&lt;p&gt;Clinical relevance of paliperidone palmitate 3-monthly in treating schizophrenia&lt;/p&gt;

Mathews, Maju; Gopal, Srihari; Nuamah, Isaac; Hargarter, L.; Savitz, Adam; Kim, Edward; Tan, Wilson M.; Soares, Bernardo; Correll, Christoph U.

doi:10.2147/ndt.s197225

Cited by 32 publications

(35 citation statements)

References 111 publications

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“…A meta-analysis of studies of other atypical antipsychotics reported an overall mean response rate for long-acting injectables of 47% vs 24% for placebo (NNT = 4) based on a ≥20% improvement in PANSS total score;11 thus, AL 441 and 882 mg were comparable with respect to this outcome, with an observed NNT of 4 (95% CI: 3–6). Similar analyses have been published regarding other antipsychotics, including paliperidone palmitate,12,13 iloperidone,14 cariprazine,15 lurasidone,16 and pimavanserin 17…”

Section: Discussionsupporting

confidence: 70%

<p>Assessing effectiveness of aripiprazole lauroxil vs placebo for the treatment of schizophrenia using number needed to treat and number needed to harm</p>

Citrome

Weiden

2019

NDT

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ObjectiveSchizophrenia clinical trials commonly measure observed changes in Positive and Negative Syndrome Scale (PANSS) total score. However, it is more intuitive to think of response vs nonresponse, a binary outcome. Assessing binary outcomes enables calculation of number needed to treat (NNT) for therapeutic outcomes, number needed to harm (NNH) for adverse outcomes, and likelihood to be helped or harmed (LHH) to demonstrate benefit/risk tradeoffs. Here, NNT, NNH, and LHH were used to evaluate the clinical usefulness of aripiprazole lauroxil in patients with an acute schizophrenia exacerbation.MethodsCategorical efficacy and tolerability data were taken from the pivotal Phase 3 trial evaluating aripiprazole lauroxil for treatment of an acute exacerbation of schizophrenia. NNT and NNH values, with 95% CIs, were calculated in this post hoc analysis.ResultsUsing the intent-to-treat population for the pooled doses of aripiprazole lauroxil (441 mg [n=196] and 882 mg [n=204] q4w), responder rates (≥30% improvement from baseline PANSS total score) were 35.3% for aripiprazole lauroxil arms vs 18.4% for placebo (n=196), yielding a NNT of 6 (95% CI: 5–11). Discontinuation rates due to adverse events (AEs) were higher among patients randomized to placebo than to either aripiprazole lauroxil dose. Akathisia was the only AE with an incidence ≥5% in each aripiprazole lauroxil group and at least twice that of placebo (11.6%, 11.5%, and 4.3% of the patients receiving aripiprazole lauroxil 441 mg, 882 mg, and placebo, respectively), producing a NNH of 14 (95% CI: 9–33) for pooled aripiprazole lauroxil doses vs placebo. Calculating LHH for therapeutic response vs akathisia, aripiprazole lauroxil was 2.3 times more likely to result in a therapeutic response than an incident of akathisia.ConclusionUsing metrics of NNT, NNH, and LHH, aripiprazole lauroxil was an efficacious and well-tolerated intervention in a pivotal study in patients with an acute schizophrenia exacerbation.

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Section: Discussionsupporting

confidence: 70%

<p>Assessing effectiveness of aripiprazole lauroxil vs placebo for the treatment of schizophrenia using number needed to treat and number needed to harm</p>

Citrome

Weiden

2019

NDT

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“…This theory is supported with ndings from Weiden et al who compared time to relapse when oral paliperidone, PP1M and PP3M were discontinued; time to relapse was longest for PP3M, followed by PP1M, then oral paliperidone [30]. These ndings have also been corroborated by Mathews et al [29].…”

Section: Discussionsupporting

confidence: 55%

“…Previous studies have reported a reduced risk of rehospitalisation and relapse in patients receiving LAT compared with oral antipsychotic treatment [28][29][30]. A decrease in hospitalisation rate has also been demonstrated speci cally with the introduction of PP1M [31] and in those switching from PP1M to PP3M [14].…”

Section: Discussionmentioning

confidence: 94%

The Patient, Investigator, Nurse, Carer Questionnaire (PINC-Q): A cross-sectional, retrospective, non-interventional study exploring the impact of less frequent medication administration with paliperidone palmitate 3-monthly as maintenance treatment for schizophrenia

Pungor

Sánchez²,

Pappa³

et al. 2020

Preprint

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Background: To understand the implications of switching from paliperidone palmitate 1-monthly (PP1M) to paliperidone palmitate 3-monthly (PP3M) treatment of schizophrenia from the perspective of four key stakeholders: patients, physicians, nurses and carers. Methods: PINC-Q was a cross-sectional, retrospective, non-interventional study comprising a one-time questionnaire for adult patients (aged ≥18 years) with schizophrenia (International Classification of Diseases; ICD-10) and their physician, nurse and carer. Questionnaires were developed in association with patient and carer advocacy groups (GAMIAN and EUFAMI) and following an advisory board formed of psychiatrists and nurses. The degree of alignment between stakeholders was also examined. Results: Responses were received from a total of 224 evaluable patients. For most patients (88.4%), responses were received from at least two other stakeholders. Patients were moderately ill with mild-to-moderate lack of insight and had received PP1M for a mean (standard deviation [SD]) of 23.9 (21.28) months before switching to PP3M (duration mean [SD] 12.8 [3.72] months). The most frequently reported reasons to switch from PP1M to PP3M were ‘to live life as normally as possible’ and ‘patient convenience’. Over 79% of responses within each stakeholder group stated that PP3M helped the patients, with increased patient activity and social involvement, improved frequency and quality of physician–patient and nurse–patient communication and decreased perceived stigma. Conclusions: The results of the PINC-Q 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.

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“…time to relapse was longest for PP3M, followed by PP1M, then oral paliperidone [30]. These ndings have also been corroborated by Mathews et al [29].…”

Section: Discussionmentioning

confidence: 53%

The Patient, Investigator, Nurse, Carer Questionnaire (PINC-Q): A Cross-Sectional, Retrospective, Non-Interventional Study Exploring the Impact of Less Frequent Medication Administration with Paliperidone Palmitate 3-Monthly as Maintenance Treatment for Schizophrenia

Wooller

Pungor

Attal³

et al. 2020

Preprint

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BackgroundTo understand the implications of switching from paliperidone palmitate 1-monthly (PP1M) to paliperidone palmitate 3-monthly (PP3M) treatment of schizophrenia from the perspective of four key stakeholders: patients, physicians, nurses and carers. Methods PINC-Q was a cross-sectional, retrospective, non-interventional study comprising a one-time questionnaire for adult patients (aged ≥18 years) with schizophrenia (International Classification of Diseases; ICD-10) and their physician, nurse and carer. Questionnaires were developed in association with patient and carer advocacy groups (GAMIAN and EUFAMI) and following an advisory board formed of psychiatrists and nurses. The degree of alignment between stakeholders was also examined.ResultsResponses were received from a total of 224 evaluable patients. For most patients (88.4%), responses were received from at least two other stakeholders. Patients were moderately ill with mild-to-moderate lack of insight and had received PP1M for a mean (standard deviation [SD]) of 23.9 (21.28) months before switching to PP3M (duration mean [SD] 12.8 [3.72] months). The most frequently reported reasons to switch from PP1M to PP3M were ‘to live life as normally as possible’ and ‘patient convenience’. Over 79% of responses within each stakeholder group stated that PP3M helped the patients, with increased patient activity and social involvement, improved frequency and quality of physician–patient and nurse–patient communication and decreased perceived stigma.ConclusionsThe results of the PINC-Q 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.

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

Cited by 32 publications

References 111 publications

<p>Assessing effectiveness of aripiprazole lauroxil vs placebo for the treatment of schizophrenia using number needed to treat and number needed to harm</p>

<p>Assessing effectiveness of aripiprazole lauroxil vs placebo for the treatment of schizophrenia using number needed to treat and number needed to harm</p>

The Patient, Investigator, Nurse, Carer Questionnaire (PINC-Q): A cross-sectional, retrospective, non-interventional study exploring the impact of less frequent medication administration with paliperidone palmitate 3-monthly as maintenance treatment for schizophrenia

The Patient, Investigator, Nurse, Carer Questionnaire (PINC-Q): A Cross-Sectional, Retrospective, Non-Interventional Study Exploring the Impact of Less Frequent Medication Administration with Paliperidone Palmitate 3-Monthly as Maintenance Treatment for Schizophrenia

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