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Recommendation grades (RG)Based on categories of evidence (CE) & safety
Medication CE RG
AripiprazoleAsenapineCarbamazepineChlorpromazineHaloperidolLithiumOlanzapinePaliperidonePhenytoineQuetiapineRisperidoneTamoxifenValproateZiprasidone
AAABAAABBAABAA
12232223321 311
CE A: 2 placebo-contr. RCT and 1 comparator RCT
CE B: 1 placebo-contr. RCT or 1 comparator RCT
--------------------------
10 drugs fulfil Category A criteria !
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Recommendation grades (RG)Based on categories of evidence (CE) & safety
Medication CE RG
AripiprazoleAsenapineCarbamazepineChlorpromazineHaloperidolLithiumOlanzapinePaliperidonePhenytoineQuetiapineRisperidoneTamoxifenValproateZiprasidone
AAABAAABBAABAA
12232223321 311
CE A: 2 placebo-contr. RCT and 1 comparator RCT
CE B: 1 placebo-contr. RCT or 1 comparator RCT
--------------------------
10 drugs fulfil Category A criteria !
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Überblick
Klinik Symptomatik & Diagnostik
- Manie und Hypomanie- gemischte Episode- depressive Episode
Differentialdiagnostik und Komorbiditäten
Therapien - aktuelle Therapieoptionen- Asenapin
Fazit
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Präklinisches Profil von Asenapin
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Molekülstruktur von Asenapin
N
CH3
CI
HC
HC
CO2H
CO2H
• Asenapin ist ein tetrazyklischer psychopharmakologischer Wirkstoff aus der Gruppe der Dibenzo‐Oxepin‐Pyrrole
• Die Struktur von Asenapin unterscheidet sich von der anderer Neuroleptika
H
O
H
Shahid M et al. J Psychopharmacol. 2009;23:65-73.
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Rezeptorprofil von Asenapin: Vergleich zu Clozapin
579
11
5HT2C 5-HT2A 5-HT7 5-HT2B 5-HT6 2B D3 H1 D4 1A 2A 2C D2 D1 5-HT5 5-HT1A 5-HT1B H2 M1
Asenapin
pKi
Clozapin
579
11
pKi
Starke Ähnlichkeit, jedoch ist Asenapin verhältnismäßig weniger wirksam an den Histamin- und Muskarin-Rezeptoren
5HT2C 5-HT2A 5-HT7 5-HT2B 5-HT6 2B D3 H1 D4 1A 2A 2C D2 D1 5-HT5 5-HT1A 5-HT1B H2 M1
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Auswahl des Dosierbereichs von Asenapin (5-10 mg BID) belegt durch PET-Daten
MRT PET Koregistriert
Asenapin-Plasmakonzentration (ng/ml)
D2-B
eleg
ung
(%)
Mittlere Konzentration5 mg BID
10 mg BID
0
20
40
60
80
100
0 0 1 10 100
PUTAMEN
HYPOPHYSE
NUCLEUSACCUMBENS
CAUDATE-KOPF
Organon. Daten in den AktenBID = zweimal täglich
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Pharmakokinetik
Orale Bioverfügbarkeit – wegen eines ausgeprägten first-pass-Effektes - ist gering (< 2%), daher sublinguale Applikation: Steigerung der Bioverfügbarkeit auf 35%.Wichtig: für ca. 10 min nach Applikation keine Zufuhr von Flüssigkeit, da Abnahme der Resorption
Schnelle Resorption, tmax = 0,5 – 1,5 h T1/2 = 24 h Hohe Plasmaeiweißbindung (ca. 95%) Steady-state nach drei Tagen bei b.i.d.
Fachinformation 2010, FDA 2009
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GIT Leber
Ausgeprägter medikamentöserFirst-pass Metabolismus
Systemische ZirkulationBioverfügbarkeit der
Asenapintablette ~2%
Konventionelle Tabletteneinnahme gingmit geringer Bioverfügbarkeit einher
Tabletteneinnahmevon
Asenapin
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GIT Leber
Systemische Zirkulation
Sublinguale Einnahme von Asenapinverbesserte die Bioverfügbarkeit
SublingualesAsenapin
Ausgeprägter medikamentöserFirst-pass Metabolismus
Bioverfügbarkeit der sublingualenAsenapintablette ~35%
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Pharmakokinetik
Kein Einfluss von Rauchen. Leberfunktionsstörungen
- leicht (Child-Pugh A): kein Einfluss- mäßig (Child-Pugh B): leichter Anstieg der
Asenapin-Konzentration; vorsichtige Anwendung- Schwer (Child-Pugh C): 7-fach erhöhte Asenapin-
Konzentration: Kontraindikation Nierenfunktion: keine Erhöhung des Plasmaspiegels
bei leichteren Formen, es liegen aber keine Daten für schwere Nierenfunktionsstörungen (Kreatinin-Clearance < 15ml/min) vor.
Fachinformation 2010, FDA 2009
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Pharmakokinetik - Metabolismus
In der Leber verstoffwechselt (UGT1A4, CYP1A2, CYP3A4, CYP2D6)- Asenapin ist ein schwacher Inhibitor von CYP2D6.- CYP1A2 und CYP3A4 werden durch Asenapin nicht induziert.- Carbamazepin (CYP1A2- und CYP3A4-Induktor), Cimetidin
(CYP3A4-Inhibitor), Paroxetin (CYP2D6-Inhibitor) haben keinen Einfluss auf die Asenapin-Konzentration.
- Die Konzentration von Paroxetin steigt unter Asenapin um nahezu 100% an.
- Fluvoxamin (CYP1A2-Inhibitor) führt zu einer deutlich erhöhten Asenapin-Konzentration.
- Valproat (UGT-Inhibitor) verändert nicht die Asenapin-Plasmakonzentration
Fachinformation 2010, FDA 2009
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Klinisches Profil von Asenapin
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Rezeptorprofil von Asenapin: Vergleich zu Clozapin
579
11
5HT2C 5-HT2A 5-HT7 5-HT2B 5-HT6 2B D3 H1 D4 1A 2A 2C D2 D1 5-HT5 5-HT1A 5-HT1B H2 M1
Asenapin
pKi
Clozapin
579
11
pKi
Starke Ähnlichkeit, jedoch ist Asenapin verhältnismäßig weniger wirksam an den Histamin- und Muskarin-Rezeptoren
5HT2C 5-HT2A 5-HT7 5-HT2B 5-HT6 2B D3 H1 D4 1A 2A 2C D2 D1 5-HT5 5-HT1A 5-HT1B H2 M1
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Asenapin besitzt eine höhere Affinität zuSerotonin-Rezeptoren
5
6
7
8
9
10
11
pKi
10.510.2
9.9 9.89.6
8.88.6
8.4
5-HT2C 5-HT2A5-HT7 5-HT2B
5-HT6 5-HT5 5-HT1A 5-HT1B
D2-Affinität
Shahid M et al. J Psychopharmacol. 2009;23:65-73.
5HT2A:Kognition, Negativ-
symptomatik, EPS
5HT2C:anti-
depressiv5HT6:
Kognition
5HT7:Angst- und Stimmungs-modulation
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Post-hoc Analyse – MADRS total score Veränderungen zur Baseline
Asenapin Plazebo Olanzapin
Bipolare Patienten mit initialem MADRS ≥20
Tag 7 Tag 21
***
*
0
-5
-10
-15
Mitt
lere
Verä
nder
ung
von
Bas
elin
e
-11.26
-4.48
-6.86
-13.58
-6.99
-10.56
Szegedi et al. BMC Psychiatry 2011,11:101
** p≤0,05 vs Olanzapin*p≤0,01 vs Plazebo
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Therapie der Bipolaren Depression
StiStab
EKT
I.
II.
III.
IV.
StiStab
StiStab NLStiStab
Monotherapie
Kombination/Wechsel
Mehrfachkombination
AD
AD AD NL
AD AD
NL
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Risikofaktoren: Medikamente
Trizyklika > SSRI
Keine Stimmungsstabilisierer
Parker und Parker, Aus N Zea J Psychiatry 2003; 37: 464-468; Goldberg and Truman, Bip Dis 2003; 5: 407-420
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Sind alle Antidepressiva gleich problematisch?
Switchrisiko
Antidepressiva
TrizyklikaReboxetinVenlafaxinDuloxetinMirtazapinMAO-I FluoxetinParoxetinFluvoxaminSertralinBupropionCitalopram/Escitalopram
Einige Forscher vertreten die Meinung, die Fähigkeit eines Antidepressivums, einen Switchauszulösen, sei ein Indikator für seine Wirksamkeit bei bipolarer Depression (z.B. Jules Angst, 2008; Eduard Vieta, 2008).
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Therapie der Bipolaren Depression
StiStab
EKT
I.
II.
III.
IV.
StiStab
StiStab NLStiStab
Monotherapie
Kombination/Wechsel
Mehrfachkombination
AD
AD AD NL
AD AD
NL
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Therapie der Bipolaren Depression
StiStab
EKT
I.
II.
III.
IV.
StiStab
StiStab NLStiStab
Monotherapie
Kombination/Wechsel
Mehrfachkombination
AD
AD AD NL
AD AD
NL
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Study week
***p<0.001 vs placebo for both active arms at all timepointsMean baseline scores: BP I 30.5; BP II 30.2
Mean change in MADRS score from baseline (ITT)
Quetiapin: significant reduction of depressive symptoms at Week 1
-18-16-14-12-10-8-6-4-20
0 1 2 3 4 5 6 7 8
Seroquel 600 mg/daySeroquel 300 mg/dayPlacebo
***************
******
***
Calabrese et al APA 2004;AstraZeneca – data on file
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***
Quetiapin improves core symptomsof depression
8-9 items separated from placebo
**p<0.01; ***p<0.001 vs placebo
Change from baseline MADRS items (LS means)
***
-3.0-2.5-2.0-1.5-1.0-0.50.0
Suicidal thoughts
Pessimistic thoughts
Inability to feel
Lassitude
Concentration difficulties
Reduced appetite
Reduced sleep
Inner tension
Reported sadness
Apparent sadness
Seroquel 600 mg/daySeroquel 300 mg/dayPlacebo
***********
******
***
********
***
**
*****
AstraZeneca - data on file
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WFSBP Guideline Bipolar Depression 2010Monotherapien
Quetiapin A 1 (Young et al 2010;McElroy et al 2010;Suppes 2010;Thase et al 2006;Calabrese et al 2005)
Fluoxetin1 B 3 (Cohn et al 1989;Tohen et al 2003)
Lamotrigin B 3 (Calabrese et al 2008;Brown et al 2008;Geddes et al 2009;Frye et al 2000; van der Loos et al, 2009)
Olanzapin B 3 (Tohen et al 2003)
Valproat B 3 (Davis et al 2005;Ghaemi et al 2007;Sachs et al 2002)
Lithium D 2 5 (Young et al 2008;Zornberg and Pope 1993)
Carbamazepin D 5 (Zhang et al, 2007)
Paroxetin E - (McElroy et al 2008)
Aripiprazol E - (Thase et al 2008)
Ziprasidon E - (Sachs et al 2009)
[1] When olanzapine monotherapy is considered as the placebo condition in the study by Tohen et al (Tohen et al 2003). Rate of TEAS low with accompanying antimanic drug, but unclear in monotherapy2 In the case of preexisting lithium treatment, antideprssive response may be achieved by dosage increase towards high plasma levels (Nemeroff et al 2001) CE B, RG 3
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Zugelassene Indikationen Atypika bei bipolaren Störungen
falls Manie in der Akuttherapie angesprochen hat
-+ Aripiprazol
--+Ziprasidon
--+Risperidon
falls Manie oder Depression in der Akuttherapie angesprochen hat
++Quetiapin
falls Manie in der Akuttherapie angesprochen hat
-+Olanzapin
--+ Asenapin
PräventionAkuttherapie Depression
Akut-therapieManie
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Zugelassene Indikationen Mood Stabilizer
+-+Valproat
Prophylaxe depressiver Episode bei BP-Pat. mit überwiegend
depressiven Episoden
--Lamotrigin
+--Carbamazepin
+einge-schränkt*
+ Lithium
ProphylaxeAkuttherapie Depression
Akut-therapieManie
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Zusammenfassung
Die Diagnose und Therapie der bipolaren Störung erfordert Sorgfalt und großes Wissen.
Die Akutbehandlung der Depression ist am schwierigsten!
Bei der Langzeitbehandlung dominiert nach wie vor Lithium.
Für die Akuttherapie der Manie sind heute Atypika die Therapie der Wahl, die, wenn Manien vorherrschen, auch die erste Wahl in der Langzeittherapie sind. Eine neue interessante Therapieoption stellt Asenapin dar.
Kombinationsbehandlungen sind häufig.