Comparative Safety of Long-Acting Injectable Antipsychotics: A Systematic Review and Network Meta-Analysis
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Objective To find the safety of long-acting injectable antipsychotics (LAIs) compared to each other, and/or placebo in the treatment of schizophrenia (SCZ) and/or schizoaffective disorder (SZA).Methods We performed a systematic review and a network meta-analysis of randomized controlled trials (RCTs) comparing the safety of LAIs versus other LAIs or placebo in adults diagnosed with SCZ or SZA. The primary outcomes were treatment emergent adverse events (TEAEs), serious treatment emergent adverse events (STEAEs), and deaths. The secondary outcomes included treatment discontinuations due to adverse events and all-cause discontinuations.Results Seventeen RCTs were included (n=7,908). There were no significant differences between LAIs and placebo in the risk of presenting TEAEs. LAIs had a significant lower risk of presenting STEAEs except for aripiprazole. No significant differences in deaths were found. LAIs showed a significant protective effect against all-cause discontinuation, except for haloperidol. Only aripiprazole had a significantly lower risk of treatment discontinuation due to adverse events.Conclusion We found no significant differences in the risk of presenting TEAEs between LAIs and placebo. The majority of LAIs had a significantly lower risk of presenting STEAEs than placebo. Development of international guidelines for the report of safety outcomes related to antipsychotics especially for LAIs in clinical trials could minimize report and interpretation biases and improve the accuracy of posterior meta-analysis.
Abstract
Objective To find the safety of long-acting injectable antipsychotics (LAIs) compared to each other, and/or placebo in the treatment of schizophrenia (SCZ) and/or schizoaffective disorder (SZA).Methods We performed a systematic review and a network meta-analysis of randomized controlled trials (RCTs) comparing the safety of LAIs versus other LAIs or placebo in adults diagnosed with SCZ or SZA. The primary outcomes were treatment emergent adverse events (TEAEs), serious treatment emergent adverse events (STEAEs), and deaths. The secondary outcomes included treatment discontinuations due to adverse events and all-cause discontinuations.Results Seventeen RCTs were included (n=7,908). There were no significant differences between LAIs and placebo in the risk of presenting TEAEs. LAIs had a significant lower risk of presenting STEAEs except for aripiprazole. No significant differences in deaths were found. LAIs showed a significant protective effect against all-cause discontinuation, except for haloperidol. Only aripiprazole had a significantly lower risk of treatment discontinuation due to adverse events.Conclusion We found no significant differences in the risk of presenting TEAEs between LAIs and placebo. The majority of LAIs had a significantly lower risk of presenting STEAEs than placebo. Development of international guidelines for the report of safety outcomes related to antipsychotics especially for LAIs in clinical trials could minimize report and interpretation biases and improve the accuracy of posterior meta-analysis.
참고문헌 (43)
- Kane JM, "Guidelines for depot antipsychotic treatment in schizophrenia", Eur Neuropsychopharmacol, 8, pp.55~66 (1998)
- Kane JM, "Guidelines for the use of long-acting injectable atypical antipsychotics", J Clin Psychiatry, 65, pp.120~131 (2004)
- Llorca PM, "Guidelines for the use and management of long-acting injectable antipsychotics in serious mental illness", BMC Psychiatry, 13, pp.340~ (2013)
- Taylor DM, "Reducing the stigma of long acting injectable antipsychotics-current concepts and future developments", Nord J Psychiatry, 72(sup1), pp.S36~S39 (2018)
- Girardi P, "Predictive factors of overall functioning improvement in patients with chronic schizophrenia and schizoaffective disorder treated with paliperidone palmitate and aripiprazole monohydrate", Hum Psychopharmacol, 33, pp.e2658~ (2018)
- Stip E, "Real-world effectiveness of long-acting antipsychotic treatments in a nationwide cohort of 3957 patients with schizophrenia, schizoaffective disorder and other diagnoses in Quebec", Ther Adv Psychopharmacol, 8, pp.287~301 (2018)
- Latorre V, "Improving the"real life"management of schizophrenia spectrum disorders by LAI antipsychotics : a one-year mirror-image retrospective study in community mental health services", PLoS One, 15, pp.e0230051~ (2020)
- Zhang F, "Efficacy, safety, and impact on hospitalizations of paliperidone palmitate in recent-onset schizophrenia", Neuropsychiatr Dis Treat, 11, pp.657~668 (2015)
- Barnett PG, "Cost and cost-effectiveness in a randomized trial of long-acting risperidone for schizophrenia", J Clin Psychiatry, 73, pp.696~702 (2012)
- Pilon D, "Treatment patterns, health care resource utilization, and spending in Medicaid beneficiaries initiating second-generation long-acting injectable agents versus oral atypical antipsychotics", Clin Ther, 39, pp.1972~1985 (2017)
- Kane JM, "Effect of long-acting injectable antipsychotics vs usual care on time to first hospitalization in early-phase schizophrenia : a randomized clinical trial", JAMA Psychiatry, 77, pp.1217~1224 (2020)
- Subotnik KL, "Long-acting injectable risperidone for relapse prevention and control of breakthrough symptoms after a recent first episode of schizophrenia : a randomized clinical trial", JAMA Psychiatry, 72, pp.822~829 (2015)
- Sajatovic M, "Initiating", maintaining long-acting injectable antipsychotics in schizophrenia, Neuropsychiatr Dis Treat, pp.2018, 14[DOI]
- Velligan DI, "Why do psychiatric patients stop antipsychotic medication? A systematic review of reasons for nonadherence to medication in patients with serious mental illness", Patient Prefer Adherence, 11, pp.449~468 (2017)
- Kane JM, "Controversies surrounding the use of long-acting injectable antipsychotic medications for the treatment of patients with schizophrenia", CNS Drugs, 35, pp.1189~1205 (2021)
- Iyer S, "A qualitative study of experiences with and perceptions regarding longacting injectable antipsychotics : part I-patient perspectives", Can J Psychiatry, 58(5 suppl), pp.14~ (2013)
- Patel MX, "Attitudes of European physicians towards the use of longacting injectable antipsychotics", BMC Psychiatry, 20, pp.123~ (2020)
- Correll CU, "The use of long-acting injectable antipsychotics in schizophrenia : evaluating the evidence", J Clin Psychiatry, 77(suppl 3), pp.1~24 (2016)
- Misawa F, "Safety and tolerability of long-acting injectable versus oral antipsychotics : a metaanalysis of randomized controlled studies comparing the same antipsychotics", Schizophr Res, 176, pp.220~230 (2016)
- Kishimoto T, "Long-acting injectable versus oral antipsychotics for the maintenance treatment of schizophrenia : a systematic review and comparative meta-analysis of randomised, cohort, and pre-post studies", Lancet Psychiatry, 8, pp.387~404 (2021)
- Page MJ, "The PRISMA 2020 statement : an updated guideline for reporting systematic reviews", BMJ, 372, pp.n71~ (2021)
- "CFR - code of federal regulations title 21"[URL]
- Harrer M, "Doing meta-analysis with R: a hands-on guide", pp.2021, Chapman & Hall
- "Cochrane handbook for systematic reviews of interventions (version 6.3, 2022)"[URL]
- McGuinness LA, "Risk-of-bias visualization(robvis) : an R package and Shiny web app for visualizing risk-of-bias assessments", Res Synth Methods, 12, pp.55~61 (2021)
- Li H, "A comparative study of paliperidone palmitate and risperidone long-acting injectable therapy in schizophrenia", Prog Neuropsychopharmacol Biol Psychiatry, 35, pp.1002~1008 (2011)
- Pandina G, "A double-blind study of paliperidone palmitate and risperidone long-acting injectable in adults with schizophrenia", Prog Neuropsychopharmacol Biol Psychiatry, 35, pp.218~226 (2011)
- Fleischhacker WW, "A randomized trial of paliperidone palmitate and risperidone long-acting injectable in schizophrenia", Int J Neuropsychopharmacol, 15, pp.107~118 (2012)
- Kane JM, "Long-acting injectable risperidone : efficacy and safety of the first long-acting atypical antipsychotic", Am J Psychiatry, 160, pp.1125~1132 (2003)
- Gopal S, "Efficacy and safety of paliperidone palmitate in adult patients with acutely symptomatic schizophrenia : a randomized, doubleblind, placebo-controlled, dose-response study", Int Clin Psychopharmacol, 25, pp.247~256 (2010)
- Hough D, "Paliperidone palmitate maintenance treatment in delaying the timeto-relapse in patients with schizophrenia : a randomized, double-blind, placebo-controlled study", Schizophr Res, 116, pp.107~117 (2010)
- Nasrallah HA, "A controlled, evidence-based trial of paliperidone palmitate, a long-acting injectable antipsychotic, in schizophrenia", Neuropsychopharmacology, 35, pp.2072~2082 (2010)
- Pandina GJ, "A randomized, placebo-controlled study to assess the efficacy and safety of 3 doses of paliperidone palmitate in adults with acutely exacerbated schizophrenia", J Clin Psychopharmacol, 30, pp.235~244 (2010)
- Kane JM, "Aripiprazole intramuscular depot as maintenance treatment in patients with schizophrenia : a 52-week, multicenter, randomized, double-blind, placebo-controlled study", J Clin Psychiatry, 73, pp.617~624 (2012)
- Kane JM, "Aripiprazole once-monthly in the acute treatment of schizophrenia : findings from a 12-week, randomized, double-blind, placebo-controlled study", J Clin Psychiatry, 75, pp.1254~1260 (2014)
- Berwaerts J, "Efficacy and safety of the 3-month formulation of paliperidone palmitate vs placebo for relapse prevention of schizophrenia : a randomized clinical trial", JAMA Psychiatry, 72, pp.830~839 (2015)
- Fu DJ, "Paliperidone palmitate once-monthly reduces risk of relapse of psychotic, depressive, and manic symptoms and maintains functioning in a double-blind, randomized study of schizoaffective disorder", J Clin Psychiatry, 76, pp.253~262 (2015)
- Weiden PJ, "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 : phase 3, randomized, double-blind, activecontrol ALPINE study", J Clin Psychiatry, 81, pp.19~ (2020)
- Meltzer HY, "A randomized, double-blind, placebo-controlled trial of aripiprazole lauroxil in acute exacerbation of schizophrenia", J Clin Psychiatry, 76, pp.1085~1090 (2015)
- Naber D, "Qualify : a randomized head-to-head study of aripiprazole once-monthly and paliperidone palmitate in the treatment of schizophrenia", Schizophr Res, 168, pp.498~504 (2015)
- Correll CU, "Efficacy and safety of once-monthly Risperidone ISM® in schizophrenic patients with an acute exacerbation", NPJ Schizophr, 6, pp.37~ (2020)
- McEvoy JP, "Effectiveness of paliperidone palmitate vs haloperidol decanoate for maintenance treatment of schizophrenia : a randomized clinical trial", JAMA, 311, pp.1978~1987 (2014)
- Saucedo Uribe E, "Preliminary efficacy and tolerability profiles of first versus second-generation long-acting injectable antipsychotics in schizophrenia : a systematic review and meta-analysis", J Psychiatr Res, 129, pp.222~233 (2020)
