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Factors associated with first- versus second-generation long-acting antipsychotics prescribed under ordinary clinical practice in Italy.

ABSTRACT: BACKGROUND:For many years, long-acting intramuscular (LAI) antipsychotics have been prescribed predominantly to chronic and severe patients, as a last resort when other treatments failed. Recently, a broader and earlier use of LAIs, particularly second-generation LAIs, has been emphasized. To date, few studies attempted to frame how this change in prescribing took place in real-world practice. Therefore, this study aimed to describe the clinical features of patients prescribed with LAIs, and to explore possible prescribing differences between first- and second-generations LAIs under ordinary clinical practice in Italy. METHODS:The STAR Network "Depot" Study is an observational, longitudinal, multicenter study involving 35 centers in Italy. In the cross-sectional phase, patients prescribed with LAIs were consecutively recruited and assessed over a period of 12 months. Descriptive statistics and multivariable logistic regression analyses were employed. RESULTS:Of the 451 recruited patients, 61% were males. The level of social and working functioning was heterogeneous, as was the severity of disease. Seventy-two per cent of the patients had a diagnosis of the schizophrenia spectrum. Seventy per cent were prescribed with second-generation antipsychotic (SGA) LAIs (mostly paliperidone, aripiprazole and risperidone). Compared to first-generation antipsychotic (FGA) LAIs, patients prescribed with SGA LAIs were more often younger; employed; with a diagnosis of the schizophrenia spectrum or bipolar disorder; with higher levels of affective symptoms; with fewer LAI prescriptions in the past. DISCUSSION:LAIs' prescribing practices appear to be more flexible as compared to the past, although this change is mostly restricted to SGA LAIs.

SUBMITTER: Ostuzzi G

PROVIDER: S-EPMC6072022 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Factors associated with first- versus second-generation long-acting antipsychotics prescribed under ordinary clinical practice in Italy.

Ostuzzi Giovanni G Mazzi Maria Angela MA Terlizzi Samira S Bertolini Federico F Aguglia Andrea A Bartoli Francesco F Bortolaso Paola P Callegari Camilla C Caroleo Mariarita M Carrà Giuseppe G Corbo Mariangela M D'Agostino Armando A Gastaldon Chiara C Lucii Claudio C Magliocco Fabio F Martinotti Giovanni G Nosé Michela M Ostinelli Edoardo Giuseppe EG Papola Davide D Piccinelli Marco Piero MP Piccoli Alberto A Purgato Marianna M Tabacchi Tommaso T Turrini Giulia G Ruggeri Mirella M Barbui Corrado C

PloS one 20180802 8

<h4>Background</h4>For many years, long-acting intramuscular (LAI) antipsychotics have been prescribed predominantly to chronic and severe patients, as a last resort when other treatments failed. Recently, a broader and earlier use of LAIs, particularly second-generation LAIs, has been emphasized. To date, few studies attempted to frame how this change in prescribing took place in real-world practice. Therefore, this study aimed to describe the clinical features of patients prescribed with LAIs, ...[more]

PMID: 30071042

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Project description:Few controlled trials compared second-generation antipsychotics (SGAs) with first-generation antipsychotics (FGAs) regarding relapse prevention in schizophrenia. We conducted a systematic review/meta-analysis of randomized trials, lasting ?6 months comparing SGAs with FGAs in schizophrenia. Primary outcome was study-defined relapse; secondary outcomes included relapse at 3, 6 and 12 months; treatment failure; hospitalization; and dropout owing to any cause, non-adherence and intolerability. Pooled relative risk (RR) (±95% confidence intervals (CIs)) was calculated using random-effects model, with numbers-needed-to-treat (NNT) calculations where appropriate. Across 23 studies (n=4504, mean duration=61.9±22.4 weeks), none of the individual SGAs outperformed FGAs (mainly haloperidol) regarding study-defined relapse, except for isolated, single trial-based superiority, and except for risperidone's superiority at 3 and 6 months when requiring ?3 trials. Grouped together, however, SGAs prevented relapse more than FGAs (29.0 versus 37.5%, RR=0.80, CI: 0.70-0.91, P=0.0007, I(2)=37%; NNT=17, CI: 10-50, P=0.003). SGAs were also superior regarding relapse at 3, 6 and 12 months (P=0.04, P<0.0001, P=0.0001), treatment failure (P=0.003) and hospitalization (P=0.004). SGAs showed trend-level superiority for dropout owing to intolerability (P=0.05). Superiority of SGAs regarding relapse was modest (NNT=17), but confirmed in double-blind trials, first- and multi-episode patients, using preferentially or exclusively raw or estimated relapse rates, and for different haloperidol equivalent comparator doses. There was no significant heterogeneity or publication bias. The relevance of the somewhat greater efficacy of SGAs over FGAs on several key outcomes depends on whether SGAs form a meaningful group and whether mid- or low-potency FGAs differ from haloperidol. Regardless, treatment selection needs to be individualized considering patient- and medication-related factors.

Project description:Psychotic disorders are characterized by significant deficits in attentional control, but the neurobiological mechanisms underlying these deficits early in the course of illness prior to extensive pharmacotherapy are not well understood. Moreover, little is known regarding the symptom and brain changes associated with amelioration of attentional impairments through antipsychotic pharmacotherapy. In this study 14 male patients experiencing a first-episode of psychosis with minimal prior antipsychotic treatment completed an attentional control task while undergoing functional magnetic resonance imaging at the onset of treatment with a second generation antipsychotic (risperidone or aripiprazole) in a double blind randomized clinical trial and then again following approximately 12 weeks of treatment. In addition, 14 age-, and performance-matched healthy male volunteers who were not treated completed the same task at a baseline timepoint and then again following 12 weeks. Patients showed significantly greater activation than healthy volunteers in the right globus pallidus, left thalamus, and right thalamus at the time of the baseline scan. Among patients there was a significant reduction in right globus pallidus blood-oxygen level dependent (BOLD) response following antipsychotic treatment that correlated significantly with improvement in response accuracy and reductions in thought disturbance. No changes in globus pallidus activation were observed in healthy volunteers over this time period. These preliminary findings suggest that improvement in attentional control and concomitant reductions in thought disturbance in first-episode psychosis may be associated with reductions in subcortical activity following administration of second-generation antipsychotics early in the course of illness. These findings have implications for understanding how changes in basal ganglia activity may be linked to improvements in attentional control through antipsychotics.

Project description:BackgroundSchizophrenia is a severe condition that affects approximately 1% of the population. Certain elements of antipsychotic treatment can only be examined in large population, thus the need for population-based real-world analyses has been increasing.Patients and methodsHungarian National Health Fund database includes all healthcare data of the population of Hungary. All patients diagnosed with schizophrenia between 01.01.2006 and 31.12.2015 were included in the study. We analyzed all patients with newly initiated second-generation antipsychotic during the inclusion period (01.01.2012-31.12.2013). Patients were followed for 2 years. All-cause treatment discontinuation served as the primary outcome of the study. Patients with newly initiated long-acting injectable treatments were further investigated in stratified analyses based on their previous treatment.Results106,624 patients had schizophrenia diagnosis during the study period. 12,232 patients met the inclusion criteria for newly initiating second-generation antipsychotic during the inclusion period. The proportion of patients still on treatment after 1 year for oral treatments varied between 17% (oral risperidone) and 31% (oral olanzapine) while the analogous data for long acting injectables were between 32% (risperidone long acting) and 64% (paliperidone long acting one monthly). The 2-year data were similarly in favor of long-actings. Median time to discontinuation in the oral group varied between 57 days (clozapine) and 121 days (olanzapine). The median time to discontinuation for long-actings was significantly longer: between 176 and 287 days; in case of paliperidone long acting, median was not reached during the observation period. Patients receiving long-acting treatment switched from another long-acting remained on the newly initiated treatment significantly longer than those switched from orals.ConclusionOur results indicate the superiority of second generation long-acting antipsychotics with regard to rates of treatment discontinuation and periods of persistence to the assigned medication.

Project description:Because early treatment choice is critical in first-episode schizophrenia-spectrum disorders (FES), this meta-analysis compared efficacy and tolerability of individual second-generation antipsychotics (SGAs) with first-generation antipsychotics (FGAs) in FES. We conducted systematic literature search (until 12 December 2010) and meta-analysis of acute, randomized trials with ?1 FGA vs. SGA comparison; patients in their first episode of psychosis and diagnosed with schizophrenia-spectrum disorders; available data for psychopathology change, treatment response, treatment discontinuation, adverse effects, or cognition. Across 13 trials (n = 2509), olanzapine (seven trials) and amisulpride (one trial) outperformed FGAs (haloperidol: 9/13 trials) in 9/13 and 8/13 efficacy outcomes, respectively, risperidone (eight trials) in 4/13, quetiapine (one trial) in 3/13 and clozapine (two trials) and ziprasidone (one trial) in 1/13, each. Compared to FGAs, extrapyramidal symptom (EPS)-related outcomes were less frequent with olanzapine, risperidone and clozapine, but weight gain was greater with clozapine, olanzapine and risperidone. Pooled SGAs were similar to FGAs regarding total psychopathology change, depression, treatment response and metabolic changes. SGAs significantly outperformed FGAs regarding lower treatment discontinuation, irrespective of cause, negative symptoms, global cognition and less EPS and akathisia, while SGAs increased weight more (p < 0.05-0.01). Results were not affected by FGA dose or publication bias, but industry-sponsored studies favoured SGAs more than federally funded studies. To summarize, in FES, olanzapine, amisulpride and, less so, risperidone and quetiapine showed superior efficacy, greater treatment persistence and less EPS than FGAs. However, weight increase with olanzapine, risperidone and clozapine and metabolic changes with olanzapine were greater. Additional FES studies including broader-based SGAs and FGAs are needed.

Project description:BackgroundPrevious studies have reported an increased risk of stroke in patients taking antipsychotics. However, most of these studies have been conducted in the elderly population.ObjectiveWe estimated stroke risk in new users of any first-generation antipsychotic or haloperidol, vs second-generation antipsychotics among patients aged 18-64 years without a recent dementia diagnosis and, separately, regardless of a recent dementia diagnosis.MethodsData were obtained from IBM MarketScan® Commercial Database (1 January, 2001-31 December, 2017). Among new users without a recent dementia diagnosis, stroke risk for first-generation antipsychotics (FGAw/oD cohort) or haloperidol (HALw/oD cohort) was compared with second-generation antipsychotics (SGAw/oD cohort). A similar comparison was conducted among new users regardless of dementia diagnosis: first-generation antipsychotics (FGA cohort) or haloperidol (HAL cohort) vs second-generation antipsychotics (SGA cohort). Crude incident stroke rates within each cohort were determined. For hazard ratios, three propensity score matching strategies were used: unadjusted (crude), Sentinel propensity score strategy, and large-scale regularized regression model (adapted propensity score strategy).ResultsEach cohort included ≥12,000 patients. The incident rates for stroke per 1000 person-years were 3.10 (FGAw/oD), 5.99 (HALw/oD), 0.85 (SGAw/oD), 3.14 (FGA), 6.12 (HAL), and 0.90 (SGA). Pre-planned analysis with adapted propensity score strategy matching yielded calibrated hazard ratios for stroke: FGAw/oD vs SGAw/oD: 2.05 (calibrated confidence interval 1.13-3.89); HALw/oD vs SGAw/oD: 2.47 (1.14-5.48), FGA vs SGA: 1.64 (0.94-2.97), and HAL vs SGA: 1.98 (0.99-4.00). A post-hoc sensitivity analysis to address potential bias introduced by the 2015 change from the International Classification of Diseases, Ninth Revision to the International Classification of Diseases, Tenth Revision yielded calibrated hazard ratios for FGAw/oD vs SGAw/oD: 1.59 (0.87-3.01), HALw/oD vs SGAw/oD: 2.79 (1.24-6.42), FGA vs SGA: 1.41 (0.79-2.62), and HAL vs SGA: 3.47 (1.63-7.92).ConclusionsAmong adults aged ≤64 years, without a recent dementia diagnosis, stroke risk is higher among those exposed to haloperidol compared with those exposed to second-generation antipsychotics.

Dataset Information

Factors associated with first- versus second-generation long-acting antipsychotics prescribed under ordinary clinical practice in Italy.

Publications

Factors associated with first- versus second-generation long-acting antipsychotics prescribed under ordinary clinical practice in Italy.

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