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

2021 ◽  
pp. 026988112110097
Author(s):  
Phoebe Wallman ◽  
Ivana Clark ◽  
David Taylor
Keyword(s):  
Clinical Practice ◽  
Treatment Duration ◽  
Maintenance Treatment ◽  
Clinical Care ◽  
Paliperidone Palmitate ◽  
Reduce Risk ◽  
Patient Refusal ◽  
Long Acting ◽  
Post Hoc

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

scholarly journals Impact of paliperidone palmitate one-month formulation on relapse prevention in patients with schizophrenia: A post-hoc analysis of a one-year, open-label study stratified by medication adherence

2018 ◽  
Vol 32 (6) ◽  
pp. 691-701 ◽  
Author(s):  
Tianmei Si ◽  
Nan Li ◽  
Huafei Lu ◽  
Shangli Cai ◽  
Jianmin Zhuo ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Hazard Ratio ◽  
Paliperidone Palmitate ◽  
Open Label ◽  
First Relapse ◽  
Continued Use ◽  
One Year ◽  
Long Acting ◽  
Post Hoc

Background: Limited data are available to help identify patients with schizophrenia who are most likely to benefit from long-acting injectable antipsychotics. Aim: To investigate the efficacy of long-acting injectable antipsychotic paliperidone palmitate one-month formulation for preventing relapses, factors influencing time to first relapse, and the effect of different antipsychotic adherence levels on time to first relapse in Chinese patients with schizophrenia. Methods: This was a post-hoc analysis from an open-label, single-arm study of stable patients (Positive and Negative Syndrome Scale total score <70; n=367) receiving paliperidone palmitate one-month formulation at the end of an acute 13-week treatment phase, who entered a naturalistic one-year follow-up period, either continuing with flexibly dosed paliperidone palmitate one-month formulation (75–150 mg eq.) or switching to another antipsychotic(s). Results: There were 362/367 patients (age=31.4±10.75 years) included in the analysis of time to first relapse (primary outcome) and 327/362 patients (39/327, poor antipsychotic adherence (<80%)) willing to receive antipsychotics were included in the exposure/adherence analysis. Overall, 84.6% (95% confidence interval=79.2–88.7) patients remained relapse-free. Poor adherence during follow-up (hazard ratio=2.97, 95% confidence interval=1.48–5.98, p=0.002) and frequent hospitalizations in the previous year (hazard ratio=1.29, 95% confidence interval=1.02–1.62, p=0.03) were associated with a significant risk of shorter time to first relapse in the univariate analysis. In patients with poor adherence, ‘no use’ (hazard ratio=13.13, 95% confidence interval=1.33–129.96, p=0.03) and ‘interrupted use’ (hazard ratio=11.04, 95% confidence interval=1.03–118.60, p=0.047) of paliperidone palmitate one-month formulation (vs continued use) showed a significantly higher risk of relapse; this was not observed in patients with good (≥80%) antipsychotic adherence. No new safety concerns were identified. Conclusion: Continued use of paliperidone palmitate one-month formulation/long-acting injectable antipsychotic was effective in preventing schizophrenia relapses, especially in patients with suboptimal antipsychotic adherence.

Paliperidone palmitate long-acting injection - prospective year-long follow-up of use in clinical practice

2013 ◽  
Vol 130 (1) ◽  
pp. 46-51 ◽  
Author(s):  
A. Attard ◽  
O. Olofinjana ◽  
V. Cornelius ◽  
V. Curtis ◽  
D. Taylor
Keyword(s):  
Clinical Practice ◽  
Paliperidone Palmitate ◽  
Long Acting

scholarly journals Is the use of two versus one long-acting bronchodilator by patients with COPD associated with a higher risk of acute coronary syndrome in real-world clinical practice?

2021 ◽  
Vol 8 (1) ◽  
pp. e000840
Author(s):  
Lianne Parkin ◽  
Sheila Williams ◽  
David Barson ◽  
Katrina Sharples ◽  
Simon Horsburgh ◽  
...  
Keyword(s):  
Acute Coronary Syndrome ◽  
Clinical Practice ◽  
Real World ◽  
Chronic Obstructive ◽  
Treatment Intensification ◽  
Cardiovascular Comorbidity ◽  
Coronary Syndrome ◽  
Long Acting ◽  
The Impact

BackgroundCardiovascular comorbidity is common among patients with chronic obstructive pulmonary disease (COPD) and there is concern that long-acting bronchodilators (long-acting muscarinic antagonists (LAMAs) and long-acting beta2 agonists (LABAs)) may further increase the risk of acute coronary events. Information about the impact of treatment intensification on acute coronary syndrome (ACS) risk in real-world settings is limited. We undertook a nationwide nested case–control study to estimate the risk of ACS in users of both a LAMA and a LABA relative to users of a LAMA.MethodsWe used routinely collected national health and pharmaceutical dispensing data to establish a cohort of patients aged >45 years who initiated long-acting bronchodilator therapy for COPD between 1 February 2006 and 30 December 2013. Fatal and non-fatal ACS events during follow-up were identified using hospital discharge and mortality records. For each case we used risk set sampling to randomly select up to 10 controls, matched by date of birth, sex, date of cohort entry (first LAMA and/or LABA dispensing), and COPD severity.ResultsFrom the cohort (n=83 417), we identified 5399 ACS cases during 281 292 person-years of follow-up. Compared with current use of LAMA therapy, current use of LAMA and LABA dual therapy was associated with a higher risk of ACS (OR 1.28 (95% CI 1.13 to 1.44)). The OR in an analysis restricted to fatal cases was 1.46 (95% CI 1.12 to 1.91).ConclusionIn real-world clinical practice, use of two versus one long-acting bronchodilator by people with COPD is associated with a higher risk of ACS.

Discontinuation, read missions and polytherapy with long-acting antipsychotics: An observational study

2016 ◽  
Vol 33 (S1) ◽  
pp. S540-S540
Author(s):  
I. García Cabeza ◽  
P. Pérez Marín ◽  
H. De Diego
Keyword(s):  
Observational Study ◽  
First Generation ◽  
Paliperidone Palmitate ◽  
Categorical Variables ◽  
Anticholinergic Drugs ◽  
Psychoactive Drugs ◽  
Oral Medications ◽  
Competing Interest ◽  
Long Acting

Introduction and aimLong-acting antipsychotics (LAIs) provide certain advantages over oral medications. The aim of our study is to determine whether there are differences between the various long-acting injectable antipsychotics available in our environment.MethodsA retrospective observational study with psychotic patients discharged with LAIs was designed. Data on discontinuation, relapses and associated drugs in the discharge and in a year follow-up were collected. Fifty-seven patients were included: 21 risperidone (RLAI), 20 paliperidone palmitate (PP) and 16 first-generation LAIs (FG). Odds ratio was used to compare discontinuation, χ2 test for categorical variables and Kruskal-Wallis test for independent samples.ResultsDiscontinuation was lower with PP: ORRLAI/PP = 2.74 and ORFGLAI/PP = 3.09. There were significant differences in readmissions: rehospitalizations (χ2 = 7.072, P = 0.029) and days of stay (χ2 = 8.251; P = 0.016), both lower in the PP group. We found less use of psychoactive drugs with PP, with significant differences in the discharge (χ2 = 11.518; P = 0.003) and in the follow-up (χ2 = 7.097; P = 0.029). There were also significant differences in the use of oral antipsychotics in the discharge (χ2 = 27.049, P = 0.000); anticholinergic drugs in the discharge (χ2 = 7.001, P = 0.03) and in the follow-up (χ2 = 11.699, P = 0.003) and benzodiazepines in the follow-up (χ2 = 8.493, P = 0.014), always lower in the group of patients treated with PP.ConclusionsTreatment with paliperidone palmitate may be more suitable than other long acting antipsychotics when it starts during the acute episode.Disclosure of interestThe authors have not supplied their declaration of competing interest.

scholarly journals Changes in attitude towards LAI antipsychotic maintenance treatment: A two-year follow-up study

2018 ◽  
Vol 53 ◽  
pp. 58-65 ◽  
Author(s):  
Francesco Pietrini ◽  
Giulio D’Anna ◽  
Lorenzo Tatini ◽  
Gabriela Alina Talamba ◽  
Costanza Andrisano ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Maintenance Treatment ◽  
Subjective Experience ◽  
Open Label ◽  
Sf 36 ◽  
Patient Reported ◽  
Long Acting ◽  
Prospective Longitudinal

AbstractBackground:To present real-world evidence on the effects of switching from oral to long-acting injectable (LAI) antipsychotic maintenance treatment (AMT) in a sample of clinically stable patients with schizophrenia, with regard to subjective experience of treatment, attitude towards drug and quality of life.Methods:50 clinically stable adult schizophrenic outpatients were recruited. At the time of enrolment (T0), all patients were under a stabilized therapy with a single oral second-generation antipsychotic (SGA) and were switched to the equivalent maintenance regimen with the long-acting formulation of the same antipsychotic. 43 patients completed the 24-month prospective, longitudinal, open-label, observational study. Participants were assessed at baseline (T0), after 12 (T1) and 24 months (T2), using psychometric scales (PANSS, YMRS and MDRS) and patient-reported outcome measures (SWN-K, DAI-10 and SF-36).Results:The switch to LAI-AMT was associated with a significant clinical improvement at T1 and T2 compared to baseline (T0). All of the psychometric indexes, as well as patients’ subjective experience of treatment (SWN-K), and quality of life (SF-36) showed a significant improvement after one year of LAI-AMT, with stable results after two years. Patients’ attitude towards drug (DAI-10) increased throughout the follow-up period, with a further improvement during the second year.Conclusions:The switch to LAI-AMT may help to address the subjective core of an optimal recovery in stabilized schizophrenic patients. A sustained improvement in patients’ attitude towards drug may help to achieve patient’s compliance. The size of this study needs to be expanded to produce more solid and generalizable results.

scholarly journals Paliperidone 3-Month Injection for Treatment of Schizophrenia: A Narrative Review

2021 ◽  
Vol 12 ◽  
Author(s):  
Amber N. Edinoff ◽  
Prithvi K. Doppalapudi ◽  
Claudia Orellana ◽  
Caroline Ochoa ◽  
Shelby Patti ◽  
...  
Keyword(s):  
Dose Interval ◽  
Paliperidone Palmitate ◽  
Critical Determinant ◽  
Once Daily ◽  
Schizophrenic Patients ◽  
Long Acting ◽  
Post Hoc ◽  
Antipsychotic Drug Treatment ◽  
Economic And Social Impacts ◽  
Risk Of Relapse

Given the typical age onset of schizophrenia, there are tremendous economic and social impacts that extend beyond the person and their families. One critical determinant of the diseases' impact is the patient's adherence to antipsychotic drug treatment. Approved in 2015 for the treatment of schizophrenia, paliperidone palmitate (Invega Trinza, a 3-month injection, noted as PP3M) is a second-generation long-acting injectable antipsychotic medication. Among the different formulations offered for palmitate paliperidone, including the 1 and 3-month formulations, the longer duration 3-month formulation was better at preventing relapse in schizophrenic patients. To date, different formulations of palmitate paliperidone that have been studied on relapse episodes of schizophrenia include once-daily extended-release oral paliperidone (ORAL paliperidone), once-monthly paliperidone palmitate (PP1M), and once-every-3-months paliperidone palmitate (PP3M). Post-hoc analyses show that patients who were withdrawn from PP1M paliperidone had the least risk of relapse, followed by patients withdrawn from PP3M and patients withdrawn from ORAL paliperidone. PP3M was better at preventing relapse compared to ORAL paliperidone. The results demonstrated that 50% of patients who were withdrawn from ORAL paliperidone, PP1M, or PP3M remained relapse-free for ~2, 6, and 13 months, respectively. Compared to PP1M, PP3M is just as safe and effective and has the added advantage of increased adherence related to a longer dose interval, decreasing the risk of relapse.

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

2020 ◽  
Vol 10 ◽  
pp. 204512532092634 ◽  
Author(s):  
Maria Paz Garcia-Portilla ◽  
Pierre-Michel Llorca ◽  
Giuseppe Maina ◽  
Vasilis P. Bozikas ◽  
Halise Devrimci-Ozguven ◽  
...  
Keyword(s):  
Treatment Period ◽  
Maintenance Treatment ◽  
Randomized Clinical Trials ◽  
Social Performance ◽  
Paliperidone Palmitate ◽  
Antipsychotic Treatment ◽  
Open Label ◽  
Open Label Phase ◽  
Symptomatic Remission ◽  
Long Acting

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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