Use Of Paliperidone Palmitate Research Articles

Use of paliperidone palmitate half-yearly release in patients diagnosed with psychotic disorder: profile and satisfaction of use

IntroductionThe lack of insight can be present among patients with a diagnosis of schizophrenia, which often results in lack of adherence to pharmacological treatments1 and, subsequently, in treatment discontinuation and relapses2. This vicious pattern leads to further clinical deterioration, impaired functioning, and reduced quality of life 3. There is a plethora of evidence supporting the fact that long-acting injectable and depot antipsychotics can increase adherence to treatment, reduce the risk of discontinuation and hospital admissions4. It is also known that low fluctuations between peaks and lows in plasma drug levels could be related to a better tolerability profiles5. A new paliperidone palmitate prolonged release formulation, which is administered twice annually, has been approved as maintenance treatment for patients with schizophrenia who are already stable on the monthly or quarterly prolonged release paliperidone palmitate6.ObjectivesWe aimed to evaluate the transition of monthly and quarterly paliperidone palmitate to the new six-monthly formulation and patients’ satisfaction with it in a real-world clinical setting.MethodsWe collected a basic epidemiologic questionnaire, responses to a query about local pain after administration, and the Drugs Attitude Inventory (DAI).ResultsA total of 21 patients from an outpatient clinic for severe mental disorders with a long evolution of their disease in Salamanca, Spain, were included. All of them had a DSM5-TR diagnosis of Schizophrenia. Sixteen were male and 5 female. The mean age was 42.6 years. 14 were receiving quartlery paliperidone palmitate (10 with high doses (525 mg) and 4 with moderate doses (350 mg)) and 7 were on monthly injections (6 with high doses (150 mg) and 1 with a moderate dose (100 mg)). Those receiving moderate doses of quarterly or monthly paliperidone palmitate were administered 700 mg of six-monthly paliperidone palmitate; 1000 mg were injected to those with higher doses. The mean score on the DAI scale was 8. Only one patient reported an increase in local pain after the injection, and another reported dissatisfaction with the administration in the gluteus instead of the deltoid muscle. The first administration of the new formulation in our site was on June 26th; to date none of these patients have required hospital admission due to relapse.ConclusionsSix-monthly prolonged release paliperidone palmitate seems to be an effective maintenance treatment for schizophrenia. In addition, this new formulation is well received and tolerated by patients previously on monthly or quarterly formulations of the same drug.Disclosure of InterestNone Declared

Effectiveness of Paliperidone Palmitate in Reducing Acute Psychiatric Service Use for Patients Suffering from Psychosis-A Retrospective Mirror-Image Study.

Poor adherence to antipsychotic treatment is a leading cause of relapse for patients suffering from psychotic disorders and the use of long-acting injectable antipsychotics (LAI) may lead to improved clinical outcomes. This was a 1-year mirror-image study examining the clinical outcomes after monthly administration of paliperidone palmitate (PP1M). The primary outcome measure was the total days of psychiatric hospitalization in the 1-year before and 1-year after initiation of PP1M. Data from 158 patients were included in the study. Most of the patients suffered from schizophrenia. In the year after initiation of PP1M, the mean number of hospitalization days fell from 106.53 to 19.10 (p < 0.001). There were significant reductions in the mean number of hospitalizations and emergency room visits. The use of paliperidone palmitate is associated with significant reduction in both the number of admissions and days of psychiatric hospitalization.

Discontinuation and relapse with paliperidone palmitate three-monthly for maintenance of schizophrenia: Two year follow-up of use in clinical practice

The use of antipsychotic long-acting injections (LAI) aims to reduce risk of relapse and hospitalisation in patients with schizophrenia compared with oral medication. Paliperidone palmitate is currently the only LAI that can be administered at three-monthly intervals for maintenance treatment of schizophrenia. This prospective study aimed to evaluate relapse and continuation in licensed use of paliperidone palmitate three-monthly (PP3M) over a 2-year follow-up in clinical practice. Non-interventional, observational study of patients treated in the South London and The Maudsley NHS Foundation Trust. A total of 166 patients initiated on PP3M, 55 were excluded from the study (non-F20 diagnosis (n = 43); F20 >65 years old (n = 12)). Of the 111 patients included, 67 (60%) continued PP3M for 2 years. Overall 102 patients received more than one dose of PP3M and 92 (90%) remained on the same dose of PP3M for the whole of their treatment duration. Relapse (defined as a step-up in clinical care) occurred in eight patients (7%) while on PP3M. The most common reason for discontinuation was patient refusal and the most frequent medication prescribed after discontinuation was paliperidone palmitate one-monthly (PP1M). Post hoc, we analysed outcome in those continuing any form of PPLAI (those continuing with PP3M and those switching back to PP1M). Continuation over 2 years with any PPLAI formulation was 73% (81/111) and relapse was recorded in 9% (10/111). Overall, PP3M was an effective maintenance treatment for schizophrenia after stabilisation on PP1M in a clinical setting.

The effectiveness of paliperidone palmitate at the stage of stabilizing treatment of schizophrenia in the outpatient department. Clinical observation

Currently, an increasing aspect in the provision of psychiatric care is shifting towards the outpatient link. After the stage of stopping therapy, it is rational to carry out the stage of stabilizing therapy in the conditions of a day hospital or outpatient department. The article presents a clinical observation when, as a result of errors in receiving supportive therapy, the patient ended up in a hospital with developed attacks of schizophrenia and after long-term treatment was discharged with residual psychotic symptoms, indicating resistance and an increase in the defect. However, the use of paliperidone palmitate * in submaximal doses in the outpatient department allowed him to stabilize his condition, restore his social and labor status, and re-transfer to maintenance therapy in medium therapeutic doses.

PMH15 BUDGET IMPACT ANALYSIS OF SCHIZOPHRENIA TREATMENT IN INDONESIA

The objective of this study was to estimate the budgetary change in per-patient-per-year costs for schizophrenia patient who administered in hospital after the introduction of Paliperidone Palmitate long acting injection. The Budget Impact Analysis included the direct costs associated with the condition for which the intervention is designed. Estimates of the percentage of patients seeking care, treatment patterns, and quantities of medications dispensed for Schizophrenia patients were measured using 2013 medical and pharmacy records in three kinds of health facilities: Mental Health Hospital, General Hospital and Health Centre. Costs for medications were assigned using the 2013 wholesale acquisition cost, and costs for physician visits were based on average 2013 health care tariff. During the study frame, the impact which were likely to occur such as percentage of cases requiring the use of Long Acting Injection antipsychotic Paliperidone Palmitate was derived to generate annual cost per patient and to estimate the total cost per year. The budget impact analysis of schizophrenia services indicates that the increasing use of long acting injection anti-psychotics results in lower relapse rate which later affects number of hospitalisation despite the increase of direct costs. The model also demonstrated the increase in the total cost by 0.4% as a result of the increase use of Paliperidone Palmitate by 1%. The total cost increased but in the other hand the number of admission and initial treatment reduced by 0.6%. Furthermore, this also reduces total relapse by 0.8%. The addition of Paliperidone Palmitate long acting injection may increase the total cost, but it could be an option for Schizophrenia that has an impact for lowering the total number of relapse.

Long-Acting Injectable Second-Generation/Atypical Antipsychotics for the Management of Bipolar Disorder: A Systematic Review.

Non-adherence to medications is a majordeterminant of poor outcome in bipolar disorder.Second-generationlong-acting injectable (LAI) antipsychotics help ensure medication adherence which in turn can lead to more favourable outcomes. However, the role of these medications in bipolar disorder is not well established. We sought to review available evidence relating to the efficacy and safety of using second-generation LAI antipsychotics in bipolar disorder. PRISMA guidelines were followed to systematically review all clinical studies that reported on the efficacy and safety of second-generation LAI antipsychotics in patients with bipolar disorder. We searched Ovid Medline, PsycINFO, and Cochrane Central Register of Controlled Trials from inception to November 2018. Of 459 identified citations, 53 studies were fully evaluated and 37 met our inclusion criteria. Overall, second-generation LAI antipsychotics were found to be well tolerated and effective for treatment of manic symptoms and preventing mood recurrences in adults with bipolar disorder. However, we found disparity in the evidence available for individual agents. While several randomized controlled trials (RCTs) reported on the use of risperidone LAI in bipolar disorder, we found only one RCT on the use of aripiprazole LAI, and none for use of paliperidone palmitate or olanzapine pamoate (evidence for the former is limited to one observational study and one case series, and for the latter to a single case report). Studies in children and adolescents were restricted to case reports and small open-label studies. Second-generation LAI antipsychotics, particularly risperidone and aripiprazole LAI, may be a safe and effective alternative to oral medications in the management of bipolar disorder.

Extent of use of long-acting injectable antipsychotics in children and adolescents within Indiana Medicaid.

Introduction:Oral formulations of the antipsychotics aripiprazole, asenapine, lurasidone, olanzapine, paliperidone, quetiapine, and risperidone are indicated for use in pediatrics for several diagnoses. Long-acting injectable (LAI) antipsychotics are of interest in this special population because they may be used due to convenience and desire to improve adherence, despite limited support in the literature. The primary intent of this study is to provide descriptive information on the use of paliperidone palmitate, risperidone microspheres, aripiprazole extended-release injection, and olanzapine pamoate in pediatric patients within Indiana Medicaid.Methods:This study was a retrospective database analysis, which retrieved information from Indiana Medicaid over a 2-year timeframe spanning from July 1, 2012, through June 30, 2014. The study included the prescription medications filled for all children and adolescents within Indiana Medicaid who received the LAI antipsychotics paliperidone palmitate, risperidone microspheres, aripiprazole extended-release injection, and olanzapine pamoate.Results:From July 1, 2012, through June 30, 2014, 150 Indiana Medicaid patients younger than 18 years old were prescribed a LAI atypical antipsychotic. A total of 1013 LAI atypical antipsychotic doses were billed to Indiana Medicaid during the study period for pediatric patients. Paliperidone palmitate was billed most frequently.Discussion:Long-acting injectable atypical antipsychotics are being prescribed for children and adolescents within Indiana Medicaid, despite minimal clinical evidence supporting use. There is a need for further research in this area to increase generalizability of results and aid in implementation of policies to prevent inappropriate use of LAI antipsychotics in children and adolescents.

P.3.d.042 - Use of paliperidone palmitate in acute units: post-hoc analysis of the shadow study according to previous antipsychotic treatment

P.3.d.042 - Use of paliperidone palmitate in acute units: post-hoc analysis of the shadow study according to previous antipsychotic treatment

Twenty-four months experience of paliperidone long-acting injection in a Spanish psychiatric service: A mirror image analysis

IntroductionLack of adherence is a common cause of relapse in schizophrenia. Long-acting antipsychotics have shown in recent studies that they improve compliance. However, some randomised controlled trials showed no difference in relapse rates between oral medication and long-acting injections.ObjectiveTo report the use of paliperidone palmitate in an Acute Psychiatrist Unit in Spain.MethodRetrospective observational study of 42 patients prescribed paliperidone palmitate (PLAI) during an admission at Acute Psychiatric unit in Málaga. In the mirror image analysis, the main outcome measure was the total number of days of psychiatric inpatient care twelve months before and after patients started Paliperidone palmitate.ResultsMost common reason for starting paliperidone palmitate was lack of adherence to oral medication (54%) followed by lack of efficacy on previous medication (31%). Olanzapine (47%) and risperidone (41%) were most commonly antipsychotics prescribed before PLAI. Thirty-four patients continued PLAI over twelve months (80%). Poor compliance was the most common reason of withdrawal. Three patients had a movement disorder adverse effect. Only one was lost because adverse effects. Total admissions and inpatients days were significantly reduced from the previous treatment to PLAI-treatment period (Table 1).ConclusionPLAI was associated with a reduction in total inpatient days. The financial saving from reduced admissions stays exceeded the acquisition and administration cost of PLAI. Improved compliance because of PLAI is the most plausible explanation of this result (Fig. 1).Disclosure of interestThe authors have not supplied their declaration of competing interest.

Effective doses of paliperidone palmitate (PAP): Retrospective analysis from three years of treatment

IntroductionThe use of PAP is already much extended in general. The recommended doses in the technical specifications of the drugs, as the result of trial studies, differ from the doses administered in habitual clinical practice. Therefore, the justification of this study is to monitor the average doses prescribed, to be able to reach an agreement on the best doses. To retrospectively analyze the first 32 patients in our area of healthcare, who were prescribed PAP, the doses used at the start of treatment and after 3 years.Materials and methodsTwo initial doses of PAP were analyzed, maximum and current (outpatient) in 32 patients attended in the area of mental health of North Jaen, who started the treatment with PAP between 2012 and 2013, with an average length of time of 2.55 years (SD 2.02). We evaluated the diagnosis (schizophrenia and related disorders, ICD-10 F20), the number of hospital admissions previous and posterior to the start of the treatment and change in weight.ResultsAverage doses: initial: 110.15 mg (SD 32.83), maximum: 165.51 mg (SD 29.76) and maintenance: 146.81 mg (SD 29.59). Average hospital admissions: prior and posterior to the start of treatment: 1.5 and 0.83. An average reduction of 44.06% in admissions was observed.ConclusionsThe data obtained suggests that a dose of 75–200 mg could be effective in the maintenance of patients with schizophrenia and for decreasing the number of new hospital admissions. Fifty percent of the cases can be compensated with long acting peliperidone as a monotherapy.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Paliperidone Palmitate for Schizoaffective Disorder: A Review of the Clinical Evidence.

IntroductionDespite being frequently diagnosed, there has been very limited study of efficacious treatments for schizoaffective disorder. Paliperidone had been approved for the treatment of schizoaffective disorder, and a recently completed relapse prevention study of the use of a once-monthly injectable paliperidone formulation has also led to an indication for that preparation to treat schizoaffective disorder.MethodsTo review the efficacy and tolerability of paliperidone for schizoaffective disorder, we conducted a systematic literature search of studies of paliperidone in the treatment of schizoaffective disorder, and briefly reviewed evidence regarding the somewhat controversial nature of that diagnostic entity.ResultsWe located several studies of the use of paliperidone extended release in the treatment of schizoaffective disorder, but only one completed study of the use of paliperidone palmitate, which demonstrated efficacy in preventing relapse. Three other studies are currently recruiting participants. Efficacy and tolerability were similar to the profile of oral paliperidone in the treatment of individuals with schizophrenia. These results were similar for both individuals treated with paliperidone palmitate alone, and for those treated with paliperidone palmitate with adjunctive mood stabilizers and/or antidepressants. The use of paliperidone palmitate does not require initial co-administration of oral paliperidone, has relatively little risk of drug–drug interactions, and its pharmacokinetics are favorable for once-monthly administration, an important treatment option for individuals with psychotic disorders, who may often be non-adherent to effective medication regimens.ConclusionPaliperidone palmitate is an approved treatment for schizoaffective disorder, and can be efficacious with or without commonly employed adjunctive treatments.Electronic supplementary materialThe online version of this article (doi:10.1007/s40120-015-0030-4) contains supplementary material, which is available to authorized users.

A Case of Hyperprolactinemia Induced by Paliperidone Palmitate: the Role of Carbegoline.

We describe a case of a man of 39 years, treated with paliperidone palmitate after treatment failure with other antipsychotics, including those of (conventional and atypical) oral and injectable, and developed secudary hyperprolactinemia. Evaluate the effectiveness of the method for management of hyperprolactinemia secondary to the use of second generation long-acting antipsychotic. Follow-up during 18 months in outpatient mental health. In the period the patient remained stable with the use of paliperidone palmitate. Serum prolactin levels were obtained at baseline, and every two months. The patient had sexual dysfunction as the main complaint. Initially adopted the gradual reduction in dosage of antipsychotic 150 mg / month to 75 mg / month, however, the patient had psychotic relapse. So, we decided to keep the dose of paliperidone palmitate and associate the drug cabergoline at a dose of 0.5 mg per week, and serum prolactin levels were normalized. There was a decrease in serum prolactin levels as well as the related sexual sphere, with the addition of cabergoline to treatment with paliperidone palmitate symptoms. The long-acting antipsychotic paliperidone palmitate is a safe and effective medicine to control the symptoms of schizophrenia. Hyperprolactinemia is a rare side effect associated with this psychotropic drug, which can be handled without difficulty with antidotes. The cabergoline proved to be an effective and free from adverse side efects alternative to reduce the levels of hyperprolactinemia secondary to use of paliperidone palmitate effects, including sexual dysfunction relieving.

Effectiveness of paliperidone palmitate vs haloperidol decanoate for maintenance treatment of schizophrenia: a randomized clinical trial.

Long-acting injectable antipsychotics are used to reduce medication nonadherence and relapse in schizophrenia-spectrum disorders. The relative effectiveness of long-acting injectable versions of second-generation and older antipsychotics has not been assessed. To compare the effectiveness of the second-generation long-acting injectable antipsychotic paliperidone palmitate with the older long-acting injectable antipsychotic haloperidol decanoate. Multisite, double-blind, randomized clinical trial conducted from March 2011 to July 2013 at 22 US clinical research sites. Randomized patients (n = 311) were adults diagnosed with schizophrenia or schizoaffective disorder who were clinically assessed to be at risk of relapse and likely to benefit from a long-acting injectable antipsychotic. Intramuscular injections of haloperidol decanoate 25 to 200 mg or paliperidone palmitate 39 to 234 mg every month for as long as 24 months. Efficacy failure, defined as a psychiatric hospitalization, a need for crisis stabilization, a substantial increase in frequency of outpatient visits, a clinician's decision that oral antipsychotic could not be discontinued within 8 weeks after starting the long-acting injectable antipsychotics, or a clinician's decision to discontinue the assigned long-acting injectable due to inadequate therapeutic benefit. Key secondary outcomes were common adverse effects of antipsychotic medications. There was no statistically significant difference in the rate of efficacy failure for paliperidone palmitate compared with haloperidol decanoate (adjusted hazard ratio, 0.98; 95% CI, 0.65-1.47). The number of participants who experienced efficacy failure was 49 (33.8%) in the paliperidone palmitate group and 47 (32.4%) in the haloperidol decanoate group. On average, participants in the paliperidone palmitate group gained weight and those in the haloperidol decanoate group lost weight; after 6 months, the least-squares mean weight change for those taking paliperidone palmitate was increased by 2.17 kg (95% CI, 1.25-3.09) and was decreased for those taking haloperidol decanoate (-0.96 kg; 95% CI, -1.88 to -0.04). Patients taking paliperidone palmitate had significantly higher maximum mean levels of serum prolactin (men, 34.56 µg/L [95% CI, 29.75-39.37] vs 15.41 µg/L [95% CI, 10.73-20.08]; P <.001, and for women, 75.19 [95% CI, 63.03-87.36] vs 26.84 [95% CI, 13.29-40.40]; P<.001). Patients taking haloperidol decanoate had significantly larger increases in global ratings of akathisia (0.73 [95% CI, 0.59-0.87] vs 0.45 [95% CI, 0.31-0.59]; P=.006). In adults with schizophrenia or schizoaffective disorder, use of paliperidone palmitate vs haloperidol decanoate did not result in a statistically significant difference in efficacy failure, but was associated with more weight gain and greater increases in serum prolactin, whereas haloperidol decanoate was associated with more akathisia. However, the CIs do not rule out the possibility of a clinically meaningful advantage with paliperidone palmitate. clinicaltrials.gov Identifier: NCT01136772.

Drug information update: paliperidone palmitate for schizophrenia

Aims and methodTo review the evidence for the use of paliperidone palmitate for people with schizophrenia and schizophrenia-like illnesses. We searched the Cochrane Schizophrenia Group Specialised Register and contacted the manufacturer of paliperidone palmitate, the US Food and Drug Administration, and the authors of papers that reported study results.ResultsBased on the evidence from five short-term, placebo-controlled studies, paliperidone palmitate is efficacious as an antipsychotic. Its adverse effects are similar to those of the closely related compounds paliperidone and risperidone. Extrapyramidal side-effects, weight gain and tachycardia are more common with paliperidone palmitate than placebo. Paliperidone palmitate was associated with substantial increases in serum prolactin but not with increased sexual side-effects in these studies. In two studies paliperidone palmitate was similar to depot risperidone.Clinical implicationsPaliperidone palmitate is an effective antipsychotic whose optimal dose appears to be between 39 and 234 mg every 4 weeks. We have no data assessing its long-term effectiveness or comparing it with any long-acting injected antipsychotic other than depot risperidone.

Tardive Dyskinesia Induced by a Switch From Haloperidol Depot to Paliperidone Palmitate

Tardive Dyskinesia Induced by a Switch From Haloperidol Depot to Paliperidone Palmitate

PMH30 Cost-Minimization-Analysis of Paliperidon Palmitate in the Treatment of Schizophrenia in Austria

Schizophrenia is marked by a characteristic interference pattern of various psychological areas such as perception, ego-function, affectivity and psychomotricity. Thus, the objective of this economic analysis is the evaluation of the cost saving potential through the use of Paliperidone Palmitate compared to Risperidon Depot. The pharmaeconomic evaluation was performed using a cost-minimization analysis, in which the above mentioned therapeutic alternatives with equal effectiveness and efficiency are compared based on the net costs to determine the most cost-effective alternative. The equivalence of the comparators was confirmed in the study of Pandina et al. (2011). Clinical data derived from this 13-week, double-blind “head-to-head” study. The time horizon is 2-years. From the perspective of the health insurance, the average costs of the therapy algorithm of Paliperidone Palmitate amount to €5,024.02 for the first year of treatment. A patient treated with Risperidone Depot is causing costs of €4,750.63. If the patient is treated with Paliperidone Palmitate as a first-line treatment in the following year, costs of €4,222.32 arise. In case of a treatment with Risperidone Depot costs amount to €4,594.76 EUR. If a patient is treated with Paliperidone Palmitate throughout the period under observation, the discounted total costs for 2-years amount to €9,247.02. Treatment with Risperidone Depot is causing costs of €9,345.40, resulting in a cost advantage for Paliperidone Palmitate compared to Risperidone Depot of €98.37 for the period of two years. Observing the costs over a time horizon of five years, a treatment with Paliperidone Palmitate is causing costs in the amount of 20,008.15 EUR. For the same period, a treatment with Risperidone Depot is causing costs of €20,851.47. In the treatment of schizophrenia, Paliperidone Palmitate is a cost-effective alternative therapy. Additionally, the sensitivity analysis shows that the analysis is, with the exception of doctor consultations, robust.

P.3.c.023 A naturalistic evaluation of the use of paliperidone palmitate: 6 month interim results on the first 120 patients

P.3.c.023 A naturalistic evaluation of the use of paliperidone palmitate: 6 month interim results on the first 120 patients

Paliperidone palmitate injection for the acute and maintenance treatment of schizophrenia in adults

PurposeTo review the use of paliperidone palmitate in treatment of patients with schizophrenia.MethodsPublished clinical trial data for the development and utilization of paliperidone palmitate for the treatment of schizophrenia were assessed in this review. Four short-term, randomized, double-blind, placebo-controlled trials investigated the efficacy of paliperidone palmitate in acute exacerbation of schizophrenia. Paliperidone palmitate was also studied as a maintenance treatment to prevent or delay relapse in stable schizophrenia. In addition, paliperidone palmitate was compared to risperidone long-acting injection for noninferiority in three studies.ResultsPaliperidone palmitate has been shown to be effective in reducing symptoms as measured by the Positive and Negative Syndrome Scale total scores in the four acute treatment studies. In the maintenance treatment studies, paliperidone palmitate was found to be more effective than placebo in preventing or delaying the time to first relapse in stable schizophrenia patients. In addition, paliperidone palmitate was shown to be noninferior to risperidone long-acting injection in two studies. It was shown to be reasonably well tolerated in all clinical trials. Acute treatment phase should be initiated with a dose of 234 mg on day one and 156 mg on day eight, followed by a recommended monthly maintenance dose of 39–234 mg based on efficacy and tolerability results from the clinical studies.ConclusionProviding an optimal long-term treatment can be challenging. Paliperidone palmitate can be used as an acute treatment even in outpatient setting, and it has shown to be well tolerated by patients. Also, it does not require overlapping oral antipsychotic supplementation while being initiated, and is dosed once per month.

Paliperidone Palmitate in a Child with Autistic Disorder

To the Editor: Autistic disorder (autism) is a neuropsychiatric disorder characterized by impairments in social interaction, communication, and stereotyped behaviors and interests (American Psychiatric Association 2000). Individuals with this disorder often exhibit associated interfering symptoms including irritability, hyperactivity, and inattention. Irritability, defined as aggression, severe tantrums, and self-injury, is a particularly limiting symptom with the capacity to diminish the quality of life for both the affected individual and their caregivers. Historically, antipsychotics have been the pharmacologic treatment of choice for irritability in youth with autism. Early research focused on typical antipsychotics such as haloperidol (Cohen et al. 1980; Anderson et al. 1984). Atypical antipsychotics have a lower rate of side effects such as dyskinesias and are currently considered first-line choice for treatment of irritability associated with autistic disorder (Erickson et al. 2007; Blankenship et al. 2010). Both risperidone and aripiprazole were approved by the U.S. Food and Drug Administration (FDA) to treat irritability in youth with autism aged 5–16 and 6–17 years, respectively. Multiple double-blind, placebo-controlled studies have demonstrated the efficacy of risperidone (Research Units on Pediatric Psychopharmacology Autism 2002; Shea et al. 2004) and aripiprazole (Marcus et al. 2009; Owen et al. 2009) for the treatment of this symptom domain. Paliperidone is the active metabolite of risperidone and was approved by FDA to treat schizophrenia and schizoaffective disorder in adults. Stigler et al. (2010) recently described the effectiveness of paliperidone in treating irritability in two individuals with autism. A 16-year-old female patient and a 20-year-old male patient, both diagnosed with autism, were treated with paliperidone (3 and 12 mg/day, respectively) after they demonstrated a lack of adequate improvement on other medication regimens. Both were judged to have significant improvement in their symptoms, including aggression and tantrums, with paliperidone treatment. No adverse events were reported. Both individuals lost weight and experienced improvements in their fasting lipid profiles while taking paliperidone. In 2009, the FDA approved a sustained-release intramuscular (IM) formulation of paliperidone, paliperidone palmitate, for the treatment of adults with schizophrenia. In this report, we demonstrate the successful use of paliperidone palmitate for the treatment of irritability in a child with autism who was unable to tolerate oral medications.

Changes in schizophrenia-related hospitalization and ER use among patients receiving paliperidone palmitate: results from a clinical trial with a 52-week open-label extension (OLE)

Background:Schizophrenia affects ∼1.1% of the United States population, resulting in substantial direct, indirect and societal costs.Objective:To evaluate hospitalization rates associated with use of paliperidone palmitate (PP).Methods:Data were from a variable-duration double-blind (DB), randomized, relapse-prevention comparison (NCT00111189) of PP vs. placebo (Pbo), followed by a 1-year open-label extension (OLE). Between-phase change in schizophrenia-related hospitalizations was evaluated using data from an investigator-completed questionnaire. Change in hospitalizations using patients before enrollment who participated in the OLE phase was also analyzed. Poisson regression was used to evaluate changes in incidence density within exposure category and by schizophrenia duration.Results:A total of 160 patients in the PP-PP group and 153 in the Pbo-PP group from the DB to the OLE phase were included. Mean age (standard deviation [SD]), gender, and duration of schizophrenia were similar at the start of the DB phase (Pbo: 38.5 years [10.6], 51.0% male, 68.0% ≥5 years’ duration; PP: 37.3 years [11.4] (p = 0.342); 51.9% male (p = 0.874); 70.0% ≥5 years’ duration (p = 0.698), respectively. From the DB to the end of the OLE phase, the number of hospitalizations per person-year for patients treated during the DB phase with Pbo significantly declined from 0.27 to 0.06 (78% reduction; p = 0.005). A statistically nonsignificant difference was observed for PP patients treated during the DB phase with PP (0.11–0.04; 63.6% reduction; p = 0.076), compared with the OLE phase. Change from before enrollment to the end of the OLE phase (n = 381) produced similar results (0.35–0.04; 88.6% reduction; p < 0.001). Patients who enroll in a clinical trial may be different from the general population and this may affect the generalizability of results.Conclusion:From the double-blind to the open-label phase and from prior to the trial until the end of the open-label phase, hospitalizations significantly decreased for patients with schizophrenia treated with PP.