Long-Acting Injectable Antipsychotics: An Underutilized Treatment Option

Heres, Stephan

doi:10.4088/jcp.14com09541

Cited by 22 publications

(12 citation statements)

References 28 publications

(23 reference statements)

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“…In fact, there is research to show that underutilization of LAIs originates more from ideologic hesitation and attitudinal barriers on the part of psychiatrists and physicians rather than on any skepticism from patients towards LAI drugs [44–48], and there is increasing acceptance that psychiatrists should consider the use of LAIs as a treatment option more often in general, and also earlier in the treatment course [49]. …”

Section: Introductionmentioning

confidence: 99%

Long-Acting Injectable Antipsychotics in Schizophrenia: Literature Review and Practical Perspective, with a Focus on Aripiprazole Once-Monthly

et al. 2017

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IntroductionPrevention of relapse is a major challenge in schizophrenia, a disease characterized by poor adherence to antipsychotic medication leading to multiple rehospitalizations and a substantial burden-of-care.MethodsWe narratively review published clinical data from the development of long-acting injectable (LAI) formulations of antipsychotic drugs and examine the comparative effectiveness of oral versus LAIs in schizophrenia, with a focus on the second-generation LAI antipsychotic aripiprazole. Evidence is presented from studies with naturalistic/pragmatic as well as explanatory trial designs, supported by the clinical experience of the authors.ResultsLAI formulations of antipsychotic drugs offer advantages over oral medications and there is good evidence for their use as a first-choice treatment and in younger patients. Key phase III studies have shown aripiprazole once-monthly 400 mg (AOM 400) to be effective and well tolerated, with high rates of adherence and low rates of impending relapse. In a recent randomized trial with a “naturalistic” study design more representative of routine clinical practice, AOM 400 was well tolerated and had significantly greater effectiveness than paliperidone LAI overall and in younger patients aged ≤35 years.ConclusionResults across the “full spectrum” of efficacy in traditional clinical trials as well as those encompassing the concept of effectiveness in a more naturalistic setting of real-life clinical practice support the use of AOM 400 as a valid long-term treatment option in schizophrenia overall, as well as earlier in the treatment course, and not solely in situations of poor adherence or when oral antipsychotics have failed.

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Section: Introductionmentioning

confidence: 99%

Long-Acting Injectable Antipsychotics in Schizophrenia: Literature Review and Practical Perspective, with a Focus on Aripiprazole Once-Monthly

et al. 2017

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“…It is believed that LAIs are an underused treatment option for schizophrenia. [1][2][3] For inpatient services, starting an LAI rather than its oral counterpart may have several advantages for patients' long-term treatment plans. Once efficacy and tolerability of the LAI are established during hospitalization, the discharge plan can include continuation of the LAI during transition to outpatient treatment.…”

mentioning

confidence: 99%

“…Once efficacy and tolerability of the LAI are established during hospitalization, the discharge plan can include continuation of the LAI during transition to outpatient treatment. 1,2,4,5 One barrier to more frequent use of LAIs could be fragmentation of psychiatric services, especially between inpatient and outpatient care. [6][7][8] Although hospitalization is an opportune time to start an LAI, other competing priorities may preclude implementation.…”

mentioning

confidence: 99%

Efficacy and Safety of a 2-Month Formulation of Aripiprazole Lauroxil With 1-Day Initiation in Patients Hospitalized for Acute Schizophrenia Transitioned to Outpatient Care

Weiden

Claxton

Kunovac³

et al. 2020

J. Clin. Psychiatry

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Objective: Evaluate efficacy and safety of a 2-month formulation of aripiprazole lauroxil (AL) with 1-day initiation during hospitalization for acute exacerbation of schizophrenia followed by transition to outpatient care. Methods: The phase 3b double-blind Aripiprazole Lauroxil and Paliperidone palmitate: INitiation Effectiveness (ALPINE) study was conducted from November 2017 to March 2019. Adults with acute schizophrenia according to DSM-5 criteria were randomized (1:1) to AL (AL NanoCrystal Dispersion + oral aripiprazole 30 mg, day 1; AL 1,064 mg, day 8 and every 8 weeks [q8wk]) or paliperidone palmitate (PP 234 mg, day 1; PP 156 mg, day 8 and then q4wk) for 25 weeks. Patients remained hospitalized ≥ 2 weeks after randomization per protocol. Primary endpoint was within-group change in Positive and Negative Syndrome Scale total score (PANSS T) from baseline to week 4. Secondary analyses included within-and between-group changes from baseline at various time points. Adverse events (AEs) and laboratory data were monitored. Results: A total of 200 patients were randomized (AL, n = 99; PP, n = 101); 56.6% and 42.6%, respectively, completed the study. For AL, the mean baseline PANSS T was 94.1; scores were significantly reduced from baseline at week 4 (−17.4; P < .001) and were also reduced at weeks 9 (−19.8) and 25 (−23.3). With PP, PANSS T also improved significantly from baseline (94.6) at week 4 (−20.1; P < .001) and also improved at weeks 9 (−22.5) and 25 (−21.7). The 3 most common AEs over 25 weeks in the AL group were injection site pain (17.2%), increased weight (9.1%), and akathisia (9.1%). The same AEs were the most common in the PP group (injection site pain [24.8%], increased weight [16.8%], and akathisia [10.9%]). Conclusions: AL and PP were efficacious and well-tolerated for initiating treatment of schizophrenia in the hospital and continuing outpatient treatment. Trial Registration: ClinicalTrials.gov identifier: NCT03345979

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“…Moreover, as antipsychotic LAI release the medication slowly, missing an injection will not lead to a precipitous drop in the blood level like after stopping oral antipsychotics, increasing the window of protection during which nonadherence can be addressed . For these reasons, LAI are considered an important treatment option for nonadherence …”

Section: Discussionmentioning

confidence: 88%

“…101 For these reasons, LAI are considered an important treatment option for nonadherence. 102 However, for the discouraging reasons detailed below, the effectiveness of SGA-LAI in reducing the risk of treatment withdrawal should be reconsidered.…”

Section: Discussionmentioning

confidence: 99%

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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Long-Acting Injectable Antipsychotics: An Underutilized Treatment Option

Cited by 22 publications

References 28 publications

Long-Acting Injectable Antipsychotics in Schizophrenia: Literature Review and Practical Perspective, with a Focus on Aripiprazole Once-Monthly

Long-Acting Injectable Antipsychotics in Schizophrenia: Literature Review and Practical Perspective, with a Focus on Aripiprazole Once-Monthly

Efficacy and Safety of a 2-Month Formulation of Aripiprazole Lauroxil With 1-Day Initiation in Patients Hospitalized for Acute Schizophrenia Transitioned to Outpatient Care

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

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