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Long-Acting Injectable Versus Oral Antipsychotics in Schizophrenia: A Systematic Review and Meta-Analysis of Mirror-Image Studies
Abstract
OBJECTIVE: Recent, large, randomized controlled trials (RCTs) showed no benefit of long-acting injectable (LAI) antipsychotics over oral antipsychotics in preventing relapse in schizophrenia, nor did a recent meta-analysis incorporating these studies. However, RCTs might enroll a disproportionate number of patients with better treatment adherence and lower illness severity. Mirror-image studies, which compare periods of oral antipsychotic versus LAI treatment in the same patients, might therefore better reflect the real-world impact of LAIs. DATA SOURCES: A systematic literature search without language restriction was conducted using MEDLINE/PubMed, Cochrane Library, Web of Science, PsycINFO, and CINAHL until May 31, 2012. Search terms included synonyms of (1) antipsychotic(s) AND (2) schizophrenia and related disorders AND (3) depot, (long-acting) injection(s), microsphere, decanoate, palmitate, enanthate. STUDY SELECTION: Of 5,483 identified citations, 607 articles were fully inspected, and 582 were ineligible. Finally, 25 mirror-image studies from 28 countries that followed 5,940 patients with schizophrenia for ≥ 12 months (≥ 6 months each on oral antipsychotic and LAI treatment) met the inclusion criteria and were analyzed. DATA EXTRACTION: Coprimary outcomes were hospitalization risk and number of hospitalizations. Secondary outcomes included hospitalization days and length of stay. DATA SYNTHESIS: LAIs showed strong superiority over oral antipsychotics in preventing hospitalization (16 studies, N = 4,066; risk ratio = 0.43; 95% CI, 0.35-0.53; P < .001) and in decreasing the number of hospitalizations (15 studies, 6,342 person-years; rate ratio = 0.38; 95% CI, 0.28-0.51; P < .001). This strong advantage was also observed for secondary outcomes and in multiple clinically relevant subpopulations and treatment groups. CONCLUSIONS: Results from mirror-image studies in patients eligible for clinical use of LAIs showed strong superiority of LAIs compared to oral antipsychotics in preventing hospitalization. The results were in contrast to the recent meta-analysis of RCTs, which showed no superiority of LAIs. Given the possible biases in mirror-image studies, such as expectation bias, natural illness course, and time effect, a cautious interpretation is required. Nevertheless, the population in mirror-image studies better reflects the population receiving LAIs in clinical practice.
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“In addition to the benefits of reduced treatment gaps with LAI versus oral antipsychotics, studies, particularly those in real-world samples, have demonstrated reduced psychopathology, relapses, hospitalizations, and mortality risk with LAI formulations [98–104].”
From Pharmacokinetic Characteristics of Long-Acting Injectable Antipsychotics for Schizophrenia: An Overview (2021) · cites this paper as [98]
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Long-Acting Injectable Antiretroviral Agents for HIV Treatment and Prevention
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“PLWH has overcome the treatment fatigue with the help of psychiatrists and would prefer therapeutic alternatives [3-6].”
BackgroundBai, Y., Wang, W., Xu, J., Zhang, F., Yu, H., Luo, C., Wang, L., Chen, X., Shan, B., Xu, L., et al. (2016) · Psychiatry Research Neuroimaging · doi:10.1016/j.pscychresns.2016.10.008 · Cited by 15
“As a newly available, long-acting, injectable antipsychotic, paliperidone palmitate injection (PAL) may show an advantage to improve adherence (Kane, 2006) and relapse prevention (Kishimoto et al., 2013) in patients than oral formulations for treating schizophrenia.”
Emsley, R. A., Parellada, E., Bioque, M., Herrera, B., Hernando, T., & Dorado, M. G. (2017) · International Clinical Psychopharmacology · doi:10.1097/yic.0000000000000195 · Cited by 15
“Therefore, there is a general agreement that more pragmatic clinical trials and observational studies are required to show how LAI antipsychotics perform in real-life settings (Haddad et al., 2011; Rossi et al., 2012; Kane et al., 2013; Kishimoto et al., 2013, 2014).”
BackgroundPerceptions of Psychiatrists Toward the Use of Long-Acting Injectable Antipsychotics
Grover, S., Sahoo, S., & Mehra, A. (2019) · Journal of Clinical Psychopharmacology · doi:10.1097/jcp.0000000000001109 · Cited by 15
Misawa, F., Okumura, Y., Takeuchi, Y., et al. (2021) · Schizophrenia Research · doi:10.1016/j.schres.2021.02.016 · Cited by 15
Pietrini, F., Spadafora, M., Tatini, L., Talamba, G. A., Andrisano, C., Boncompagni, G., Manetti, M., Ricca, V., & Ballerini, A. (2016) · European Psychiatry · doi:10.1016/j.eurpsy.2016.05.008 · Cited by 15
“This result, together with the reported superiority of LAI-AMT over oral-AMT in reducing rehospitalization rates [20,49], could lead to consider LAI antipsychotic treatment as a first-line treatment of early episodes of psychotic disorders, rather than reserved for the last stages [50–55].”
ResultSouaiby, L., Gauthier, C., Rieu, C., Krebs, M., Advenier-Iakovlev, E., & Raphaël Gaillard, B. (2017) · Schizophrenia Research · doi:10.1016/j.schres.2017.01.036 · Cited by 16
“On the other hand, switching to an antipsychotic long-acting injectable (LAI) is frequently recommended to ensure adherence (Kishimoto et al., 2013; Leucht et al., 2011;Malla et al., 2013).”
Lee, D., Lee, B. C., Choi, S., et al. (2020) · Clinical Psychopharmacology and Neuroscience · doi:10.9758/cpn.2020.18.2.303 · Cited by 15
“PP has a half-life of 25−49 days and is administered to patients by healthcare professionals on a monthly basis, which aids in treatment adherence and thereby reduces the relapse and hospitalization rates [8,9].”
BackgroundLong-acting injectable antipsychotics for the treatment of schizophrenia in Spain
Arango, C., Baeza, I., Bernardo, M., Cañas, F., de Dios, C., Díaz-Marsá, M., García-Portilla, M., Gutiérrez-Rojas, L., Olivares, J., Rico-Villademoros, F., et al. (2019) · Revista de Psiquiatría y Salud Mental (English Edition) · doi:10.1016/j.rpsmen.2018.03.004 · Cited by 28
Engineered PLGA microspheres for extended release of brexpiprazole: in vitro and in vivo studies
Wu, B., Wu, L., He, Y., Yin, Z., & Deng, L. (2021) · Drug Development and Industrial Pharmacy · doi:10.1080/03639045.2021.1934859 · Cited by 14
Pappa, S., Barnett, J., & Mason, K. (2022) · CNS Drugs · doi:10.1007/s40263-022-00976-4 · Cited by 14
Effectiveness of long-acting paliperidone palmitate in borderline personality disorder
Palomares, N., Montes, A., Díaz‐Marsá, M., & Carrasco, J. L. (2015) · International Clinical Psychopharmacology · doi:10.1097/yic.0000000000000095 · Cited by 14
“In terms of adherence to treatment in patients with schizophrenia, several studies have suggested that long-acting injectable antipsychotic therapy reduces relapse rates (Hough et al., 2010; Kishimoto et al., 2013; Leucht et al., 2013) and enhances adherence to treatment (Cañas et al., 2013).”
BackgroundSi, T., Zhang, L., Li, J., Zhao, Y.-J., & Su, Y. (2016) · Neuropsychiatric Disease and Treatment · doi:10.2147/ndt.s64672 · Cited by 14
“34,43,44 The studies on PP were fewer than those on paliperidone ER; a People’s Republic of China international survey in 2012 showed that only 2.75% of patients with schizophrenia use LAI antipsychotics, and only 0.48% use atypical LAIs.”
InfluentialMauri, M. C., Paletta, S., Pace, C. D., Reggiori, A., Rovera, C., Fiorentini, A., & Altamura, C. A. (2017) · Pharmacopsychiatry · doi:10.1055/s-0037-1601396 · Cited by 14
Si, T., Zhuo, J., Turkoz, I., Mathews, M., Tan, W., & Feng, Y. (2017) · Expert Opinion on Pharmacotherapy · doi:10.1080/14656566.2017.1401608 · Cited by 14
“A large meta-analysis has also demonstrated the superiority of LAIs in reducing the risk of hospitalizations [25].”
BackgroundLong-Acting Injectable Antipsychotic Medications in Pregnancy: A Review
O’Sullivan, D. L., Byatt, N., & Dossett, E. C. (2021) · Journal of the Academy of Consultation-Liaison Psychiatry · doi:10.1016/j.jaclp.2021.08.011 · Cited by 14
The pharmacological treatment of schizophrenia: how far have we come?
Rubio, J. M., & Kane, J. M. (2022) · Psychiatry and Clinical Neurosciences Reports · doi:10.1002/pcn5.13 · Cited by 13
“76 In addition, the clinical trial itself changes the ecology of care and might promote better adherence in the control condition than usual care.”
BackgroundBernardo, M., Cañas, F., Herrera, B., & Dorado, M. G. (2017) · Revista de Psiquiatría y Salud Mental (English Edition) · doi:10.1016/j.rpsmen.2017.05.008 · Cited by 13
The safety, efficacy and tolerability of Abilify Maintena for the treatment of schizophrenia
Kahn, R. S., & Giannopoulou, A. (2015) · Expert Review of Neurotherapeutics · doi:10.1586/14737175.2015.1070670 · Cited by 13
“But given the possible biases in mirror-image studies, a cautious consideration would be recommended [29,30].”
BackgroundOya, K., Kishi, T., & Iwata, N. (2015) · Neuropsychiatric Disease and Treatment · doi:10.2147/ndt.s91397 · Cited by 13
“A mirror image study of risperidone as LAI found strong superiority over OAP regarding relapse prevention as measured by hospitalization rate.(11) Aripiprazole once monthly (AOM) is a newer LAI regimen, and four recent randomized controlled trials (RCTs) have evaluated AOM efficacy and safety.”
Cordiner, M., Shajahan, P., McAvoy, S., Bashir, M., & Taylor, M. (2016) · Therapeutic Advances in Psychopharmacology · doi:10.1177/2045125315623168 · Cited by 16
Bioque, M., & Bernardo, M. (2018) · Expert Opinion on Pharmacotherapy · doi:10.1080/14656566.2018.1515915 · Cited by 14
“iority in preventing hospitalizations of depot formulation to their oral antipsychotics [9,17].”
Background
Metadata
- Authors
- Kishimoto, T., Nitta, M., Borenstein, M., Kane, J. M., & Correll, C. U.
- Affiliations
- Keio University (JP)
- Sumitomo Dainippon Pharma (Japan) (JP)
- Biostat (United States) (US)
- Zucker Hillside Hospital (US)
- Corresponding author
- Correll, Christoph U.
- Venue
- The Journal of Clinical Psychiatry
- Publisher
- Physicians Postgraduate Press, Inc
- Published
- 2013-10-15
- Volume
- 74
- Issue
- 10
- Pages
- 957-965
- ISSN
- 0160-6689 (ISSN-L)
- OpenAlex
- W2088866491
- Cited by
- 427
- References
- 0
- Citations by year
- 2026: 10 · 2025: 19 · 2024: 18 · 2023: 20 · 2022: 42 · 2021: 53 · 2020: 36 · 2019: 44 · 2018: 37 · 2017: 41 · 2016: 45 · 2015: 37 · 2014: 23 · 2013: 1
- FWCI
- 25.04
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Clinical Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institute of Mental Health (P30MH090590)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Social Sciences › Psychology › Clinical Psychology › Psychiatric care and mental health services
- Social Sciences › Psychology › Clinical Psychology › Historical Psychiatry and Medical Practices
- Keywords
- long-acting injectable antipsychotics, oral antipsychotics, schizophrenia, hospitalization, relapse prevention, mirror-image study, medication adherence, real-world effectiveness, length of hospital stay, antipsychotic adverse effects, antipsychotic switching, antipsychotic discontinuation
- MeSH terms
- Administration, Oral, Delayed-Action Preparations, Humans, Injections, Psychiatric Status Rating Scales, Schizophrenia, Antipsychotic Agents, Drug Monitoring, Patient Selection, Medication Adherence, Secondary Prevention, Comparative Effectiveness Research
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