Prospective, Open Study of Long-Acting Injected Risperidone versus Oral Antipsychotics in 88 Chronically Psychotic Patients

Girardi, Paolo; Serafini, Gianluca; Pompili, Maurizio; Innamorati, Marco; Tatarelli, Roberto; Baldessarini, R. J.

doi:10.1055/s-0029-1239541

Cited by 15 publications

(5 citation statements)

References 35 publications

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“…Hyperprolactinemia, EPS, cardiovascular events (e.g., orthostatic hypotension and tachycardia), and weight gain are well‐known complications of chronic treatment with RIS‐LAI and PP, either in oral or injectable formulations . Regarding the propensity of RIS‐LAI to induce weight gain, these data confirm what it has been demonstrated for SGA oral formulations: during treatment lasting more than 1 year, with the exception of ziprasidone, there are no large differences between SGAs in the liability to induce clinically relevant weight gain .…”

Section: Literature Searchsupporting

confidence: 72%

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Adverse Effects Associated with Second‐Generation Antipsychotic Long‐Acting Injection Treatment: A Comprehensive Systematic Review

Gentile¹

2013

Pharmacotherapy

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As second-generation antipsychotic long-acting injections (SGA-LAIs) are rapidly replacing depot first-generation antipsychotics as first-line agents in treating schizophrenia spectrum disorders, a systematic assessment of their adverse effects is timely. English-language, peer-reviewed articles reporting original data on the safety and tolerability of SGA-LAIs were identified electronically by searching the MEDLINE, EMBASE, PsycINFO, and DARE databases and the Cochrane Library (January 2001-April 2013). In addition to second-generation (atypical) antipsychotics and long-acting injection (depot) antipsychotics, a separate search was performed for each available drug: aripiprazole LAI, olanzapine pamoate, paliperidone palmitate, and risperidone LAI. Articles were excluded if they were review articles, post hoc analyses, analyses of subsets of patients enrolled in previous trials, single case reports, case series studies, small naturalistic studies (involving less than 50 patients), studies providing no safety data, and studies lasting less than 8 weeks. Of 181 articles identified from the search, 140 were excluded; thus, 41 articles met the inclusion criteria. Predictably, the reviewed information revealed that SGA-LAIs have safety profiles consistent with their oral parent formulations. However, they seem to also show unforeseen and worrisome safety signals. Indeed, the routine use of olanzapine-LAI in clinical practice could be limited not only by the well-known risk of postinjection syndrome, whose clinical management remains a matter of concern, but also by the risk of worsening of psychosis. The reviewed information seems to suggest that worsening of psychotic symptoms and depression could also be associated with both risperidone-LAI and paliperidone palmitate. The leading cause of death among patients enrolled in risperidone-LAI studies was suicide. Given the exponential growth in the clinical use of SGA-LAIs, further studies must be urgently performed in order to confirm or exclude the potential safety signals associated with such drugs.

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Section: Literature Searchsupporting

confidence: 72%

“…Such findings were further assessed in some extension‐phase studies . However, some studies do exist that did not assess or confirm this relevant safety concern. Twenty‐two deaths (six attributed to suicide) occurred in these studies overall, which included more than 3400 patients receiving RIS‐LAI treatment …”

Section: Literature Searchmentioning

confidence: 99%

Adverse Effects Associated with Second‐Generation Antipsychotic Long‐Acting Injection Treatment: A Comprehensive Systematic Review

Gentile¹

2013

Pharmacotherapy

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“…To our knowledge, this is the first study showing that LAI ameliorated psychotic symptoms in patients with TRS, without any relapse during a 2-year period. One study did report the effectiveness of RLAI for 88 patients with TRS for over a 2-year period (Girardi et al, 2010).…”

Section: Discussionmentioning

confidence: 99%

Risperidone long-acting injectable in the treatment of treatment-resistant schizophrenia with dopamine supersensitivity psychosis: Results of a 2-year prospective study, including an additional 1-year follow-up

et al. 2016

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“…In seven long-term studies, discontinuation rates widely ranged between 7% and 84%, [85][86][87][88][89][90][91] but the main reasons of discontinuation were reported in just five studies (withdrawal of consent, 85 patient decision, 87,88,90 and ineffectiveness 91 ).…”

Section: Pubmed Cochrane Librarymentioning

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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Prospective, Open Study of Long-Acting Injected Risperidone versus Oral Antipsychotics in 88 Chronically Psychotic Patients

Cited by 15 publications

References 35 publications

Adverse Effects Associated with Second‐Generation Antipsychotic Long‐Acting Injection Treatment: A Comprehensive Systematic Review

Adverse Effects Associated with Second‐Generation Antipsychotic Long‐Acting Injection Treatment: A Comprehensive Systematic Review

Risperidone long-acting injectable in the treatment of treatment-resistant schizophrenia with dopamine supersensitivity psychosis: Results of a 2-year prospective study, including an additional 1-year follow-up

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

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