Efficacy and Safety of Paliperidone Extended-Release Tablets: Results of a 6-Week, Randomized, Placebo-Controlled Study

Marder, Stephen R.; Kramer, Michelle; Ford, Lisa; Eerdekens, Els; Lim, Pilar; Eerdekens, Mariëlle; Lowy, Adam

doi:10.1016/j.biopsych.2007.01.017

Cited by 191 publications

(166 citation statements)

References 26 publications

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“…Due to its pharmacological profile as a dopamine D2-receptor antagonist, paliperidone ER was found to elevate mean serum prolactin levels to upper than the normal limit in the 6-week studies (26)(27)(28). risperidone group and reported rates from previous studies.…”

Section: Discussionmentioning

confidence: 84%

Comparison of short term effects of risperidone and paliperidone on serum prolactin levels in female patients

Albayrak¹,

Ünsal²,

Beyazyüz³

et al. 2014

JMOOD

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Section: Discussionmentioning

confidence: 84%

Comparison of short term effects of risperidone and paliperidone on serum prolactin levels in female patients

Albayrak¹,

Ünsal²,

Beyazyüz³

et al. 2014

JMOOD

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“…A series of studies have evaluated the pharmacodynamics, efficacy, and tolerability of paliperidone. The results obtained from randomized, double-blinded, placebo-controlled studies indicate that the drug is effective and safe at all doses, resulting in significant improvements in the symptoms of schizophrenia and related disorders [3,[12][13][14][15][16].…”

Section: ) (Rs)-3-[2-[4-(6-fluorobenzo[d]mentioning

confidence: 99%

Studies on Paliperidone in OROS Tablets: Extraction Procedure and Chromatographic Analysis

Barbosa

Mantovani

Garcia

et al. 2012

ISRN Chromatography

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A stability-indicating liquid chromatographic (LC) method was studied for the determination of paliperidone in osmoticcontrolled release oral delivery system (OROS) tablets. A tablet extraction procedure was developed by testing the efficiency of solvents (water, HCl, NaOH, acetonitrile, methanol) and techniques (ultrasonic bath, magnetic stirrer), and evaluating the release of the drug with respect to time. A forced degradation study was conducted to demonstrate the stability-indicating power of the method. Chromatographic separation was achieved using an isocratic elution in a reversed-phase system with a mobile phase prepared from a mixture of phosphate buffer and acetonitrile. The use of an ultrasonic bath demonstrated paliperidone release from OROS tablets in a total time of 60 min. Verifying the efficiency of the chromatographic procedure, the theoretical plates (N = 12634.21) and tailing factor (tf = 1.31) were constant during repeated injections. The retention time of paliperidone was 4.8 min, and the method was validated within the concentration range of 10-50 µg mL −1 (r = 0.9999). Adequate reproducibility (RSD% = 0.30-0.59), interday precision (RSD% = 1.81), and accuracy were obtained. The proposed method was successfully applied to paliperidone determination in the presence of degradation products, and an efficient extraction procedure from the OROS tablets was developed.

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“…Il meccanismo per cui un farmaco antipsicotico con profilo farmacocinetico costante è in grado di massimizzare il rapporto tra efficacia e tollerabilità è legato all'occupazione dei recettori D2: è risultato che il livello ottimale di occupazione di tali recettori è tra il 65% e l'80% [21]; più stabili sono le concentrazioni plasmatiche, minore è la probabilità che venga ---superata la soglia di occupazione recettoriale dell'80% e quindi minore è la probabilità di effetti collaterali [9].…”

Section: Paliperidone Erunclassified

“…Gli studi pivotal (SCH-303, 304 e 305) [9,[22][23] erano studi di 6 settimane, in doppio cieco, placebo controllati, randomizzati, a dose fissa e comprendevano anche un braccio di trattamento con olanzapina 10 mg/die (pari alla DDD), come braccio per valutare la sensibilità. I risultati delle fasi di estensione in aperto a 52 settimane di questi tre studi [24] confermano le evidenze di efficacia e tollerabilità già rilevate a 6 settimane.…”

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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Efficacy and Safety of Paliperidone Extended-Release Tablets: Results of a 6-Week, Randomized, Placebo-Controlled Study

Cited by 191 publications

References 26 publications

Comparison of short term effects of risperidone and paliperidone on serum prolactin levels in female patients

Comparison of short term effects of risperidone and paliperidone on serum prolactin levels in female patients

Studies on Paliperidone in OROS Tablets: Extraction Procedure and Chromatographic Analysis

Decision analytic economic paliperidone ER in relapsing schizophrenic patients in Italy

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