scholarly journals Long-term Remission in Schizophrenia and Schizoaffective Disorder: Results from the Risperidone Long-acting Injectable Versus Quetiapine Relapse Prevention Trial (constatre)

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1 ◽  
Author(s):  
E. Smeraldi ◽  
R. Cavallaro ◽  
V. Folnegovic Smalc ◽  
L. Bidzan ◽  
E. Ceylan ◽  
...  
Keyword(s):  
Adverse Events ◽  
Schizoaffective Disorder ◽  
Relapse Prevention ◽  
Package Insert ◽  
Prevention Trial ◽  
Treatment Groups ◽  
Conventional Antipsychotics ◽  
Full Remission ◽  
Long Acting

Objective:To report the long-term remission results from the relapse prevention trial (ConstaTRE) in stable patients treated either with risperidone long-acting injectable (RLAI) or the oral atypical antipsychotic quetiapine.Methods:Clinically stable adults with schizophrenia or schizoaffective disorder treated with oral risperidone, olanzapine, or oral conventional antipsychotics were randomized to treatment with RLAI or oral quetiapine. Dosing was according to package-insert recommendation. Efficacy and tolerability were recorded for up to 24 months of treatment. Remission was defined as achieving and maintaining mild or less symptoms of schizophrenia over a 6-month period as defined by Andreasen et al, (2005).Results:710 patients were randomized (n=355 per group) to either RLAI or quetiapine. Demographics were similar between treatment groups. Relapse occurred in 54 RLAI (16.5%) and 102 quetiapine (31.3%) patients (p< 0.001). Full remission was achieved by 51% RLAI and 39% of quetiapine-treated patients (p=0.003) and was maintained until the end of the trial by 44% of RLAI and 31% of quetiapine patients. Mean duration of full remission was 540.8±181.4 and 508.1±188.0 days for RLAI and quetiapine groups, respectively (p=0.1325). Tolerability was similar between treatment groups. Most adverse events (AEs) were transient. Six RLAI and 10 quetiapine patients discontinued study treatment due to AEs.Conclusions:Among stable patients with schizophrenia or schizoaffective disorder, remission was more likely to occur in patients switching to RLAI when compared with quetiapine. both RLAI and quetiapine treatments were well tolerated.

Descriptive Analyses of the Aripiprazole Arm in the Risperidone Long-acting Injectable Versus Quetiapine Relapse Prevention Trial (constatre)

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1
Author(s):  
R. de Arce ◽  
E. Eding ◽  
J. Marques-Teixeira ◽  
V. Milanova ◽  
E. Rancans ◽  
...  
Keyword(s):  
Schizoaffective Disorder ◽  
Relapse Prevention ◽  
Descriptive Analysis ◽  
Prevention Trial ◽  
Open Label ◽  
Treatment Groups ◽  
Full Remission ◽  
Kaplan Meier ◽  
Long Acting ◽  
Time To Relapse

Objective:A recent randomized, open-label, relapse prevention trial (ConstaTRE) of risperidone long-acting injectable (RLAI) versus quetiapine and the oral atypical antipsychotic aripiprazole was carried out. Here we report the descriptive analysis of the aripiprazole arm.Methods:Clinically stable adults with schizophrenia or schizoaffective disorder previously treated with oral risperidone, olanzapine, or oral conventional antipsychotic were randomized to treatment with RLAI, quetiapine, or aripiprazole (in some countries). Efficacy and tolerability were monitored for up to 24 months of treatment.Results:A total of 45 patients were treated with aripiprazole (10-30 mg/day) and 329 patients with RLAI. Relapse occurred in 27.3% aripiprazole and 16.5% RLAI-treated patients. Kaplan-Meier estimates of mean relapse-free period were 314 versus 607 days for aripiprazole and RLAI patients, respectively. Full-remission, as defined by Andreasen et al, (2005), was achieved by 34% aripiprazole and 51% RLAI patients and was maintained until the end of the trial by 30% aripiprazole and 44% RLAI patients. According to Clinical Global Impression-Severity, there were 61% aripiprazole and 62% RLAI patients moderately ill or worse at baseline, and 59% aripiprazole and 45% RLAI at endpoint, respectively. Tolerability was generally similar between aripiprazole and RLAI treatment groups. However, weight gain, extrapyramidal adverse events (AEs), and possibly prolactin-related AEs were more common with RLAI treatment. Gastrointestinal disorders were more common in aripiprazole-treated patients.Conclusions:Time-to-relapse in stable patients with schizophrenia or schizoaffective disorder tended to be longer in RLAI-treated patients when compared with aripiprazole-treated patients. both RLAI and aripiprazole treatments were generally well tolerated.

scholarly journals Long-term remission in schizophrenia and schizoaffective disorder: results from the risperidone long-acting injectable versus quetiapine relapse prevention trial (ConstaTRE)

2013 ◽  
Vol 3 (4) ◽  
pp. 191-199 ◽  
Author(s):  
Enrico Smeraldi ◽  
Roberto Cavallaro ◽  
Vera Folnegović-Šmalc ◽  
Leszek Bidzan ◽  
Mehmet Emin Ceylan ◽  
...  
Keyword(s):  
Schizoaffective Disorder ◽  
Relapse Prevention ◽  
Prevention Trial ◽  
Long Acting

scholarly journals Relapse Prevention in Schizophrenia and Schizoaffective Disorder with Risperidone Long-Acting Injectable vs Quetiapine: Results of a Long-Term, Open-Label, Randomized Clinical Trial

2010 ◽  
Vol 35 (12) ◽  
pp. 2367-2377 ◽  
Author(s):  
Wolfgang Gaebel ◽  
Andreas Schreiner ◽  
Paul Bergmans ◽  
Rosario de Arce ◽  
Frédéric Rouillon ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Schizoaffective Disorder ◽  
Relapse Prevention ◽  
Open Label ◽  
Long Acting

Functional recovery results from the risperidone long-acting injectable versus quetiapine relapse prevention trial (ConstaTRE)

2013 ◽  
Vol 25 (5) ◽  
pp. 297-306 ◽  
Author(s):  
Frédéric Rouillon ◽  
Lars Eriksson ◽  
Benjaminas Burba ◽  
Jiri Raboch ◽  
Georgios Kaprinis ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Functional Recovery ◽  
Schizoaffective Disorder ◽  
Relapse Prevention ◽  
Short Form ◽  
Prevention Trial ◽  
Antipsychotic Treatment ◽  
Quality Of Life Scale ◽  
Long Acting

ObjectiveConstaTRE is an open-label, randomised, controlled, relapse prevention trial in patients with stable schizophrenia or schizoaffective disorder switched to risperidone long-acting injectable (RLAI) or oral quetiapine, and was designed to test the hypothesis that injectable antipsychotic treatment with risperidone would be more effective than oral therapy with quetiapine. Here we report the functional recovery results from the ConstaTRE trial.MethodsClinically stable adults previously treated with oral risperidone, olanzapine, or oral first-generation antipsychotics were randomised to RLAI or quetiapine for 24 months. Functional recovery was assessed using the Social and Occupational Functioning Assessment Scale (SOFAS) and two quality-of-life (QoL) measures [Medical Outcomes Survey Short Form-12 (SF-12) and Schizophrenia Quality-of-Life Scale Revision 4 (SQLS-R4)].ResultsA total of 666 patients were randomised and treated with RLAI (n = 329) or quetiapine (n = 337). Relapse occurred in 16.5% RLAI and 31.3% quetiapine patients. Significant improvements in SOFAS, SF-12, and SQLS-R4 scores were observed from baseline to month 24 with both RLAI and quetiapine. At months 6, and 12, and endpoint, improvement in SOFAS score was significantly greater for RLAI than quetiapine (p < 0.05).ConclusionsAmong patients with stable schizophrenia or schizoaffective disorder, the likelihood of functional recovery appears to be higher in those switching to RLAI than to quetiapine, although improvements in functional status and QoL were observed with both treatments.

scholarly journals Functional Recovery in Schizophrenia and Schizoaffective Disorder: Results from the Risperidone Long-acting Injectable Versus Quetiapine Relapse Prevention Trial (constatre)

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1 ◽  
Author(s):  
F. Rouillon ◽  
L. Eriksson ◽  
B. Burba ◽  
J. Raboch ◽  
G. Kaprinis ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Functional Recovery ◽  
Schizoaffective Disorder ◽  
Relapse Prevention ◽  
Short Form ◽  
Prevention Trial ◽  
Open Label ◽  
Quality Of Life Scale ◽  
Long Acting

Objective:To report the functional recovery results from an open-label, randomized-controlled, relapse prevention trial (ConstaTRE) in stable patients with schizophrenia or schizoaffective disorder treated with risperidone long-acting injectable (RLAI) or the oral atypical antipsychotic quetiapine.Methods:Clinically stable adults with schizophrenia or schizoaffective disorder previously treated with oral risperidone, olanzapine, or oral conventional antipsychotics were randomized to treatment with either RLAI (25 mg every-two-weeks) or quetiapine (300-400 mg/day) for 24 months. Functional recovery was assessed using the Social and Occupational Functioning Assessment Scale (SOFAS) and two quality-of-life (QoL) measures (Short -Form 12 [SF-12] and Schizophrenia Quality-of-Life Scale Revision 4 [SQLS-R4]).Results:710 subjects were randomized to treatment with RLAI or quetiapine (n=355 patients/group). Baseline demographics were similar between treatment groups. Relapse occurred in 16.5% RLAI and 31.3% quetiapine patients. A total of 105 RLAI and 107 quetiapine patients dropped out of the study for other reasons than relapse, most commonly due to withdrawal of consent. A significant improvement in SOFAS, SF-12, and SQLS-R4 scores was observed from baseline to month-24 with both RLAI and quetiapine. at months 6, 12, and endpoint, SOFAS had significantly increased more for RLAI than quetiapine (p< 0.05).Conclusions:Among stable patients with schizophrenia or schizoaffective disorder, the likelihood of functional recovery appears to be higher in those switching to RLAI. Improvement in functional status and QoL from baseline was observed with both RLAI and quetiapine.

scholarly journals Efficacy, Safety, and Durability of Long-Acting Cabotegravir and Rilpivirine in Adults With HIV-1 Infection: ~5-Year Results From the LATTE-2 Study

2021 ◽  
Author(s):  
Graham H R Smith ◽  
W Keith Henry ◽  
Daniel Podzamczer ◽  
Maria Del Mar Masiá ◽  
Christopher J Bettacchi ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Adverse Events ◽  
Maintenance Therapy ◽  
Comparable Efficacy ◽  
Maintenance Period ◽  
Injection Site Reactions ◽  
Long Acting ◽  
Hiv 1 ◽  
Extension Period

Abstract Background In the LATTE-2 phase IIb study, long-acting (LA) injectable cabotegravir + rilpivirine dosed every 8 weeks (Q8W) or 4 weeks (Q4W) demonstrated comparable efficacy with daily oral antiretroviral therapy (ART) through 96 weeks in ART-naive adults with HIV-1. Here we report efficacy, tolerability, and safety of cabotegravir + rilpivirine LA over ~5 years. Methods After 20 weeks of oral cabotegravir + abacavir/lamivudine, participants were randomized to cabotegravir + rilpivirine LA Q8W or Q4W or continue oral ART through the 96-week maintenance period. In the extension period through Week 256, participants continued their current LA regimen (randomized Q8W/Q4W groups) or switched from oral ART to Q8W or Q4W LA therapy (extension-switch groups). Endpoints assessed included proportion of participants with HIV-1 RNA &lt;50 copies/mL (Snapshot algorithm) and adverse events (AEs). Results At Week 256, 186 (81%) of 230 participants in randomized Q8W/Q4W groups and 41 (93%) of 44 participants in extension-switch groups had HIV-1 RNA &lt;50 copies/mL. No protocol-defined virologic failures occurred after Week 48. Injection-site reactions infrequently resulted in discontinuation (4 [2%] and 1 [2%] participants in randomized Q8W/Q4W and extension-switch groups, respectively). Three participants in randomized Q8W/Q4W groups experienced drug-related serious AEs, including 1 fatal serious AE (Q4W group); none occurred in extension-switch groups. Of 25 participants with AEs leading to withdrawal, 20 were in the randomized Q4W group; no AE leading to withdrawal occurred in &gt;1 participant. Conclusions Cabotegravir + rilpivirine LA exhibited long-term efficacy and tolerability, demonstrating its durability as maintenance therapy for HIV-1 infection (ClinicalTrials.gov, NCT02120352).

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