An assessment of injection site reaction and injection site pain of 1-month and 3-month long-acting injectable formulations of paliperidone palmitate

Sliwa, Jennifer Kern; Savitz, Adam; Nuamah, Isaac; Mathews, Maju; Gopal, Srihari; Elefant, Erica; Najarian, Dean; Alphs, Larry

doi:10.1111/ppc.12267

Cited by 12 publications

(26 citation statements)

References 12 publications

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“…Low visual analog scale scores suggested mild injection-site pain and reduction from DB baseline to endpoint without notable differences between PP3M (Mean [SD]=19.5 [20.7] to 15.6 [17.9]) and PP1M (18.4 [20.4] to 15.5 [18.3]). Severity of injection-site induration, redness, and swelling were mild, with low frequency in both treatment groups, without any significant influence of the formulation difference 70. Overall, the safety profile of PP3M in the global patient population was consistent with findings in the East Asian, 71 European, and Latin American sub-groups, suggesting an absence of regional or ethnic influences.…”

Section: Efficacy and Outcomes For Pp3m Treatment In Schizophreniasupporting

confidence: 57%

<p>Clinical relevance of paliperidone palmitate 3-monthly in treating schizophrenia</p>

Mathews¹,

Gopal²,

Nuamah³

et al. 2019

NDT

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Antipsychotics are the mainstay in schizophrenia management, and long-acting injectable (LAI) antipsychotics contribute to the successful maintenance of treatment by improving non-adherence and preventing relapses. Paliperidone palmitate 3-monthly (PP3M) formulation is the only available LAI antipsychotic that offers an extended 3-month window of stable plasma drug concentration, enabling only four injections per year. This paper summarizes clinically relevant endpoints from available evidence for PP3M to bridge translational research gaps and provide measurable outcomes that can be interpreted in clinical practice. Low number-needed-to-treat (NNT) for relapse prevention (NNT [95% CI] 6-month estimate: 4.8 [3.2; 10.0]; 12-month estimate: 3.4 [2.2; 7.0]), and high number-needed-to-harm (NNH [95% CI] akathisia, 27.1 [12.3; −667.1]; tremor, 80.0 [22.5; 67.3]; dyskinesia, −132.6 [44.5; −23.2]; parkinsonism, 160.0 [28.9; −49.8]) quantify the relative benefits and low propensity for adverse events with PP3M. Symptom remission and reductions in positive and negative symptoms indicate treatment stability. Additionally, meaningful functional remission, reduced dosing frequency, and freedom from daily negotiations favorably impact patient preference and attenuate burdensome aspects of caregiving, representing important healthcare determinants that enhance prospects of treatment continuity in schizophrenia. This information can potentially improve clinicians’ judgment of treatment choices, clinical response, and patient selection in routine care. Taken together, PP3M is a valuable antipsychotic treatment option, meriting consideration for a broader role in the long-term management of schizophrenia; its utility should not be limited to patients with poor adherence or when oral antipsychotics have failed.

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Section: Efficacy and Outcomes For Pp3m Treatment In Schizophreniasupporting

confidence: 57%

<p>Clinical relevance of paliperidone palmitate 3-monthly in treating schizophrenia</p>

Mathews¹,

Gopal²,

Nuamah³

et al. 2019

NDT

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“… 11 , 17–27 Various injection site reactions for different LAI antipsychotics were reported in these studies, including pain, bleeding, and swelling. The most common injection site reaction was pain which was mainly reported in the studies by Hay, 17 Jones et al, 18 Atkins et al, 23 and Kern Sliwa et al 26 ( Table 2 ). The majority of the studies presented comparative data among different LAI antipsychotics.…”

Section: Resultsmentioning

confidence: 96%

“… 7 Atkins et al (2014) 23 Olanzapine 45–405 mg injection at 2-, 3- or 4-week intervals Pain was the most commonly reported, occurring in 2.9% of patients All other types of reactions occurred in <1% of patients Rates of discontinuation were low 8 Kisely et al (2015) 24 Fluphenazine q2w or q1M Paliperidone q1M Risperidone q2w Olanzapine q2w Haloperidol q1M Q2w injections were significantly less likely to lead to pain (RR=0.16, 95% CI=0.07–0.38; 2 studies n= 1667). Risperidone q2w was less likely to lead to site pain than q1M paliperidone (not statistically significant) 9 Chen et al (2016) 25 FGAPs Risperidone FGAPs showed lower injection pain severity compared to patients receiving risperidone LAI (VAS ratings), P<0.05 10 Misawa et al (2016) 11 Paliperidone Zuclopenthixol Risperidone Olanzapine Fluphenazine The prevalence of injection site reactions was not significantly different between the various antipsychotic formulations investigated 11 Kern Sliwa et al (2018) 26 Paliperidone q1M vs q3M Spontaneously-reported injection site pain for PP3M vs PP1M (3% vs 2%). Investigator-rated injection site reactions for PP3M vs PP1M: Induration (12% vs 10%), redness (10% vs 9%), swelling (7% vs 9%).…”

Section: Resultsmentioning

confidence: 98%

Long-Acting Injectable Antipsychotics: A Systematic Review of Their Non-Systemic Adverse Effect Profile

Zolezzi¹,

Abouelhassan²,

Eltorki³

et al. 2021

NDT

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Introduction Long acting injectable (LAI) antipsychotics are commonly used in the treatment of schizophrenia to improve adherence and clinical outcomes. Concerns have been reported in relation to their non-systemic or injection site adverse effect profile. As such, this study aims to review and evaluate all evidence reporting injection site adverse effects with LAI antipsychotics. Methods An electronic search was systematically conducted through four databases (PubMed, Embase, SCOPUS, Cochrane) in order to identify studies investigating injection-site reactions associated with LAI antipsychotics. Unpublished studies such as conference proceedings and clinical trial registries were also searched. The search was limited to literature published in English without year limits. Results Of a total of 189 citations that were identified from the electronic database search, 12 were selected for inclusion in this review. Various injection site reactions were reported in these studies, including pain, bleeding, and swelling. Overall, the studies reported a low incidence of these injection site reactions. Only a minority of the included articles compared injection site reactions between different LAI antipsychotics. Conclusion Injection site pain was the most commonly reported injection site adverse effect across all articles reviewed. The low incidence of injection site adverse effects associated with LAI antipsychotics indicates that these formulations appear to be well tolerated by patients. More head-to-head trials comparing second generation LAI antipsychotics are needed.

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“…However, the sample size for the study comparing monthly versus two-monthly aripiprazole injections were small (n = 35 in each arm) (Risinger et al, 2017). The reasons for this are unclear, as injection site pain does not seem to be dependent on injection volume, dose, or site of administration (Atkins et al, 2014;Kern Sliwa et al, 2018). This may potentially be due to different injection techniques, although there is also the suggestion that the incidence of injection site pain reduces with an increasing number of injections received (Atkins et al, 2014).…”

Section: Discussionmentioning

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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An assessment of injection site reaction and injection site pain of 1-month and 3-month long-acting injectable formulations of paliperidone palmitate

Abstract: Injection site reactions and pain were low and similar between both treatments, regardless of administration site and dose.

Cited by 12 publications

References 12 publications

<p>Clinical relevance of paliperidone palmitate 3-monthly in treating schizophrenia</p>

<p>Clinical relevance of paliperidone palmitate 3-monthly in treating schizophrenia</p>

Long-Acting Injectable Antipsychotics: A Systematic Review of Their Non-Systemic Adverse Effect Profile

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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