Olanzapin in der Behandlung bipolarer affektiver Erkrankungen

Zusammenfassung

Olanzapin ist ein atypisches Antipsychotikum, das sowohl zur Therapie der akuten Manie als auch zur Phasenprophylaxe der bipolaren Erkrankung zugelassen ist. Es gibt mittlerweile acht doppelblinde, plazebokontrollierte Studien, die die Wirksamkeit der Substanz in der Therapie der akuten Manien und fünf, die sie im Rückfallschutz belegen. Eine doppelblinde, plazebokontrollierte Studie untersuchte die Wirksamkeit von Olanzapin bei der bipolaren Depression. Olanzapin ist dabei mindestens genauso gut wirksam wie klassische stimmungsstabilisierende Substanzen, in einigen Studien ist es diesen sogar überlegen. Im folgenden Beitrag werden die einzelnen Studien zu den genannten Indikationsgebieten vorgestellt und kritisch diskutiert. Dabei wird auch auf Aspekte der Lebensqualität unter Olanzapintherapie und das Sicherheitsprofil der Substanz eingegangen.

Abstract

Olanzapin is an atypical antipsychotic drug, which is approved for use in acute mania and in the prophylaxis of bipolar disorder. There are eight double-blind, placebo-controlled studies, which show its efficacy in the treatment of acute mania, five, which document its efficacy in the long-term treatment of bipolar disorder and one that shows its use in bipolar depression. The following overview presents and critically evaluates these studies. Quality of life aspects on olanzapine treatment and the safety profile of the drug will also be discussed.

Literatur

• 1 Ereshefsky L. Pharmacokinetics and drug interactions: update for new antipsychotics.  J Clin Psychiatry. 1996;  57, Suppl 11 12-25
• 2 Fulton B, Goa K L. Olanzapine. A review of its pharmacological properties and therapeutic efficacy in the management of schizophrenia and related psychoses.  Drugs. 1997;  53 (2) 281-298
• 3 Callaghan J T, Bergstrom R F, Ptak L R, Beasley C M. Olanzapine. Pharmacokinetic and pharmacodynamic profile.  Clin Pharmacokinet. 1999;  37 (3) 177-193
• 4 Kassahun K, Mattiuz E, Nyhart Jr E, Obermeyer B, Gillespie T, Murphy A. et al . Disposition and biotransformation of the antipsychotic agent olanzapine in humans.  Drug Metab Dispos. 1997;  25 (1) 81-93
• 5 Weigmann H, Hartter S, Maehrlein S, Kiefer W, Kramer G, Dannhardt G. et al . Simultaneous determination of olanzapine, clozapine and demethylated metabolites in serum by on-line column-switching high-performance liquid chromatography.  J Chromatogr B Biomed Sci Appl. 2001;  759 (1) 63-71
• 6 Chiu J A, Franklin R B. Analysis and pharmacokinetics of olanzapine (LY170053) and two metabolites in rat plasma using reversed-phase HPLC with electrochemical detection.  J Pharm Biomed Anal. 1996;  14 (5) 609-615
• 7 Bymaster F P, Hemrick-Luecke S K, Perry K W, Fuller R W. Neurochemical evidence for antagonism by olanzapine of dopamine, serotonin, alpha 1-adrenergic and muscarinic receptors in vivo in rats.  Psychopharmacology (Berl). 1996;  124 (1 - 2) 87-94
• 8 Schlicker E, Marr I. The moderate affinity of clozapine at H3 receptors is not shared by its two major metabolites and by structurally related and unrelated atypical neuroleptics.  Naunyn Schmiedebergs Arch Pharmacol. 1996;  353 (3) 290-294
• 9 Naber D, Lambert M, Krausz M, Haasen C. Atypische Neuroleptika in der Behandlung schizophrener Patienten. 2^nd ed. Bremen; Uni-Med Science 2000
• 10 Stephenson C M, Pilowsky L S. Psychopharmacology of olanzapine. A review.  Br J Psychiatry Suppl. 1999;  (38) 52-58
• 11 Tohen M, Jacobs T G, Grundy S L, McElroy S L, Banov M C, Janicak P G. et al . Efficacy of olanzapine in acute bipolar mania: a double-blind, placebo-controlled study. The Olanzapine HGGW Study Group.  Arch Gen Psychiatry. 2000;  57 (9) 841-849
• 12 Tohen M, Sanger T M, McElroy S L, Tollefson G D, Chengappa K N, Daniel D G. et al . Olanzapine versus placebo in the treatment of acute mania. Olanzapine HGEH Study Group.  Am J Psychiatry. 1999;  156 (5) 702-709
• 13 Tohen M, Baker R W, Altshuler L L, Zarate C A, Suppes T, Ketter T A. et al . Olanzapine versus divalproex in the treatment of acute mania.  Am J Psychiatry. 2002;  159 (6) 1011-1017
• 14 Zajecka J M, Weisler R, Sachs G, Swann A C, Wozniak P, Sommerville K W. A comparison of the efficacy, safety, and tolerability of divalproex sodium and olanzapine in the treatment of bipolar disorder.  J Clin Psychiatry. 2002;  63 (12) 1148-1155
• 15 Tohen M, Chengappa K N, Suppes T, Zarate Jr C A, Calabrese J R, Bowden C L. et al . Efficacy of olanzapine in combination with valproate or lithium in the treatment of mania in patients partially nonresponsive to valproate or lithium monotherapy.  Arch Gen Psychiatry. 2002;  59 (1) 62-69
• 16 Tohen M, Goldberg J F, Gonzalez-Pinto Arrillaga A M, Azorin J M, Vieta E, Hardy-Bayle M C. et al . A 12-week, double-blind comparison of olanzapine vs haloperidol in the treatment of acute mania.  Arch Gen Psychiatry. 2003;  60 (12) 1218-1226
• 17 Meehan K, Zhang F, David S, Tohen M, Janicak P, Small J. et al . A double-blind, randomized comparison of the efficacy and safety of intramuscular injections of olanzapine, lorazepam, or placebo in treating acutely agitated patients diagnosed with bipolar mania.  J Clin Psychopharmacol. 2001;  21 (4) 389-397
• 18 Goodwin F K, Jamison K R. Manic-depressive illness. New York; Oxford University Press 1990
• 19 Himmelhoch J M, Garfinkel M E. Mixed mania, diagnosis and treatment: sources of lithium resistance.  Psychopharmacology Bulletin. 1986;  22 613-620
• 20 Himmelhoch J M, Mulla D, Neil J F, Detre T P, Kupfer D J. Incidence and significance of mixed affective states in a bipolar population.  Arch Gen Psychiatry. 1976;  33 (9) 1062-1066
• 21 World Health Organization .Internationale Klassifikation psychischer Störungen, ICD 10. Bern, Switzerland; Hans Huber 1994
• 22 American Psychiatric Association .Diagnostic and Statistical Manual of Mental Disorders. 4^th edition. Washington, DC; American Psychiatric Press 1996
• 23 Bräunig P. Diagnose, Verlauf und Ausgang zykloider Psychosen. Habilitationsschrift, Band I ed. 1992
• 24 Boland R J, Keller M B. Mixed-State bipolar disorders: outcome data from the NIMH Collaborative Program on the Psychobiology of Depression. In: Goldberg JF, Harrow JM (eds) Bipolar disorders: clinical course and outcome. Washington DC; American Psychiatric Press 1999: 115-128
• 25 Goldberg J F, Garno J L, Leon A C, Kocsis J H, Portera L. Association of recurrent suicidal ideation with non-remission from acute mixed mania.  Am J Psychiat. 1998;  155 (12) 1753-1755
• 26 Goldberg J F, Garno J, Portera L, Leon A C, Kocsis J H, Whiteside H L. Correlates of suicidal ideation in dysphoric mania.  J Affect Disord. 1999;  56 (1) 75-81
• 27 Krüger S, Cooke R G, Spegg C, Bräunig P. Relevance of the catatonic syndrome to the mixed manic episode.  Journal of Affective Disorder. 2003;  74 (3) 279-285
• 28 Himmelhoch J M, Garfinkel M E. Sources of lithium resistance in mixed mania.  Psychopharmacol Bull. 1986;  22 (3) 613-620
• 29 Tohen M, Vieta E, Calabrese J, Ketter T A, Sachs G, Bowden C. et al . Efficacy of olanzapine and olanzapine-fluoxetine combination in the treatment of bipolar I depression.  Arch Gen Psychiatry. 2003;  60 (11) 1079-1088
• 30 Tohen M, Ketter T A, Zarate C A, Suppes T, Frye M, Altshuler L. et al . Olanzapine versus divalproex sodium for the treatment of acute mania and maintenance of remission: a 47-week study.  Am J Psychiatry. 2003;  160 (7) 1263-1271
• 31 Baker R W, Tohen M, Fawcett J, Risser R C, Schuh L M, Brown E. et al . Acute dysphoric mania: treatment response to olanzapine versus placebo.  J Clin Psychopharmacol. 2003;  23 (2) 132-137
• 32 Dennehy E B, Doyle K, Suppes T. The efficacy of olanzapine monotherapy for acute hypomania or mania in an outpatient setting.  Int Clin Psychopharmacol. 2003;  18 (3) 143-145
• 33 Ketter T A, Winsberg M E, DeGolia S G, Dunai M, Tate D L, Strong C M. Rapid efficacy of olanzapine augmentation in nonpsychotic bipolar mixed states [letter] [see comments].  J Clin Psychiatry. 1998;  59 (2) 83-85
• 34 Sharma V, Pistor L. Treatment of bipolar mixed state with olanzapine.  J Psychiatry Neurosci. 1999;  24 (1) 40-44
• 35 Baldassano C F, Ballas C A, O'Reardon J P. Rethinking the treatment paradigm for bipolar depression: the importance of long-term management.  CNS Spectr. 2004;  9 (9 Suppl 9) 11-18
• 36 Hirschfeld R M. Bipolar depression: the real challenge.  Eur Neuropsychopharmacol. 2004;  14, Suppl 2 S83-S88
• 37 Gijsman H J, Geddes J R, Rendell J M, Nolen W A, Goodwin G M. Antidepressants for bipolar depression: a systematic review of randomized, controlled trials.  Am J Psychiatry. 2004;  161 (9) 1537-1547
• 38 Vieta E, Reinares M, Corbella B, Benabarre A, Gilaberte I, Colom F. et al . Olanzapine as long-term adjunctive therapy in treatment-resistant bipolar disorder.  J Clin Psychopharmacol. 2001;  21 (5) 469-473
• 39 Sanger T M, Grundy S L, Gibson P J, Namjoshi M A, Greaney M G, Tohen M F. Long-term olanzapine therapy in the treatment of bipolar I disorder: an open-label continuation phase study.  J Clin Psychiatry. 2001;  62 (4) 273-281
• 40 Tohen M, Chengappa K N, Suppes T, Baker R W, Zarate C A, Bowden C L. et al . Relapse prevention in bipolar I disorder: 18-month comparison of olanzapine plus mood stabiliser v. mood stabiliser alone.  Br J Psychiatry. 2004;  184 337-345
• 41 Barrios C, Chaudhry T A, Goodnick P J. Rapid cycling bipolar disorder.  Expert Opin Pharmacother. 2001;  2 (12) 1963-1973
• 42 Calabrese J R, Shelton M D, Rapport D J, Kujawa M, Kimmel S E, Caban S. Current research on rapid cycling bipolar disorder and its treatment.  J Affect Disord. 2001;  67 (1 - 3) 241-255
• 43 Sanger T M, Tohen M, Vieta E, Dunner D L, Bowden C L, Calabrese J R. et al . Olanzapine in the acute treatment of bipolar I disorder with a history of rapid cycling.  J Affect Disord. 2003;  73 (1 - 2) 155-161
• 44 Meyer C, Rumpf H J, Hapke U, John U. Impact of psychiatric disorders in the general population: satisfaction with life and the influence of comorbidity and disorder duration.  Soc Psychiatry Psychiatr Epidemiol. 2004;  39 (6) 435-441
• 45 Perlis R H, Miyahara S, Marangell L B, Wisniewski S R, Ostacher M, DelBello M P. et al . Long-term implications of early onset in bipolar disorder: data from the first 1000 participants in the systematic treatment enhancement program for bipolar disorder (STEP-BD).  Biol Psychiatry. 2004;  55 (9) 875-881
• 46 Dean B B, Gerner D, Gerner R H. A systematic review evaluating health-related quality of life, work impairment, and healthcare costs and utilization in bipolar disorder.  Curr Med Res Opin. 2004;  20 (2) 139-154
• 47 Martinez-Aran A, Vieta E, Colom F, Torrent C, Sanchez-Moreno J, Reinares M. et al . Cognitive impairment in euthymic bipolar patients: implications for clinical and functional outcome.  Bipolar Disord. 2004;  6 (3) 224-232
• 48 Martinez-Aran A, Vieta E, Reinares M, Colom F, Torrent C, Sanchez-Moreno J. et al . Cognitive function across manic or hypomanic, depressed, and euthymic states in bipolar disorder.  Am J Psychiatry. 2004;  161 (2) 262-270
• 49 Shi L, Namjoshi M A, Swindle R, Yu X, Risser R, Baker R W. et al . Effects of olanzapine alone and olanzapine/fluoxetine combination on health-related quality of life in patients with bipolar depression: secondary analyses of a double-blind, placebo-controlled, randomized clinical trial.  Clin Ther. 2004;  26 (1) 125-134
• 50 Shi L, Namjoshi M A, Zhang F, Gandhi G, Edgell E T, Tohen M. et al . Olanzapine versus haloperidol in the treatment of acute mania: clinical outcomes, health-related quality of life and work status.  Int Clin Psychopharmacol. 2002;  17 (5) 227-237
• 51 Namjoshi M A, Risser R, Shi L, Tohen M, Breier A. Quality of life assessment in patients with bipolar disorder treated with olanzapine added to lithium or valproic acid.  J Affect Disord. 2004;  81 (3) 223-229
• 52 Namjoshi M A, Rajamannar G, Jacobs T, Sanger T M, Risser R, Tohen M F. et al . Economic, clinical, and quality-of-life outcomes associated with olanzapine treatment in mania. Results from a randomized controlled trial.  J Affect Disord. 2002;  69 (1 - 3) 109-118
• 53 Haberfellner E M, Rittmannsberger H. Weight gain during long-term treatment with olanzapine: a case series.  Int Clin Psychopharmacol. 2004;  19 (4) 251-253
• 54 Liberty I F, Todder D, Umansky R, Harman-Boehm I. Atypical antipsychotics and diabetes mellitus: an association.  Isr Med Assoc J. 2004;  6 (5) 276-279
• 55 American Diabetes Association, American Psychiatric Association, American Association of Clinical Endocrinologists, North American Association for the Study of Obesity . Consensus Development Conference in antipsychotic drugs an obesity and diabetes.  Diabetes Care. 2004;  27 596-601
• 56 Vieta E, Sanchez-Moreno J, Goikolea J M, Colom F, Martinez-Aran A, Benabarre A. et al . Effects on weight and outcome of long-term olanzapine-topiramate combination treatment in bipolar disorder.  J Clin Psychopharmacol. 2004;  24 (4) 374-378
• 57 Kanner A M, Wuu J, Faught E, Tatum W O, Fix A, French J A. A past psychiatric history may be a risk factor for topiramate-related psychiatric and cognitive adverse events.  Epilepsy Behav. 2003;  4 (5) 548-552
• 58 Meador K J, Loring D W, Hulihan J F, Kamin M, Karim R. Differential cognitive and behavioral effects of topiramate and valproate.  Neurology. 2003;  60 (9) 1483-1488