Effectiveness Of Paliperidone Palmitate Research Articles

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.

Effects of Paliperidone Palmitate on Healthcare Utilization and Costs for Patients with Schizophrenia: A Claim-based Mirror-image Study in South Korea.

ObjectiveLong-acting injectable (LAI) antipsychotics, such as paliperidone palmitate (PP), are known to improve treatment adherence in patients with schizophrenia, which can lead to reductions in relapse and hospitalization rates. However, relatively few studies have demonstrated the economic impact of LAIs, especially in Asian populations.MethodsWe conducted a claim-based mirror-image study to explore changes in healthcare utilization and associated costs, among 1,272 South Korean patients with schizophrenia (ICD-10-CM code F20), between the 1-year periods before and after the initiation of PP treatment.ResultsPatients accessed outpatient services more frequently after versus before starting PP treatment, with the number of prescription days increasing by 133.45 (p < 0.0001) and the associated costs increasing by USD 1,497.15 (p < 0.0001). The number of admission days was reduced by 11.33 after starting PP treatment (p < 0.0001) and the associated costs were reduced by USD 1,220.75 (p < 0.0001). However, admission cost savings were different according to patients’ oral drug compliance. The daily dosages for benztropine, procyclidine, and propranolol decreased, showing that there were fewer side-effects after PP-treatment (p < 0.0001).ConclusionAlthough the high acquisition cost of PP has been regarded as an obstacle to its clinical use, our results imply that the high prescription costs for PP may be counterbalanced by the reduced admission costs associated with its use. Economic outcomes for patients treated with LAIs should be investigated further to help healthcare decision-makers and providers to determine the value of LAIs relative to other treatment medications.

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.

F228. EFFECTIVENESS OF PALIPERIDONE PALMITATE VS OTHER LONG-ACTING INJECTABLE (LAI) ANTIPSYCHOTICS – AN ELECTRONIC CASE REGISTER STUDY

BackgroundPaliperidone palmitate is a 2nd generation long-acting injectable (LAI) antipsychotic which is increasingly prescribed for patients with chronic schizophrenia. However, it is more expensive than 1st generation LAI antipsychotics and little is known about its effectiveness in a real world clinical setting. We sought to address this issue by analyzing a large electronic case register of patients with schizophrenia treated with LAI antipsychotics.MethodsData were obtained from 1,281 patients in the South London and Maudsley NHS Foundation Trust (SLaM) Biomedical Research Centre (BRC) Case Register who were treated with an LAI antipsychotic between 1st April 2011 and 31st January 2015. The number of days spent as a psychiatric inpatient and the number of admissions to a psychiatric hospital were extracted using the Clinical Record Interactive Search tool (CRIS) and analyzed in each of the 3 years before and after LAI prescription using multivariable regression.ResultsPatients who received paliperidone palmitate (n=430; 33.6%) spent more time in hospital (β coefficient 12.3 days, 95% CI 2.3 to 19.2, p=0.001) and were admitted to hospital more frequently (IRR 1.44, 95% CI 1.29 to 1.61, p<0.001) in the year prior to treatment than those treated with other LAI antipsychotics (n=851, 66.4%). However, there were no significant differences between paliperidone and the other LAI antipsychotics in the 3 years after initiation with respect to the number of days spent in hospital (β coefficient 5.4 days, 95% CI -57.3 to 68.2, p=0.86) or frequency of hospital admissions (Incidence rate ratio 1.07, 95% CI 0.62 to 1.83, p=0.82).DiscussionPaliperidone palmitate was more likely to be prescribed in patients with more severe illness, as indicated by a history of more frequent and lengthy hospital admissions prior to initiation. The absence of differences in outcomes after initiation indicates that the effectiveness of paliperidone palmitate was similar to that of other LAI antipsychotics. However, paliperidone palmitate may be better tolerated than other 1st generation LAI antipsychotics with a lower rate of discontinuation. These findings merit consideration in relation to the high cost of paliperidone palmitate compared to other LAI antipsychotics.

An open-treatment six-week study of the clinical effectiveness of Paliperidone Palmitate in schizophrenia: data from acute units in Spain (SHADOW study)

Objectives: To evaluate clinical evolution of patients with schizophrenia admitted in acute units because of a relapse and treated with once-monthly Paliperidone Palmitate (PP1M).Methods: This multicentre, open-label, prospective observational study followed patients with schizophrenia treated with PP1M in acute psychiatric units for up to 6 weeks.Results: Out of the 280 enrolled patients, 61 received PP1M as antipsychotic monotherapy, and 219 in combination with other antipsychotics. The average Clinical Global Impression–Schizophrenia (CGI-SCH) score decreased from 4.7 at baseline to 3.3 at final visit (p < .0001); the change was clinically and statistically significant both in patients treated with PP1M in monotherapy and in combination with other antipsychotics. Clear improvements in functioning and high patient satisfaction with the treatment were observed. Time from admission to PP1M therapy initiation correlated with the length of hospital stay (p < .0001); earlier start of PP1M treatment was associated with shorter hospital stay. Adverse events were reported in 7.1% of patients (all non-serious).Conclusions: PP1M was effective and well tolerated in treatment of acute episodes of schizophrenia both in monotherapy and in combination with other antipsychotics in clinical setting. Early start of PP1M therapy in acute schizophrenia episodes might help to shorten hospital stay.

Real-world paliperidone palmitate data from acute units: The SHADOW study

IntroductionThere is an increasing interest in understanding how antipsychotic treatments work in a real-world-setting. This is especially important with long-acting-antipsychotics, where explanatory trials may not always represent the real-world-population. Observational studies and pragmatic-clinical trials could provide additional information about new therapies, which could inform decision-making processes.ObjectivesTo assess the effectiveness of Paliperidone-Palmitate(PP) in an acute setting within real-world-conditions. Functionality, satisfaction with treatment and pattern of use were also evaluated.MethodsAn observational, prospective 6-week follow-up study was performed in acute units including adult patients with acute exacerbation of schizophrenia that started treatment with PP. Data were collected from initiation of PP until week-6 (or patient's discharge if earlier). Clinical-Global Inventory-Severity (CGI-S) was used to assess effectiveness as well as changes in illness severity. Other outcomes included total score on the Personal and Social Performance scale (PSP), patient-satisfaction with medication (MSQ) and tolerability. Student's-t tests were used to assess changes from baseline in CGI-S and PSP.ResultsTwo hundred and eighty patients were included in the analysis (mean age: 40.5 ± 12.2 [SD] years). A significant decrease in mean (SD) CGI-S score between baseline (4.7 [0.9]) and endpoint (3.3 [0.9]) (P &lt; 0.0001) was observed. (Note that 21% of patients were discharged on PP-monotherapy). Patient-functioning also significantly improved from baseline to endpoint (P &lt; 0.0001). Seventy-four percent of patients were satisfied (measured by MSQ) at the end of follow-up. Anticholinergic-treatment was less frequent for PP discharged on monotherapy vs. not monotherapy (12.5% vs 21.2% respectively). Overall, PP was well-tolerated. Twenty-five AEs were reported in 20 patients (incidence 7.1%). No serious AEs occurred.ConclusionsThese results support the effectiveness and tolerability of PP in an acute setting under daily-clinical-practice with good acceptance by patients.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Cost effectiveness of paliperidone palmitate versus oral antipsychotics in patients with schizophrenia and a history of criminal justice involvement

Objective:Conduct a cost effectiveness analysis for the Paliperidone palmitate Research In Demonstrating Effectiveness (PRIDE) trial.Research design and methods:PRIDE was a 15 month, prospective, randomized, open-label study in which once monthly paliperidone palmitate significantly delayed the time to first treatment failure (healthcare or criminal justice system [HC/CJS] events) versus oral antipsychotics in recently incarcerated adults with schizophrenia. The present analysis used a state government perspective and HC/CJS event data that were collected on a resource use questionnaire (RUQ) every 3 months.Main outcome measures:Since cost information was not collected in the trial, cost estimates from published literature and an analysis of multistate Medicaid data for CJS and HC events, respectively, were applied to RUQ event data. Effectiveness and costs were adjusted to 456 days (trial duration). Incremental cost effectiveness was calculated as the adjusted cost difference divided by the adjusted effectiveness difference.Results:Adjusted costs (in US dollars) in the paliperidone palmitate group (n = 198) and the oral antipsychotic group (n = 193), respectively, were: non-drug costs $22,331 and $25,027; drug costs $18,592 and $7833; and total costs $40,923 and $32,860. Adjusted effectiveness differences and corresponding incremental cost effectiveness per event avoided (in parentheses) for paliperidone palmitate versus oral antipsychotics were as follows: 0.33 fewer CJS events ($24,409), 0.13 fewer psychiatric hospitalizations ($60,484), 0.46 fewer psychiatric hospitalizations or CJS events combined ($17,391), and 0.30 fewer incarcerations ($26,754).Conclusions:Costs for HC/CJS events avoided offset 25% of the greater drug cost for the paliperidone palmitate versus oral antipsychotic treatment group in this vulnerable population. Use of a recall-dependent RUQ for event rates and cost estimates instead of actual costs are potential limitations and may make the results conservative from a state government perspective. Indirect costs are likely to be substantial for this population, but were not considered in the analysis.

A Case Report: Improvement of Zuclopenthixol Decanoate Induced Tardive Dyskinesia After Switching to Paliperidone Palmitate.

Introduction Long acting antipsychotics are an effective option in improving treatment adherence, but tardive dyskinesia can be problem in som cases1 Objectives Atypical antipsychotics with long acting formulations offer a safer option for extrapyramidal side effects but it is not clear if they are safer in tardive dyskinesia. Aims We report a 45 year old male patient with 25 year history of schizophrenia aiming to reveal the effects of paliperidone palmitate on oropharyngeal dyskinesia. Methods Chlorpromazine, haloperidole, zuclopenthixol, olanzapine and quetiapine were the antipsychotics which were used in the last 12 months. The patient had been using olanzapine 20 mg/day, biperiden 4 mg/day and zuclopenthixol decanoate 200 mg every 2 weeks in the index consultation that the oropharyngeal dyskinesia was observed. Olanzapine was discontinued and since there was need for long acting antipsychotics because of the former history of treatment non-adherence, zuclopenthixol was switched to paliperidone palmitate 150 mg every 4 weeks. Abnormal Involuntary Movement Scale was used weekly to score the dyskinetic movements. Results Marked improvement in movement disorder was observed after a switch from zuclopenthixol decanoate to paliperidone palmitate. Conclusion Long acting atypical antipsychotics may be a preferable option in patients with tardive dyskinesia if treatment non-adherence is a problem.

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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.

Effects of paliperidone palmitate on coagulation: an experimental study.

Objective. The aim of the present study was to examine the effects of a new antipsychotic drug paliperidone palmitate on hemogram and coagulation parameters in rats. Materials and Methods. Experiments were performed on 22 female albino Wistar rats (8–12 weeks old). Control group was given drinking water as vehicle (0.3 mL). PAL-1 rats were given 1 mg/kg paliperidone palmitate (in 0.3 mL drinking water) by oral gavage once a day for ten days and PAL-3 rats received 3 mg/kg paliperidone palmitate (in 0.3 mL drinking water) by oral gavage for ten days. Blood samples were drawn from the heart 24 hours after the last drug dose, and hemogram and coagulation parameters were measured with automated analyzers. Results. Hemogram did not change in the paliperidone treated groups compared to the controls. Factor VIII levels decreased in the PAL-1 and PAL-3 groups; and this decrease was significantly greater in the PAL-3. Factor IX levels decreased in PAL-3 rats, but its levels also increased in PAL-1 rats compared to the control. Discussion. Paliperidone has led to changes in the serum levels of coagulation factors VIII and IX in rats. As a result, paliperidone may be causing thromboembolism or bleeding in a dose-independent manner.

Effectiveness of Paliperidone Palmitate vs Haloperidol Decanoate for Maintenance Treatment of Schizophrenia: A Randomized Clinical Trial

Effectiveness of Paliperidone Palmitate vs Haloperidol Decanoate for Maintenance Treatment of Schizophrenia: A Randomized Clinical Trial

Cost effectiveness of paliperidone palmitate versus risperidone long-acting injectable and olanzapine pamoate for the treatment of patients with schizophrenia in Sweden

Objective:To model the cost effectiveness of paliperidone palmitate (paliperidone long-acting injectable; PLAI), a new once-monthly long-acting antipsychotic therapy, compared with risperidone long-acting injectable (RLAI) and olanzapine pamoate (OLAI), in multi-episode patients (two or more relapses) with schizophrenia in Sweden.Methods:A Markov decision analytic model was developed to simulate the history of a cohort of multi-episode patients transitioning through different health states on a monthly basis over a 5-year time horizon from the perspective of the Swedish healthcare system. Therapeutic strategies consisted of starting treatment with RLAI (mean dose 37.5 mg every 2 weeks), PLAI (mean dose 75 mg equivalent (eq.) every month) or OLAI (150 mg every 2 weeks or 300 mg every 4 weeks). Probability of relapse, level of adherence, side-effects (extrapyramidal symptoms, tardive dyskinesia, weight gain and diabetes) and treatment discontinuation (switch) were derived from long-term observational data when feasible. Incremental cost-effectiveness outcomes, discounted at 3% annually, included cost per quality-adjusted life-year (QALY) and cost per relapse avoided (expressed in 2009 Swedish Krona SEK).Results:Relative to RLAI and OLAI, PLAI is economically dominant: more effective (additional QALYs, less relapses) and less costly treatment option over a 5-year time horizon. The results were robust when tested in sensitivity analysis.Limitations:The impact of once-monthly treatment on adherence levels is not yet known, and not all variables that could impact on real-world outcomes and costs were included in this model.Conclusion:PLAI was cost saving from a Swedish payer perspective compared with RLAI and OLAI in the long-term treatment of multi-episode (two or more relapses) schizophrenia patients.