Paliperidone Extended-release Tablets Research Articles

Analyzing Demographic Variabilities Associated With Age of Diagnosis of Schizophrenia Among Patients in Controlled Clinical Trials

AbstractBackgroundPrior literature and epidemiological data suggests that the age of diagnosis of schizophrenia (AOD) follows a bimodal and trimodal distribution for males and females, respectively. The studies used to generate these findings were often small and relied on self-reported patient data from a single geographic region in addition to other methodological limitations. We replicated these studies using a modern big data approach by combining raw data from large randomized controlled clinical trials.MethodsPatient-level data from 15 similarly designed, randomized, double-blind, placebo-controlled, crossover studies with patients using paliperidone extended-release tablets, paliperidone palmitate 1-month, and paliperidone palmitate 3-month, were obtained through the Yale Open Data Access Initiative (YODA). Descriptive statistics and histograms were calculated for continuous variables. A multivariable linear regression was performed with AOD as the outcome variable. Race and sex were used as predictor variables.ResultsOur final analysis included 7881 patients consisting of male (n=4962) and female (n=2919) patients among different racial demographics. Race was consolidated into the following groups: Asian (n=949), Black (n=1692), Hispanic (n=3), Southeast Asian (n=17), White (n=4769), and other (n=343) based on patient self-identification on the YODA datasets. A chi-square test revealed that there is a statistically significant association between patient sex and AOD (x2=295.61, df=68, p < 0.0001). By proxy, this likely means that sex affects age of onset (AOS) as well. Our linear regression output with sex as a predictor of AOD revealed that only the male variable was found to have a statistically significant relationship (p<0.0001) with AOD and resulted in a lower AOD. Histograms generated with the frequency of occurrences against AOD for both male and female patients appeared to be unimodally distributed and skewed right. However, the AOD for female and male patients were found to be 28.79 and 25.44 years old, respectively. This demonstrates that while both male and female AOD are distributed unimodally, there are slight differences in their distributions.ConclusionOur analysis differs from previous studies and finds that AOD for male and female patients are seen in a unimodal distribution as compared to previous literature that shows a bimodal and trimodal distribution. Our findings not only call for a re-evaluation of previous epidemiological understandings of AOD but may support future efforts in understanding the origins and typical clinical presentations of patients with newly developed symptomatology of schizophrenia as well as support clinicians’ perspectives as part of clarifying differential diagnoses. Further studies can also continue to evaluate possible correlations among different races.FundingNo Funding

Paliperidone Extended-Release Tablets for the Treatment of Methamphetamine Use Disorder in Chinese Patients After Acute Treatment: A Randomized, Double-Blind, Placebo-Controlled Exploratory Study.

Background: To test paliperidone extended-release (ER) for efficacy in decreasing methamphetamine (METH) use and reducing psychotic symptoms in METH-dependent patients after detoxification. Rates of adverse events with paliperidone ER versus placebo were also compared. Methods: After discharge and 7 days without medication, 80 treatment-seeking METH-dependent participants were randomly assigned to paliperidone ER (3 mg once daily; n = 40) or placebo (once daily; n = 40) for 84 days under double-blind conditions. The participants attended clinics weekly to provide urine samples that were analyzed for METH metabolites, to complete research assessments, and to receive substance use and medication counseling. Results: Fifty-six percent of follow-up visits and final visits were completed. The placebo group had a significantly lower retention [51.5 days; 95% confidence interval (CI), 41.6–61.4] than the paliperidone ER group (69.4 days,; 95% CI, 61.9–76.9; p = 0.016). Paliperidone ER was a protective factor against psychotic symptom relapse [hazard ratio (HR) = 0.15, p = 0.003]. Moreover, there were statistically significant effects of paliperidone ER on psychosis severity and METH craving, assessed by mean changes in Positive and Negative Syndrome Scale (PANSS) total scores, Clinical Global Impression—Severity (CGI-S) scores, and METH craving scores over time (p = 0.006, p = 0.002, and p = 0.03 for the medication-by-time interaction effect, respectively). There were no statistically significant differences between the two groups in METH use. There were no serious adverse events related to the study drug. Conclusion: Compared with placebo, paliperidone ER administration resulted in a better retention rate and lower psychotic symptom relapse, but we did not find significantly reduced METH use among adults after acute METH detoxification treatment.

Evaluation of paliperidone on social function in patients with chronic schizophrenia

BackgroundThe impairment of social function is widespread in the patients with chronic schizophrenia, which seriously affects family, life and work conditions.AimsThe main purpose of this study was to investigate the...

Efficacy and safety of paliperidone extended-release tablets in the treatment of schizophrenia

Objective To study the clinical effect and safety of paliperidone extended-release tablets in the treatment of schizophrenia. Methods 80 patients with schizophrenia were selected as the research subjects.According to randomized single blind, the patients were divided into two groups, 40 cases in each group.The control group was given risperidone treatment, the observation group used paliperidone extended-release tablets treatment.The total effective rate, positive and negative symptoms score (PANSS score), mental disability score (WHO-DAS score II) and the incidence of adverse reactions were compared between the two groups. Results The clinical total effective rate (95.00%) in the observation group was significantly higher than the control group (80.00%, χ2=4.114, P 0.05). Conclusion The clinical efficacy of paliperidone extended-release tablets in the treatment of schizophrenia is significant, which can effectively relieve patients with mental disorders, and it is safe and reliable. Key words: Schizophrenia; Paliperidone extended-release tablets; Risperidone; Safety

Evaluation of sleep profile in schizophrenia patients treated with extended-release paliperidone: an open-label prospective study in Southeast Asia.

ObjectiveTo evaluate the effect of 6 months of treatment with paliperidone extended-release (ER) tablets on the sleep profile of patients with schizophrenia.MethodsA total of 984 patients meeting the The Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for schizophrenia who switched their antipsychotic to paliperidone ER were recruited from 61 sites in five countries in Southeast Asia. We recorded patient demographics and assessed sleep quality and daytime drowsiness using visual analog scales.ResultsApproximately 70% of patients completed the 6-month study. After the use of paliperidone ER, patients reported significantly better sleep quality (76.44 vs 65.48; p<0.001) and less daytime drowsiness compared with their baseline value (23.18 vs 34.22; p<0.001). Factors predicting sleep profile improvement were completion of the study and higher baseline Positive and Negative Syndrome Scale scores.ConclusionPaliperidone ER can help schizophrenia patients to improve sleep quality and reduce daytime drowsiness; this was seen especially in the patients who completed the 6-month treatment period and had higher baseline Positive and Negative Syndrome Scale scores.

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

ObjectiveThe aim of this study was to evaluate the changes in treatment satisfaction after switching to paliperidone extended-release (ER) in Chinese schizophrenia patients dissatisfied with their previous antipsychotic treatment.MethodsIn this 8-week, open-label, single-arm, multicenter, prospective study, 1,693 patients dissatisfied with previous antipsychotic medication were enrolled and switched to paliperidone ER tablets (3–12 mg/d) based on clinical judgment. The primary efficacy end point was change in Medication Satisfaction Questionnaire (MSQ) score from baseline to week 8. The secondary end points included percentage of patients with MSQ score ≥4, as well as changes in Clinical Global Improvement-Severity (CGI-S) and Personal and Social Performance (PSP) scores.ResultsMSQ scores increased significantly from baseline (mean [standard deviation {SD}]: 2.48 [0.55]) to week 8 (5.47 [0.89], P<0.0001; primary end point, full analysis set). The percentage of patients with MSQ score ≥4 was 95.9% at week 8, indicating that most of the patients were satisfied with their treatment. Significant (P<0.0001) improvements from baseline to week 8 were noted in CGI-S score (2.37 [1.20]) and PSP score (25.5 [15.0]). A total of 174 (10.28%) patients experienced adverse events (AEs). The most common (>10 patients) events were extrapyramidal disorder (n=84, 4.96%), poor quality sleep (n=18, 1.06%) and akathisia (n=13, 0.77%). The majority of AEs were mild to moderate in severity. No deaths occurred.ConclusionTreatment satisfaction improved after switching to paliperidone ER from the previous antipsychotic in Chinese patients with schizophrenia.

Efficacy and Tolerability of Paliperidone Extended-release in the Treatment of First-episode Psychosis: An Eight-week, Open-label, Multicenter Trial.

ObjectiveWe investigated the efficacy and tolerability of paliperidone extended-release (ER) tablets in patients with first-episode psychosis (n=75).MethodsThis was an 8-week, open-label, multicenter trial. The primary outcome variable was scores on the Positive and Negative Syndrome Scale (PANSS); secondary measures included the Scale for the Assessment of Negative Symptoms (SANS), the Cognitive Assessment Interview (CAI), and the Global Assessment of Functioning (GAF). To assess safety, we measured drug-related adverse events, weight, lipid-related variables, and prolactin and administered the Simpson–Angus Rating Scale (SARS), the Abnormal Involuntary Movement Scale (AIMS), the Barnes Akathisia Scale (BAS), the Arizona Sexual Experiences Scale (ASEX), and the Udvalg for Kliniske Undersogelser side effect rating scale (UKU).ResultsThe administration of paliperidone ER resulted in significant improvement in the PANSS, SANS, CAI, and GAF scores (p<0.001) over time. This improvement was evident as early as 1 week. The most frequent adverse events were akathisia, somnolence, anxiety, and sedation, which were well tolerated. Modest increases in weight and lipid profiles were also noted. Prolactin levels were substantially increased at the endpoint in both male and female patients.ConclusionThese results indicate that paliperidone ER is effective and is characterized by good tolerability in the treatment of positive and negative symptoms and cognitive functioning in first-episode psychosis.

Rapid onset of treatment effects on psychosis, depression, and mania in patients with acute exacerbation of schizoaffective disorder following treatment with oral extended-release paliperidone

BackgroundPatients with schizoaffective disorder (SCA) experience complicated interplays of psychotic, depressive, and manic symptoms. Paliperidone extended-release (pali ER) tablets have been shown to be efficacious in these patients, but treatment response has not been studied relative to the onset of effects for these symptom domains. MethodsIn a pooled analysis of data from two 6-week, randomized, placebo-controlled studies, the onset of treatment effects with oral pali ER was evaluated by symptom domain (psychosis, depression, mania) in patients with an acute SCA exacerbation. Subjects were categorized as having prominent psychotic (Positive and Negative Syndrome Scale score >70), depressive (Hamilton Rating Scale for Depression–21 score ≥16), or manic (Young Mania Rating Scale score ≥16) symptoms at baseline. ResultsOf the 614 patients in these analyses, 597 (97.2%), 411 (66.9%), and 488 (79.5%) had prominent psychotic, depressive, and manic symptoms at baseline, respectively. Pali ER treatment was associated with rapid and significant improvement of all three symptom domains versus placebo within 1 week of initiation, regardless of whether treatment was given as monotherapy or in combination with mood stabilizers and/or antidepressants. Adverse events were similar to those reported in the original published studies. LimitationsThis post hoc analysis of two phase 3 trials requires confirmation in prospective studies. ConclusionThis pooled analysis suggests that treatment with pali ER is associated with rapid control of psychotic, depressive, and manic symptoms in patients with SCA. Its findings support the benefit of pali ER as a primary treatment for the management of SCA.

Paliperidone extended-release tablets in Chinese patients with schizophrenia: meta-analysis of randomized controlled trials.

BackgroundPrevious meta-analyses have compared paliperidone extended-release (ER) tablets with other antipsychotics, but none have involved Chinese patients or studies from People’s Republic of China. Further, the results of these meta-analyses may not be applicable to Chinese patients. In the present study, we evaluated the efficacy, safety, and acceptability of paliperidone ER compared with other second-generation antipsychotics (SGAs) for Chinese patients with schizophrenia.MethodsRandomized controlled studies of paliperidone ER and other SGAs as oral monotherapy in the acute phase treatment of schizophrenia were retrieved from Medline, Embase, and the Cochrane Library (CENTRAL), as well as from Chinese databases including the China National Knowledge Infrastructure, Wanfang, and VIP Information/Chinese Scientific Journals Database. We pooled data on response rates, chance of withdrawal due to adverse events, probability of adverse events, and odds of withdrawal for any reason.ResultsFifty randomized controlled trials were identified. The response rate for paliperidone ER was significantly higher than that of other pooled SGAs (risk ratio [RR] 0.83, 95% confidence interval [CI] 0.72–0.96) and ziprasidone (RR 0.57, 95% CI 0.39–0.82). Paliperidone ER significantly reduced the chance of withdrawal due to adverse events and the chance of any adverse events compared with other pooled SGAs (RR 0.32, 95% CI 0.17–0.58 and RR 0.88, 95% CI 0.79–0.97) and risperidone (RR 0.31, 95% CI 0.14–0.67 and RR 0.70, 95% CI 0.57–0.86). The incidence of extrapyramidal symptoms on paliperidone ER was comparable with other pooled SGAs (RR 0.94, 95% CI 0.66–1.35) and significantly lower than that of risperidone (RR 0.56, 0.41–0.77) but higher than that of olanzapine (RR 1.88, 95% CI 1.05–3.36). Paliperidone ER was superior to other pooled SGAs (RR 0.32, 95% CI 0.21–0.49 and RR 0.50, 95% CI 0.35–0.72) and olanzapine (RR 0.23, 95% CI 0.15–0.33 and RR 0.33, 95% CI 0.23–0.47) as far as weight gain and somnolence were concerned. Further, prolactin-related adverse events caused by paliperidone ER were comparable with other pooled SGAs (RR 1.30, 95% CI 0.73–2.33), but outnumbered those caused by olanzapine (RR 7.53, 95% CI 2.05–27.71).ConclusionPaliperidone ER is efficacious, safe, and well accepted when compared with other pooled SGAs for the treatment of Chinese patients with schizophrenia.

Development and validation of a rapid and sensitive UHPLC–MS/MS method for the determination of paliperidone in beagle dog plasma

In order to evaluate the pharmacokinetic profile of paliperidone extended-release tablets in vivo, a simple and rapid ultra-high performance liquid chromatography–tandem mass spectrometry (UHPLC–MS/MS) method was developed and validated for the determination of paliperidone in beagle dog plasma. Paliperidone and diazepam (internal standard) were extracted from plasma samples with diethyl ether, and then separated on a C18 column (2.1 × 50 mm, 2.6 μm) under gradient elution with methanol–0.1% formic acid at a flow rate of 0.3 ml/min. The compounds were detected using a triple-quadrupole mass spectrometer equipped with an electrospray ionization (ESI) source. The validated method was linear over the concentration range of 1.00–1000.00 ng/ml and the lower limit of quantitation was 1.00 ng/ml. The intra-day and inter-day precision values were not more than 15% (relative standard deviation < 20% at low levels), while the accuracy was within ±10% of nominal values. The validated UHPLC–MS/MS method was successfully applied to an oral pharmacokinetic study of paliperidone extended-release tablets in a beagle dog.

Effect analysis of antipsychotic drugs on the social function recovery in acute phase schizophrenia patients

Objective To understand the clinical symptoms and treatment method of acute schizophrenia,to explore the effect of antipsychotic drugs on the social function recovery in acute phase schizophrenia patients.Methods In our hospital from 2010 June to 2013 June,we treated 45 cases of the acute phase of schizophrenia patients as the research object.By using the method of random with the intention we divided them into three groups,15 cases in each group.Among them,group A was treated with anti psychotic drugs typical,group B was treated with atypical antipsychotic drugs for treatment,group C used paliperidone extended-release tablets for treatment,and then used the personal and social performance scale (PSP) and positive and negative symptom scale (PANSS) on the treatment of three groups of patients before treatment,4 weeks,12 weeks and 24 weeks after treatment,we evaluated the social function,then carried on the contrast analysis.Results After the analysis,we compared three groups of patients before and after treatment,the PANSS score had significant statistical difference (P ＜ 0.01),and in group C patients after 4 weeks,the PANSS scores (with the exception of positive symptom score) were significantly lower than those in group A and group B,showing a significant statistical difference (P ＜ 0.05),and 12 weeks and 24 weeks later,in group B and C,the PANSS scores (with the exception of positive symptom score) were significantly lower than those of group A,showing significant statistical difference (P ＜ 0.05); the three groups before and after treatment PSP scores showed significant statistical difference (P ＜ 0.01),but for PSP score,the treatment group A after treatment for 12 weeks and 24 weeks ago there was no significant statistical difference (P ＞ 0.05),the group C at 4 weeks after treatment PSP score was significantly higher than that of group A and B group,after treatment for 12 weeks and 24 weeks in the group B the PSP score was higher than that in group A,group C,PSP scores were significantly higher than that in group B,showing significant statistical difference (P ＜ 0.05).Conclusions Antipsychotic drugs can improve the social function of acute phase patients with schizophrenia,but from the effects of view,atypical antipsychotics are better than typical antipsychotic drugs,especially with paliperidone extended-release tablets optimal.But the influencing factors during the acute phase of the social function of schizophrenia patients recovery is relatively complex,so the drug of choice for patients with acute schizophrenia for the social function recovery has very big impact,therefore,clinical attention should be emphasized. Key words: Schizophrenia; Acute period; Antipsychotic drugs; Social function; Recovery; Influence

Relapse prevention study of paliperidone extended-release tablets in Chinese patients with schizophrenia

The objective of this study was to evaluate the long-term efficacy, safety, and tolerability of paliperidone extended-release (pali ER), in Chinese patients with schizophrenia. In this parallel-group, relapse prevention, phase-3 study (screening [14-day], pali ER open-label run-in [8-week] and stabilization [6-week] phases, and double-blind (DB) treatment [variable duration], and open-label extension phases [24-week]), 136/201 patients with schizophrenia were randomized (1:1) to pali ER (3-12 mg) or placebo during the DB phase. Final analysis showed that, out of 135 patients in ITT (DB) population, 71 (52.6%) had a relapse event, 45 (33.3%) were ongoing at the time the study was stopped, and 19 (14.1%) discontinued from the DB phase. Time to relapse (primary endpoint) favored pali ER (hazard ratio=5.23 [95% CI: 2.96, 9.25], p <0.0001). Rate of relapses (55/71 [77.5%] placebo; 16/64 [25%] pali ER) and secondary endpoints (change from baseline in Positive And Negative Syndrome Scale [PANSS] and Clinical Global Impression - Severity Scores) were significantly lower (p<0.001) in pali ER group vs placebo, in favor of pali ER. More psychiatric-related treatment-emergent adverse events (TEAEs) occurred in placebo- (21.1%) than pali ER group (10.9%). Most common (>3%) TEAEs in placebo group were insomnia and schizophrenia (8.5% each), while in pali ER group were aggression and akathisia (4.7% each), and schizophrenia, tremor, nausea, amenorrhea, and salivary hypersecretion (3.1% each). All serious TEAEs were psychiatric-related (schizophrenia, aggression, completed suicide, auditory hallucination, suicide attempt) and more frequent in placebo- (11.3%) versus pali ER group (3.1%). Death and tardive dyskinesia-related discontinuation (n=1 each) occurred in placebo group. Body weight increase from run-in baseline was greater in pali ER group (mean increase: 3.90 kg) versus placebo (mean increase: 2.05 kg). This study confirms the findings from earlier pali ER global relapse-prevention studies and demonstrates that pali ER treatment (3-12 mg) is efficacious over the long-term and significantly delays relapse in Chinese patients with schizophrenia. No new safety signals were detected in this population.

Successful Use of Paliperidone in a Clozapine-Resistant Schizophrenic Patient

Back to table of contents Previous article Next article LettersFull AccessSuccessful Use of Paliperidone in a Clozapine-Resistant Schizophrenic PatientTing-Hung Hsieh, M.D., and Cheng-Tsung Liu, M.D.Ting-Hung HsiehSearch for more papers by this author, M.D., and Cheng-Tsung LiuSearch for more papers by this author, M.D.Published Online:1 Apr 2013https://doi.org/10.1176/appi.neuropsych.12040087AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack Citations ShareShare onFacebookTwitterLinked InEmail To the Editor: The use of paliperidone has been examined in many studies since it was first utilized in schizophrenic patients. Here, we describe a patient with clozapine-resistant schizophrenia, whose psychosis and associated depression remitted significantly after switching treatment from clozapine to paliperidone.Case Report“Mr. Y,” who was a 35-year-old man with a 10-year history of schizophrenia, was hospitalized because of frequent auditory hallucinations, persecutory delusions, and associated depression. He had been treated with olanzapine 20 mg daily, quetiapine 800 mg daily, and clozapine 400 mg daily, for around 1–2 months each. Sertraline 100 mg daily had also been administered concurrently with each of these medications since hospitalization. However, psychotic symptoms and associated depression continued to worsen, even though behavioral and psychosocial interventions had been utilized, as well. Therefore, paliperidone was considered with the hopes of significantly improving his symptoms.In a 1-month period, clozapine had been gradually tapered off and then discontinued, while paliperidone had been titrated from 3 mg daily to 12 mg daily. Sertraline 100 mg daily had been used continuously. When paliperidone 9 mg daily was used, Mr. Y had fewer auditory hallucinations and feelings of being persecuted. He also felt less depressed, and could actively participate in rehabilitative activities. Adverse effects did not occur during the period of drug-switching, and his psychotic symptoms had not noticeably worsened in the 3 months since paliperidone was started.DiscussionClozapine has been considered probably the most effective atypical antipsychotic agent for patients with refractory schizophrenia. However, the risk of agranulocytosis, the requirement of periodic monitoring of blood neutrophil counts, and other side effects considerably decrease the drug compliance of patients. Consequently, clinicians may choose other antipsychotic agents instead of clozapine.In contrast, paliperidone has shown clinical efficacy, safety, and tolerability in the acute and maintenance treatment of schizophrenia.1,2 Even in elderly patients and those with liver dysfunction, paliperidone is generally well tolerated.3,4 Interestingly, depressed mood is likely to be improved when paliperidone is used, and there were case reports describing patients who displayed manic symptoms after paliperidone was administered, indicating that paliperidone may have the potential to alter mood states.5Although a single case does not firmly demonstrate that paliperidone is always effective in clozapine-resistant patients, we believe that paliperidone might be a useful medication for a certain group of schizophrenic patients who show poor response to other medications, especially when their symptoms are associated with depression. Therefore, clinicians are encouraged to use paliperidone when other antipsychotics, including clozapine, fail to improve the symptoms in schizophrenic patients.The limitation of this case report is that we could not determine whether the improvement in depression was due to paliperidone only, paliperidone combined with sertraline, or ameliorated psychotic symptoms followed by secondary improvement of depression. In summary, for schizophrenic patients associated with depression, further studies are required to investigate whether preferable outcomes will be obtained when paliperidone is used as a monotherapy or used with other psychotropics.Tri-Services General Hospital, Beitou Branche-mail: Dr. Liu: ablush.[email protected]hinet.netReferences1 Kramer M, Simpson G, Maciulis V, et al.: Paliperidone extended-release tablets for prevention of symptom recurrence in patients with schizophrenia: a randomized, double-blind, placebo-controlled study. J Clin Psychopharmacol 2007; 27:6–14Crossref, Medline, Google Scholar2 Meltzer HY, Bobo WV, Nuamah IF, et al.: Efficacy and tolerability of oral paliperidone extended-release tablets in the treatment of acute schizophrenia: pooled data from three 6-week, placebo-controlled studies. J Clin Psychiatry 2008; 69:817–829Crossref, Medline, Google Scholar3 Tzimos A, Samokhvalov V, Kramer M, et al.: Safety and tolerability of oral paliperidone extended-release tablets in elderly patients with schizophrenia: a double-blind, placebo-controlled study with six-month open-label extension. Am J Geriatr Psychiatry 2008; 16:31–43Crossref, Medline, Google Scholar4 Paulzen M, Orfanos S, Gründer G: Remission of drug-induced hepatitis after switching from risperidone to paliperidone. Am J Psychiatry 2010; 167:351–352Crossref, Medline, Google Scholar5 Hsieh C-HMD, Liou Y-JMD: Manic symptoms induced by paliperidone. J Clin Psychopharmacol 2010; 30:202–204Crossref, Medline, Google Scholar FiguresReferencesCited byDetailsCited byPaliperidone Palmitate for Refractory and Clozapine-Resistant SchizophreniaJoão Paulo Maia-de-Oliveira, M.D., M.Sc., Ph.D. Emerson Arcoverde Nunes, M.D. Juliana Mayumi Ushirohira, M.D. João Paulo Machado-de-Sousa, Ph.D. Rodrigo Affosenca Bressan, M.D., Ph.D. Jaime Eduardo Cecílio Hallak, M.D., Ph.D.26 February 2015 | The Journal of Neuropsychiatry and Clinical Neurosciences, Vol. 27, No. 1 Volume 25Issue 2 Spring 2013Pages E36-E36 Metrics PDF download History Published online 1 April 2013 Published in print 1 April 2013

Influencing Factors and Predictors of Early Response in Schizophrenia Patients Receiving the Paliperidone Extended-Release Tablets (Paliperidone ER)

ObjectivePaliperidone extended-release tablet (paliperidone ER) is a new oral psychotropic agent developed for schizophrenia treatment. There have been some studies about paliperidone's good efficacy and tolerability. Clinicians appear to change the antipsychotic medication to paliperidone ER. However, it is not known what patients are favorable responsive to paliperidone ER. The aim of this study was to evaluate the characteristics of early responders and investigate predictors of acute response when the medications changed to paliperidone ER.MethodsData were analyzed from schizophrenic patients who participated in a multi-center, open-label, non-comparative clinical trial. Total 320 patients were examined in this study. Sociodemographic, psychopathology, social function and metabolic data were evaluated. Unpaired t-test for continuous and χ2 for categorical data, respectively, were used to compare early responder and non-responders. Logistic regression analysis was used to establish a prediction model.Results38.7% of study subjects (124 of 320) responded to paliperidone ER treatment. Logistic regression analysis showed that a good paliperidone ER response was more likely when patients were social drinkers, when patients had started medication at inpatient, when negative symptoms were less severe, and when patients' social relationship and self-care were better.ConclusionEarly response to paliperidone ER treatment is associated with less negative symptoms and good social relationships and self-care. Strategies to reduce these symptoms may contribute to early response to paliperidone ER.

Interaction between paliperidone extended release and TS-1&amp;reg;, an oral anticancer drug containing a 5-fluorouracil derivative, in a schizophrenic patient

Until now there has been no information available on drug interaction between paliperidone and TS-1®, an oral anticancer drug containing a 5-fluorouracil derivative. The patient in the case presented here was a 39-year-old man with a 15-year history of schizophrenia. The patient’s usual treatment of 2 mg/day of risperidone was changed to 3 mg/day of paliperidone extended release. He experienced worsening psychotic symptoms after switching from risperidone to paliperidone while he was also receiving TS-1. Retrospective analyses showed plasma concentration of paliperidone was consistently lower during the treatment with TS-1 than without TS-1. This case suggests there is drug interaction between paliperidone extended-release tablets and TS-1.

564 – Effects of paliperidone extended-release tablets (paliperidone er) and olanzapine on metabolic profile, weight, insulin resistance and β-cell function in schizophrenic patients: a randomized 12-week study

Metabolic syndrome induced by atypical antipsychotics is more prevalence in schizophrenic patients. Much less is known regarding paliperidone ER. The objective of this study was to compare matched paliperidone-ER- and olanzapine-treated schizophrenic patients on measures of glucose and lipid metabolism. Eighty hospitalized patients with schizophrenia (DSM-) were randomly assigned to treatment with paliperidone ER or olanzapine for 12 weeks. At baseline and every 4 weeks, we assessed weight, subcutaneous fat, waist and hip circumferences, fasting glucose, insulin, glycohemoglobin A1, cholesterol, triglycerides, high density level (HDL) cholesterol, low density level (LDL) cholesterol and prolactin. And we also evaluate the body mass index (BMI), homeostasis insulin resistance (HOMA-IR) and homeostasis β-cell function (HOMA-B). 33 patients randomly assigned to paliperidone ER and 23 patients randomly assigned to olanzapine completed the entire 12-week treatment. Within-group overall analysis showed that the fasting measures were increased in weight, BMI, waist circumferences, hip circumferences, subcutaneous fat, cholesterol, triglyceride and prolactin for two groups, and fasting glucose, LDL and HOMA-B were increased for olanzapine group. There was significantly difference in serum prolactin between paliperidone ER and olanzapine group. And there was a trend for HOMA-B to increase in olanzapine group over 12 weeks compared to paliperidone ER group. However, there were no overall differential drug effects over 12 weeks on the fasting measures of BMI, glucose, glycohemoglobin A1, insulin, HDL, LDL, cholesterol, triglyceride and HOMA-IR. The study further reinforces the necessity of regular monitoring the metabolic parameters in schizophrenic patients with atypical antipsychotics including paliperidone ER.

Possible Paliperidone-Induced Neuroleptic Malignant Syndrome: A Case Report

Possible Paliperidone-Induced Neuroleptic Malignant Syndrome: A Case Report

Dose Pattern and Effectiveness of Paliperidone Extended-Release Tablets in Patients With Schizophrenia

The objectives of this 12-week multicenter, open-label, noncomparative study were to evaluate the overall effectiveness of paliperidone extended release (ER), the feasibility of maintaining patients on the initial dose of 6 mg, and the relationship between dose pattern and treatment response in schizophrenic patients with inadequate responses to initial treatment in a natural setting. All patients received 6 mg of paliperidone ER during the first 2 weeks, and subsequently, the dose was adjusted at each visit based on the patient response. We examined the response rate and the effectiveness of different dose patterns of paliperidone ER such as "early increase (dose increased to 9 mg at week 2)," "late increase (dose increased to 9 mg at week 4)," and "maintenance group." The response rate based on the Clinical Global Impression of Improvement or Severity response criteria was 33.6% or 61.7%, respectively. The proportion of patients who stayed with the initial dose of 6 mg was 44.5% and the response rate of these patients was 79.8%. When the treatment response to the initial dose of 6 mg is inadequate (Clinical Global Impression of Improvement ≥ 4 at week 2), an early increase in the dose seems to be more effective than maintenance or late increase of the initial dose. This study suggests that paliperidone ER may be an effective and well-tolerated antipsychotics in the treatment of patients with schizophrenia.

Efficacy of paliperidone extended-release tablets in the improvement of social functions in schizophrenics: a randomized and controlled study

To explore the efficacy of paliperidone extended-release tablets in the improvement of social functions in schizophrenics. A total of 81 schizophrenics were randomly divided into study group with paliperidone extended-release tablets and control group with risperidone for a 12-week treatment. They were assessed and analyzed by positive and negative symptoms scales (PANSS), social disability screening schedule (SDSS) and treatment emergent symptom scale (TESS) at baseline, 6(th) weekend and 12(th) weekend. In study group, the factors and total scores of PANSS in the 12(th) weekend of treatment [(12.0 ± 2.8), (12.1 ± 3.6), (26.2 ± 5.0), (50.2 ± 8.7)] were all significantly lower than those at baseline [(24.7 ± 5.3), (23.8 ± 3.6), (45.0 ± 2.9), (93.5 ± 6.8)] (t = 9.60-16.78, P < 0.05). In study group, the positive factor, negative factor and total scores of PANSS in the 12(th) weekend of treatment [(12.0 ± 2.8), (12.1 ± 3.6), (50.2 ± 8.7)] were all significantly lower than those in the 6(th) weekend of treatment [(14.2 ± 1.8), (14.6 ± 2.4), (56.5 ± 6.4)] (t = 2.58-4.26, P < 0.05). In the 12(th) weekend of treatment, the factors and total scores of PANSS in study group [(12.0 ± 2.8), (12.1 ± 3.6), (26.2 ± 5.0), (50.2 ± 8.7)] were all significantly lower than those in control group [(16.9 ± 4.9), (18.7 ± 5.3), (32.5 ± 5.1), (68.1 ± 13.0)] (t = -4.28--5.67, P < 0.05). In study group, the total scores of SDSS in the 12(th) weekend of treatment (5.93 ± 2.78) were significantly lower than those at baseline (13.9 ± 3.4) (t = 10.83, P < 0.05). In study group, the total scores of SDSS in the 12(th) weekend of treatment (5.9 ± 2.8) were significantly lower than those in the 6(th) weekend of treatment (7.6 ± 2.9) (t = 5.21, P < 0.05). But there was no significant improvement in control group (t = 1.88, P > 0.05). In the 12(th) weekend of treatment, the total scores of SDSS in study group (5.9 ± 2.8) were significantly lower than those in control group (8.8 ± 2.9) (t = -4.49, P < 0.05). No severe adverse effect was reported in either group. Paliperidone extended-release tablets are effective to improve social functions and psychiatric symptoms of schizophrenics.

One-Year Open-Label Safety and Efficacy Study of Paliperidone Extended-Release Tablets in Patients With Schizophrenia

This 52-week open-label extension (OLE) to a double-blind placebo-controlled recurrence prevention study examined the long-term safety and efficacy of flexibly-dosed paliperidone extended-release (ER) tablets in patients with schizophrenia. Patients entering the OLE either entered from the double-blind phase (placebo or paliperidone ER treatment) or entered directly from the run-in or stabilization phase (paliperidone ER) of the earlier study. During the OLE, patients were treated with flexibly-dosed paliperidone ER (3-15 mg/day; 9 mg starting dose). Safety and tolerability assessments included incidence of adverse events and extrapyramidal symptoms. Efficacy was also assessed. The study population (n=235) was predominantly men (66%), 18-58 years of age. Twelve patients (5%) experienced an adverse event requiring treatment discontinuation. One or more serious treatment-emergent adverse events were reported in 13 patients (6%). There was one death. The mean Positive and Negative Syndrome Scale total score decreased from open-label baseline to endpoint for all groups, regardless of previous double-blind treatment (placebo or paliperidone ER). This year-long OLE provides information on the long-term safety and tolerability of paliperidone ER in patients with schizophrenia. The resulting safety and tolerability profile was similar to that seen in earlier short-term studies.