Clinical improvement, relapse and treatment adherence with paliperidone palmitate 1-month formulation: 1-year treatment in a naturalistic outpatient setting

Lorenzo, Rosaria Di; Cameli, Michela; Piemonte, Chiara; Bolondi, Marisa; Landi, Giulia; Pollutri, Gabriella; Spattini, Ludovica; Moretti, Valentina; Ferri, Paola

doi:10.1080/08039488.2017.1420819

Cited by 10 publications

(9 citation statements)

References 35 publications

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“…With regard to the primary objective of this study, PP, Hal-D, and Apr prolonged release proved to be equally effective in the prevention of relapses both at 6 and 12 months, resulting in a significant decrease in urgent consultations, psychiatric hospitalizations, and days of hospitalization. Our study confirms results obtained from previous research conducted with mirror analysis23,26,73–75 or cohort-study design25,30 that demonstrated greater efficacy of LAI-APDs compared to oral APD therapies in the prevention of relapses. These results were not confirmed by the double-blind RCTs,6 probably because RCTs are not an optimal study methodology for effectiveness studies in clinical practice 29.…”

Section: Discussionsupporting

confidence: 90%

Effectiveness of 1-year treatment with long-acting formulation of aripiprazole, haloperidol, or paliperidone in patients with schizophrenia: retrospective study in a real-world clinical setting

Lorenzo¹,

Ferri²,

Cameli³

et al. 2019

NDT

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BackgroundSchizophrenia is a chronic mental illness that requires lifelong antipsychotic treatment. Therapy discontinuation, often due to poor adherence, increases the risk of relapses after both first and subsequent psychotic episodes. Long-acting injectable (LAI) antipsychotic drugs (APDs) have been introduced to increase therapeutic adherence, reducing blood-level variability compared to corresponding oral preparations.PurposeTo compare the effectiveness of three LAI-APDs: aripiprazole (Apr) prolonged release once monthly (OM) haloperidol decanoate (Hal-D) and paliperidone palmitate (PP-OM).MethodsWe retrospectively collected data for all patients with schizophrenia or other psychoses (n=217) treated with the three LAI-APDs for the first time from January 1, 2012 to October 31, 2016: n=48 with Apr-OM, n=55 with Hal-D, and n=114 with PP-OM. After 6 and 12 months of LAI treatments, we assessed clinical and functioning improvement, urgent consultations, psychiatric hospitalizations, adverse effects, and dropout. We compared urgent consultations and psychiatric hospitalizations required by the same patient 6 and 12 months before and after LAI implementation. Data were statistically analyzed.ResultsThe three LAI groups differed significantly only for “need for economic support from social service” (more frequent in the Hal-D group) and “schizoaffective disorder” (prevalent in the Apr-OM group). Apr-OM was prescribed at the maximum dose required by the official guidelines, whereas the other two LAIs were prescribed at lower doses. After 6 and 12 months’ treatment with the three LAI-APDs, we registered similar and significant reductions in both urgent consultations and psychiatric hospitalizations (P<0.001) and overlapping clinical and functioning improvement-scale scores (P<0.001), and 14.28% of patients dropped out, with no difference among the three LAI-APDs. Different kinds of adverse effects, though similar for number and severity, were reported in the three LAI groups.ConclusionOur results suggest that both first- and second-generation LAI-APDs represent important therapeutic options, useful for improving schizophrenia’s clinical course and its economic burden. Our study, which offers a wide and comprehensive observation of real-world clinical settings, combined an effectiveness evaluation through mirror analysis performed for each individual patient to a subsequent comparison among the three LAI-APDs, allowing us a more complete evaluation of clinical efficacy.

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Section: Discussionsupporting

confidence: 90%

Effectiveness of 1-year treatment with long-acting formulation of aripiprazole, haloperidol, or paliperidone in patients with schizophrenia: retrospective study in a real-world clinical setting

Lorenzo¹,

Ferri²,

Cameli³

et al. 2019

NDT

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“…17 A recent systematic review has estimated at 3% the one-year recurrence rate for patients who continued antipsychotics whereas the risk of recurrence is increased to over 90% among patients who had discontinued antipsychotic therapy within 2 years. 18 There is a general consensus on the fact that lack of adherence represents the major criticality in treatments, especially long-term ones, in the most severely ill patients 19 with further negative repercussions on both the patient's quality of life and Mental Health Services. 20 One of the most immediate consequences of lack of adherence is a high rate of relapse, which can favour the so-called "revolving door" phenomenon.…”

Section: Introductionmentioning

confidence: 99%

<p>Attitude Towards Drug Therapy in a Community Mental Health Center Evaluated by the Drug Attitude Inventory</p>

Lorenzo¹,

Perrone²,

Montorsi³

et al. 2020

PPA

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Introduction: Negative attitude towards drug therapy can foster limited adherence to treatment, which remains one of the biggest obstacles for implementing effective treatments, especially long term. Purposes: The purposes of the study were 1) to evaluate the attitude towards drug therapy among a representative sample of patients treated in a community psychiatric service using 30-item Drug Attitude Inventory (DAI-30); 2) to evaluate the DAI-30 dimensions, applying factorial analysis; and 3) to highlight the socio-demographic and clinical variables correlated to DAI-30 score and factors. Methods: The DAI was administered, over a 7-month period, to all patients treated in our psychiatric outpatient services who agreed to participate in this study and provided their informed consent. Data were statistically analyzed. Results: With a response rate of 63.3%, 164 females and 136 males completed the DAI-30 with an average score of 14.24 (±10.46 SD), indicating moderately positive attitude towards drug therapy. The analysis of DAI-30 internal consistency confirmed its reliability (Cronbach's alpha=0.84). Our factorial analysis highlighted three factors: Factor 1 (Cronbach's alpha=0.81), composed of 7 items which indicate positive, trustful attitude; Factor 2 (Cronbach's alpha=0.78), composed of 5 items indicating negative attitude of suspiciousness; and Factor 3 (Cronbach's alpha=0.66), composed of 4 items suggesting defensive and control attitude towards drug therapy. Discussion: Among the selected variables, "monotherapy" and "total number of hospitalizations" were negatively correlated to the final score of DAI-30, whereas being "married" was positively correlated to it, in a statistically significant way, using the multiple linear regression model. These correlations suggest that positive attitude towards drug therapy could be reinforced by the condition of being married and reduced by relapses with hospitalization, as literature highlighted, and, paradoxically, by a monotherapy, which could suggest a sort of psychological dependence on therapy and, indirectly, on psychiatric service, potentially correlated to the long-term treatments of our patients.

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“…54 The main causes of drug discontinuation before the planned study end were adverse events 45,46,61,62,65 and ineffectiveness. 47,51,59,62,65,66 The two available long-term studies on PPM3 showed a rate of premature discontinuation similar to that shown by the active comparator (PP1M). 68,69 However, only one 68 reported the reasons of premature withdrawal (the most frequent being the occurrence of adverse events).…”

Section: Discussionmentioning

confidence: 87%

“…In the small study by Di Lorenzo et al ., the main causes of dropout were lack of therapeutic adherence and inefficacy.…”

Section: Resultsmentioning

confidence: 99%

“…The only study reporting the advantage of PP1M on oral antipsychotics showed several limitations, the main being a suboptimal statistical power due to the small sample size and the inclusion in the study cohort of both new and old PP1M users . The main causes of drug discontinuation before the planned study end were adverse events and ineffectiveness . The two available long‐term studies on PPM3 showed a rate of premature discontinuation similar to that shown by the active comparator (PP1M) .…”

Section: Discussionmentioning

confidence: 99%

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Discontinuation rates during long‐term, second‐generation antipsychotic long‐acting injection treatment: A systematic review

Gentile

2019

Psychiatry Clin Neurosci

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Aim The aim of this review was to analyze the discontinuation rates during long‐term treatment with second‐generation antipsychotic long‐acting injection (SGA‐LAI) in adults with either schizophrenia spectrum or bipolar disorders. Methods A systematic search (PubMed, Scopus, and the Cochrane Library) of studies published in English (1 January 2001–12 October 2018) identified 1214 abstracts, which were analyzed independently by the author and two colleagues. Studies were retrieved and reviewed if they reported primary data on the discontinuation rate before the study end during treatment lasting ≥36 weeks. Data were extracted from 51 articles meeting the inclusion criteria. Results In all head‐to‐head comparisons, and studies on patients with schizophrenia spectrum or bipolar disorders, the discontinuation rate before the study end in patients treated with SGA‐LAI was, at best, similar to that recorded in patients treated with first‐generation antipsychotics in either oral or LAI formulations or with oral SGA. In particular, in most of the SGA‐LAI long‐term studies, the rate of premature dropout was higher than 50%. Conclusion Reviewed data suggest that SGA‐LAI show no clear superiority over less expensive drugs (including first‐generation antipsychotic LAI and oral antipsychotic formulations) in reducing the risk of premature antipsychotic discontinuation. Thus, alternative strategies should be considered to improve medication persistence and lower discontinuation rates in patients with severe psychiatric disorders. Planning tailored, individualized, and integrated approaches (including frequent clinical evaluations, and behavioral or other flexible techniques adaptable to different settings and patients) may be an effective intervention for improving patient adherence in long‐term pharmacological treatment regimens.

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Clinical improvement, relapse and treatment adherence with paliperidone palmitate 1-month formulation: 1-year treatment in a naturalistic outpatient setting

Abstract: This naturalistic study indicates that long-term PP1M treatment was safe and effective in preventing hospitalizations and urgent consultations as well as in improving clinical course.

Cited by 10 publications

References 35 publications

Effectiveness of 1-year treatment with long-acting formulation of aripiprazole, haloperidol, or paliperidone in patients with schizophrenia: retrospective study in a real-world clinical setting

Effectiveness of 1-year treatment with long-acting formulation of aripiprazole, haloperidol, or paliperidone in patients with schizophrenia: retrospective study in a real-world clinical setting

<p>Attitude Towards Drug Therapy in a Community Mental Health Center Evaluated by the Drug Attitude Inventory</p>

Discontinuation rates during long‐term, second‐generation antipsychotic long‐acting injection treatment: A systematic review

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