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Keywords = paliperidone palmitate

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25 pages, 770 KiB  
Systematic Review
Combination of Two Long-Acting Antipsychotics in Schizophrenia Spectrum Disorders: A Systematic Review
by Salvatore Cipolla, Pierluigi Catapano, Daniela D’Amico, Rocchina Monda, Nunzia Paola Sallusto, Francesco Perris, Valeria De Santis, Francesco Catapano, Mario Luciano and Andrea Fiorillo
Brain Sci. 2024, 14(5), 433; https://doi.org/10.3390/brainsci14050433 - 26 Apr 2024
Cited by 2 | Viewed by 4217
Abstract
Background: Up to 34% of patients with schizophrenia are resistant to several treatment trials. Lack of continuous and adequate treatment is associated with relapse, rehospitalization, a lower effect of antipsychotic therapy, and higher risk of side effects. Long-acting injectables antipsychotics (LAI APs) enhance [...] Read more.
Background: Up to 34% of patients with schizophrenia are resistant to several treatment trials. Lack of continuous and adequate treatment is associated with relapse, rehospitalization, a lower effect of antipsychotic therapy, and higher risk of side effects. Long-acting injectables antipsychotics (LAI APs) enhance compliance and improve clinical outcomes and quality of life in patients with schizophrenia, and thus it may be advisable to administer two LAI APs at the same time in cases of treatment-resistant schizophrenia. The purpose of this review is to summarize the available literature regarding the combined use of two LAI APs in patients with schizophrenia or other psychotic spectrum disorders. Methods: An extensive literature search for relevant articles regarding any combination of two long-acting injectable antipsychotics has been performed from inception up to 9 February 2024, on PubMed, Scopus and APA PsycInfo, according to the PRISMA statement. Only studies reporting combination of two LAI APs and its clinical outcome in patients with schizophrenia and related disorders were selected. Results: After the selection process, nine case reports, four case series and two observational retrospective studies were included in the final analysis. All patients treated with dual LAI APs reported a good response, and no new or unexpected adverse effects due to the combination of two LAIs were reported. Different drug combinations were used, and the most frequent association resulted in aripiprazole monohydrate + paliperidone palmitate once monthly (32 times). Conclusions: Our review highlights that the treatment regimen with two concurrent LAI APs is already widely used in clinical practice and is recognized as providing a promising, effective, and relatively safe therapeutic strategy for treating the schizophrenia spectrum disorders. Full article
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32 pages, 2428 KiB  
Review
Second Generation Long-Acting Injectable Antipsychotics in Schizophrenia: The Patient’s Subjective Quality of Life, Well-Being, and Satisfaction
by Claudio Brasso, Silvio Bellino, Paola Bozzatello, Cristiana Montemagni, Marco Giuseppe Alberto Nobili, Rodolfo Sgro and Paola Rocca
J. Clin. Med. 2023, 12(22), 6985; https://doi.org/10.3390/jcm12226985 - 8 Nov 2023
Cited by 4 | Viewed by 3083
Abstract
Schizophrenia (SZ) is among the twenty most disabling diseases worldwide. Subjective quality of life, well-being, and satisfaction are core elements to achieving personal recovery from the disorder. Long-acting injectable second-generation antipsychotics (SGA-LAIs) represent a valid therapeutic option for the treatment of SZ as [...] Read more.
Schizophrenia (SZ) is among the twenty most disabling diseases worldwide. Subjective quality of life, well-being, and satisfaction are core elements to achieving personal recovery from the disorder. Long-acting injectable second-generation antipsychotics (SGA-LAIs) represent a valid therapeutic option for the treatment of SZ as they guarantee good efficacy and adherence to treatment. The aim of this rapid review is to summarize the evidence on the efficacy of SGA-LAIs in improving subjective quality of life, well-being, and satisfaction. The PubMed database was searched for original studies using SGA, LAI, risperidone, paliperidone, aripiprazole, olanzapine, SZ, and psychosis as keywords. Twenty-one studies were included: 13 clinical trials, 7 observational studies, and 1 post hoc analysis. It has been shown that SGA-LAIs bring an improvement to specific domains of subjective and self-rated quality of life, well-being, or satisfaction in prospective observational studies without a control arm and in randomized controlled trials versus placebo. The superiority of SGA-LAIs as compared with oral equivalents and haloperidol-LAI has been reported by some randomized controlled and observational studies. Although promising, the evidence is still limited because of the lack of studies and several methodological issues concerning the choice of the sample, the evaluation of the outcome variables, and the study design. New methodologically sound studies are needed. Full article
(This article belongs to the Special Issue Diagnosis, Treatment, and Prognosis of Neuropsychiatric Disorders)
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13 pages, 1004 KiB  
Article
Effectiveness of SGA-LAIs on Clinical, Cognitive, and Social Domains in Schizophrenia: Results from a Prospective Naturalistic Study
by Renato de Filippis, Filippo Antonio Staltari, Matteo Aloi, Elvira Anna Carbone, Marianna Rania, Laura Destefano, Luca Steardo Jr., Cristina Segura-Garcia and Pasquale De Fazio
Brain Sci. 2023, 13(4), 577; https://doi.org/10.3390/brainsci13040577 - 29 Mar 2023
Cited by 9 | Viewed by 2508
Abstract
We hypothesized that shifting from oral second-generation antipsychotics (SGA) to their long-acting injectable (LAI) counterpart would be beneficial for the psychopathological, cognitive, social, and general health domains in outpatients suffering from schizophrenia. We aimed to evaluate the prospective usefulness of SGA-LAI treatment by [...] Read more.
We hypothesized that shifting from oral second-generation antipsychotics (SGA) to their long-acting injectable (LAI) counterpart would be beneficial for the psychopathological, cognitive, social, and general health domains in outpatients suffering from schizophrenia. We aimed to evaluate the prospective usefulness of SGA-LAI treatment by carrying out a head-to-head comparison of two different medications (i.e., aripiprazole monohydrate (Ari-LAI) and paliperidone palmitate 1 and 3 month (PP1M, PP3M)) in a real-world setting, assessing the effectiveness and tolerability of Ari-LAI and PP1M/PP3M over a 15 month follow-up. A total of 69 consecutive individuals affected by schizophrenia were screened for eligibility. Finally, 46 outpatients (29 treated with Ari-LAI, 13 with PP1M, and four with PP3M) were evaluated through clinical, functional, and neuropsychological assessment administrated at baseline and after 3-, 12-, and 15-month follow-up periods. Moreover, periodic general medical evaluations were carried out. We estimated an overall improvement over time on the explored outcomes, without differences with respect to the type of LAI investigated, and with a global 16.4% dropout rate. Our findings suggest that switching from oral SGA to SGA-LAIs represents a valid and effective treatment strategy, with significant improvements on psychopathological, cognitive, social, and clinical variables for patients suffering from schizophrenia, regardless of the type of molecule chosen. Full article
(This article belongs to the Special Issue New Insights in Psychiatric Disorder Psychopharmacology)
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10 pages, 1055 KiB  
Article
Effectiveness of Paliperidone Palmitate in Reducing Acute Psychiatric Service Use for Patients Suffering from Psychosis—A Retrospective Mirror-Image Study
by Chun Ting Chan, Swapna Verma, Mythily Subramaniam, Edimansyah Abdin and Jenny Tay
Int. J. Environ. Res. Public Health 2023, 20(4), 3403; https://doi.org/10.3390/ijerph20043403 - 15 Feb 2023
Viewed by 1736
Abstract
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 [...] Read more.
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. Full article
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18 pages, 5196 KiB  
Article
Comparison of Paliperidone Palmitate from Different Crystallization Processes and Effect on Formulations In Vitro and In Vivo
by Junfeng Shi, Dan Wang, Yang Tian, Zengming Wang, Jing Gao, Nan Liu, Xiang Gao, Aiping Zheng, Hui Zhang and Meixian Xiang
Pharmaceutics 2022, 14(5), 1094; https://doi.org/10.3390/pharmaceutics14051094 - 20 May 2022
Cited by 6 | Viewed by 4285
Abstract
The quality of active pharmaceutical ingredients (APIs) is an important factor which can affect the safety and efficacy of pharmaceuticals. This study was designed to investigate the nature of paliperidone palmitate (PP) obtained by different crystallization processes, then compare the characteristics between test [...] Read more.
The quality of active pharmaceutical ingredients (APIs) is an important factor which can affect the safety and efficacy of pharmaceuticals. This study was designed to investigate the nature of paliperidone palmitate (PP) obtained by different crystallization processes, then compare the characteristics between test formulations which prepared PP of different crystallization and reference formulations (Invega Sustenna®) in vitro and in vivo. Two different PPs, namely PP-1 and PP-2, were prepared by different crystallization methods. Contact angle, morphology, and crystallinity of the PPs were characterized. Taking the particle sizes and distribution of Invega Sustenna® as reference, test formulations were prepared by the wet milling method using either a PP-1 or PP-2 sample. Their release behavior, stability in vitro, and pharmacokinetics in vivo were subsequently investigated. The results indicated that PP-2 had a higher surface free energy (SFE). More small particles were attached to the PP-1 surface under the influence of crystallization temperature. Different crystallization processes did not change the crystal of PP, but changed the crystallinity of PP. There was no obvious difference in in vitro releases between test formulations. However, the stability and state of formulation containing PP-2 were better compared to formulations containing PP-1, indicated by differences in crystallinity and SFE. Meanwhile, pharmacokinetic in vivo results demonstrated that the pharmacokinetic profiles and parameters of formulation containing PP-2 and Invega Sustenna® tended to be consistent, but those of formulations containing PP-1 were significantly different from those of formulations containing PP-2 or Invega Sustenna®, and there was burst release phenomenon of formulations containing PP-1 in rats. PP made by different crystallization processes could induce changes in appearance, SFE, and crystallinity, and further affect the stability, state, and pharmacokinetic in vivo formulation. Full article
(This article belongs to the Special Issue Advances in Pharmaceutical Solid Forms)
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9 pages, 250 KiB  
Article
Use of Long-Acting Injectable Antipsychotics in Inpatients with Schizophrenia Spectrum Disorder in an Academic Psychiatric Hospital in Switzerland
by Stephan Reymann, Georgios Schoretsanitis, Stephan T. Egger, Alexey Mohonko, Matthias Kirschner, Stefan Vetter, Philipp Homan, Erich Seifritz and Achim Burrer
J. Pers. Med. 2022, 12(3), 441; https://doi.org/10.3390/jpm12030441 - 11 Mar 2022
Cited by 15 | Viewed by 3790
Abstract
Long-acting injectable antipsychotics (LAIs) offer many benefits to patients with schizophrenia spectrum disorder (SSD). They are used with very different frequencies due to questions of eligibility or patients and prescribers’ attitudes towards LAI use. We assessed the prescribing rates of LAIs in a [...] Read more.
Long-acting injectable antipsychotics (LAIs) offer many benefits to patients with schizophrenia spectrum disorder (SSD). They are used with very different frequencies due to questions of eligibility or patients and prescribers’ attitudes towards LAI use. We assessed the prescribing rates of LAIs in a large academic psychiatric hospital with a public service mandate in Switzerland and compared them with other countries and health care systems. To our knowledge, this study is the first to investigate inpatient LAI use in Europe. Medical records of all patients diagnosed with SSD discharged from the Clinic of Adult Psychiatry of the University Hospital of Psychiatry Zurich over a 12 month period from January to December 2019 were evaluated regarding the prescribed antipsychotics at the time of discharge. The rates of use of LAIs among all patients and among patients receiving LAI-eligible antipsychotic substances were assessed retrospectively. We assessed records of 885 patients with SSD. Among all cases, 13.9% received an LAI. Among patients who received antipsychotic medication that was eligible for LAI use (n = 434), 28.1% received an agent as an LAI. LAI use included paliperidone palmitate (69.9%), aripiprazole monohydrate (14.6%), risperidone (4.9%) and first-generation LAIs (9.8%). Compared to international frequencies of LAI administration, the prescription rate of LAIs in SSD patients was low. Further studies will evaluate patient- and prescriber-related reasons for this low rate. Full article
16 pages, 358 KiB  
Review
Paliperidone to Treat Psychotic Disorders
by Hormazd D. Minwalla, Peter Wrzesinski, Allison Desforges, Joshua Caskey, Brittany Wagner, Patrick Ingraffia, James C. Patterson, Amber N. Edinoff, Adam M. Kaye, Alan D. Kaye, Omar Viswanath and Ivan Urits
Neurol. Int. 2021, 13(3), 343-358; https://doi.org/10.3390/neurolint13030035 - 28 Jul 2021
Cited by 11 | Viewed by 7424
Abstract
Purpose of Review: This is a comprehensive review of the literature regarding the use of paliperidone in the treatment of schizophrenia and schizoaffective disorder. It covers the background and presentation of schizophrenia and schizoaffective disorder, as well as the mechanism of action and [...] Read more.
Purpose of Review: This is a comprehensive review of the literature regarding the use of paliperidone in the treatment of schizophrenia and schizoaffective disorder. It covers the background and presentation of schizophrenia and schizoaffective disorder, as well as the mechanism of action and drug information for paliperidone. It covers the existing evidence of the use of paliperidone for the treatment of schizophrenia and schizoaffective disorder. Recent Findings: Schizophrenia and schizoaffective disorder lead to significant cognitive impairment. It is thought that dopamine dysregulation is the culprit for the positive symptoms of schizophrenia and schizoaffective disorder. Similar to other second-generation antipsychotics, paliperidone has affinity for dopamine D2 and serotonin 5-HT2A receptors. Paliperidone was granted approval in the United States in 2006 to be used in the treatment of schizophrenia and in 2009 for schizoaffective disorder. Summary: Schizophrenia and schizoaffective disorder have a large impact on cognitive impairment, positive symptoms and negative symptoms. Patients with either of these mental illnesses suffer from impairments in everyday life. Paliperidone has been shown to reduce symptoms of schizophrenia and schizoaffective disorder. Full article
(This article belongs to the Special Issue Advances in the Treatment of Schizophrenia)
5 pages, 190 KiB  
Case Report
Exercise and Worsening of Extrapyramidal Symptoms during Treatment with Long-Acting Injectable Antipsychotics
by David D. Kim, Donna J. Lang, Darren E. R. Warburton, Alasdair M. Barr, Randall F. White, William G. Honer and Ric M. Procyshyn
Pharmacy 2021, 9(3), 123; https://doi.org/10.3390/pharmacy9030123 - 3 Jul 2021
Cited by 5 | Viewed by 5238
Abstract
Second-generation antipsychotic medications are used to treat schizophrenia and a range of other psychotic disorders, although adverse effects, including cardiovascular and metabolic abnormalities and extrapyramidal symptoms, are often inevitable. Studies have shown that exercise, as an adjunct therapy, can be effective in reducing [...] Read more.
Second-generation antipsychotic medications are used to treat schizophrenia and a range of other psychotic disorders, although adverse effects, including cardiovascular and metabolic abnormalities and extrapyramidal symptoms, are often inevitable. Studies have shown that exercise, as an adjunct therapy, can be effective in reducing the core symptoms of schizophrenia as well as ameliorating intrinsic and antipsychotic-induced cardiometabolic abnormalities. However, it is noteworthy that exercise may need to be implemented with caution in some individuals receiving certain antipsychotic treatment regimens. We report here two cases of exercise-associated worsening of extrapyramidal symptoms in two individuals with schizoaffective disorder treated with a long-acting injectable antipsychotic medication over the course of a 12-week exercise program. This worsening of extrapyramidal symptoms can be attributed to an increase in blood flow to the site of injection during exercise, accelerating the rate of absorption and bioavailability of the antipsychotic medication and subsequently increasing dopamine D2 receptor blockade. When monitoring drug therapy for patients receiving long-acting injectable antipsychotic medications, pharmacists and other healthcare professionals need to consider exercise as a contributing factor for the emergence of extrapyramidal symptoms. Full article
(This article belongs to the Special Issue Addiction and Mental Health in Pharmacy)
8 pages, 262 KiB  
Article
Paliperidone Palmitate Every Three Months (PP3M) 2-Year Treatment Compliance, Effectiveness and Satisfaction Compared with Paliperidone Palmitate-Monthly (PP1M) in People with Severe Schizophrenia
by Juan J. Fernández-Miranda, Silvia Díaz-Fernández, Domenico De Berardis and Francisco López-Muñoz
J. Clin. Med. 2021, 10(7), 1408; https://doi.org/10.3390/jcm10071408 - 1 Apr 2021
Cited by 22 | Viewed by 3411
Abstract
Paliperidone palmitate every three months (PP3M) is expected to facilitate patient’s treatment compliance and satisfaction. The objective here was to compare PP3M treatment compliance and satisfaction, effectiveness and tolerability, with paliperidone palmitate-monthly (PP1M) in patients with severe schizophrenia. A 24-month prospective, open-label study [...] Read more.
Paliperidone palmitate every three months (PP3M) is expected to facilitate patient’s treatment compliance and satisfaction. The objective here was to compare PP3M treatment compliance and satisfaction, effectiveness and tolerability, with paliperidone palmitate-monthly (PP1M) in patients with severe schizophrenia. A 24-month prospective, open-label study of patients with severe schizophrenia treated with PP3M after at least 2 years of stabilization with PP1M (n = 84) was carried out. Treatment satisfaction was assessed with the Treatment Satisfaction Questionnaire for Medication (TSQM) and with a Visual Analogue Scale (VAS). Effectiveness was measured with psychiatric hospital admissions and the Clinical Global Impression-Severity (CGI-S) scale. Tolerability assessments included laboratory tests, weight and adverse effects. Reasons for treatment discontinuation were recorded. CGI-S significantly improved after 24 months. Three patients changed back to PP1M due to adverse effects, and four were hospitalized. There were neither abandoning nor significant changes in weight or biological parameters, and lower incidence of side effects, with PP3M treatment. TSQM and VAS scales increased. No differences were found related to doses. Apart from somewhat improvement in treatment adherence, effectiveness, and tolerability, patients with severe schizophrenia lengthy treated with PP1M showed more satisfaction with PP3M, even those who needed high doses to get clinical stabilization. Full article
(This article belongs to the Special Issue Hot Topics in Schizophrenia Research - Part I)
15 pages, 1413 KiB  
Article
Efficacy, Tolerability, and Safety of Aripiprazole Once-Monthly versus Other Long-Acting Injectable Antipsychotic Therapies in the Maintenance Treatment of Schizophrenia: A Mixed Treatment Comparison of Double-Blind Randomized Clinical Trials
by Istvan M. Majer, Fiona Gaughran, Christophe Sapin, Maud Beillat and Maarten Treur
J. Mark. Access Health Policy 2015, 3(1), 27208; https://doi.org/10.3402/jmahp.v3.27208 - 10 Sep 2015
Cited by 14 | Viewed by 418
Abstract
Background: Treatment with long-acting injectable (LAI) antipsychotic medication is an important element of relapse prevention in schizophrenia. Recently, the intramuscular once-monthly formulation of aripiprazole received marketing approval in Europe and the United States for schizophrenia. Objective: This study aimed to compare [...] Read more.
Background: Treatment with long-acting injectable (LAI) antipsychotic medication is an important element of relapse prevention in schizophrenia. Recently, the intramuscular once-monthly formulation of aripiprazole received marketing approval in Europe and the United States for schizophrenia. Objective: This study aimed to compare aripiprazole once-monthly with other LAI antipsychotics in terms of efficacy, tolerability, and safety. Data sources: A systematic literature review was conducted to identify relevant double-blind randomized clinical trials of LAIs conducted in the maintenance treatment of schizophrenia. MEDLINE, MEDLINE In-Process, Embase, the Cochrane Library, PsycINFO, conference proceedings, clinical trial registries, and the reference lists of key review articles were searched. The literature search covered studies dating from January 2002 to May 2013. Study selection: Studies were required to have ≥24 weeks of follow-up. Patients had to be stable at randomization. Studies were not eligible for inclusion if efficacy of acute and maintenance phase treatment was not reported separately. Six trials were identified (0.5% of initially identified studies), allowing comparisons of aripiprazole once-monthly, risperidone LAI, paliperidone palmitate, olanzapine pamoate, haloperidol depot, and placebo. Data extraction: Data extracted included study details, study duration, the total number of patients in each treatment arm, efficacy, tolerability, and safety outcomes. The efficacy outcome contained the number of patients that experienced a relapse, tolerability outcomes included the number of patients that discontinued treatment due to treatment-related adverse events (AEs), and that discontinued treatment due to reasons other than AEs (e.g., loss to follow-up). Safety outcomes included the incidence of clinically relevant weight gain and extrapyramidal symptoms. Data synthesis: Data were analyzed by applying a mixed treatment comparison competing risks model (efficacy) and using binary models (safety). There was no statistically significant difference between any study outcome, including the risk of relapse, the risk of discontinuations, and safety outcomes. Conclusions: Aripiprazole once-monthly is similarly efficacious to other LAIs with relatively low rates of discontinuation due to AEs and due to reasons other than AEs than other LAIs. Full article
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