Paliperidone Extended-Release Tablets for Prevention of Symptom Recurrence in Patients With Schizophrenia

Abstract

We evaluated the efficacy of paliperidone extended-release (ER), an investigational psychotropic agent, in delaying symptom recurrence in adult patients with schizophrenia and its safety and tolerability. In this randomized, double-blind, placebo-controlled, multicenter study, patients' symptoms were stabilized during an 8-week run-in and a 6-week stabilization phases using open-label, flexibly dosed paliperidone ER (3-15 mg once daily, starting dose = 9 mg). The primary efficacy variable was the time of first recurrence of schizophrenia symptoms, which included predefined changes in symptom scores, psychiatric hospitalization, self-injury, and suicidal or aggressive behavior during the double-blind phase (paliperidone ER or placebo treatment). Based on positive efficacy, the study was terminated at the preplanned interim analysis (43 recurrence events). The interim analysis (primary analysis) included 113 patients (mean age = 41 years; 51% men, 85% white). In the intent-to-treat group, 14 paliperidone ER-treated patients (25%) experienced a recurrence event versus 29 (53%) for placebo. Time-to-recurrence was significantly different, favoring the paliperidone ER group (P = 0.005, log-rank test): 25% quantile of time-to-recurrence was 83 days (paliperidone ER) versus 23 days (placebo). Final analyses (n = 205) were confirmatory. During initial open-label treatment with paliperidone ER, symptoms improved significantly. This improvement was maintained with continued treatment, as were functioning and quality-of-life measures. Treatment-emergent adverse events rates were similar: 35% for paliperidone ER and 40% for placebo. Paliperidone ER treatment versus placebo significantly delayed time-to-recurrence in patients with schizophrenia, maintained symptom stability and measures of functioning, and was generally well tolerated in this patient population.

Dyskinesia, cardiac arrhythmia and partial seizure associated with paliperidone overdose: a case report

“…12 In several studies, tachycardia was one of the most common adverse events observed. 4,13 Boom and coll.…”

“…2 In premarketing studies, paliperidone was similarly linked to several cardiac problems, including bradyarrhythmias (0.1-1%), tachyarrhythmias (12-14%), and Q-T interval prolongation (3-5%). 3,4,13 Atypical antipsychotics have a potential to lower seizure thereshold. 2 According to the FDA's Adverse Event Reporting System (AERS) several reports of seizures have been linked to risperidone therapy.…”

Decision analytic economic paliperidone ER in relapsing schizophrenic patients in Italy

“…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. Gli altri due studi della fase registrativa sono stati condotti l'uno nella popolazione anziana (con un disegno simile agli studi pivotal con l'eccezione della flessibilità del dosaggio, di un endpoint primario di sicurezza e tollerabilità, anziché di efficacia e della durata della fase di estensione pari a 24 settimane) [25], l'altro nella popolazione adulta schizofrenica per studiare l'effetto di paliperidone ER sulla prevenzione delle ricadute [26]. Di questo studio è stata recentemente presentata la fase di estensione [27].…”

“…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];…”

Recovery outcomes of schizophrenia patients treated with paliperidone palmitate in a community setting: patient and provider perspectives on recovery

“…Clinical research on schizophrenia has focused primarily on symptom-based outcomes [6][7][8][9] , but it fails to consider the spectrum of components related to mental health recovery. Examples of outcomes that go beyond symptom management include indicators such as a person's sense of self-direction, empowerment, and hope 10 .…”