Efficacy and tolerability of oral paliperidone extended-release tablets in the treatment of acute schizophrenia: pooled data from three 6-week placebo-controlled studies (PAL-SCH-303/304/305)

Meltzer, H.Y.; Hargarter, L.; Kramer, Michelle; Sherr, Jay D.; Gassmann-Mayer, Cristiana; Lim, Peter Huat Chye; Bobo, William V.; Eerdekens, Mariëlle

doi:10.1055/s-2007-991757

Cited by 52 publications

(119 citation statements)

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“…Sulla base degli studi sopra descritti i principali vantaggi clinici osservati con l'utilizzo di paliperidone ER nei pazienti schizofrenici comprendono, da un punto di vista dell'efficacia: efficacia nel trattamento dei sintomi acuti della schizofrenia [29] con una rapida comparsa dell'effetto terapeutico (miglioramento della sintomatologia evidente già al 4° giorno di terapia) [30]; efficacia nel mantenere il controllo sintomatologico con un trattamento continuativo come evidenziato dalle fasi di estensione [24,27]; efficacia nel ritardare la comparsa di ricadute dopo un periodo di stabilizzazione [26];…”

Section: Paliperidone Erunclassified

“…miglioramento del funzionamento sociale e personale dei pazienti, misurato mediante la scala specifica e validata PSP (Personal and Social Performance scale) [29,31];…”

Section: Paliperidone Erunclassified

“…in un'analisi di dati aggregati dei tre studi pivotal di 6 settimane la percentuale di eventi avversi è risultata paragonabile a placebo alla dose raccomandata di 6 mg/die, compresi EPS e aumento ponderale [29,33];…”

Section: Paliperidone Erunclassified

“…cambiamenti nei livelli di lipidi, inclusi colesterolo totale, LDL, HDL e trigliceridi erano bassi e paragonabili a placebo sia [29], che nelle fasi di estensione a lungo termine [24];…”

Section: Paliperidone Erunclassified

“…bassa incidenza di eventi avversi correlati alla prolattina (1-2% sia nel gruppo placebo che nei gruppi trattati con paliperidone ER 3-6-9-12 mg/die nei tre studi pivotal) [29], confermata anche nel lungo termine (1%) con l'eccezione dell'amenorrea (4%) nei soggetti che avevano ricevuto paliperidone ER in entrambe le fasi dello studio [19,24];…”

Section: Paliperidone Erunclassified

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Decision analytic economic paliperidone ER in relapsing schizophrenic patients in Italy

Berto

Negrini

Ferrannini³

2008

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Schizophrenia, with its typical chronic and relapsing course, is very burdensome, both clinically and economically. Its pharmacological management relies on two main drug classes: the older, or typical, antipsychotics, which are quite effective on positive symptoms, but limited by low tolerability and poor efficacy on negative symptoms, and atypical antipsychotics, which are better tolerated and effective on a wider range of psychotic symptoms. In this article, the authors briefly discuss current management options for patients with schizophrenia and highlight some unmet clinical needs in the field. After outlining the main clinical features shown by paliperidone ER, a novel antipsychotic, in its clinical development program, a decision analytic economic appraisal of its use in relapsing schizophrenic patients in Italy, as compared to the other available atypical antipsychotics, is presented. Under base-case assumption and after applying national costs and tariffs, the model predicts paliperidone ER to be associated with better clinical outcomes, expressed in terms of stable days, and lower costs; this means that paliperidone is dominant over the alternatives, according to the principles of economic evaluation of healthcare technologies. One-way sensitivity analyses conducted on structural and cost parameters indicated robustness of base-case estimates, which remain to be confirmed by "real world" national data. Attualmente il trattamento farmacologico della schizofrenia si basa su due principali classi di farmaci: Keywordsantipsicotici di 1 a generazione (detti anche antipsicotici "tipici o convenzionali"), molto efficaci sui sintomi positivi (deliri, allucinazioni, pensiero disorganizzato, comportamento disorganizzato), ma inefficaci su altre dimensioni della schizofrenia e caratterizzati da una scarsa tollerabilità (es. elevata incidenza di effetti extrapiramidali) [2,3]; antipsicotici di 2 a generazione (detti "atipici"), con efficacia paragonabile ai precedenti sui sintomi positivi, ma caratterizzati da un'efficacia su un più ampio spettro di sintomi quali quelli negativi (ridotta emotività, appiattimento affettivo, apatia, anedonia, alogia), quelli affettivi e cognitivi e da un migliore profilo di tollerabilità neurologica rispetto ai tradizionali (minore propensione ad indurre effetti extrapiramidali) [2, 3]. -- INTRODUZIONELa schizofrenia rappresenta un disturbo psichiatrico severo e invalidante. È una patologia con tendenza alla cronicizzazione, che insorge prevalentemente in età giovanile e che si ritiene causata da più fattori concomitanti (genetici, ambientali biologici, psicosociali).Le manifestazioni cliniche più frequenti sono sintomi psicotici (deliri, allucinazioni, pensiero e/o comportamento disorganizzato), apatia, isolamento sociale e disturbi cognitivi.La schizofrenia colpisce circa l'1% della popolazione (prevalenza lifetime) e mostra un'incidenza annuale di 0,2-0,4/1.000. È una patologia estremamente gravosa sia per il paziente che per i suoi familiari: comporta conseguenze di dis...

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Section: Paliperidone Erunclassified

“…miglioramento del funzionamento sociale e personale dei pazienti, misurato mediante la scala specifica e validata PSP (Personal and Social Performance scale) [29,31];…”

Section: Paliperidone Erunclassified

“…cambiamenti nei livelli di lipidi, inclusi colesterolo totale, LDL, HDL e trigliceridi erano bassi e paragonabili a placebo sia [29], che nelle fasi di estensione a lungo termine [24];…”

Section: Paliperidone Erunclassified

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Decision analytic economic paliperidone ER in relapsing schizophrenic patients in Italy

Berto

Negrini

Ferrannini³

2008

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Efficacy and metabolic influence of paliperidone ER, aripiprazole and ziprasidone to patients with first‐episode schizophrenia through 52 weeks follow‐up in China

Zhang¹,

Dai²

2012

Human Psychopharmacology

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Paliperidone ER, aripiprazole and ziprasidone are effective in treating first-episode schizophrenia, and the ranking of efficacy from high to low is paliperidone ER > aripiprazole > ziprasidone. Paliperidone ER can impair lipid metabolism potentially but had no influence on glucose metabolism. Aripiprazole can damage glucose metabolism and has little influence on lipid metabolism. Ziprasidone is considered an atypical antipsychotic with no evidence of harm to glucose and lipid metabolism.

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Akathisia and Newer Second‐Generation Antipsychotic Drugs: A Review of Current Evidence

et al. 2020

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Akathisia continues to present a significant challenge in clinical practice. As a class, so-called atypical, or second-generation, antipsychotics (SGAs) are the mainstay of treatment for schizophrenia and are commonly used to treat mood disorders. These medications have traditionally been distinguished from first-generation antipsychotics by their lowered risk of extrapyramidal side effects (EPS) such as dystonia, dyskinesia, akathisia, and pseudoparkinsonism. However, the occurrence of EPS, particularly akathisia, has been demonstrated to some degree in all commercially available SGAs. This review examines the incidence of akathisia in nine newer SGAs in patients with schizophrenia, bipolar disorder, and major depressive disorder (MDD). We performed a search of PubMed, ClinicalTrials.gov, Cochrane Central Register, and Google Scholar, as well as manufacturer websites and product labeling for published and unpublished clinical trials, meta-analyses, and systematic reviews. Studies evaluating adult patients with schizophrenia, bipolar disorder, or MDD were eligible for inclusion. Data on treatment-emergent akathisia rates were gathered from each study, and potential dose-response relationships were explored. A total of 177 studies were included in this review, comprising 58,069 patients across 414 treatment arms. Compared with placebo with a composite 3.7% incidence of akathisia, individual SGAs produced akathisia at total composite rates ranging from 2.9-13.0% across the included studies. High doses of an SGA were generally associated with an increased risk of akathisia. Clinicians should consider the risk of akathisia when choosing a treatment option and monitor for akathisia in patients beginning therapy with an SGA or following a dose increase of the SGA. KEY WORDS akathisia, antipsychotics, bipolar disorder, major depressive disorder, schizophrenia. (Pharmacotherapy 2020;40(6):565-574)

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Efficacy and tolerability of oral paliperidone extended-release tablets in the treatment of acute schizophrenia: pooled data from three 6-week placebo-controlled studies (PAL-SCH-303/304/305)

Cited by 52 publications

References 0 publications

Decision analytic economic paliperidone ER in relapsing schizophrenic patients in Italy

Decision analytic economic paliperidone ER in relapsing schizophrenic patients in Italy

Efficacy and metabolic influence of paliperidone ER, aripiprazole and ziprasidone to patients with first‐episode schizophrenia through 52 weeks follow‐up in China

Akathisia and Newer Second‐Generation Antipsychotic Drugs: A Review of Current Evidence

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