Critical evaluation of paliperidone in the treatment of schizophrenia in Chinese patients: a systematic literature review

Abstract

BackgroundPaliperidone (9-hydroxyrisperidone), the major active metabolite of risperidone, has been introduced as a novel atypical antipsychotic agent in many countries. It is available both as an oral extended-release (ER) formulation and as a long-acting injection (paliperidone palmitate, PP), which have been approved for treating schizophrenia in the People’s Republic of China since 2009 and 2012, respectively. This systematic review summarizes the efficacy, effectiveness, and safety of paliperidone in the treatment of schizophrenia in the Chinese population.MethodsA systematic literature search was conducted on the databases covering international and Chinese core journals, published from January 1, 2008, to May 22, 2015.ResultsA total of 122 publications were retrieved, of which 63 studies were identified for inclusion; most studies were related to paliperidone ER (n=53), nine were related to PP, and one study was related to both agents. Paliperidone ER demonstrated at least comparable efficacy with active comparators, including risperidone, olanzapine, ziprasidone, or aripiprazole, and was found to be superior with respect to the onset of action and improvement in the Personal and Social Performance Scale score. Paliperidone ER appeared to be associated with a lower risk of metabolic syndromes; the most common treatment-emergent adverse events were extrapyramidal symptoms, akathisia, insomnia, and somnolence. Results from interventional and observational studies showed that PP was also an effective and well-tolerated treatment for Chinese patients with schizophrenia. The findings were generally consistent with those observed in non-Chinese populations.ConclusionBoth paliperidone ER and PP were effective and well-tolerated agents for the treatment of schizophrenia in the Chinese population according to the data we reviewed. No new safety signals specific for the Chinese population were raised for paliperidone. Further studies may be needed to collect more data on long-term treatment of schizophrenia in the People’s Republic of China.

Efficacy, tolerability, and safety of oral paliperidone extended release in the treatment of schizophrenia: a 24-week, open-label, prospective switch study in different settings in Taiwan

“… 26 The efficacy and safety of paliperidone ER for the treatment of schizophrenia, including the use of a flexible dose regimen, have also been confirmed in the Chinese population. 27 , 28 …”

Treatment satisfaction with paliperidone extended-release tablets: open-label study in schizophrenia patients dissatisfied with previous antipsychotic medication

“…A recent network meta-analysis, comparing the efficacy, acceptability and tolerability of 8 atypical antipsychotics in Chinese patients with acute schizophrenia, demonstrated paliperidone ER to be in a position of superior efficacy with lower discontinuation risk 20. Another systematic review summarizing the clinical evidence of the efficacy, effectiveness and safety of paliperidone in the Chinese population reported that paliperidone ER demonstrated superior improvement in the PSP scores and at least comparable efficacy with active comparators assessed 15. The documented efficacy and safety profile of paliperidone ER and its positive effect on functional status may contribute to the improvement in patient satisfaction with the treatment.…”

“…Paliperidone extended-release (paliperidone ER), marketed as Invega ® (Janssen Pharmaceutica, Beerse, Belgium), is a once-daily atypical antipsychotic tablet formulation approved for the treatment of schizophrenia in the People’s Republic of China in 2009 15. Paliperidone is the major active metabolite of risperidone, and it acts as an antagonist of dopamine-2 (D2) receptors and 5-hydroxytryptamine 2A (5-HT2A) receptors, with a higher affinity for 5-HT2A receptors 15,16.…”

Evaluation of paliperidone on social function in patients with chronic schizophrenia

“…Although paliperidone is the active metabolite of risperidone 9-hydroxyrisperidone, previous clinical studies have shown that the pharmacological characteristics of paliperidone are not exactly the same as risperidone 8. Paliperidone has a slightly higher affinity for dopamine D1, D2, D3 and D5 receptors and a higher affinity for norepinephrine α2 and 5-HT7 receptors when compared with risperidone 9. The alpha 2 methadrenergic receptor in the prefrontal cortex plays an important role in the mediation of cognitive function,10 and 5-HT7 receptor plays an important role in emotion, learning and memory and endocrine regulation 11.…”