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LEPONEX - ANNEXE ANTIPSYCHOTIQUES - Version anglaise

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41 Pages
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Présentation LEPONEX 100 mg, comprimé sécable B/14 - Code CIP : 3551404 B/28 - Code CIP : 3551410 LEPONEX 25 mg, comprimé sécable B/14 - Code CIP : 3551350 B/28 - Code CIP : 3551367 B/7 - Code CIP : 3551344 Mis en ligne le 19 mars 2013 Substance active (DCI) clozapine Progrès thérapeutique modéré dans le traitement de la schizophrénie Six antipsychotiques de seconde génération (ASG) ont l'AMM dans la schizophrénie : ABILIFY (aripiprazole), LEPONEX et génériques (clozapine), RISPERDAL et génériques (rispéridone), SOLIAN et génériques (amisulpride), XEROQUEL (quétiapine) et ZYPREXA et génériques (olanzapine).Les ASG constituent une classe hétérogène en termes d’efficacité et de tolérance. Cependant, les données ne permettent pas de privilégier un ASG plutôt qu’un autre. Code ATC N05AH02 Laboratoire / fabricant Laboratoire NOVARTIS PHARMA S.A.S. LEPONEX 100 mg, comprimé sécable B/14 - Code CIP : 3551404 B/28 - Code CIP : 3551410 LEPONEX 25 mg, comprimé sécable B/14 - Code CIP : 3551350 B/28 - Code CIP : 3551367 B/7 - Code CIP : 3551344 Mis en ligne le 19 mars 2013

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Published 30 November 2011
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 The legally binding text is the original French version  TRANSPARENCY COMMITTEE  OPINION  30 November 2011   List of medicines concerned:  SECOND-GENERATION ORAL ANTIPSYCHOTICS  100 mg, 200  SOLIANmg, 400 mg tablet, SOLIAN 100 mg/ml oral solution and generics (amisulpride)  ABILIFY 5 mg, 10 mg, 15 mg tablet, 10 mg, 15 mg orodispersible tablet (aripiprazole)   LEPONEX 25 mg, 100 mg tablet and generics (clozapine) 10 mg coated tablet, ZYPREXA VELOTAB 5 mg, 10 mg, 15 5 mg, 7.5 mg,  ZYPREXA mg, 20 mg orodispersible tablet and generics (olanzapine) SR 50 mg, 300 mg, 400 mg sustained-release tablet (quetiapine) SEROQUEL oral solution, RISPERDALORO 0.5 mg, 1 RISPERDAL 1 mg, 2 mg, 4 mg tablet, 1 mg/ml mg, 2 mg, 3 mg, 4 mg orodispersible tablet and generics (risperidone)  Reason for the examination: Re-assessment of the actual benefit and improvement in actual benefit in the treatment of schizophrenia in adults in accordance with the Article R-163-21 of the French Social Security Code.      Medical, Economic and Public Health Evaluation Division
 
 
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TABLE OF CONTENTS
Context and introduction...................................................................................................................... 3 
I. II.
Objective of the Transparency Committee initiative ................................................... 4 General description.................................................................................................... 5
Literature searches............................................................................................................................... 7 
Data on clinical efficacy....................................................................................................................... 8 
I. Data from meta-analyses ........................................................................................... 8 I.I. Meta-analyses of studies comparing second-generation antipsychotics with first-generation antipsychotics ............................................................................................... 8 I.II. Meta-analyses of studies comparing individual oral atypical antipsychotics ........11 I.III. The NICE meta-analysis .....................................................................................15 II. DATA FROM PRAGMATIC STUDIES ......................................................................17 II.I. CATIE study .......................................................................................................17 II.II. CUtLASS study...................................................................................................21 II.III. EUFEST study ....................................................................................................23 II.IV. Summary ............................................................................................................25
Safety.............26....................................................................................................................................... 
I. DATA FROM META-ANALYSES ..............................................................................26 I.I. Meta-analyses of studies comparing second-generation antipsychotics with first-generation antipsychotics ..............................................................................................26 I.II. Meta-analyses of studies comparing individual second-generation antipsychotics  28 I.III. Summary ............................................................................................................31 II. Pharmacovigilance data............................................................................................32 II.I. Aripiprazole (ABILIFY) ........................................................................................32 II.II. Amisulpride (SOLIAN) ........................................................................................32 II.III. Olanzapine (ZYPREXA)......................................................................................32 II.IV. Risperidone (RISPERDAL) .................................................................................32 II.V. Quetiapine (SEROQUEL SR) .............................................................................33 II.VI. Clozapine (LEPONEX)........................................................................................33
Conclusions................................................................................................................35......................... 
Usage data........73.................................................................................................................................. 
I. ANALYSIS OF REIMBURSEMENTS BASED ON THE general sample of beneficiaries .....................................................................................................................37 I.I. Objective ............................................................................................................37 I.II. Methods..............................................................................................................37 I.III. Results.......................................................................................................................................... 38 BIBLIOGRAPHICAL REFERENCES................................................................Erreur ! Signet non défini. 
 
 
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LITERATURE SEARCHES
The therapeutic management of schizophrenia is comprehensive, combining psychosocial and educational measures with medicinal treatments. Antipsychotic medicines are the standard pharmacological treatment for schizophrenia. They are used in acute-phase treatment and in maintenance treatment to prevent relapses. In terms of chemical structure, antipsychotics are a heterogeneous group of molecules (phenothiazines, thioxanthenes, butyrophenones, benzamides, etc.). Pharmacologically, they all exert an antagonistic effect on dopamine receptors, in particular D2 receptors. Blockade of D2 receptors contributes to their antipsychotic action but is also responsible for the occurrence of extrapyramidal effects (1). The "atypical antipsychotic" concept was devised after it was found that clozapine could have an antipsychotic effect without triggering extrapyramidal adverse effects. Several molecules were developed in the wake of clozapine and termed "atypical" or second-generation antipsychotics (SGA). It was claimed that each one had one or more atypical features compared with conventional or first-generation antipsychotics (FGAs), in particular: no extrapyramidal effects, no hyperprolactinaemia, efficacy in treatment-resistant forms of schizophrenia and efficacy against negative symptoms. The efficacy and adverse effects of these atypical features were attributed to pharmacodynamic factors: reduced affinity for D2 receptors, blockade of other dopamine receptors and action on other types of receptors, in particular serotonin, histamine, cholinergic and alpha-adrenergic receptors (1–3). The reality and impact of these pharmacodynamic factors on therapeutic efficacy remain, however, controversial. In addition, the discovery and confirmation of particularly troublesome adverse effects, in particular metabolic, has cooled the initial enthusiasm for these substances.
In France, six antipsychotics defined as "atypical" are currently marketed:amisulpride, aripiprazole, clozapine, olanzapine, quetiapine and risperidone. Against this background, the HAS decided to re-evaluate the efficacy and safety of these six products in the treatment of schizophrenia in adults.
 
 
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I.
OBJECTIVE OF THE TRANSPARENCY COMMITTEE INITIATIVE
The Transparency Committee of the HAS opened its own enquiry to re-evaluate the actual benefit and the improvement in actual benefit of SGAs in oral form for treating schizophrenia in adults in the light of recent data in the literature and documentation submitted by the manufacturers concerned. This re-evaluation was structured around the following points:  of the efficacy and safety of SGAs as a class versus FGAs; and Comparison  Comparison of the efficacy and safety of individual SGAs; The following do not come within the scope of this re-evaluation:  SGAs used for rapid control of agitation and behavioural disorders in schizophrenic Injectable patients when oral treatment is not appropriate;  injectable SGAs; and Long-acting  management. Non-pharmacological
 
 
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