Paliperidone ER: a review of the clinical trial data

Janicak, Philip G.; Winans, Elizabeth A

doi:10.2147/ndt.s1365

Cited by 44 publications

(29 citation statements)

References 23 publications

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“…As paliperidone is the major active metabolite of risperidone, the mechanism of PRL elevation for paliperidone is likely similar to that of risperidone [260–262]. However, two recently published studies suggest that PRL levels seem to decrease after switching from risperidone to paliperidone in patients with a psychotic disorder [263, 264].…”

Section: Prl and Antipsychoticsmentioning

confidence: 99%

The Effects of Novel and Newly Approved Antipsychotics on Serum Prolactin Levels: A Comprehensive Review

et al. 2014

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Since the 1970s, clinicians have increasingly become more familiar with hyperprolactinemia (HPRL) as a common adverse effect of antipsychotic medication, which remains the cornerstone of pharmacological treatment for patients with schizophrenia. Although treatment with second-generation antipsychotics (SGAs) as a group is, compared with use of the first-generation antipsychotics, associated with lower prolactin (PRL) plasma levels, the detailed effects on plasma PRL levels for each of these compounds in reports often remain incomplete or inaccurate. Moreover, at this moment, no review has been published about the effect of the newly approved antipsychotics asenapine, iloperidone and lurasidone on PRL levels. The objective of this review is to describe PRL physiology; PRL measurement; diagnosis, causes, consequences and mechanisms of HPRL; incidence figures of (new-onset) HPRL with SGAs and newly approved antipsychotics in adolescent and adult patients; and revisit lingering questions regarding this hormone. A literature search, using the MEDLINE database (1966–December 2013), was conducted to identify relevant publications to report on the state of the art of HPRL and to summarize the available evidence with respect to the propensity of the SGAs and the newly approved antipsychotics to elevate PRL levels. Our review shows that although HPRL usually is defined as a sustained level of PRL above the laboratory upper limit of normal, limit values show some degree of variability in clinical reports, making the interpretation and comparison of data across studies difficult. Moreover, many reports do not provide much or any data detailing the measurement of PRL. Although the highest rates of HPRL are consistently reported in association with amisulpride, risperidone and paliperidone, while aripiprazole and quetiapine have the most favorable profile with respect to this outcome, all SGAs can induce PRL elevations, especially at the beginning of treatment, and have the potential to cause new-onset HPRL. Considering the PRL-elevating propensity of the newly approved antipsychotics, evidence seems to indicate these agents have a PRL profile comparable to that of clozapine (asenapine and iloperidone), ziprasidone and olanzapine (lurasidone). PRL elevations with antipsychotic medication generally are dose dependant. However, antipsychotics having a high potential for PRL elevation (amisulpride, risperidone and paliperidone) can have a profound impact on PRL levels even at relatively low doses, while PRL levels with antipsychotics having a minimal effect on PRL, in most cases, can remain unchanged (quetiapine) or reduce (aripiprazole) over all dosages. Although tolerance and decreases in PRL values after long-term administration of PRL-elevating antipsychotics can occur, the elevations, in most cases, remain above the upper limit of normal. PRL profiles of antipsychotics in children and adolescents seem to be the same as in adults. The hyperprolactinemic effects of antipsychotic medication are mostly correlated with their affi...

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Section: Prl and Antipsychoticsmentioning

confidence: 99%

The Effects of Novel and Newly Approved Antipsychotics on Serum Prolactin Levels: A Comprehensive Review

et al. 2014

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“…-The 9-hydroxyrisperidone is now marketed as an antipsychotic in its own right (15,42,43). The absolute oral bioavailability of paliperidone is 28 %.…”

Section: Tdm Of Particular Atypical Antipsychotic Drugsmentioning

confidence: 99%

Therapeutic drug monitoring of atypical antipsychotic drugs

2014

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Schizophrenia is a severe psychiatric disorder often associated with cognitive impairment and affective, mainly depressive, symptoms. Antipsychotic medication is the primary intervention for stabilization of acute psychotic epi sodes and prevention of recurrences and relapses in patients with schizophrenia. Typical antipsychotics, the older class of antipsychotic agents, are currently used much less frequently than newer atypical antipsychotics. Therapeutic drug monitoring (TDM) of antipsychotic drugs is the specific method of clinical pharmacology, which involves measurement of drug serum concentrations followed by interpretation and good cooperation with the clinician. TDM is a powerful tool that allows tailor-made treatment for the specific needs of individual patients. It can help in monitoring adherence, dose adjustment, minimizing the risk of toxicity and in cost-effectiveness in the treatment of psychiatric disorders. The review provides complex knowledge indispensable to clinical pharmacologists, pharmacists and clinicians for interpretation of TDM results.

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“…While the efficacy and safety of paliperidone ER have been demonstrated in various international patient groups,5,6,8,9 there are no data available for Thai patients specifically. Thailand, in common with other Southeast Asian countries, has different socioeconomic, cultural, political, linguistic, health care, and reimbursement systems compared with other parts of the world 10.…”

Section: Discussionmentioning

confidence: 99%

“…Paliperidone (9-OH-risperidone) is the major active metabolite of risperidone, and is approved for use as a long-term antipsychotic treatment for schizophrenia 4. A paliperidone extended-release (ER) formulation has been developed that has been shown to be effective and well tolerated in the treatment of schizophrenia 5. A number of studies have assessed paliperidone in the context of hostility and aggressive behavior 6–9.…”

Section: Introductionmentioning

confidence: 99%

Effects of paliperidone extended release on hostility among Thai patients with schizophrenia

Jariyavilas¹,

Thavichachart

Kongsakon

et al. 2017

NDT

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ObjectiveThis open-label prospective study investigated the effects of paliperidone extended release (ER) on hostility in Thai patients with schizophrenia.BackgroundPatients diagnosed with schizophrenia may be hostile or exhibit aggressive behavior, which can occasion their admission to psychiatric hospital. Antipsychotic medications are often used to treat hostility and aggression in such patients. Paliperidone ER is effective and well tolerated in the treatment of schizophrenia. However, there are no data available for paliperidone ER with regard to its efficacy on hostility and aggression among Thai patients. This study was a part of the PERFEcT study, a 6-month, open-label, multicenter, multicountry, prospective trial to explore the safety, efficacy, and functionality of paliperidone ER tablets. The current study included only the data obtained from Thai participants.Materials and methodsFlexible dosing of paliperidone ER in a range of 3–12 mg/day was used, allowing investigators to adjust the dosage of each subject individually. The 199 Thai patients had a stable Clinical Global Impression – severity score before enrollment. Demographic data were collected at enrollment, and assessments took place at 1, 2, 3, and 6 months postbaseline. The Positive and Negative Syndrome Scale (PANSS) and Personal and Social Performance (PSP) scale were used to evaluate efficacy. In this analysis, we report the findings for the specific PANSS factor P7 (hostility) and the PSP subscale disturbing and aggressive behavior. Data were analyzed using paired t-test method to investigate changes in mean PANSS and PSP total and subscale scores. The significance level was set at P<0.05.ResultsFrom a total of 199 Thai patients, 148 patients (74.4%) participated in all visits. There was a significant reduction in mean scores for all total PANSS measures from 1 month onward compared with baseline, as well as ongoing significant reductions in scores from visit to visit. There was a significant reduction in mean hostility score at 2 months (P<0.05), 3 months (P<0.05), and 6 months (P<0.01) (n=148). For the PSP scale, there was a significant across-the-board reduction of mean scores from 3 months onward, including in the disturbing and aggressive behavior subscale (P<0.001) (n=148).ConclusionSwitching from previously unsuccessful antipsychotic treatments to paliperidone ER may be a useful option to reduce hostility and disturbing behavior in patients with schizophrenia. This study in Thai patients is in line with findings in other countries and cultures concerning the management of hostility in patients with schizophrenia.

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Paliperidone ER: a review of the clinical trial data

Cited by 44 publications

References 23 publications

The Effects of Novel and Newly Approved Antipsychotics on Serum Prolactin Levels: A Comprehensive Review

The Effects of Novel and Newly Approved Antipsychotics on Serum Prolactin Levels: A Comprehensive Review

Therapeutic drug monitoring of atypical antipsychotic drugs

Effects of paliperidone extended release on hostility among Thai patients with schizophrenia

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