311.0±146.1 (10 − 653) d and 327.4±139.6 (15 − 631) d, respectively]. Adverse event (AE) incidence was lower during the extension (asenapine, 62%; olanzapine, 55%) than during the core study (78%, 80%). In both groups, body weight increase and incidence of extrapyramidal AEs were negligible during the extension. Mean PANSS total score changes during first year of treatment were  − 37.0 for asenapine and  − 35.3 for olanzapine, with further changes of 1.6 for asenapine and  − 0.8 for olanzapine at the extension study endpoint.

Conclusions:

Clinical stability on asenapine as well as olanzapine was maintained, with few recurrent or newly emerging AEs beyond 1 year of treatment.

NCT number: NCT00212771

Key words

asenapine - schizoaffective disorder - schizophrenia - tolerability - olanzapine

• References

• 1 Saha S, Chant D, Welham J et al. A systematic review of the prevalence of schizophrenia. PLoS Med 2005; 2: e141
• 2 Perala J, Suvisaari J, Saarni SI et al. Lifetime prevalence of psychotic and bipolar I disorders in a general population. Arch Gen Psychiatry 2007; 64: 19-28
• 3 Weiden PJ. EPS profiles: the atypical antipsychotics are not all the same. J Psychiatr Pract 2007; 13: 13-24
• 4 Tandon R, Jibson MD. Comparing efficacy of first-line atypical antipsychotics: no evidence of differential efficacy between risperidone, olanzapine, quetiapine, ziprasidone, and aripiprazole. Int J Psychiatry Clin Pract 2005; 9: 204-212
• 5 Tandon R, Fleischhacker WW. Comparative efficacy of antipsychotics in the treatment of schizophrenia: a critical assessment. Schizophr Res 2005; 79: 145-155
• 6 Volavka J, Citrome L. Oral antipsychotics for the treatment of schizophrenia: heterogeneity in efficacy and tolerability should drive decision-making. Expert Opin Pharmacother 2009; 10: 1917-1928
• 7 Saphris® (asenapine sublingual tablets) . Full Prescribing Information, Schering Corporation, a subsidiary of Merck & Co., Inc. Whitehouse Station; NJ: 2010
• 8 European Medicines Agency. Sycrest (asenapine) Available at http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001177/human_med_001379.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d124&jsenabled=true. Accessed September 28, 2010
• 9 Kane JM, Cohen M, Zhao J et al. Efficacy and safety of asenapine in a placebo- and haloperidol-controlled trial in patients with acute exacerbation of schizophrenia. J Clin Psychopharmacol 2010; 30: 1-10
• 10 Potkin SG, Cohen M, Panagides J. Efficacy and tolerability of asenapine in acute schizophrenia: a placebo- and risperidone-controlled trial. J Clin Psychiatry 2007; 68: 1492-1500
• 11 Schoemaker J, Naber D, Vrijland P et al. Long-term assessment of asenapine vs. olanzapine in patients with schizophrenia or schizoaffective disorder. Pharmacopsychiatry 2010; 43: 138-146
• 12 Strauss JS, Carpenter Jr WT. The prediction of outcome in schizophrenia. I. Characteristics of outcome. Arch Gen Psychiatry 1972; 27: 739-746
• 13 Strauss JS, Carpenter Jr WT. Prediction of outcome in schizophrenia. III. Five-year outcome and its predictors. Arch Gen Psychiatry 1977; 34: 159-163
• 14 Agid O, Kapur S, Remington G. Emerging drugs for schizophrenia. Expert Opin Emerg Drugs 2008; 13: 479-495
• 15 Komossa K, Rummel-Kluge C, Hunger H et al. Olanzapine versus other atypical antipsychotics for schizophrenia. Cochrane Database Syst Rev 2010; 3: CD006654