Oral versus depot antipsychotic drugs for schizophrenia—A critical systematic review and meta-analysis of randomised long-term trials

Leucht, Claudia; Heres, Stephan; Kane, John M.; Kissling, Werner; Davis, John M.; Leucht, Stefan

doi:10.1016/j.schres.2010.11.020

Cited by 378 publications

(304 citation statements)

References 36 publications

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“…Leucht et al (2011) could identify only 10 randomized studies that compared intramuscular depot with oral formulations of antipsychotic drugs in people with schizophrenia or related disorders in long-term studies defined as 1 year or longer (Leucht et al, 2011). A more recent metaanalysis including 21 randomized controlled studies (RCTs) found that oral and depot formulations of antipsychotics were similar for relapse prevention and the authors emphasized, that RCTs are less representative of real-world patients than naturalistic studies and called for further studies with ''real word'' patients (Kishimoto et al, 2013).…”

Section: Introductionmentioning

confidence: 99%

Comparative effectiveness of depot and oral second generation antipsychotic drugs in schizophrenia: A nationwide study in Hungary

Bitter

Katona²,

Zámbori³

et al. 2013

European Neuropsychopharmacology

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We conducted a nationwide, full-population based investigation to evaluate the comparative effectiveness of all marketed second generation antipsychotic drugs (SGA) prescribed for outpatients with the diagnosis of schizophrenia in Hungary. Using the national central register, our observational follow-up study included all patients with schizophrenia or related disorder between 01/01/2006 and 30/06/2008. The study cohort comprised 9567 patients who started new SGA during the inclusion period (01/07/2007-30/06/2008). All-cause medication discontinuation of 8 SGAs (1 depot and 7 oral formulations) marketed during the inclusion period, and the time to all-cause discontinuation were the main outcomes. Statistical models included the Kaplan-Meier and the Cox proportional hazards models with propensity score adjustment. Patients treated with a depot formulation risperidone had the longest time to discontinuation with a median of 215 days (95%CI:181-242 days), which was statistically significantly different compared to patients treated with the rest of the medications: E-mail address: czobor.pal@med.semmelweis-univ.hu (P. Czobor). 1 Istvan Bitter MD, PhD and Lajos Katona MS are co-first authors contributed equally to the article. 2 At the time of beginning of the study he worked as a psychiatry expert for NHIF.European Neuropsychopharmacology (2013Neuropsychopharmacology ( ) 23, 1383Neuropsychopharmacology ( -1390 with patients who were discharged from their first hospitalization for schizophrenia (Tiihonen et al., 2006(Tiihonen et al., , 2011; namely the median times to all-cause medication discontinuation were o120 days for the majority of the oral SGA. In terms of medication differences, our data support the superior effectiveness of the depot formulation regarding all-cause discontinuation, followed by olanzapine at the efficacy rank order.

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Section: Introductionmentioning

confidence: 99%

Comparative effectiveness of depot and oral second generation antipsychotic drugs in schizophrenia: A nationwide study in Hungary

Bitter

Katona²,

Zámbori³

et al. 2013

European Neuropsychopharmacology

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“…Remarkably, similar considerations apply to the whole evidence base on LAIs. There are interesting pharmacokinetic features of LAIs that may suggest potential advantages over oral antipsychotics (Ereshefsky & Mascarenas, 2003;Moncrieff, 2006), however systematic reviews of clinical trial data, including a recent meta-analysis of randomised trials comparing oral v. LAIs of the same antipsychotic drug, failed to find any differences in terms of efficacy or tolerability (Leucht et al 2011;Kishimoto et al 2014;Misawa et al 2016). Another expected advantage of LAIs would be better treatment adherence.…”

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confidence: 99%

New EMA report on paliperidone 3-month injections: taking clinical and policy decisions without an adequate evidence base

Ostuzzi

Papola

Gastaldon

et al. 2016

Epidemiol Psychiatr Sci

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This Section of Epidemiology and Psychiatric Sciences appears in each issue of the Journal to stress the role of the epidemiological approach to promote advances in the field of clinical psychopharmacology, with a particular attention to controversial findings. The ultimate aims are to help develop a more critical attitude towards the results of research studies published in the international literature, to promote original research projects with higher methodological standards, and to implement the most relevant results of research in every-day clinical practice. These contributions are written in house by the journal's editorial team or commissioned by the Section Editor (no more than 1000 words, short unstructured abstract, 4 key-words, one Table or Three-month long-acting paliperidone is a new, recently marketed, formulation of paliperidone, characterised by the longest available dosing interval among long-acting antipsychotics. The clinical profile of 3-month long-acting paliperidone was recently summarised by the European Medicines Agency (EMA) in a public assessment report, released in April 2016. In this commentary, the main strengths and limitations of the EMA assessment report were appraised and discussed, in order to highlight possible implications for clinical practice, future research and regulatory practices for drug approval. In April 2016, the European Medicines Agency (EMA) released a public assessment report on paliperidone palmitate 3-month injections (PP3M), a new longacting injectable (LAI) formulation of paliperidone that requires an injection once every third month. This new formulation adds to other two already in use formulations: an oral prolonged-release tablet formulation, and a 1-month long-acting formulation (PP1M). The EMA document reported a positive opinion for granting a marketing authorisation for four new strengths of PP3M, with an indication for the maintenance treatment of schizophrenia in adult patients who have been adequately treated with PP1M (European Medicines Agency, Committee for Medicinal Products for Human Use, 2016). The main innovation of PP3M relies in a much slower release in the bloodstream as compared with PP1M. This Commentary critically appraises the clinical data reported in the EMA document, and attempts to identify some of the challenging issues related to the use of PP3M in everyday practice.The EMA report covers two randomised studies: one phase-3, randomised, double-blind, placebocontrolled trial comparing PP3M v. placebo (Berwaerts et al. 2015), and one phase-3, randomised, double-blind, head-to-head, non-inferiority trial, comparing PP3M v. PP1M (Savitz et al. 2016).The placebo-controlled trial included 305 randomised subjects in the double-blind phase and showed the superiority of PP3M over placebo in terms of relapse prevention (hazard ratio (HR) 3.45; 95% * Address for correspondence: Dr G. Ostuzzi, Section of Psychiatry, University of Verona, Ospedale Policlinico GB Rossi, Piazzale L.A. Scuro, 10 -37134 Verona, Italy.(Email: giovanni.ostuzzi@gm...

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“…Indeed, less than 30% of patients with schizophrenia are currently treated with LAIs. 2 There is a widespread belief that LAIs have more and even worse adverse effects than their equivalent oral preparations. Although there is support for this notion in the literature, 3 a recent review of randomized controlled studies has shown that, whereas some of the LAIs currently available may cause similar or more severe side effects, others such as risperidone have similar or even milder side-effect profiles than their oral counterparts.…”

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confidence: 99%

“…5 Recent evidence has shown that LAIs are more effective in preventing both relapse and re-hospitalization when compared with oral medications. 2 Furthermore, the availability of depot medication gives psychiatrists the opportunity to readily identify non-adherence to treatment and to reduce the risk of self-intoxication by inappropriate medication use. 2 A large body of clinical and neurobiological evidence has shown that psychotic relapse is associated with brain volume reductions and clinical deterioration.…”

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confidence: 99%

“…2 Furthermore, the availability of depot medication gives psychiatrists the opportunity to readily identify non-adherence to treatment and to reduce the risk of self-intoxication by inappropriate medication use. 2 A large body of clinical and neurobiological evidence has shown that psychotic relapse is associated with brain volume reductions and clinical deterioration. This effect is particularly important in the years following the first psychotic episode.…”

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confidence: 99%

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Why we should use long-acting injectable antipsychotics more frequently

Maia‐de‐Oliveira

Bressan

Elkis³

et al. 2013

Rev. Bras. Psiquiatr.

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Oral versus depot antipsychotic drugs for schizophrenia—A critical systematic review and meta-analysis of randomised long-term trials

Cited by 378 publications

References 36 publications

Comparative effectiveness of depot and oral second generation antipsychotic drugs in schizophrenia: A nationwide study in Hungary

Comparative effectiveness of depot and oral second generation antipsychotic drugs in schizophrenia: A nationwide study in Hungary

New EMA report on paliperidone 3-month injections: taking clinical and policy decisions without an adequate evidence base

Why we should use long-acting injectable antipsychotics more frequently

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