Long-acting Injectable Paliperidone Research Articles

(202) Use of Long-Acting Injectable Paliperidone to Increase Medication Compliance in Individuals with ESRD and Schizophrenia

(202) Use of Long-Acting Injectable Paliperidone to Increase Medication Compliance in Individuals with ESRD and Schizophrenia

Paliperidone long-acting injection in the treatment of an adolescent with schizophrenia with fluctuating mental symptoms during menstrual period: a case report.

The treatment of schizophrenia, a chronic disabling psychiatric disorder, mainly relies on antipsychotics to control the disease and improve clinical symptoms. Various medication options are available, and differences in treatment effects, even for the same medication, have been noted. Treatment efficacy is correlated with the patient's sex, age, and physical condition. When a drug fails to achieve the desired effect or the symptoms are unstable, the drug dose is often increased or a change in medication is advised according to the patient's situation. We report the case of a 16 years-old girl with schizophrenia and apparent psychotic symptoms. According to the genetic testing results, the symptoms were effectively controlled, and she was discharged from the hospital with the prescription of paliperidone sustained-release tablets. During the follow-up, her symptoms fluctuated during menstrual period, causing her great distress. Furthermore, her compliance gradually declined during the following 2 years of treatment, and the medication was often discontinued. We changed the drug from an oral tablet to an injection preparation while maintaining the active ingredients of the drug. The patient's symptoms were significantly controlled, and no fluctuation of symptoms occurred during the menstrual cycle. Long-acting antipsychotic injections can be administered to female adolescents with schizophrenia who experience fluctuating psychotic symptoms during menstruation. This technique can ensure both consistency of medication and improvement in clinical symptoms.

Barriers to the use of three-month Paliperidone Palmitate formulation: a study from an Italian real-world setting

ABSTRACT Background Long-acting injectable paliperidone can improve adherence in psychotic patients and reduce relapses and healthcare resource utilization (HRU). This study compares the effectiveness of the three-monthly paliperidone palmitate (PP3M) with the one-monthly formulation (PP1M) and investigates reasons that hinder the use of PP3M in real-world settings. Methods The authors conducted a three-phase observational study. For subjects recruited from six psychiatric services in Milan, HRU outcomes of PP3M prescription were evaluated through a 12-month mirror-image design (phase 1) and a comparison of HRU of PP1M-only subjects and PP3M subjects during the year prior to PP3M initiation (phase 2). Lastly, they conducted a survey among physicians concerning reasons for not switching to PP3M (phase 3). Results A total of 119 subjects (61 on PP3M and 58 on PP1M) were included. One year after PP3M initiation, outpatients’ visits decreased significantly. Comparing PP3M with PP1M subjects, no significant difference was found in HRU. Perception of patient’s unstable clinical condition was the main reason for maintaining PP1M (32.8%), followed by the need for monthly monitoring (19.7%). Conclusion PP3M initiation was associated with an overall HRU reduction. Subjects switched to PP3M had similar HRU when compared to those who did not, suggesting similar clinical conditions in both groups.

Switching from Monthly to Three-Monthly Long-Acting Injectable Paliperidone: A Survey on Subjective Satisfaction and Safety.

Poor adherence to antipsychotic medication is common in the treatment of schizophrenia and other psychotic disorders. Paliperidone palmitate 3-monthly (PP3M) is the first long-acting injectable (LAI) antipsychotic to allow for only four medication administrations per year, and although there is sufficient information available about the clinical effects, there is relatively limited insight into the subjective experience of people with lived experience. This descriptive, cross-sectional survey explored patient's satisfaction and perspectives on the advantages and disadvantages of switching from monthly to 3-monthly paliperidone while also reporting on perceived levels of safety with regard to the reducing dose regimen during the Covid-19 pandemic. Information on discontinuation and hospitalisation rates at one year was also collected from the electronic records. Of the 46 patients included in the study, the vast majority reported feeling satisfied (89.2%) and safer (93.5%) after switching to the three-monthly formulation. Participants highlighted several advantages of changing to PP3M, most notably convenience (93.5%), improved quality of life (58.7%), decreased stigma (39.1%) and better adherence (28.3%). Furthermore, 93.5% of respondents experienced no disadvantages, while 6.5% described worsening side effects or symptoms. In fact, only one patient discontinued PP3M at one year with the overall number of hospitalisations also reducing in the same period compared to the year before switching. Our findings add to the small, but growing, body of evidence supporting patient satisfaction and acceptance with the use of PP3M and may reinforce the use of less frequent LAIs in clinical practice to enhance individual experience and treatment persistence and decrease levels of stigmatisation.

EE132 Cost-Utility Analysis of Long-Acting Injectable (1-, 3-, AND 6-MONTH INJECTION) and Oral Paliperidone in Adults with Stable Schizophrenia

To assess cost-effectiveness among long-acting injectable (LAI) paliperidone formulations administered every month (PP1M), 3 months (PP3M), or 6 months (PP6M) and oral paliperidone extended-release (ER).

Prospective, randomized, multicenter clinical trial evaluating longitudinal changes in brain function and microstructure in first-episode schizophrenia patients treated with long-acting injectable paliperidone palmitate versus oral antipsychotics.

Widespread anatomical alterations and abnormal functional connectivity have shown strong association with symptom severity in first-episode schizophrenia (FES) patients. Second-generation antipsychotic treatment might slow disease progression and possibly modify the cerebral plasticity in FES patients. However, whether a long-acting injectable antipsychotic (paliperidone palmitate [PP]), available in monthly and every-3-months formulations, is more effective than oral antipsychotics (OAP) in improving cerebral organization has been unclear. Therefore, in the current longitudinal study, we evaluated the differences in functional and microstructural changes of 68 FES patients in a randomized clinical trial of PP vs OAP. When compared to OAP treatment, PP treatment was more effective in decreasing abnormally high fronto-temporal and thalamo-temporal connectivity, as well as increasing fronto-sensorimotor and thalamo-insular connectivity. Consistent with previous studies, multiple white matter pathways showed larger changes in fractional anisotropy (FA) and mean diffusivity (MD) in response to PP compared with OAP treatment. These findings suggest that PP treatment might reduce regional abnormalities and improve cerebral connectivity networks compared with OAP treatment, and identified changes that may serve as reliable imaging biomarkers associated with medication treatment efficacy.

Long-acting new generation antipsychotics in the maintenance treatment of bipolar disorders

IntroductionMaintaining remission, preventing from future episodes, better treatment adherence and improving the quality of life are main aims of long-term treatment in bipolar disorders (BD). In recent years, new generation long-acting injectable (LAI) antipsychotics have been frequently used in maintenance treatment for bipolar disorders.ObjectivesWe aimed to review socio-demographic and clinical characteristics of bipolar patients taking LAI treatment for maintenance treatment.MethodsClinical records of 56 bipolar patients who are on LAI treatment and followed in Mazhar Osman Mood Clinic (MOMC) of Selcuk University Medical Faculty were evaluated. Descriptive statistical analysis was performed with Statistical Package for the Social Sciences (SPSS).ResultsNearly half of the patients were male (n:29, 52%). 49,1% of the patients were married. The mean age was 37.1±12.2 years and the mean duration of education was 11.1±4.2 years. All of the patients were diagnosed with bipolar 1 disorder. Most of the patients (64,7%) was on aripiprazole LAI while remaining was receiving paliperidone LAI for maintenance treatment. We found a significant reduction in the number of manic episodes after long-acting treatment (p<0.001), but we could not find any difference for depression. Ten of the patients discontinued the treatment due to the side effects, extrapyramidal side effects were the most common side effects. Eight of the patients were switched from paliperidone treatment to aripiprazole treatment due to side effects, especially hyperprolactinemia. Relapse was observed in 46,4% of the patients and there was no difference between aripiprazole and paliperidone in terms of relapse rate.ConclusionsLAI new generation antipsychotics are taking place in long-term treatment of bipolar disorder via improving treatment adherence. Side effect profile of aripiprazole and paliperidone are different. However, we could not find any difference between two drugs in terms of side effects and relapse rates. Small sample size and shorter duration of follow-up should be considered as limitations.Disclosure of InterestNone Declared

Effectiveness of Switching to Long-acting Injectable Aripiprazole in Patients with Recent-onset and Chronic Schizophrenia.

This study investigated the effectiveness of switching to once-monthly long-acting injectable (LAI) aripiprazole from other second-generation antipsychotics including LAI paliperidone palmitate in both recent-onset and chronic schizophrenia patients. This was a 24-week prospective, open-label, flexible dose-switching study in patients with schizophrenia. Scores on the Positive and Negative Syndrome Scale (PANSS), Personal and Social Performance (PSP) scale, Clinical Global Impression (CGI), Subjective Well-being Under Neuroleptics-Short Form (SWN-K), and a computerized emotional recognition test (ERT) were evaluated. Subjects were divided into two groups (recent onset and chronic) based on 5 years' duration of the illness. Among the 82 patients participating, 67 (81.7%) completed the 24-week study. The discontinuation rate after switching to LAI aripiprazole did not differ according to clinical characteristics including type of previous antipsychotics. Scores on the PANSS, PSP, SWN-K, CGI, and ERT were significantly improved after a switch to LAI aripiprazole without exacerbation of metabolic parameters and bodyweight. The improvements in the PANSS, PSP, and CGI scores were significantly greater in patients with recent-onset than in those with chronic schizophrenia; the improvement in metabolic parameters was significantly greater in the latter group. High rates of successful switching to LAI aripiprazole from other antipsychotics suggest its good tolerability and effectiveness. Improvements in psychopathology and social functioning were more evident in patients with recent- onset schizophrenia, and improvements in metabolic abnormalities were more prominent in patients with chronic schizophrenia.

Can multisite clinical trial results change clinical practice? Use of long-acting injectable risperidone nationally in the Veterans Health Administration

BackgroundMultisite practical clinical trials evaluate treatments in real-world practice. A multisite randomized Veterans Health Administration (VHA) cooperative study (CSP#555) published in 2011 compared the first long-acting injectable (LAI) second-generation antipsychotic (SGA), Risperidone Consta®, in veterans with a diagnosis of schizophrenia or schizoaffective disorder, to oral antipsychotics, with unexpected null results for effectiveness and cost-effectiveness. Whether null results of this type could change VHA practice has not been studied.MethodsA longitudinal observational analysis was used to evaluate the impact of the trial findings on VHA clinical practices. National administrative data compared new starts on LAI risperidone during the 4 years before the publication of CSP#555 in 2011 to new starts on LAI risperidone during the 4 years after.ResultsAmong 119,565 Veterans with the indicated diagnoses treated with antipsychotics from 2007 to 2015, the number and proportion of new starts on LAI risperidone declined significantly following the study publication, as did the total number of annual users and drug expenditures. However, data from 2007 to 2010 showed the decline in new starts actually preceded the publication of CSP#555. This change was likely explained by the increase in new starts, total use, and expenditures on a newer medicine, LAI paliperidone, a 4-week LAI treatment, in the 2 years prior to the publication of CSP#555.ConclusionsThe declining use of LAI risperidone likely primarily reflects the substitution of a longer-acting LAI SGA, paliperidone, that came to market 2 years before the study publication, a substitution that may have been reinforced by null CSP#555 study results for LAI risperidone.

Efficacy of oral versus long-acting antipsychotic treatment in patients with early-phase schizophrenia in Europe and Israel: a large-scale, open-label, randomised trial (EULAST)

Schizophrenia is a severe psychiatric disorder with periods of remission and relapse. As discontinuation of antipsychotic medication is the most important reason for relapse, long-term maintenance treatment is key. Whether intramuscular long-acting (depot) antipsychotics are more efficacious than oral medication in preventing medication discontinuation is still unresolved. We aimed to compare time to all-cause discontinuation in patients randomly allocated to long-acting injectable (LAI) versus oral medication. EULAST was a pragmatic, randomised, open-label trial conducted at 50 general hospitals and psychiatric specialty clinics in 15 European countries and Israel. Patients aged 18 years and older, with DSM-IV schizophrenia (as confirmed by the Mini International Neuropsychiatric Interview 5 plus) and having experienced their first psychotic episode from 6 months to 7 years before screening, were randomly allocated (1:1:1:1) using block randomisation to LAI paliperidone, LAI aripiprazole, or the respective oral formulations of these antipsychotics. Randomisation was stratified by country and duration of illness (6 months up to 3 years vs 4 to 7 years). Patients were followed up for up to 19 months. The primary endpoint was discontinuation, regardless of the reason, during 19 months of treatment. We used survival analysis to assess the time until all-cause discontinuation in the intention-to-treat (ITT) group, and per protocol analyses were also done. This trial is registered with ClinicalTrials.gov, NCT02146547, and is complete. Between Feb 24, 2015, and Dec 15, 2018, 533 individuals were recruited and assessed for eligibility. The ITT population included 511 participants, with 171 (33%) women and 340 (67%) men, and a mean age of 30·5 (SD 9·6) years. 410 (80%) of 511 participants were White, 35 (7%) were Black, 20 (4%) were Asian, and 46 (9%) were other ethnicity. In the combined oral antipsychotics treatment group of 247 patients, 72 (29%) patients completed the study and 175 (71%) met all-cause discontinuation criteria. In the combined LAI treatment arm of 264 patients, 95 (36%) completed the study and 169 (64%) met the all-cause discontinuation criteria. Cox regression analyses showed that treatment discontinuation for any cause did not differ between the two combined treatment groups (hazard ration [HR] 1·16, 95% CI 0·94-1·43, p=0·18). No significant difference was found in the time to all-cause discontinuation between the combined oral and combined LAI treatment groups (log rank test χ2=1·87 [df 1]; p=0·17). During the study, 121 psychiatric hospitalisations occurred in 103 patients, and one patient from each of the LAI groups died; the death of the patient assigned to paliperidone was assessed to be unrelated to the medication, but the cause of other patient's death was not shared with the study team. 86 (25%) of 350 participants with available data met akathisia criteria and 70 (20%) met parkinsonism criteria at some point during the study. We found no substantial advantage for LAI antipsychotic treatment over oral treatment regarding time to discontinuation in patients with early-phase schizophrenia, indicating that there is no reason to prescribe LAIs instead of oral antipsychotics if the goal is to prevent discontinuation of antipsychotic medication in daily clinical practice. Lundbeck and Otsuka.

Retrospective analysis of hospitalization rates in patients with schizophrenia 12 months before and 12 months after the switch on once-monthly long-acting injectable paliperidone palmitate

Background/Aim. There is no available published data about the use of long-acting injectable paliperidone palmitate (PP) in schizophrenia patients in the Republic of Serbia. The aim of this study was to assess hospitalization rates be-fore and after the switch to once-monthly long-acting injectable PP in schizophrenia patients, as well as their compliance with this drug. Methods. We conducted a retrospective cross-sectional study in which hospitalization rates were evaluated 12 months before and 12 months after the switch to once-monthly long-acting injectable PP in 113 schizophrenia patients. The age of the enrolled patients was between 18 and 66 years. Results. The average age of the enrolled patients was 38.36 ? 11.62 years. Among them, 77 (68.1%) were male, and 36 (31.9%) were female. Out of the total number of 113 patients treated with once-monthly injectable PP, 78 (69.03%) were on monotherapy, while 35 (30.97%) had one additional oral antipsychotic (risperidone, olanzapine, aripiprazole, or clozapine). Out of the total number of 113 patients, 68 (60.18%) were not hospitalized in the 12-month period before the switch to once-monthly long-acting injectable PP, while 45 (39.82%) were hospitalized in the same period. Given that 8 patients out of the total number of 113 were excluded from therapy due to an adverse event or their own decision in the period after the switch to PP, the analysis of the hospitalization rate after the switch to PP was performed for the remaining 105 patients, of which 9 (8.57%) were hospitalized in the period after the switch to PP, and 96 (91.43%) were not. Conclusion. Our results show high compliance in the treatment with once-monthly injectable PP and a positive impact of treatment with this drug on low hospitalization rate in a 12-month period in patients with schizophrenia. Considering the availability of this drug in the Republic of Serbia, these results encourage the use of once-monthly injectable PP as an important therapeutic option in schizophrenia patients.

Long-acting injectable paliperidone palmitate induced severe cutaneous allergic reaction in a patient with first episode delusional disorder tolerating oral paliperidone regimen: a case report

BackgroundPaliperidone is a second-generation antipsychotic agent that is effective in the treatment of schizophrenia and schizoaffective disorder as well as an adjunct to mood stabilizers and antidepressants for bipolar and depressive disorders. Paliperidone is available in both oral and injection forms. Here we report an unexpected case of cutaneous allergic reaction induced by paliperidone long-acting injection (LAI) following oral tolerance.Case presentationA 55-year-old man with first episode delusional disorder was treated with paliperidone tablets with tolerance. On day seven he received the paliperidone LAI and developed an allergic reaction in minutes including flushing of the face, widespread urticaria with mild airway constriction. The allergic symptoms were relived following the administration of antihistamine within several minutes.ConclusionThe allergic reaction that occurred post administration of the paliperidone LAI but not the oral tablets suggest it is likely due to the excipients in the formulation of the LAI rather than paliperidone itself. This case highlights the necessity of monitoring allergic reactions in psychiatric patients when converting from oral to LAI format of paliperidone.

Comparing Relapse Rates in Real-World Patients with Schizophrenia Who Were Adequately versus Not Adequately Treated with Paliperidone Palmitate Once-Monthly Injections Before Transitioning to Once-Every-3-Months Injections.

PurposeThis retrospective cohort study evaluated real-world data on relapses in adult patients with schizophrenia who transitioned to long-acting injectable paliperidone palmitate once-every-3-months (PP3M) following treatment with once-monthly paliperidone palmitate (PP1M).Patients and MethodsData derived from the IBM® MarketScan® Multi-State Medicaid Database were analyzed. Adults aged ≥18 years with ≥1 schizophrenia diagnosis claim and ≥12 months of continuous medical and prescription enrollment before and/or at index date of PP3M were eligible for inclusion. Patients were matched on propensity score to 2 PP3M cohorts: (1) adequately treated (AT), defined as patients treated with PP1M for ≥4 months, with the last 2 doses the same and a PP3M initiation dose meeting the corresponding PP1M-to-PP3M dose conversion, or (2) not adequately treated (NAT), defined as patients who received ≤2 or no PP1M doses. Relapse rates and time to relapse distributions based on the first occurrence of a qualifying event during the 2-year follow-up period were compared between PP3M cohorts using Kaplan–Meier survival curves and log rank test statistics. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated using Cox proportional hazards models. Two sensitivity analyses using different matched populations were performed to assess the robustness of the primary findings.ResultsPropensity score matching yielded a sample of 1314 patients (657 per group). Most patients were male (68.9%) and aged 25–64 years (90.1%). The relapse rate was significantly lower in the AT (18.4%) versus NAT cohort (26.8%), P = 0.0002. Risk of relapse decreased by 35% for AT versus NAT (HR: 0.65 [95% CI: 0.51–0.81]). Relapse reductions favored the AT cohort in both sensitivity analyses (HR: 0.67 [95% CI: 0.54–0.83] and HR: 0.74 [95% CI: 0.56–0.97]).ConclusionIn this analysis of Medicaid claims data, patients adequately treated with PP1M before transitioning to PP3M demonstrated significantly lower relapse rates and delayed time to relapse.

Therapeutic Drug Monitoring of Paliperidone in Patients With Schizophrenia in Taiwan.

The blood level of antipsychotics affects clinical responses to the drug; it can be influenced by race and several individual factors. This study analyzed the therapeutic plasma concentrations (Cps) of paliperidone for both oral and long-acting injectable (LAI) formulations in clinical samples from Taiwanese patients. Patients diagnosed with schizophrenia and treated with either oral paliperidone for at least 4 weeks or LAI paliperidone for at least 6 months were enrolled. Blood samples were taken before the morning dose of oral paliperidone or the injection of LAI paliperidone to obtain the trough Cps. Among the patients in this study, 51 were taking oral paliperidone, and 26 were receiving LAI paliperidone. In the oral group, the mean Cps were 40.2 ± 19.8 ng/mL in patients taking 9 mg/d and 44.2 ± 15.9 ng/mL in those taking 12 mg/d. In the LAI group, the mean Cps were 32.9 ± 12.7 ng/mL in patients receiving 100 mg per 28 days and 49.9 ± 25.9 ng/mL in those receiving 150 mg per 28 days. The mean Cps per daily dose (Cps/DD) were 4.11 ± 1.99 ng/mL/mg in the oral group and 9.24 ± 3.78 ng/mL/mg in the LAI group. Under the suggested DD for oral and LAI paliperidone treatment, most Taiwanese patients with schizophrenia can reach the suggested therapeutic Cps range. Wide interindividual differences were observed in the Cps/DD for both the oral (7-fold) and LAI paliperidone (4-fold) groups. Compared with Western reports, no difference was observed in the body weight-adjusted Cps/DD.

Long-acting new generation antipsychotics in the maintenance treatment of bipolar disorders

IntroductionMaintaining remission, preventing from future episodes, better treatment adherence and improving the quality of life are main aims of long-term treatment in bipolar disorders (BD). In recent years, new generation long-acting injectable (LAI) antipsychotics have been frequently used in maintenance treatment for bipolar disorders.ObjectivesWe aimed to review socio-demographic and clinical characteristics of bipolar patients taking LAI treatment for maintenance treatment.MethodsClinical records of 44 bipolar patients who are on LAI treatment and followed in Mazhar Osman Mood Clinic (MOMC) of Selcuk University Medical Faculty were evaluated.ResultsNearly half of the patients were male (n:24, 54%). 43,2% of the patients were married. The mean age was 36.6±11.9 years and the mean duration of education was 11.5±3.9 years. All of the patients were diagnosed with bipolar 1 disorder. Most of the patients (65.9%) was on aripiprazole LAI while remaining was receiving paliperidone LAI for maintenance treatment. Ten of the patients discontinued the treatment due to the side effects and extrapyramidal side effects was the most common side effect. Relapse was observed in 25% of the patients and there was no difference between aripiprazole and paliperidone in terms of relapse rate.ConclusionsLAI new generation antipsychotics are taking place in long-term treatment of bipolar disorder via improving treatment adherence. Side effect profile of aripiprazole and paliperidone are different. However, we could not find any difference between two drugs in terms of side effects and relapse rates. Small sample size and shorter duration of follow-up should be considered as limitations.DisclosureNo significant relationships.

Paliperidone palmitate-induced enuresis: a case report

IntroductionSchizophrenia is a severe mental illness that requires long-term treatment with antipsychotics and the intramuscular (IM) long-acting injectable (LAI) formulations may enhance treatment adherence. Some antipsychotics have been associated with enuresis, including atypical antipsychotics such as risperidone(6.2%), quetiapine(6.7%), olanzapine (9.6% ) and clozapine (20.7%) [1]. Although oral paliperidone has been related to urinary incontinence, there is only 1 report of urinary incontinence linked to monthly paliperidone palmitate [2]. [1] Harrison-Woolrych, M., Skegg, K., Ashton, J., Herbison, P., Skegg, D.C., 2011. Nocturnal enuresis in patients taking clozapine, risperidone, olanzapine and quetiapine: comparative cohort study. British Journal of Psychiatry 199, 140–144. doi:10.1192/bjp.bp.110.087478 [2] Karslıoǧlu, E.H., Özalp, E., Çayköylü, A., 2016. Paliperidone Palmitate-induced Urinary Incontinence: A Case Report. Clinical Psychopharmacology and Neuroscience 14, 96–100. doi:10.9758/cpn.2016.14.1.96ObjectivesTo establish an association between paliperidone palmitate and enuresis.MethodsCase report and a narrative review of the literature.ResultsThe patient was a 25-year-old healthy man when he was diagnosed with schizophrenia. Doctors prescribed paliperidone palmitate (LAI) 200mg monthly and he started to complain of enuresis. He was clearly suffering with this unpleasant and embarrassing adverse effect so the LAI was reduced to 150mg. Enuresis remained, so it was prescribed oxybutynin 20 mg/day and the patient improved.ConclusionsWe reported a case in which enuresis is likely to be associated with high-dose paliperidone LAI (with no clinical evidence of an organic cause). To treat it, the most effective strategy was oxybutynin 20 mg/day. This case is also important to show the impact of this symptom, which is not actively investigated.DisclosureNo significant relationships.

Long-acting Paliperidone Palmitate treatment in an Ekbom’s Syndrome secondary to Lewy Body Dementia: A case report

IntroductionEkbom Syndrome (ES) is a condition characterized by the fixed, delusional belief that one’s body is infested by parasites or other vermin, in absence of supporting clinical evidence. Literature suggests antipsychotic treatment for the management of behavioural and psychotic symptomatology, long-acting-injectable (LAI) antipsychotics for poor compliance.ObjectivesA case report of a 70-year-old woman with an ES diagnosis treated with LAI palmitate paliperidone was followed-up for an 8-months period, resulting in a confirmed diagnosis of secondary ES to Lewy Body Dementia (LBD).MethodsPatient was admitted to the local psychiatry ward presenting with new-onset visual and tactile hallucinations and social withdrawal. She was diagnosed with ES in a context of executive functions impairment. She was initially treated with risperidone, then switched to LAI Paliperidone due to poor compliance. Subsequently she was monitored monthly for 8 months by administering PANSS, MOCA, GAF, BPRS, PSP, complete neurocognitive assessment and neuroimaging studiesResultsAfter 8 months a progressive cognitive deterioration and worsening of motor impairment confirmed a secondary ES to a LBD. Meanwhile, a significant reduction of psychotic symptomatology (delusions and somatic hallucinations) was observed at BPRS and PANSS positive scale, even after treatment discontinuation due to the onset of extrapyramidal symptoms of the underlying condition.ConclusionsLAI Paliperidone treatment induced a complete remission of psychotic symptoms, with no relapse even after discontinuation of treatment. Moreover, close observation during follow-up allowed early diagnosis of LBD, which has been associated with a more favorable course.DisclosureNo significant relationships.

Long-Acting Injectable Antipsychotics in a Prescription Claims Data Source: A Validation Study.

BackgroundThe effectiveness of long-acting injectable antipsychotics (LAIAs) has been demonstrated in studies using prescription claims data. However, the validity of claims data for LAIAs has not been established.ObjectiveWe aimed to validate date dispensed, quantity dispensed and days supplied fields in prescription claims data, and to compare claims- and medical record-derived persistence estimates.MethodsWe evaluated LAIA dispensations in the Drug Programs Information Network prescription claims database from Manitoba, Canada against a random sample of medical records. Adults with one or more LAIA prescription between April 2015 and March 2016 were eligible. Results were stratified by LAIA type (first-generation LAIA, risperidone LAI or paliperidone LAI). Persistence estimates were assessed using Kaplan–Meier survival analysis and proportion of patients covered method.ResultsClaims data had high positive predictive value, ranging from 80.0% (95% CI 51.9–95.7) to 100.0% (95% CI 89.7–100.0), but low negative predictive value, ranging from 0.0% (95% CI 0.0–2.5) to 62.5% (95% CI 40.6–81.2). Quantity dispensed and days supplied exactly matched dose and dosing interval, respectively, for 99.7% and 97.1% of risperidone LAI doses, 100.0% and 76.6% of paliperidone doses, and 8.9% and 28.3% of first-generation LAIA doses. There were no significant differences in claims-derived versus medical record-derived persistence estimates.ConclusionsQuantity dispensed and days supplied provide valid estimates of dose and dosing interval for second-generation LAIAs, but underestimated these parameters for first-generation LAIAs. However, a large proportion of medical record-confirmed doses were missing from claims data, and dose and dosing interval are underestimated in claims data.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40801-022-00297-4.

Impact of 3-Monthly Long-Acting Injectable Paliperidone Palmitate in Schizophrenia: A Retrospective, Real-World Analysis of Population-Based Health Records in Spain.

BackgroundTreatment of schizophrenia requires long-term medication to prevent relapse. Treatment nonadherence may increase the risk of relapse, leading to increased hospitalizations and emergency room (ER) visits. Long-acting injectables (LAIs) such as paliperidone palmitate have improved treatment adherence and therefore symptoms. However, real-world studies comparing 3-monthly LAI formulations with other LAIs and oral antipsychotics (OAs) are scarce.ObjectiveThe objective of this study was to investigate and evaluate the clinical effectiveness of paliperidone palmitate LAI monthly (PP1M; Xeplion®) and 3-monthly (PP3M; Trevicta®) formulations compared with the monthly LAI aripiprazole (AM; Abilify Maintena®) and OAs in Spain.MethodsThis was a retrospective, observational study including 2275 adult patients with schizophrenia in a Spanish population. Data from hospital, primary care, and pharmacy dispensation electronic medical records were obtained between January 2017 and February 2018. The main outcomes included psychiatric hospitalizations and ER visit rates, days on treatment, and treatment persistence.ResultsPatients receiving PP3M had a significantly lower mean hospitalization rate (0.00046 ± standard deviation [SD] 0.00181; p < 0.0001) than other treatment groups. Kaplan–Meier curves revealed that 92.0 and 88.4% of patients receiving PP3M remained hospitalization free by 12 and 18 months, respectively. All treatment groups had at least a twofold significantly higher risk of psychiatric hospitalizations compared with those receiving PP3M or OAs, and the hospitalization risk among the PP3M group was significantly lower (hazard ratio [HR] 0.46; 95% confidence interval [CI] 0.31–0.67). The risk of ER visits was significantly lower with both PP3M and PP1M than with OAs, and lowest with PP3M (HR 0.462 [95% CI 0.29–0.62] and HR 0.833 [95% CI 0.59–0.97], respectively). Time until treatment switch with PP3M was high, with more than 86.5% of patients remaining on treatment at 18 months.ConclusionsPP3M was more effective than OAs and monthly LAIs in improving clinical outcomes for patients with schizophrenia in a real-world setting in Spain.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40263-022-00917-1.

A health economics study of long-acting injectable once-monthly paliperidone palmitate in schizophrenia: a one-year mirror-image study in China

Schizophrenia is ranked among the top 25 leading causes of disability worldwide in 2013 which resulting in social and economic burden. By observing patients with schizophrenia one year before and after switching from oral antipsychotics (OAPs) to once-monthly paliperidone palmitate (PP1M), we can better understand the change of total costs in schizophrenic patients, including direct costs and indirect costs, after switching treatment patterns.A total of 100 schizophrenic (ICD-10) patients from Shandong Mental Health Center were collected from December 2016 to June 2019. Treatment modalities, health care resource utilization and costs were compared before and after switching directly from oral antipsychotics to PP1M.Of the 82 patients included in the main analyses, treatment with PP1M resulted in an increase in direct costs of 31.92% (P < 0.01), an increase in medicine costs of approximately 142% (P < 0.01), and a reduction in hospital costs of 68.15% (P > 0.05). There was no significant increase in total costs (P = 0.25), while 31.92% increase in direct costs (P < 0.01), and 35.62% decrease in indirect costs (P < 0.01) after conversion to PP1M. Compared with before administration of PP1M, patients with ≥ 1 inpatient stay in 1 year Pre-PP1M treatment with OAPs (n = 32) had a 20.16% decrease in direct costs (P < 0.01), a 144% increase in medicine costs (P < 0.01), and a significant 72.02% decrease in hospital costs (P < 0.01). The observed reduction in the number of hospitalizations (t = 2.56, P ≤ 0.01) and inpatient stays (t = 1.73, P < 0.05) and after transition to PP1M resulted in a reduction in hospitalization costs (P < 0.01).Switching from OAPs to PP1M decreased the household workforce burden without increasing clinical healthcare costs. Direct costs were significantly reduced in patients with ≥ 1 inpatient stay in 1 year pre-PP1M treatment with OAPs after the switch, which decreased by improving adherence to therapy and reducing the number and length of hospital stays, suggesting that those patients may benefit after switching to PP1M.