- |||||||||| Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
Clinical, Journal: Impact on carer burden when stable patients with schizophrenia transitioned from 1-monthly to 3-monthly paliperidone palmitate. (Pubmed Central) - May 21, 2021
The results of this study add to the increasing body of evidence supporting the benefits of PP3M in a population of patients with schizophrenia representative of real-world clinical practice. Reducing the frequency of antipsychotic medication administration in stable patients with schizophrenia by switching from PP1M to PP3M may reduce carer burden.
- |||||||||| Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
[VIRTUAL] Acute Pulmonary Embolism Associated With Paliperidone Palmitate in a Young Patient With Few Other Risk Factors: A Case Report () - May 2, 2021 - Abstract #APA2021APA_491;
Paliperidone palmitate was discontinued and his psychosis was instead addressed with aripiprazole. This case report aims to highlight the need for larger studies of the risk of VTE in patients taking antipsychotics, alerting patients of associated VTE risk when providing informed consent, identification of patients who may benefit from antithrombotic prophylaxis during antipsychotic initiation, and stratification of preferred antipsychotics in patients who are at risk of decompensation if they are off psychotropics.
- |||||||||| Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
[VIRTUAL] Adolescents and dual pathology. Assessment of treatment with paliperidona palmitato long-term injectables. (e-Poster Gallery) - Apr 26, 2021 - Abstract #EPA2021EPA_1474;
Determine the consumption of toxins after treatment. Methods Sample: Adolescents, 14-17 years old, with a diagnosis of Personality Limit T and cocaine consumption who start treatment with Paliperidone Palmitate LD IM (50-100mg / month) in monotherapy, with Diazepam 5mg if significant anxiety...A decrease in the consumption of toxins was observed in 65% of the cases. Conclusions In our experience, the management of toxic consumption in adolescent population with severe impulsivity symptoms has great limitations due to the scarce resources available. The Palpitate of Paliperidone long-term treatment has been useful in the approach of serious registered cases, being associated with symptomatic improvement and decrease in consumption.
- |||||||||| Abilify Maintena (aripiprazole depot formulation) / Otsuka, Lundbeck, Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
[VIRTUAL] Assessment of hospitalizations in schizophrenia patients treated with Paliperidone 1-monthly (PP1M), Paliperidone 3-monthly (PP3M), Aripiprazole once-monthly (AOM) and other oral antipsychotics (OAP) in clinical practice. (e-Poster Gallery) - Apr 26, 2021 - Abstract #EPA2021EPA_965;
However, limited real world evidence is available as to whether there are differences among the various formulations marketed. Objectives This study aims to assess the impact on several prognosis variables of PP1M,PP3M,AOM and OAP drugs. Methods All adults (≥18 years) with schizophrenia who were initiated on PP1M, PP3M, AOM, or OAP treatment (chlorpromazine,levomepromazine,fluphenazine,haloperidol,ziprasidone,zuclopenthixol,olanzapine,quetiapine,asenapine,amisulpride, risperidone,aripiprazole,paliperidone) between 2017 and 2018 were identified in IQVIA’s database(1.8M of inhabitants from 4 Spanish areas)...01) for PP3M (23%) than for PP1M (36.9%), OAP (43.5%),and AOM (46.2%). Persistence rates were higher for PP3M (91%) than for any other treatment (p<0.01). Conclusions Our results outline that patients treated with PP3M experienced fewer relapses and decompensations compared to all other treatments analyzed, which might help improve the prognosis and quality of life of patients.
- |||||||||| Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
[VIRTUAL] Projecting the Economic Outcomes of Switching Patients with Schizophrenia from Oral Atypical Antipsychotics to Once-Monthly Paliperidone Palmitate and Once-Every-Three-Months Paliperidone Palmitate () - Apr 12, 2021 - Abstract #ISPOR2021ISPOR_1019;
Trends were similar among young adults: switching 5% of patients saved $1,002, $1,885, and $1,759 PPS for years 1, 2, 3; at the plan-level, $0.9M was saved and 205 relapses were avoided after 3 years. CONCLUSIONS Switching from OAAs to PP1M and PP3M is associated with substantial cost savings and reduced relapse rates in both nonadherent recently relapsed and young adult patients with schizophrenia.
- |||||||||| Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
[VIRTUAL] The Systematic Analysis of Psychiatric Outcomes in Patients Converted from 1-month to 3-month Paliperidone Palmitate Long-Acting Injections () - Apr 4, 2021 - Abstract #CPNP2021CPNP_237;
Patients are considered non-adherent if a subsequent dose was administered within greater than four months since previous dose. Outcomes: We will report the number and percentages of subjects with worsened/improved adherence, hospitalizations, and efficacy in patients converted from PP1M to PP3M as a function of demographic characteristics, MHICM/ALF enrollment, dual anti-psychotic treatment, and indication for conversion to PP3M.
- |||||||||| Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
[VIRTUAL] Treatment of Schizophrenic Patients with Once-Every-3- Months Paliperidone Palmitate Injectable () - Mar 7, 2021 - Abstract #CINP2021CINP_176;
The psychiatric symptoms 0f the patients were adequately managed by medications. PP3m has the potential to improve drug adherence and lead to better prognoses as the patients only need 4 intramuscular doses per year.
- |||||||||| Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
[VIRTUAL] Seasonal Antipsychotic in Schizophrenia - Outcomes in Naturalistic Settings in Canada (SEASONS): Real-Life Results of the Switch from 1-Month Paliperidone to 3-Month Paliperidone Long Acting Injectable Formulation () - Mar 1, 2021 - Abstract #SIRS2021SIRS_281;
In 2016, a 3-monthly LAI formulation of paliperidone palmitate (Invega Trinza®) was introduced as a new therapeutic tool for schizophrenia treatment...In regard to previous antipsychotic treatment, patients had been receiving Invega Sustenna® for 2.3 years on average and only initial Invega Trinza® mean dose differed between those who relapsed and those who did not (430mg vs 381mg, p = .013)...While adequate compliance to Invega Trinza® treatment was thoroughly documented in the present study, adherence to other pharmacological and non-pharmacological treatments, such as psychotherapy, was not. Although other components of this study are still ongoing, results available so far highlight the importance of considering population characteristics included in RCTs before generalizing findings to real-life clinical settings.
- |||||||||| Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
[VIRTUAL] Seasonal Antipsychotic in Schizophrenia - Outcomes in Naturalistic Settings in Canada (SEASONS): Real-Life Results of the Switch from 1-Month Paliperidone to 3-Month Paliperidone Long Acting Injectable Formulation () - Mar 1, 2021 - Abstract #SIRS2021SIRS_109;
In 2016, a 3-monthly LAI formulation of paliperidone palmitate (Invega Trinza®) was introduced as a new therapeutic tool for schizophrenia treatment...In regard to previous antipsychotic treatment, patients had been receiving Invega Sustenna® for 2.3 years on average and only initial Invega Trinza® mean dose differed between those who relapsed and those who did not (430mg vs 381mg, p = .013)...While adequate compliance to Invega Trinza® treatment was thoroughly documented in the present study, adherence to other pharmacological and non-pharmacological treatments, such as psychotherapy, was not. Although other components of this study are still ongoing, results available so far highlight the importance of considering population characteristics included in RCTs before generalizing findings to real-life clinical settings.
- |||||||||| Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
Clinical, Retrospective data, Journal: Defining "Adequately Treated": A Post Hoc Analysis Examining Characteristics of Patients with Schizophrenia Successfully Transitioned from Once-Monthly Paliperidone Palmitate to Once-Every-3-Months Paliperidone Palmitate. (Pubmed Central) - Jan 15, 2021
P3
After 4 months' PP1M treatment, PANSS and CGI-S scores were significantly lower and PSP scores significantly higher in randomized patients versus non-randomized patients (least squares means [95% CI]: 57.1 [55.7, 58.6] vs 62.2 [60.0, 64.3], 2.9 [2.8, 3.1] vs 3.3 [3.1, 3.4], and 67.0 [65.7, 68.3] vs 64.5 [62.6, 66.4], respectively); changes from baseline between groups differed significantly (all P ≤0.009). Confirming adequate stabilization with PP1M prior to transitioning to PP3M is critical in maximizing treatment response; clinicians should consider transitioning patients to PP3M only if patients respond well to PP1M for at least 4 months and their last two consecutive doses are the same.
- |||||||||| Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
Journal: Switching from clozapine to paliperidone palmitate-3-monthly improved obesity, hyperglycemia and dyslipidemia lowering antipsychotic dose equivalents in a treatment-resistant schizophrenia cohort. (Pubmed Central) - Jan 15, 2021
In the last decade, new antipsychotics, such as paliperidone palmitate (PP), have emerged as well as its long acting-injectable (LAI) formulations, available as PP-1-monthly (PP1M) and the newest PP-3-montlhy (PP3M)...Antipsychotics and benzodiazepines dosages were compared using by the defined daily dose (DDD) method and haloperidol or diazepam dose equivalents...Switching clozapine to PP3M led to a significant lower pharmacological exposure to antipsychotics, by both the DDD (P < 0.05) and haloperidol dose equivalents (P < 0.001) methods without increasing the dose of benzodiazepines while biperiden was more used under PP3M...In conclusion, our findings suggest that switching clozapine to PP3M improved endocrine and hepatic profile with a lower total exposure to antipsychotics. More studies are needed to truly establish the role of PP3M in treatment-resistant schizophrenia and should be compared against clozapine by using clinical trials.
- |||||||||| Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
Journal, Interview: "I live, I don't work, but I live a very normal life"-A qualitative interview study of Scandinavian user experiences of schizophrenia, antipsychotic medication, and personal recovery processes. (Pubmed Central) - Dec 3, 2020
Analysis will include descriptive and statistical data on the clinical impact of PPM1 administration site and the incidence of psychiatric decompensation. The participants emphasize the importance of trustful relations with healthcare professionals, therapeutic conversations, antipsychotic medication in a 3-monthly formulation, and support from relatives.
- |||||||||| Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
Reimbursement, Journal, HEOR, Medicaid: Projecting the Long-Term Economic Impact of Once-Monthly Paliperidone Palmitate Versus Oral Atypical Antipsychotics in Medicaid Patients with Schizophrenia. (Pubmed Central) - Nov 7, 2020
The participants emphasize the importance of trustful relations with healthcare professionals, therapeutic conversations, antipsychotic medication in a 3-monthly formulation, and support from relatives. Pharmacy costs associated with switching nonadherent OAA patients with a recent relapse to PP1M were offset by reduced relapse rates and health care costs at years 1, 2, and 3, with earlier use of PP1M resulting in increased cost savings at all years.
- |||||||||| Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
Clinical, PK/PD data, Journal: Need for Bioequivalence Standards that Reflect the Clinical Importance of the Complex Pharmacokinetics of Paliperidone Palmitate Long-Acting Injectable Suspension. (Pubmed Central) - Aug 11, 2020
We recommend that new Canadian standards be developed for multiphasic and biphasic intramuscular / subcutaneous (IM/SC) products, including paliperidone palmitate LAI products, because, similar to modified-release oral dosage forms, a different PK profile in modified-release IM/SC products can result in clinically meaningful differences in safety, efficacy, and tolerability. To ensure bioequivalence for both newly initiated and switch patients, this paper proposes bioequivalence standards that could be adopted in Canada that include two studies, a multiple-dose cross-over study, and a single-dose study with partial AUC metrics.
- |||||||||| risperidone / Generic mfg., Egis, olanzapine / Generic mfg., clozapine / Generic mfg.
[VIRTUAL] One plus one sometimes equals more than two: long-acting injectable aripiprazole adjunction in clozapine-resistant schizophrenia (Poster Area) - Aug 5, 2020 - Abstract #ECNP2020ECNP_914;
but PANSS total score was 108; therefore, we added paliperidone palmitate LAI 100 mg/month i.m. Nevertheless, in addition to new-onset side effects, his positive symptoms did not improve despite being treated with olanzapine 20 mg/d p.o. and paliperidone palmitate LAI 100 mg/month for three months...with exacerbations or persistence of positive symptoms, which are no longer effectively treated with the initial dose of antipsychotic drugs. This model could explain both treatment-resistant schizophrenia and clozapine resistance.
- |||||||||| risperidone / Generic mfg., Egis, Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
[VIRTUAL] Paliperidone palmitate long-acting formulations in recent-onset psychosis: a retrospective, non-interventional study (Poster Area) - Aug 5, 2020 - Abstract #ECNP2020ECNP_895;
Patients receiving 1-monthly and 3-monthly paliperidone palmitate formulations obtained greater improvements compared to the oral treatment group in main domains evaluated in the PANSS, general improvement in the PSP scale, and in overall CGI-I and CGI-S scales (p<0.001)...As previously mentioned, oral paliperidone or risperidone and paliperidone palmitate long-acting formulations were generally well tolerated. At final assessment, significant reductions were observed in the main clinical scales assessed, maintaining psychopathological stability throughout the 12-month evaluation for all groups, where an improvement in general psychosocial and global functioning was observed.
- |||||||||| Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
[VIRTUAL] Comparison of possible safety risks on clinical trials between PP3M and PP1M (Poster Area) - Aug 5, 2020 - Abstract #ECNP2020ECNP_890;
In the clinical trials, PP3M was required to be switched from PP1M after more than 4 months treatment and stabilized. Therefore, the incident rate of TEAEs of PP3M was same to lower compared to PP1M, and no new safety risks for PP3M were identified.
- |||||||||| Abilify Maintena (aripiprazole depot formulation) / Otsuka, Lundbeck, Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
[VIRTUAL] From one-month to three-month paliperidone palmitate: an Italian real-world, retrospective, one-year mirror image study (Poster Area) - Aug 5, 2020 - Abstract #ECNP2020ECNP_797;
Introduction A 3-months formulation of paliperidone palmitate injections (PP3M) was marketed in Italy in 2017, providing a useful treatment option for schizophrenic patients clinically stable with 1-month formulation (PP1M) [1]...Fifty per cent of the whole sample (53% of PP1Mp, 44% of PP3Mp) was already on a LAI prior to PP; 23% of the whole sample (24% of PP1Mp, 19% of PP3Mp) had been previously treated with Haloperidol depot, 11% (9% of PP1Mp, 13% of PP3Mp) with Fluphenazine depot, 10% (12% of PP1Mp, 6% of PP3Mp) with Risperidone depot, 8% (9% of PP1Mp, 6% of PP3Mp) with Zuclopenthixol depot, 2% (3% of PP1Mp and no PP3Mp) with Aripiprazole depot...Conclusions In the present sample PP3M efficacy was confirmed comparing pre-initiation and post-initiation 6-months time intervals: hospitalizations number significantly decreased, while the continuity of care was preserved. Studies about longer durations of therapy are necessary to support these preliminary data.
- |||||||||| Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
Clinical, Retrospective data, Journal: Comparison of Relapse Prevention with 3 Different Paliperidone Formulations in Patients with Schizophrenia Continuing versus Discontinuing Active Antipsychotic Treatment: A Post-Hoc Analysis of 3 Similarly Designed Randomized Studies. (Pubmed Central) - Jul 3, 2020
P3
Hazard ratios (HR) of the three paliperidone formulations relative to their respective placebos were PP3M ([HR: 3.81; 95% CI: 2.08, 6.99; P PP1M [HR: 3.60; 95% CI: 2.45, 5.28; P paliperidone ER [HR: 2.83; 95% CI: 1.73, 4.63; P<0.001]). The lower percentage of relapse during active treatment and longer time to relapse after discontinuing active treatment with longer-duration antipsychotic formulations suggests the benefit of longer-acting over shorter-acting formulations, especially in patients susceptible to poor adherence.Clinical trial registration: paliperidone ER (NCT00086320), PP1M (NCT00111189), and PP3M (NCT01529515).
- |||||||||| Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Hafyera (paliperidone palmitate extended-release 6-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
Trial completion, Trial completion date: A Study of Paliperidone Palmitate 6-Month Formulation (clinicaltrials.gov) - Jun 17, 2020
P3, N=841, Completed,
All-cause medical cost reduction fully offset increased pharmacy costs among VHA patients with schizophrenia who transitioned from PP1M to PP3M. Active, not recruiting --> Completed | Trial completion date: Aug 2020 --> May 2020
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