Second-generation LAI are associated to favorable outcome in a cohort of incident patients diagnosed with schizophrenia

Nielsen, René Ernst; Hessellund, Kristian Bjørn; Valentin, Jan Brink; Licht, Rasmus W

doi:10.1016/j.schres.2018.07.020

Cited by 16 publications

(8 citation statements)

References 32 publications

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“…The regular drug delivery afforded by LATs has translated into improved clinical outcomes versus daily oral antipsychotic treatment in people with schizophrenia, including a reduced risk of relapse and hospitalization, 11,19,23–25 improved quality of life, 26–28 and a reduced risk of mortality. 7…”

Section: Introductionmentioning

confidence: 99%

“…21 The long apparent elimination half-life of these medications also provides a wider window for healthcare professionals to intervene before plasma drug levels drop below therapeutic thresholds. 22 The regular drug delivery afforded by LATs has translated into improved clinical outcomes versus daily oral antipsychotic treatment in people with schizophrenia, including a reduced risk of relapse and hospitalization, 11,19,[23][24][25] improved quality of life, [26][27][28] and a reduced risk of mortality. 7 Paliperidone palmitate 3-monthly (PP3M) is a LAT formulation that is approved in many countries and regions worldwide, including the United States and Europe, for the maintenance treatment of adults with schizophrenia who have been stabilized with paliperidone 1-monthly (PP1M) formulation.…”

Section: Introductionmentioning

confidence: 99%

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Symptomatic and functional outcomes after treatment with paliperidone palmitate 3-month formulation for 52 weeks in patients with clinically stable schizophrenia

García-Portilla

Llorca²,

Maina

et al. 2020

Therapeutic Advances in Psychopharmacology

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Background: Paliperidone palmitate 3-monthly (PP3M) formulation is a long-acting, injectable antipsychotic treatment approved in many countries worldwide for the maintenance treatment of adult patients with schizophrenia. This single-arm, open-label, phase IIIb study evaluated the efficacy and safety of converting patients with schizophrenia stabilized with paliperidone palmitate 1-month (PP1M) to PP3M in a naturalistic clinical setting. Methods: After screening (days –7 to 1), patients were converted from PP1M (50–150 mg eq.) to PP3M (175–525 mg eq.), and entered a 52-week, flexible-dose PP3M treatment period. The primary efficacy endpoint was symptomatic remission (SR) (Andreasen criteria) at last observation carried forward (LOCF) endpoint. Results: Patients ( n = 305) received PP3M, of whom 291 (95.4%) completed the study. Doses of PP3M remained stable during the 12-month treatment period, and changes in dose were uncommon. Overall, 56.8% of patients [95% confidence interval (CI): 51.0, 62.4] achieved SR, and 31.8% achieved both symptomatic and functional remission (Personal and Social Performance scale total score > 70) at LOCF endpoint. Secondary endpoint results were generally consistent with primary endpoint results. There were improvements in Positive and Negative Syndrome Scale total, subscale and Marder factor scores, and also Clinical Global Impression-Severity and -Change scores from baseline to LOCF endpoint. Carer burden was reduced, and the proportion of patients requiring hospitalization for psychiatric reasons decreased from 13.5% in the 12 months prior to baseline to 4.6% during the treatment period. No new safety signals were identified. Conclusion: Results from this naturalistic study were similar to those observed in previous randomized clinical trials of PP3M and underline the importance of continuous maintenance treatment in patients with schizophrenia.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Symptomatic and functional outcomes after treatment with paliperidone palmitate 3-month formulation for 52 weeks in patients with clinically stable schizophrenia

García-Portilla

Llorca²,

Maina

et al. 2020

Therapeutic Advances in Psychopharmacology

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“…Paliperidone palmitate (PP-1M) is a once monthly LAI formulation of the paliperidone palmitoyl ester that became commercially available in the early 2010’s. PP-1M has proven effective in a number of studies (especially observational ones) in reducing hospitalizations, number of bed days and treatment related costs in patients with schizophrenia [ 2 , 13 - 17 ]. Contrary to that, randomized controlled trials have generally shown comparable efficacy of LAI and oral formulations in preventing relapse, symptom reduction and treatment discontinuation in schizophrenia [ 11 ].…”

Section: Introductionmentioning

confidence: 99%

The Impact of Long-acting Paliperidone in Reducing Hospitalizations and Clinical Severity in Recent Onset Schizophrenia: A Mirror-image Study in Real-world Clinical Setting

Peitl

Margetić

Vidrih

et al. 2022

Clin Psychopharmacol Neurosci

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Objective: Schizophrenia is a debilitating disease that disrupts the lives of many affected individuals and exerts a toll on the health system. Only few studies assessed once-monthly injectable formulation of paliperidone palmitate (PP-1M) and other long-acting antipsychotics in recent onset schizophrenia (ROS). To evaluate whether PP-1M is efficacious in reducing frequency and length of hospitalizations and psychosis symptom severity in patients with ROS. Methods: This mirror-image study included 112 patients, suffering from ROS admitted in a psychiatric ward and successively treated with PP-1M for 1-year. Other psychotic disorders were excluded. We collected socio-demographic data of all subjects included, number and days of hospitalization, as well as Clinical Global Impression-Severity scale (CGI-S) and Clinician-Rated Dimensions of Psychosis Symptom Severity (CRDPSS) scores at the initiation and after 1-year of PP treatment. Results: After 1-year PP-1M treatment, mean scores of both CGI and CRDPSS significantly decreased (p ＜ 0.001), as well as the mean number of hospitalizations (p = 0.002) and total hospitalization days (p ＜ 0.001) in comparison with those of the previous year. Conclusion: Our results suggest that PP-1M can be considered as an important therapeutic option in patients with ROS. Its use led to a meaningful reduction in the patient's use of hospital services, as well as a significant clinical improvement of psychotic symptoms in our sample.

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“…5,6 In addition, evidence supported by neuroimaging suggests that the early use of LAI risperidone may improve clinical outcomes in patients with schizophrenia. [7][8][9][10] LAI antipsychotic treatments are underused. 11,12 Most clinical practice guidelines recommend the use of LAI antipsychotics only in patients who are noncompliant with oral therapy, have frequent recurrence of schizophrenic symptoms, or simply prefer this route of administration.…”

mentioning

confidence: 99%

“…The use of a long‐acting injectable (LAI) antipsychotic agent could increase compliance in patients with schizophrenia 5,6 . In addition, evidence supported by neuroimaging suggests that the early use of LAI risperidone may improve clinical outcomes in patients with schizophrenia 7–10 …”

mentioning

confidence: 99%

Population Pharmacokinetic Modeling and Simulation of TV‐46000: A Long‐Acting Injectable Formulation of Risperidone

Perlstein¹,

Wagner

Goméni³

et al. 2022

Clinical Pharm in Drug Dev

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TV‐46000 is a long‐acting subcutaneous antipsychotic that uses a novel copolymer drug delivery technology in combination with a well‐characterized molecule, risperidone, that is in clinical development as a treatment for schizophrenia. A population pharmacokinetic (PPK) modeling and simulation approach was implemented to identify TV‐46000 doses and dosing schedules for clinical development that would provide the best balance between clinical efficacy and safety. The PPK model was created by applying pharmacokinetic data from a phase 1 study of 97 patients with a diagnosis of schizophrenia or schizoaffective disorder who received either single or repeated doses of TV‐46000. The PPK model was used to characterize the complex release profile of the total active moiety (TAM; the sum of the risperidone and 9‐OH risperidone concentrations) concentration following subcutaneous injections of TV‐46000. The PK profile was best described by a double Weibull function of the in vivo release rate and by a 2‐compartment disposition and elimination model. Simulations were performed to determine TV‐46000 doses and dosing schedules that maintained a median profile of TAM concentrations similar to published TAM exposure following oral risperidone doses that have been correlated to a 40% to 80% dopamine‐D2 receptor occupancy therapeutic window. The simulations showed that therapeutic dose ranges for TV‐46000 are 50 to 125 mg for once‐monthly and 100 to 250 mg for the once every 2 months regimens. This PPK model provided a basis for prediction of patient‐specific exposure and dopamine‐D2 receptor occupancy estimates to support further clinical development and dose selection for the phase 3 studies.

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Second-generation LAI are associated to favorable outcome in a cohort of incident patients diagnosed with schizophrenia

Abstract: Even though the design does not allow inferences regarding causality, these population-based findings support the use of second generation LAI antipsychotics.

Cited by 16 publications

References 32 publications

Symptomatic and functional outcomes after treatment with paliperidone palmitate 3-month formulation for 52 weeks in patients with clinically stable schizophrenia

Symptomatic and functional outcomes after treatment with paliperidone palmitate 3-month formulation for 52 weeks in patients with clinically stable schizophrenia

The Impact of Long-acting Paliperidone in Reducing Hospitalizations and Clinical Severity in Recent Onset Schizophrenia: A Mirror-image Study in Real-world Clinical Setting

Population Pharmacokinetic Modeling and Simulation of TV‐46000: A Long‐Acting Injectable Formulation of Risperidone

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