Use of Paliperidone Palmitate Throughout a Schizoaffective Disorder Patient’s Gestation Period

Rodríguez, Fausto J.; Vega, C.; Hernández, María Rosa Sánchez-Waisen; Guisado, Juan A.; Leal, Francisco J. Vaz

doi:10.1055/s-0042-110492

Cited by 10 publications

(9 citation statements)

References 7 publications

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“…Two case reports of women in treatment with PP1M during pregnancy reported no congenital malformation and no perinatal complications of the newborns. 77 , 78 …”

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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“…Two case reports of women in treatment with PP1M during pregnancy reported no congenital malformation and no perinatal complications of the newborns. 77 , 78 …”

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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“…Finally, we added another article suggested by a peer reviewer that hadn’t appeared in our search [8]. The six articles were case reports referring to use of LAI antipsychotics during pregnancy.…”

Section: Discussionmentioning

confidence: 99%

“…One case used LAI risperidone [9], two cases LAI paliperidone [8, 10], one case LAI olanzapine [11], another used zuclopenthixol decanoate [12] and the last used LAI aripiprazole [13] but in this case, only the first month of pregnancy. None of the six published cases reported congenital malformations in children.…”

Section: Discussionmentioning

confidence: 99%

Use of long acting injectable aripiprazole before and through pregnancy in bipolar disorder: a case report

Ballester-Gracia

Perez-Almarcha

Hernández-Viadel

2019

BMC Pharmacol Toxicol

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Background Long-acting injectable (LAI) antipsychotics for psychotic disorders provide advantages in treatment compliance, but data on their use in pregnancy are very limited. We present a clinical case of aripiprazole LAI use in pregnancy. Case presentation A 43-year-old woman diagnosed with bipolar disorder, with several relapses due to treatment interruption while trying to conceive. Finally, aripiprazole LAI treatment was planned by mutual agreement between doctor and the patient, who took aripiprazole LAI before and during pregnancy. She gave birth at 40 weeks to a 3500 g baby girl with no congenital malformations, who was healthy at 5 months after delivery. Conclusion As far as we know, this is the first case report on aripiprazole LAI use during pregnancy. Although we exercise caution in drawing conclusions from a single case, and each case should be weighed up individually, aripiprazole LAI could be a therapeutic option in similar circumstances.

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“…Due to the extended dosing interval associated with PP3M, the likelihood of fetal exposure is increased when compared to other AP-dosage forms. Two case reports have been published detailing the use of PP1M during pregnancy 25,26. In both cases, PP1M appears to have been well tolerated, with no fetal or neonatal complications apparent at time of publication 25,26…”

Section: Special Populationsmentioning

confidence: 99%

<p>Role of paliperidone palmitate 3-monthly in the management of schizophrenia: insights from clinical practice</p>

López¹,

Rey²

2019

NDT

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Schizophrenia is a complex, chronic psychiatric disorder associated with reduced quality of life and shortened life span. The majority of patients with schizophrenia will relapse within 1 year following an acute episode. The ultimate goals of treatment are to improve functional capabilities, minimize residual symptoms during periods of remission, and decrease relapse frequency and duration, as each relapse brings with it the possibility of a worsening prognosis. Maintaining therapeutic continuity is essential for long-term, positive patient outcomes in schizophrenia. Medication nonadherence and symptomatic relapses magnify the disease burden associated with this disorder. Medication adherence in chronic disease states generally improves with a decrease in dosing frequency. Long-acting injectable (LAI) antipsychotics were developed to improve patient outcomes secondarily to improving medication adherence. Paliperidone palmitate 3-monthly injection (PP3M) is the only LAI available with a quarterly dosing interval. PP3M has been US Food and Drug Administration-approved for use in the long-term maintenance treatment of schizophrenia in patients already controlled on once-monthly PP LAI (paliperidone palmitate once-monthly injection [PP1M]) for a minimum of 4 months. As current evidence supports the efficacy and tolerability of PP3M compared to PP1M and placebo, PP3M appears to be a viable treatment option for patients previously maintained on PP1M. However, to truly establish the place of PP3M in therapy relative to other oral antipsychotics and LAIs, more research is needed. This narrative review aims briefly to describe the pharmacotherapeutic characteristics of PP3M and summarize current literature pertaining to the use of PP3M in the management of schizophrenia.

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Use of Paliperidone Palmitate Throughout a Schizoaffective Disorder Patient’s Gestation Period

Cited by 10 publications

References 7 publications

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

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

Use of long acting injectable aripiprazole before and through pregnancy in bipolar disorder: a case report

<p>Role of paliperidone palmitate 3-monthly in the management of schizophrenia: insights from clinical practice</p>

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