Nervenheilkunde 2016; 35(12): 847-856
DOI: 10.1055/s-0037-1616456
Übersichtsartikel
Schattauer GmbH

Mono-, Kombinations- und Augmentationstherapie depressiver Patienten mit Agomelatin

Ergebnisse einer Subgruppenanalyse der Studie VIVREMono-, combination and augmentation therapy of depressive patients with agomelatineResults of a subgroup analysis of the study VIVRE
H.-P. Volz
1   Krankenhaus für Psychiatrie, Psychotherapie und Psychosomatische Medizin, Schloss Werneck, Werneck
,
M.-L. Escafit-Schülke
2   Servier Deutschland GmbH, Medical Affairs, München
› Author Affiliations
Further Information

Publication History

eingegangen am: 08 February 2016

angenommen am: 21 September 2016

Publication Date:
10 January 2018 (online)

Zusammenfassung

Gegenstand und Ziel: Die Subgruppenanalyse der nicht interventionellen Studie VIVRE (Valdoxan® ImproVes depRession with anxiEty symptoms) evaluierte die Verbesserung von Angstsymptomen der Depression und sozialer Funktionsfähigkeit unter Agomelatin, abhängig von der antidepressiven bzw. psychotropen Komedikation. Methoden: Patienten von 4 Subgruppen (A–D) erhielten über 12 Wochen Agomelatin in Monotherapie (A, n = 965), Kombinationstherapie (B, n = 187), Augmentationstherapie (C, n = 549) oder in Kombinations- plus Augmentationstherapie (D, n = 190). Der klinische Verlauf wurde mit Clinical-Global-Impression (CGI), Patient-Global-Impressions (PGI), COVI- und Sheehan-Disability-Skala (SDS) dokumentiert. Ergebnisse: Die depressive Symptomatik verbesserte sich bei mehr als drei Viertel der Patienten aller Subgruppen mit Response-/Remissionsraten (CGI-I/S) von 83,0%/44,1% (A), 75,3%/23,2% (B), 86,1%/42,2% (C) und 70,3%/26% (D). Die Angstsymptome der Depression (COVI) verbesserten sich bei 92,7% (A), 91,3% (B), 94,8% (C) und 89,8% (D) und die soziale Funktionsfähigkeit (SDS) bei 94,3% (A), 93,2% (B), 95,8% (C) und 93,1% (D) der Patienten. Schlussfolgerung: Verbesserung von depressiven Symptomen, Angstsymptomen bei Depression und sozialer Funktionsfähigkeit konnten unter Agomelatin sowohl als Mono-, Kombinations- bzw. Augmentationstherapie bei guter Verträglichkeit im Praxisalltag beobachtet werden.

Summary

Objective: The subgroup analysis of the non-interventional study VIVRE investigated the improvements of agomelatine on depressive symptoms, depression-related anxiety symptoms and social functioning depending on antidepressant or psychotropic comedication. Methods: Patients were divided into 4 subgroups (A-D) with agomelatine for 12 weeks either in monotherapy (A, n = 965), combination- (B, n = 187), augmentation- (C, n = 549), or both combination- and augmentation- therapy (D, n = 190). Clinical effects were evaluated by use of Clinical Global Impressions- (CGI), Patient Global Impressions- (PGI), COVI- and Sheehan-Disability-Scale (SDS). Results: Depressive symptoms improved in more than three quarters of patients of all subgroups. The percentage of responder/remitters (CGI-I/S) was 83,0%/44.1% (A), 75.3%/23.2% (B), 86.1%/42.2% (C) and 70.3%/26% (D). Anxiety symptoms of depression (COVI) improved in 92.7% (A), 91.3% (B), 94.8% (C) and 89.8% (D) and social functioning (SDS) in 94.3% (A), 93.2% (B), 95.8% (C) und 93.1% (D) of patients. Conclusion: Improvements on depressive symptoms, depression-related anxiety symptoms and social functioning were observed under agomelatine in monotherapy, combination or augmentation together with a good safety profile in daily practice.

 
  • Literatur

  • 1 D‘Avanzato C, Martinez J, Attiullah N, Friedman M, Toba C, Boerescu DA, Zimmerman M. Anxiety symptoms among remitted depressed outpatients: Prevalence and association with quality of life and psychosocial functioning. J Affect Disord 2013; 151: 401-404.
  • 2 Davidson JR, Meoni P, Haudiquet V, Cantillon M, Hackett D. Achieving remission with venlafaxine and fluoxetine in major depression: its relationship to anxiety symptoms. Depress Anxiety 2002; 16: 4-13.
  • 3 Di Giannantonio M, Martinotti G. Anhedonia and major depression: the role of agomelatine. Eur Neuropsychopharmacol 2012; 22 (Suppl. 03) S505-510.
  • 4 DGPPN, Leitliniengruppe. S3-Leitlinie/Nationale Versorgungsleitlinie Unipolare Depression. DGPPN, ÄZQ, AWMF; 2012
  • 5 Fava M, Rush AJ, Alpert JE, Balasubramani GK, Wisniewski SR. et al. Difference in treatment outcome in outpatients with anxious versus nonanxious depression: a STAR*D report. Am J Psychiatry 2008; 165: 342-351.
  • 6 Guaiana G, Gupta S, Chiodo D, Davies SJC. et al. Agomelatine versus other antidepressive agents for major depression. Cochrane Database Syst Rev 2013; 12: CD008851.
  • 7 Jeste ND, Hays JC, Steffens DC. Clinical correlates of anxious depression among elderly patients with depression. J Affect Disord 2006; 90: 37-41.
  • 8 Kahl K. G., Eberlein C., Frieling H. Combination of agomelatine and bupropion for treatment-resistant depression: a case series. J Eur Psychiatric Assoc 2012; 27: P-1090.
  • 9 Khoo AL, Zhou HJ, Teng M. et al. Network meta-analysis and cost-effectiveness analysis of new generation antidepressants. CNS Drugs. 2015 Aug 21. [Epub ahead of print]
  • 10 Laux G. Antidepressive Therapie mit Agomelatin in der Facharztpraxis. Ergebnisse der VIVALDI-Studie. Psychopharmakotherapie 2011; 18: 18-26.
  • 11 Laux G, Huttner N. Agomelatin in der Depressionsbehandlung über 12 Monate. Follow-up der VIVALDI-Studie. Psychopharmakotherapie 2013; 20: 119-127.
  • 12 Laux G, Huttner N. Subgroup analysis of the non interventional study VIVALDI: Agomelatin in treatment naïve patients, in combination therapy and after treatment switch. Int J Psychiatry Clin Pract 2014; 18: 86-96.
  • 13 Murray G. Diurnal mood variation in depression: a signal of disturbed circadian function?. J Affect Disord 2007; 102: 47-53.
  • 14 Murray C, Lopez A. Alternative projections of mortality and disability by cause 1990 to 2020 global burden of disease study. Lancet 1997; 349: 1498-504.
  • 15 Rapaport MH, Clary C, Fayyad R, Endicott J. Quality-of-life impairment in depressive and anxiety disorders. Am J Psychiatry 2005; 162: 1171-1178.
  • 16 Sanderson K, Tilse E, Nicholson J, Oldenburg B, Graves N. Which presenteeism measures are more sensitive to depression and anxiety?. J Affect Disord 2007; 101: 65-74.
  • 17 Sparshatt A, McAllister Williams RH, Baldwin DS, Haddad PM, Bazire S, Weston E. et al. A naturalistic evaluation and audit database of agomelatine: clinical outcome at 12 weeks. Acta Psychiatr Scand 2013; 128 (03) 203-11.
  • 18 Stein DJ, Ahokas A, Albarran C, Olivier V, Allgulander C. Agomelatine prevents relapse in generalized anxiety disorder: a 6-month randomized, double-blind, placebo-controlled discontinuation study. J Clin Psychiatry 2012; 73: 1002-1008.
  • 19 Stein DJ, Ahokas AA, de Bodinat C. Efficacy of agomelatine in generalized anxiety disorder: a randomized, double-blind, placebo-controlled study. J Clin Psychopharmacol 2008; 28: 561-566.
  • 20 Stein DJ, Ahokas A, Márquez MS, Höschl C. et al. Agomelatine in generalized anxiety disorder: An active comparator and placebo-controlled study. J Clin Psychiatry 2014; 75: 362-368.
  • 21 Stein DJ, Picarel-Blanchot F, Kennedy SH. Efficacy of the novel antidepressant agomelatine for anxiety symptoms in major depression. Hum Psychopharmacol 2013; 28: 151-159.
  • 22 Sühs K. et al. Combination of agomelatine and bupropion for treatment-resistant depression: results from a chart review study including a matched control group. Brain and Behavior 2015; Feb 19; e00318
  • 23 Taylor D, Sparshatt A, Varma S, Olofinjana O. Antidepressant efficacy of agomelatine: meta-analysis of published and unpublished studies. BMJ 2014; 348: g1888.
  • 24 Volz HP. Agomelatin – Update aktueller Daten 2015. Die Psychiatrie 2015; 12: 128-137.
  • 25 Volz HP, Escafit-Schülke M. -L.. Effekte von Agomelatin bei depressiven Patienten im Praxisalltag. Ergebnisse der nicht-interventionellen Studie VIVRE. Nervenheilkunde 2015; 34: 809-817.
  • 26 WHO. Burden of disease: DALYs. GBD report update. 2004
  • 27 Zajecka J, Schatzberg A, Stahl S, Shah A, Caputo A, Post A. Efficacy and safety of agomelatine in the treatment of major depressive disorder: a multicenter, randomized, double-blind, placebo-controlled trial. J Clin Psychopharmacol 2010; 30: 135-144.
  • 28 Zimmerman M, McGlinchey JB, Posternak MA, Friedman M, Attiullah N, Boerescu D. How should remission from depression be defined? The depressed patient‘s perspective. Am J Psychiatry 2006; 163: 148-150.