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oktober 2013 til tilskudsstatus for antipsykotiske lægemidler

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At Seroquel Prolong bidrager til opfyldelse af flere af de definerede kvalitetsmål, der er fastsat for medicinsk behandling af danske psykiatriske patienter, understreges af: Behandlingen af ​​patienter med skizofreni og andre psykotiske lidelser i det skizofrene spektrum er en vanskelig og kompleks opgave. Vi anbefaler derfor, at alle præparater i 1./2. valgsgruppen i RADS-behandlingsvejledningen (dvs. amisulprid, aripiprazol, paliperidon, risperidon, quetiapin) generelt bevarer ikke-klosteret tilskud.

Den medicinske behandling af patienter med skizofreni er i høj grad individuel, og de begrænsninger, som de foreslåede tilskudsregler vil medføre, vil medvirke til at begrænse muligheden for individuel tilpasning af medicin - til skade for patienterne. Endelig er det et irrationelt synspunkt at fokusere snævert på omkostningerne ved at behandle patienter med skizofreni, som alle sundhedsøkonomiske beregninger viser. Ydermere forekommer det uforståeligt, at anbefalingen går ind for at opretholde den generelt ikke-klausulære tilsætning af chlorprothixen (Truxal) som et uspecifikt beroligende og angstdempende middel.

Det argumenteres i Lægemiddeltilskudsnævnets indstilling, at chlorprothixen er et vigtigt præparat til behandling af angst. Til korttidsbehandling af angst er benzodiazepiner blevet langt bedre undersøgt, og til behandling af primære kroniske angstlidelser er der evidens for behandling med antidepressiva optimalt kombineret med kognitiv. Til behandling af angst komorbid med andre psykiske lidelser bør man først optimere den primære psykofarmakologiske behandling i stedet for at kombinere den med chlorprothixen på udokumenteret basis og risikere interaktioner og generelt øget belastning af bivirkninger med polyfarmaci.

Endvidere vil vi gerne understrege, at omkostningerne til antipsykotisk medicin kun udgør en meget lille del af de samlede omkostninger ved behandling af skizofreni, og at de sociale omkostninger ved at begrænse individualiserede antipsykotiske muligheder kan risikere at udhule besparelserne i medicinomkostningerne.

Medicintilskudsnævnet Att.: Ulla Kirkegaard Madsen

Melperon – et atypisk antipsykotikum

Produktresuméet for Buronil viser en generel bivirkningsprofil med et meget begrænset antal meget almindelige bivirkninger.

  • Melperon er i perioden 1999-2012 ikke blevet anvendt som et høj-dosis antipsykotikum i den danske psykiatri

Ændringer i udskrivningsmønster for antipsykotika

Bilag A. Melperon bivirkninger sammenlignet med Chlorprothixen

Luftveje, thorax og mediastinum Meget almindelig (≥1/10). kan ikke estimeres ud fra tilgængelige data). kan ikke estimeres ud fra tilgængelige data). Meget sjælden Galaktoré, gynækomasti, oligomenoré, amenoré, erektil dysfunktion. kan ikke estimeres ud fra tilgængelige data). Tardiv dyskinesi (ved langvarig behandling eller efter seponering), som kan være irreversibel. kan ikke estimeres ud fra tilgængelige data). kan ikke estimeres ud fra tilgængelige data).

Ikke almindelig(≥1/1.000,<1/10) Pancytopeni, agranulocytose, trombocytopeni, leukopeni. kan ikke estimeres ud fra forhåndenværende data). kan ikke estimeres ud fra forhåndenværende data). Almene symptomer og reaktioner på administrationssted Meget almindelig(≥1/10). kan ikke estimeres ud fra forhåndenværende data). De mest almindelige symptomer er kvalme, opkastning, anorexi, diaré, næseflåd,. svedtendens, myalgier, paræstesier, insomnia, rastløshed, angst og agitation. svimmelhed, følelse af at være hhv. varm og kold og tremor. kan ikke estimeres ud fra forhåndenværende data). kan ikke estimeres ud fra forhåndenværende data). kan ikke estimeres ud fra forhåndenværende data). kan ikke estimeres ud fra forhåndenværende data) Forlænget QT-interval.

Graviditet, barseltid og perinatal periode Meget almindelig (≥1/10). kan ikke estimeres ud fra tilgængelige data) Neonatal abstinenssyndrom.

Bilag B. Buronil (Melperon) 1999-2012 primær sektor

  • Januar 2014
  • Bervoets CNS Drugs DOI 10.1007
  • Schlagenhauf Schizophrenia Research 118 (2010) 189–200
  • Hori Journal of Psychiatric Research 46 (2012) 757-761
  • de Hert: Metabolic and cardsiovascular effects associated with antipsychotic drugs Nat.rev Endocrinol.2011

Robert Kerwin et al., A multicenter, randomized, naturalistic, open-label study between aripiprazole and standard of care in community treatment - between aripiprazole and standard of care in community-treated patients with schizophrenia. Aripiprazole Schizophrenia Trial: (STAR) Study, European Psychiatry xx. Pia Jeppesen: Rates of transition from schizotypal disorder to psychotic disorder in first-contact patients enrolled in the OPUS trial. It has been proposed that there are two phases—a time-limited active phase of deterioration that begins in the prodrome and lasts for the early years after the first episode, followed by a chronic plateau phase with relative disease stability (2).

In another 7-year cohort study comparing first- and second-episode treatment responses in schizophrenic patients who were treated with an identical protocol during the 2 years following each episode, treatment failure occurred in 16%. of participants who responded well to treatment during the first episode and relapsed after an intermittent antipsychotic treatment regimen (17). There is now accumulating evidence from longitudinal studies that changes in brain volume are progressive over the course of the disease (11). In a large longitudinal study, it has been shown that different age-related trajectories of brain tissue loss are present in patients compared to healthy subjects, suggesting that brain maturation occurring in the third and fourth decades of life is abnormal in schizophrenia (19). .

Due to the devastating consequences of disease progression in the early years during the active phase of schizophrenia, it is absolutely critical that it is treated appropriately to limit as much as possible the occurrence of new relapses and subsequent deterioration, including brain damage and functional decline. . In this regard, antipsychotics offer patients effective therapeutic options that can improve psychotic symptoms in the phases of acute exacerbation of the disease and prevent relapses (21). When an antipsychotic is introduced, mostly during the acute exacerbation phases of the illness, the same medication is continued long-term after an initial response to treatment has been achieved.

Although antipsychotic agents are primarily initiated during acute phases of exacerbation, aspects of long-term tolerability must be considered in the decision-making process of which drug to administer. Indeed, many long-term adverse events reported with antipsychotic agents will either affect quality of life, worsen physical health, increase stigma, or, even more importantly, decrease treatment adherence/lead to discontinuation. of treatment, which will significantly increase further risk. relapse and subsequent progression of the disease. Today it is the first and only partial agonist at D2 receptors approved for the treatment of schizophrenia in the European Union.

Aripiprazole is able to modulate the dopamine signal at D2 receptors, whereas most other atypical antipsychotics act as dopamine blockers at this receptor, which increases the risk of adverse events such as EPS or prolactin elevation (24). Aripiprazole was first approved in the European Union in June 2004 for the treatment of schizophrenia. In conclusion, these 2 very recent meta-analyses confirm the strong efficacy of aripiprazole in both the short and long term, as well as its safety and tolerability advantages over other atypical antipsychotics in multiple endpoints.

Because long-term tolerability of antipsychotics has a significant impact on stigma, quality of life, physical health, and treatment adherence, drugs with a better long-term safety profile, such as aripiprazole, should be recommended as first-line treatment in the active phase of schizophrenia (18 to 35/40 years). Failure to provide better-tolerated first-line antipsychotics to patients with active schizophrenia would limit available treatment options to less tolerable antipsychotics, potentially affecting patient outcomes on an individual basis.

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