Drug safety and efficacy evaluation of sertindole for schizophrenia

Bibliography

• Saha S, Chant D, Welham J, A systematic review of the prevalence of schizophrenia. PLoS Med 2005;2:e141
   PubMed Web of Science ®Google Scholar
• Jablensky A, Sartorius N, Ernberg G, Schizophrenia: manifestations, incidence and course in different cultures. A World Health Organization ten-country study. Psychol Med Monogr Suppl 1992;20:1-97
   PubMedGoogle Scholar
• Cannon M, Jones P. Schizophrenia. J Neurol Neurosurg Psychiatry 1996;60:604-13
   PubMed Web of Science ®Google Scholar
• Nuechterlein KH, Dawson ME. A heuristic vulnerability/stress model of schizophrenic episodes. Schizophr Bull 1984;10:300-12
   PubMed Web of Science ®Google Scholar
• Knoll JL IV, Garver DL, Ramberg JE, Heterogeneity of the psychoses: is there a neurodegenerative psychosis? Schizophr Bull 1998;24:365-79
   PubMed Web of Science ®Google Scholar
• Lieberman JA. Is schizophrenia a neurodegenerative disorder? A clinical and neurobiological perspective. Biol Psychiatry 1999;46:729-39
   PubMed Web of Science ®Google Scholar
• Haefner H, Maurer K, Loeffler W, Modeling the early course of schizophrenia. Schizophr Bull 2003;29:325-40
   PubMed Web of Science ®Google Scholar
• Weinberger DR, Gallhofer B. Cognitive function in schizophrenia. Int Clin Psychopharmacol 1997;12(Suppl 4):S29-36
   Google Scholar
• Addington J, Addington D. Neurocognitive and social functioning in schizophrenia. Schizophr Bull 1999;25:173-82
   PubMed Web of Science ®Google Scholar
• Tamminga CA, Holcomb HH. Phenotype of schizophrenia: a review and formulation. Mol Psychiatry 2005;10:27-39
   PubMed Web of Science ®Google Scholar
• Tiihonen J, Loennqvist J, Wahlbeck K, 11-year follow-up of mortality in patients with schizophrenia: a population-based cohort study (FIN11 study). Lancet 2009;374:620-7
   PubMed Web of Science ®Google Scholar
• Brown S, Inskip H, Barraclough B. Causes of the excess mortality of schizophrenia. Br J Psychiatry 2000;177:212-17
   PubMed Web of Science ®Google Scholar
• Davies LM, Drummond MF. Economics and schizophrenia: the real cost. Br J Psychiatry Suppl 1994;25:18-21
   PubMedGoogle Scholar
• Hoiberg MP, Nielsen B. Antipsychotic treatment and extrapyramidal symptoms amongst schizophrenic inpatients. Nord J Psychiatry 2006;60:207-12
   PubMed Web of Science ®Google Scholar
• Tarsy D. Neuroleptic-induced extrapyramidal reactions: classification, description, and diagnosis. Clin Neuropharmacol 1983;6(Suppl 1):S9-26
   Google Scholar
• Naber D, Moritz S, Lambert M, Improvement of schizophrenic patients' subjective well-being under atypical antipsychotic drugs. Schizophr Res 2001;50:79-88
   PubMed Web of Science ®Google Scholar
• Miyamoto S, Duncan GE, Marx CE, Treatments for schizophrenia: a critical review of pharmacology and mechanisms of action of antipsychotic drugs. Mol Psychiatry 2005;10:79-104
   PubMed Web of Science ®Google Scholar
• Tandon R, Belmaker RH, Gattaz WF, World psychiatric association pharmacopsychiatry section statement on comparative effectiveness of antipsychotics in the treatment of schizophrenia. Schizophr Res 2008;100:20-38
   PubMed Web of Science ®Google Scholar
• Leucht S, Corves C, Arbter D, Second-generation versus first-generation antipsychotic drugs for schizophrenia: a meta-analysis. Lancet 2009;373:31-41
   PubMed Web of Science ®Google Scholar
• Davis JM, Chen N, Glick ID. A meta-analysis of the efficacy of second-generation antipsychotics. Arch Gen Psychiatry 2003;60:553-64
   PubMed Web of Science ®Google Scholar
• Henderson DC, Cagliero E, Copeland PM, Glucose metabolism in patients with schizophrenia treated with atypical antipsychotic agents: a frequently sampled intravenous glucose tolerance test and minimal model analysis. Arch Gen Psychiatry 2005;62:19-28
   PubMed Web of Science ®Google Scholar
• Lieberman JA, Stroup TS, McEvoy JP, Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med 2005;353:1209-23
   PubMed Web of Science ®Google Scholar
• Lambert M, Naber D, Schacht A, Rates and predictors of remission and recovery during 3 years in 392 never-treated patients with schizophrenia. Acta Psychiatr Scand 2008;118:220-9
   PubMed Web of Science ®Google Scholar
• Mortimer AM. Cognitive function in schizophrenia–do neuroleptics make a difference? Pharmacol Biochem Behav 1997;56:789-95
   PubMed Web of Science ®Google Scholar
• Cleghorn JM, Kaplan RD, Szechtman B, Neuroleptic drug effects on cognitive function in schizophrenia. Schizophr Res 1990;3:211-19
   PubMed Web of Science ®Google Scholar
• Cutmore TRH, Beninger RJ. Do neuroleptics impair learning in schizophrenic-patients. Schizophr Res 1990;3:173-86
   PubMed Web of Science ®Google Scholar
• Meltzer HY, McGurk SR. The effects of clozapine, risperidone, and olanzapine on cognitive function in schizophrenia. Schizophr Bull 1999;25:233-55
   PubMed Web of Science ®Google Scholar
• Keefe RS, Bilder RM, Davis SM, Neurocognitive effects of antipsychotic medications in patients with chronic schizophrenia in the CATIE Trial. Arch Gen Psychiatry 2007;64:633-47
   PubMed Web of Science ®Google Scholar
• Hoff AL, Faustman WO, Wieneke M, The effects of clozapine on symptom reduction, neurocognitive function, and clinical management in treatment-refractory state hospital schizophrenic inpatients. Neuropsychopharmacology 1996;15:361-9
   PubMed Web of Science ®Google Scholar
• Goldberg TE, Greenberg RD, Griffin SJ, The effect of clozapine on cognition and psychiatric symptoms in patients with schizophrenia. Br J Psychiatry 1993;162:43-8
   PubMed Web of Science ®Google Scholar
• Moore N. Higher cardiovascular mortality with sertindole in ADROIT: a signal not confirmed. Int J Psychiatry Clin Pract 2002;6:S3-9
   PubMed Web of Science ®Google Scholar
• Eckardt L, Haverkamp W, Mertens H, Drug-related torsades de pointes in the isolated rabbit heart: comparison of clofilium, d,l-sotalol, and erythromycin. J Cardiovasc Pharmacol 1998;32:425-34
   PubMed Web of Science ®Google Scholar
• Hondeghem LM, Carlsson L, Duker G. Instability and triangulation of the action potential predict serious proarrhythmia, but action potential duration prolongation is antiarrhythmic. Circulation 2001;103:2004-13
   PubMed Web of Science ®Google Scholar
• Eckardt L, Breithardt G, Haverkamp W. Electrophysiologic characterization of the antipsychotic drug sertindole in a rabbit heart model of torsade de pointes: low torsadogenic potential despite QT prolongation. J Pharmacol Exp Ther 2002;300:64-71
   PubMed Web of Science ®Google Scholar
• Wilton LV, Heeley EL, Pickering RM, Comparative study of mortality rates and cardiac dysrhythmias in post-marketing surveillance studies of sertindole and two other atypical antipsychotic drugs, risperidone and olanzapine. J Psychopharmacol 2001;15:120-6
   PubMed Web of Science ®Google Scholar
• Lindstrom E, Levander S. Sertindole: efficacy and safety in schizophrenia. Expert Opin Pharmacother 2006;7:1825-34
   PubMed Web of Science ®Google Scholar
• Mork A, Witten LM, Arnt J. Effect of sertindole on extracellular dopamine, acetylcholine, and glutamate in the medial prefrontal cortex of conscious rats: a comparison with risperidone and exploration of mechanisms involved. Psychopharmacology (Berl) 2009;206:39-49
   PubMed Web of Science ®Google Scholar
• Hietala J, Kuonnamaeki M, Paelvimaeki EP, Sertindole is a serotonin 5-HT2c inverse agonist and decreases agonist but not antagonist binding to 5-HT2c receptors after chronic treatment. Psychopharmacology (Berl) 2001;157:180-7
   PubMed Web of Science ®Google Scholar
• Arnt J, Skarsfeldt T. Do novel antipsychotics have similar pharmacological characteristics? A review of the evidence. Neuropsychopharmacology 1998;18:63-101
   PubMed Web of Science ®Google Scholar
• Hyttel J, Nielsen JB, Nowak G. The acute effect of sertindole on brain 5-HT2, D2 and alpha 1 receptors (ex vivo radioreceptor binding studies). J Neural Transm Gen Sect 1992;89:61-9
   PubMed Web of Science ®Google Scholar
• Hyttel J, Arnt J, Costall B, Pharmacological profile of the atypical neuroleptic sertindole. Clin Neuropharmacol 1992;15(Suppl 1 Pt A):267A-8A
   Google Scholar
• Herrick-Davis K, Grinde E, Teitler M. Inverse agonist activity of atypical antipsychotic drugs at human 5-hydroxytryptamine2C receptors. J Pharmacol Exp Ther 2000;295:226-32
   PubMed Web of Science ®Google Scholar
• Wong SL, Granneman GR. Modeling of sertindole pharmacokinetic disposition in healthy volunteers in short term dose-escalation studies. J Pharm Sci 1998;87:1629-31
   PubMed Web of Science ®Google Scholar
• Wong SL, Linnen P, Mack R, Effects of food, antacid, and dosage form on the pharmacokinetics and relative bioavailability of sertindole in healthy volunteers. Biopharm Drug Dispos 1997;18:533-41
   PubMed Web of Science ®Google Scholar
• Wong SL, Menacherry S, Mulford D, Pharmacokinetics of sertindole and dehydrosertindole in volunteers with normal or impaired renal function. Eur J Clin Pharmacol 1997;52:223-7
   PubMed Web of Science ®Google Scholar
• Wong SL, Cao G, Mack RJ, Pharmacokinetics of sertindole in healthy young and elderly male and female subjects. Clin Pharmacol Ther 1997;62:157-64
   PubMed Web of Science ®Google Scholar
• Muscatello MR, Bruno A, Pandolfo G, Emerging treatments in the management of schizophrenia - focus on sertindole. Drug Des Devel Ther 2010;4:187-201
   PubMed Web of Science ®Google Scholar
• Cincotta SL, Rodefer JS. Emerging role of sertindole in the management of schizophrenia. Neuropsychiatr Dis Treat 2010;6:429-41
   PubMed Web of Science ®Google Scholar
• Haduch A, Wojcikowski J, Daniel WA. Direct effects of neuroleptics on the activity of CYP2A in the liver of rats. Pharmacol Rep 2005;57:867-71
   PubMed Web of Science ®Google Scholar
• Haduch A, Ogorka T, Boksa J, Interactions between neuroleptics and CYP2C6 in rat liver - in vitro and ex vivo study. Pharmacol Rep 2005;57:872-7
   PubMed Web of Science ®Google Scholar
• Ereshefsky L. Pharmacokinetics and drug interactions: update for new antipsychotics. J Clin Psychiatry 1996;57:12-25
   PubMed Web of Science ®Google Scholar
• Glassman AH, Bigger JT. Antipsychotic drugs: prolonged QTc interval, torsade de pointes, and sudden death. Am J Psychiatry 2001;158:1774-82
   PubMed Web of Science ®Google Scholar
• Wong SL, Locke C, Staser J, Lack of multiple dosing effect of sertindole on the pharmacokinetics of alprazolam in healthy volunteers. Psychopharmacology (Berl) 1998;135:236-41
   PubMed Web of Science ®Google Scholar
• Skarsfeldt T. Electrophysiological profile of the new atypical neuroleptic, sertindole, on midbrain dopamine neurones in rats: acute and repeated treatment. Synapse 1992;10:25-33
   PubMed Web of Science ®Google Scholar
• Zimbroff DL, Kane JM, Tamminga CA, Controlled, dose-response study of sertindole and haloperidol in the treatment of schizophrenia. Sertindole Study Group. Am J Psychiatry 1997;154:782-91
   PubMed Web of Science ®Google Scholar
• Nyberg S, Olsson H, Nilsson U, Low striatal and extra-striatal D2 receptor occupancy during treatment with the atypical antipsychotic sertindole. Psychopharmacology (Berl) 2002;162:37-41
   PubMed Web of Science ®Google Scholar
• Pilowsky LS, O' Connell P, Davies N, In vivo effects on striatal dopamine D-2 receptor binding by the novel atypical antipsychotic drug sertindole - A I-123 IBZM single photon emission tomography (SPET) study. Psychopharmacology (Berl) 1997;130:152-8
   PubMed Web of Science ®Google Scholar
• Kasper S, Tauscher J, Kuefferle B, Sertindole and dopamine D-2 receptor occupancy in comparison to risperidone, clozapine and haloperidol - a I-123-IBZM SPECT study. Psychopharmacology (Berl) 1998;136:367-73
   PubMed Web of Science ®Google Scholar
• Petit-Taboue MC, Landeau B, Barre L, Parametric PET imaging of 5HT2A receptor distribution with 18F-setoperone in the normal human neocortex. J Nucl Med 1999;40:25-32
   PubMed Web of Science ®Google Scholar
• Didriksen M, Kreilgaard M, Arnt J. Sertindole, in contrast to clozapine and olanzapine, does not disrupt water maze performance after acute or chronic treatment. Eur J Pharmacol 2006;542:108-15
   PubMed Web of Science ®Google Scholar
• Rodefer JS, Nguyen TN, Karlsson JJ, Reversal of subchronic PCP-induced deficits in attentional set shifting in rats by sertindole and a 5-HT6 receptor antagonist: comparison among antipsychotics. Neuropsychopharmacology 2008;33:2657-66
   PubMed Web of Science ®Google Scholar
• Didriksen M, Skarsfeldt T, Arnt J. Reversal of PCP-induced learning and memory deficits in the Morris' water maze by sertindole and other antipsychotics. Psychopharmacology (Berl) 2007;193:225-33
   PubMed Web of Science ®Google Scholar
• Buchsbaum MS, Haznedar M, Newmark RE, FDG-PET and MRI imaging of the effects of sertindole and haloperidol in the prefrontal lobe in schizophrenia. Schizophr Res 2009;114:161-71
   PubMed Web of Science ®Google Scholar
• Azorin JM, Kaladjian A, Fakra E, Sertindole for the treatment of schizophrenia. Expert Opin Pharmacother 2010;11:3053-64
   PubMed Web of Science ®Google Scholar
• van Kammen DP, McEvoy JP, Targum SD, A randomized, controlled, dose-ranging trial of sertindole in patients with schizophrenia. Psychopharmacology (Berl) 1996;124:168-75
   PubMed Web of Science ®Google Scholar
• Hale A, Azorin JM, Kasper S, Sertindole improves both the positive and negative symptoms of schizophrenia: results of a phase III trial. Int J Psychiatry Clin Pract 2000;4:55-62
   PubMed Web of Science ®Google Scholar
• Daniel DG, Wozniak P, Mack RJ, Long-term efficacy and safety comparison of sertindole and haloperidol in the treatment of schizophrenia. Psychopharmacol Bull 1998;34:61-9
   PubMed Web of Science ®Google Scholar
• Azorin JM, Strub N, Loft H. A double-blind, controlled study of sertindole versus risperidone in the treatment of moderate-to-severe schizophrenia. Int Clin Psychopharmacol 2006;21:49-56
   PubMed Web of Science ®Google Scholar
• Kane JM, Potkin SG, Daniel DG, A double-blind, randomized study comparing the efficacy and safety of sertindole and risperidone in patients with treatment-resistant schizophrenia. J Clin Psychiatry 2011;72:194-204
   PubMed Web of Science ®Google Scholar
• Azorin JM, Murteira S, Hansen K, Evaluation of patients on sertindole treatment after failure of other antipsychotics: a retrospective analysis. BMC Psychiatry 2008;8:16
   PubMedGoogle Scholar
• Komossa K, Rummel-Kluge C, Hunger H, Sertindole versus other atypical antipsychotics for schizophrenia. Cochrane Database Syst Rev 2009;CD006752
   Google Scholar
• Nielsen J, Emborg C, Gydesen S, Augmenting clozapine with sertindole: a double-blind, randomized, placebo-controlled study. J Clin Psychopharmacol 2012;32:173-8
   PubMed Web of Science ®Google Scholar
• Gallhofer B, Jaanson P, Mittoux A, Course of recovery of cognitive impairment in patients with schizophrenia: a randomised double-blind study comparing sertindole and haloperidol. Pharmacopsychiatry 2007;40:275-86
   PubMed Web of Science ®Google Scholar
• Peuskens J, Moore N, Azorin JM, The European sertindole safety and exposure survey: a follow-up study of 8600 patients. Pharmacoepidemiol Drug Saf 2007;16:804-11
   PubMed Web of Science ®Google Scholar
• Kasper S, Moller HJ, Hale A. The European Post-marketing Observational Sertindole Study: an investigation of the safety of antipsychotic drug treatment. Eur Arch Psychiatry Clin Neurosci 2010;260:59-68
   PubMed Web of Science ®Google Scholar
• Lancon C, Toumi M, Sapin C, The sertindole safety survey: a retrospective analysis under a named patient use programme in Europe. BMC Psychiatry 2008;8:57
   PubMed Web of Science ®Google Scholar
• Branford D, Thompson B, Muldoon C. Mortality experience in three comparative cohorts of patients who received sertindole, risperidone and olanzapine: a hospital-based, retrospective study. Schizophr Res 2003;60:353-3
   Web of Science ®Google Scholar
• Peuskens J, Tanghoj P, Mittoux A. The Sertindole Cohort Prospective (SCoP) study: rationale, design and methodology. Pharmacoepidemiol Drug Saf 2008;17:425-33
   PubMed Web of Science ®Google Scholar
• Thomas SH, Drici MD, Hall GC, Safety of sertindole versus risperidone in schizophrenia: principal results of the sertindole cohort prospective study (SCoP). Acta Psychiatr Scand 2010;122:345-55
   PubMed Web of Science ®Google Scholar
• Perquin L, Steinert T. A review of the efficacy, tolerability and safety of sertindole in clinical trials. CNS Drugs 2004;18:19-30
   PubMed Web of Science ®Google Scholar
• Spina E, Zoccali R. Sertindole: pharmacological and clinical profile and role in the treatment of schizophrenia. Expert Opin Drug Metab Toxicol 2008;4:629-38
   PubMed Web of Science ®Google Scholar
• Hale A, Azorin JM, Kasper S, Sertindole is associated with a low level of extrapyramidal symptoms in schizophrenic patients: results of a phase III trial. Int J Psychiatry Clin Pract 2000;4:47-54
   PubMed Web of Science ®Google Scholar
• Lewis R, Bagnall AM, Leitner M. Sertindole for schizophrenia. Cochrane Database Syst Rev 2005;CD001715
   Google Scholar
• Gao XM, Sakai K, Tamminga CA. Chronic olanzapine or sertindole treatment results in reduced oral chewing movements in rats compared to haloperidol. Neuropsychopharmacology 1998;19:428-33
   PubMed Web of Science ®Google Scholar
• Perquin LN. Treatment with the new antipsychotic sertindole for late-occurring undesirable movement effects. Int Clin Psychopharmacol 2005;20:335-8
   PubMed Web of Science ®Google Scholar
• Oulis P, Koulouris GC, Konstantakopoulos G, Marked elevation of creatine kinase with sertindole: a case report. Pharmacopsychiatry 2007;40:295-6
   PubMed Web of Science ®Google Scholar
• De Hert M, Mittoux A, He Y, A head-to-head comparison of sertindole and risperidone on metabolic parameters. Schizophr Res 2010;123:276-7
   PubMed Web of Science ®Google Scholar
• Allison DB, Casey DE. Antipsychotic-induced weight gain: a review of the literature. J Clin Psychiatry 2001;62(Suppl 7):22-31
   PubMed Web of Science ®Google Scholar
• Yap YG, Camm J. Risk of torsades de pointes with non-cardiac drugs. Doctors need to be aware that many drugs can cause qt prolongation. BMJ 2000;320:1158-9
   PubMed Web of Science ®Google Scholar
• Drici MD, Wang WX, Liu XK, Prolongation of QT interval in isolated feline hearts by antipsychotic drugs. J Clin Psychopharmacol 1998;18:477-81
   PubMed Web of Science ®Google Scholar
• Nielsen J, Graff C, Hardahl T, Sertindole causes distinct electrocardiographic T-wave morphology changes. Eur Neuropsychopharmacol 2009;19:702-7
   PubMed Web of Science ®Google Scholar
• Kasper S, Toumi M. The clinical safety and tolerability profile of sertindole. Int J Neuropsychopharmacol 2004;7:S422-2
   Web of Science ®Google Scholar
• Titier K, Girodet PO, Verdoux H, Atypical antipsychotics - from potassium channels to torsade de pointes and sudden death. Drug Saf 2005;28:35-51
   PubMed Web of Science ®Google Scholar
• Harrigan EP, Miceli JJ, Anziano R, A randomized evaluation of the effects of six antipsychotic agents on QTc, in the absence and presence of metabolic inhibition. J Clin Psychopharmacol 2004;24:62-9
   PubMed Web of Science ®Google Scholar
• Agelink MW, Majewski T, Wurthmann C, Effects of newer atypical antipsychotics on autonomic neurocardiac function: a comparison between amisulpride, olanzapine, sertindole, and clozapine. J Clin Psychopharmacol 2001;21:8-13
   PubMed Web of Science ®Google Scholar
• Hatta K, Takahashi T, Nakamura H, Prolonged QT interval in acute psychotic patients. Psychiatry Res 2000;94:279-85
   PubMed Web of Science ®Google Scholar
• DuBuske LM. Second-generation antihistamines: the risk of ventricular arrhythmias. Clin Ther 1999;21:281-95
   PubMed Web of Science ®Google Scholar
• Witchel HJ, Hancox JC. Familial and acquired long QT syndrome and the cardiac rapid delayed rectifier potassium current. Clin Experiment Pharmacol Physiol 2000;27:753-66
   PubMed Web of Science ®Google Scholar
• Titier K, Canal M, Deridet E, Determination of myocardium to plasma concentration ratios of five antipsychotic drugs: comparison with their ability to induce arrhythmia and sudden death in clinical practice. Toxicol Appl Pharmacol 2004;199:52-60
   PubMed Web of Science ®Google Scholar
• Thomsen MB, Volders PG, Stengl M, Electrophysiological safety of sertindole in dogs with normal and remodeled hearts. J Pharmacol Exp Ther 2003;307:776-84
   PubMed Web of Science ®Google Scholar
• Thomsen MB, Volders PG, Beekman JD, Beat-to-beat variability of repolarization determines proarrhythmic outcome in dogs susceptible to drug-induced torsades de pointes. J Am Coll Cardiol 2006;48:1268-76
   PubMed Web of Science ®Google Scholar
• Nielsen J, Graff C, Kanters JK, Assessing QT interval prolongation and its associated risks with antipsychotics. CNS Drugs 2011;25:473-90
   PubMed Web of Science ®Google Scholar
• Nielsen J, Andersen MP, Graff C, The effect of sertindole on QTD and TPTE. Acta Psychiatr Scand 2010;121:385-8
   PubMed Web of Science ®Google Scholar
• Ray WA, Chung CP, Murray KT, Atypical antipsychotic drugs and the risk of sudden cardiac death. N Engl J Med 2009;360:225-35
   PubMed Web of Science ®Google Scholar
• Allison DB, Casey DE. Antipsychotic-induced weight gain: a review of the literature. J Clin Psychiatry 2001;62(Suppl 7):22-31
   PubMed Web of Science ®Google Scholar