Practical guidance for dosing and switching from paliperidone palmitate 1 monthly to 3 monthly formulation in schizophrenia

Gopal, Srihari; Vermeulen, An; Nandy, Partha; Ravenstijn, Paulien; Nuamah, Isaac; Vidal, José Antonio Buron; Berwaerts, Joris; Savitz, Adam; Hough, David; Samtani, Mahesh N.

doi:10.1185/03007995.2015.1085849

Cited by 27 publications

(47 citation statements)

References 29 publications

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“…The first paper reported the results of a Phase 1, single dose, randomized, open label study conducted to investigate the PK, safety, and tolerability of PP-3M in patients with schizophrenia, 25 the second paper focused on the efficacy and safety of PP-3M emerging from a four phase RCT 26 ( Table 1 ), whilst the third related to practical issues implicated in the dosing and switching from PP-1M to PP-3M. 27 Of the five posters retrieved, two 28 , 29 reported data from the randomized clinical trials more extensively described in a paper by Berwaerts et al; 26 the others 30 – 32 reported data more extensively described in a paper by Ravenstijn et al 25 For the purpose of the present review, the main findings relating to the formulation, pharmacodynamics and PK, safety, tolerability, and efficacy of PP-3M will be described, followed by the presentation of practical issues encountered while using this new formulation. The review will conclude with considerations of the position occupied by PPM-3M in the current therapeutic scenario.…”

Section: Resultsmentioning

confidence: 99%

“…Based on published studies, Gopal et al 27 have provided guidance for the practical use of PP-3M. In particular, switching to PP-3M is only recommended in patients who have previously been treated with PP-1M for at least 4 months; the first injection should be given at the time of the first scheduled administration of PP-1M, with a dosing window of ±1 week.…”

Section: Practical Issues For Dosing and Switchingmentioning

confidence: 99%

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Critical appraisal of 3-monthly paliperidone depot injections in the treatment of schizophrenia

Carpiniello¹,

Pinna²

2016

DDDT

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AimsThree-monthly injections of paliperidone palmitate (PP-3M) represent a new and recently introduced long-acting antipsychotic therapeutic option. This review focuses on available data relating to the efficacy and safety of PP-3M and its position in the current therapeutic scenario.MethodAn analysis of PubMed, Scopus, and ISI Web of Knowledge databases was conducted, and all available papers on PP-3M, including poster presentations, were selected and considered for the purpose of the present review. Findings: to date, three full papers have been published, the first, a Phase 1 randomized, open label study investigating the pharmacokinetics, safety, and tolerability of the drug; the second, a Phase 3 double blind study vs placebo focusing on efficacy and tolerability; and the last relating to the practical use of PP-3M. The five posters identified describe data reported in the above-cited papers. Overall, the pharmacokinetic findings obtained in these studies highlight the feasibility of administering PP-3M on a 3-monthly basis, subsequent to the administration of four 1-monthly injections of PP at doses 3.5 times higher than the stabilized dose of 1-monthly injections of PP (ie, 175, 300, 450, and 525 mgs). The published studies highlight a significantly longer time to relapse compared to placebo, and significantly better results compared to placebo for all secondary end-points (Positive and Negative Syndrome Scale, Clinical Global Impression-Severity Scale, Personal and Social Performance Scale scores), in addition to reasonably good safety and tolerability profiles.ConclusionPP-3M emerges as a potential candidate for use as a first-line long-acting agent in the maintenance treatment of patients with schizophrenia. Further studies should however be conducted to confirm this expectation. In view of its efficacy, tolerability, and safety, together with the longer timespan between injections, PP-3M currently represents one of the best available options, and may contribute towards addressing the issue of poor adherence, even in early psychosis.

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Section: Resultsmentioning

confidence: 99%

Section: Practical Issues For Dosing and Switchingmentioning

confidence: 99%

Critical appraisal of 3-monthly paliperidone depot injections in the treatment of schizophrenia

Carpiniello¹,

Pinna²

2016

DDDT

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“…These tiny drug crystals are dispersed in an aqueous suspension (nanosuspensions), which is the LAI formulation of PP. 72 The PP3M formulation utilizes Nano-Crystal technology similar to the PP1M but with increased particle size, allowing an extended sustained release. 59 These nanoparticles dissolve slowly after intramuscular (IM) injection before being hydrolyzed to paliperidone by the esterases present in muscle tissue.…”

Section: Discussionmentioning

confidence: 99%

“…Then paliperidone diffuses into the systemic circulation. 72 , 73 PP3M is available in dose strengths of 273, 410, 546 and 819 mg paliperidone palmitate that undergo hydrolysis, resulting in dose strengths of 175, 263, 350 and 525 mg of paliperidone, respectively. 72 …”

Section: Discussionmentioning

confidence: 99%

Role of 3-monthly long-acting injectable paliperidone in the maintenance of schizophrenia

Brasso¹,

Bellino²,

Bozzatello³

et al. 2017

NDT

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AimsPaliperidone palmitate 3-month (PP3M) represents a new long-acting injectable antipsychotic therapeutic option. This review aims: 1) to summarize available data relating to efficacy, safety, tolerability and costs of PP3M; 2) to describe hospitalization rate, occupational status, treatment preference, satisfaction, adherence and caregiver burden of patients with schizophrenia who participate in PP3M clinical trials; 3) to examine ethical implications, pros and cons of PP3M use and 4) to propose study designs to further assess PP3M.MethodsOn August 21, 2017, a search on PubMed about PPM3, without any filter restriction, was conducted and all available records were analyzed. Records written in a language other than English were excluded.ResultsTwenty-two records were included in this review: 6 reviews, 1 report, 4 pharmacokinetic studies, 2 cost-effectiveness analyses, 1 open-label clinical trial, 2 randomized controlled trials (RCTs), 5 studies based on these 2 RCTs and 1 observational study.DiscussionAccording to these last 9 studies, when compared with placebo, PP3M showed a longer time to relapse and good safety and tolerability profiles. Furthermore, when compared with paliperidone palmitate 1 month (PP1M), PP3M treatment showed: 1) non-inferiority in terms of efficacy, safety, tolerability, rate of hospitalization, symptomatic and functional remission, treatment preference and variations of the occupational status; 2) a longer time to relapse after treatment discontinuation and 3) a similar reduction of the caregiver burden.ConclusionPP3M is the only 3-monthly long-acting injectable antipsychotic available on the market. This makes it a unique option of treatment, which could be chosen both in early and advanced phases of illness. Nonetheless, longer naturalistic follow-up studies, two-arm head-to-head superiority trials and mirror studies, based on real-world samples of patients, are needed to further assess long-term safety and advantages of this new option of treatment and to define patients’ sub-populations that would most beneficiate from it.

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“…Intention-to treat analyses were used, where appropriate. Equivalent doses were determined through published tables of chlorpromazine equivalents (Andreasen et al, 2010), or in the case of paliperidone 3-monthly through published guidelines (Gopal et al, 2015).…”

Section: A C C E P T E D Accepted Manuscriptmentioning

confidence: 99%

Does the frequency of administration of long acting injectable antipsychotics impact psychiatric outcomes and adverse effects: A systematic review and meta-analysis

Ting

Kamalvand

Shang

et al. 2019

Journal of Psychiatric Research

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words)Dosing regimens for depot antipsychotics range from two-to twelve-weekly administration.There are limited meta-analytic data regarding the effect of different injection frequencies of the same depot antipsychotic at the equivalent dose on psychiatric outcomes and adverse effects. This study investigated differences in psychiatric outcomes and adverse effects between different frequencies of depot antipsychotics through a systematic review and metaanalysis. We performed a systematic search of MEDLINE, EMBASE, Cochrane database, PsycINFO and two Chinese databases for RCTs that compared the frequency of depot antipsychotic administration. The primary outcome was psychiatric symptomatology, with secondary outcomes of quality of life, admission rates, adverse drug reactions, costeffectiveness and compliance. Twelve studies were included in the meta-analysis. Most studies compared two-and four-weekly injections (n = 10). Different injection frequencies did not lead to differences in clinical outcomes or adverse events. However, two-weekly injections led to significantly greater improvements on the CGI-S scale than four-weekly administration. A sensitivity analysis by removing low quality studies showed lower incidence of somnolence and injection site pain for 2-weekly compared with 4-weekly injections. There were limited data on admission rates and no RCT data on cost-effectiveness or compliance. While there is limited evidence on secondary measures to support 2-weekly over 4-weekly injections, patient choice and convenience should remain the priority when considering certain antipsychotics. Cost-effectiveness and adherence should also be considered, although further studies are required to further evaluate these parameters.

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Practical guidance for dosing and switching from paliperidone palmitate 1 monthly to 3 monthly formulation in schizophrenia

Abstract: ClinicalTrials.gov identifier: NCT01559272 and NCT01529515.

Cited by 27 publications

References 29 publications

Critical appraisal of 3-monthly paliperidone depot injections in the treatment of schizophrenia

Critical appraisal of 3-monthly paliperidone depot injections in the treatment of schizophrenia

Role of 3-monthly long-acting injectable paliperidone in the maintenance of schizophrenia

Does the frequency of administration of long acting injectable antipsychotics impact psychiatric outcomes and adverse effects: A systematic review and meta-analysis

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