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Efficacy and safety of once-monthly Risperidone ISM^® in schizophrenic patients with an acute exacerbation.

ABSTRACT: To evaluate the efficacy and safety of Risperidone ISM^® against placebo in patients with acute exacerbation of schizophrenia. A multicenter, randomized, double-blind, placebo-controlled study was conducted between June 2017 and December 2018 (NCT03160521). Eligible patients received once-monthly intramuscular injections of Risperidone ISM^® (75 or 100?mg) or placebo for 12 weeks. The primary efficacy outcome was change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 12. The key secondary efficacy outcome was change from baseline in Clinical Global Impressions-Severity of Illness scale (CGI-S) score. Altogether, 438 patients were randomized (1:1:1) and 390 included in the modified ITT efficacy set. The PANSS total score (mean difference, 95% CI) improved significantly from baseline to day 85 with Risperidone ISM^® 75 and 100?mg, with placebo-adjusted differences of -13.0 (95% CI, -17.3 to -8.8); (p?® compared with placebo -0.7 (-1.0 to -0.5); p?® provided rapid and progressive reduction of symptoms in patients with acutely exacerbated schizophrenia without need of oral risperidone supplementation or loading doses. Both doses were safe and well tolerated.

SUBMITTER: Correll CU

PROVIDER: S-EPMC7688968 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Efficacy and safety of once-monthly Risperidone ISM® in schizophrenic patients with an acute exacerbation.

Correll Christoph U CU Litman Robert E RE Filts Yuriy Y Llaudó Jordi J Naber Dieter D Torres Ferran F Martínez Javier J

NPJ schizophrenia 20201125 1

To evaluate the efficacy and safety of Risperidone ISM® against placebo in patients with acute exacerbation of schizophrenia. A multicenter, randomized, double-blind, placebo-controlled study was conducted between June 2017 and December 2018 (NCT03160521). Eligible patients received once-monthly intramuscular injections of Risperidone ISM® (75 or 100 mg) or placebo for 12 weeks. The primary efficacy outcome was change in Positive and Negative Syndrome Scale (PANSS) total sc ...[more]

PMID: 33239746

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Project description:PURPOSE:Reducing the dosing frequency of antipsychotics (APs) with long-acting injectables (LAIs) such as once-monthly paliperidone palmitate (PP1M) can improve adherence and clinical outcomes for schizophrenia patients. This US study compared physical and psychiatric comorbidity-related outcomes, AP adherence, healthcare resource utilization (HRU), and costs pre- and post-transition to PP1M among schizophrenia patients treated with oral risperidone/paliperidone pre-PP1M transition. METHODS:Health insurance claims from the IQVIA™ PharMetrics Plus database (01/01/2012-07/31/2018) were used to identify adults with???2 schizophrenia diagnoses,???1 claim for PP1M, and???30 days of treatment with oral risperidone/paliperidone in the 60 days before the first PP1M claim (i.e., the index date). Comorbidity-related outcomes, adherence to APs (measured via the proportion of days covered [PDC]), all-cause per-patient-per-month (PPPM) HRU, and all-cause PPPM medical, pharmacy, and total costs (i.e., sum of medical and pharmacy costs) during the 6-month periods pre- and post-transition to PP1M were compared using generalized estimating equation models adjusted for repeated measurements. Analyses were replicated in the subset of patients with???1 all-cause inpatient stay pre-PP1M transition. FINDINGS:Among 427 schizophrenia patients transitioning from oral risperidone/paliperidone to PP1M, the mean age was 41.1 years and 37.9% were female. Following the PP1M transition, patients were less likely to have claims with a diagnosis for psychoses (odds ratio [OR] 0.41; P?<?0.001), hypertension (OR 0.80; P?=?0.011), depression (OR 0.70; P?<?0.001), drug abuse (OR 0.60; P?<?0.001), substance-related and addictive disorders (OR 0.73; P?=?0.003), bipolar and related disorders (OR 0.59; P?<?0.001), sleep-wake disorders (OR 0.68; P?=?0.017), anxiety disorders (OR 0.78; P?=?0.034), and other conditions that may require a focus of clinical attention (OR 0.58; P?<?0.001). Mean PDC by APs was higher post-PP1M (mean?=?0.81) versus pre-PP1M (mean?=?0.68) transition. Post-PP1M, patients were less likely to have an all-cause emergency room visit (OR 0.51; P?<?0.001) or inpatient stay (OR 0.39; P?<?0.001) compared to pre-PP1M. All-cause total healthcare costs remained similar post- versus pre-transition to PP1M (mean monthly cost difference [MMCD]?=?$228; P?=?0.260). Pharmacy costs increased post-PP1M (MMCD?=?$960; P?<?0.001), but were offset by decreasing medical costs (MMCD?=?- $732; P?<?0.001), largely driven by lower costs related to inpatient stays (MMCD?=?- $695; P?<?0.001) and emergency room visits (MMCD?=?- $63; P?<?0.001). For patients with???1 all-cause inpatient stay pre-PP1M transition (N?=?177), a more pronounced improvement in comorbidity-related outcomes, a more pronounced reduction in HRU, and a reduction in total healthcare costs (MMCD?=?- $1308; P?<?0.001) were observed post-transition to PP1M. IMPLICATIONS:Among schizophrenia patients in the US, transitioning to PP1M following oral risperidone/paliperidone treatment was associated with improved comorbidity-related outcomes, higher adherence, and a reduction in HRU, while remaining cost neutral. Furthermore, patients with???1 all-cause inpatient stay pre-PP1M transition had significantly lower total healthcare costs post-PP1M transition.

Project description:BackgroundRehabilitation robotics is a field of study which aims to understand and augment rehabilitation through the use of robotics devices.ObjectiveThis proof of concept study aimed to test the safety (no. adverse events, incidence of infection), feasibility (program demand, adherence, participant satisfaction) and efficacy (Peak Oxygen uptake (VO2peak), 6-min walk test, gait speeds, Canadian Occupational Performance Measure, quality of life) of Lokomat® and Armeo®Spring training in children and adolescents and young adults (AYAs) during or soon after cancer treatment.MethodThis was a 6-week single arm pre-post study. Cancer patients with significant musculoskeletal, neurological, gait and/or upper limb deficiency aged 5 to 25 years were recruited. The rehabilitation program included access to two robotic orthoses: the Lokomat® and/or Armeo®Spring. Robotic devices utilised real-time biofeedback and computer games to engage and guide participants through a repetitive functional range of movement aimed at improving functional deficiencies. Progressive increases in exercise intensity and duration were encouraged.ResultsTwentey-eight participants were approached for study; twenty-one consented. Seventy-six percent completed the six-week intervention with an overall adherence of 83%. The mean participant satisfaction score was 8.8/10. Forty-nine adverse events were recorded throughout the course of the study, forty-five grade 1, three grade 2 and one grade 3. No adverse events led to withdrawal from the study. Preliminary efficacy results indicate large beneficial effects on VO2peak (r = 0.63), 10 m comfortable pace walk (r = 0.51) and maximal pace walk (r = 0.60), 6-min walk test (r = 0.60), maximal back and leg strength (r = 0.71), trunk flexibility (r = 0.60), The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) (r = 0.61), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT F) r = 0.53 and the Canadian Occupational Performance Measure, satisfaction (r = 0.88) and performance scores (r = 0.83), and moderate beneficial effects on Leisure Score Index (LSI) (r = 0.30).ConclusionOur results suggest that Lokomat® and Armeo®Spring training is safe and feasible for use in children and AYAs who are currently undergoing or have recently completed cancer therapy. A larger controlled trial investigating the efficacy of robotics rehabilitation in this cohort is warranted.

Project description:Objective: To evaluate the effect of aripiprazole once-monthly 400 mg (AOM 400; Abilify Maintena®) on symptom stability in acute treatment and maintenance therapy settings in patients with schizophrenia. Methods: Results were analyzed from two pivotal maintenance studies (Studies 246 and 247), a long-term (52 weeks), open-label extension of these studies (Study 248), an open-label, mirror-image study in patients switching from oral to long-acting injectable antipsychotic therapy (Study 283), and a study of AOM 400 in the acute setting (Study 291). Symptom stability was assessed using the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impression (CGI) scale (CGI-Severity of Illness and CGI-Improvement). Results are reported for the total study population and in subgroups stratified by age. Results: In Study 246, AOM 400 resulted in significantly greater improvements from baseline vs placebo on all measures of symptom stability, with improvements maintained through 52 weeks. In Study 247, a non-inferiority study, AOM 400 resulted in improvements in PANSS and CGI scores comparable or significantly greater at all timepoints vs oral aripiprazole. In Study 248, AOM 400 resulted in the long-term stability of symptom improvements from the earlier studies. In Study 283, AOM 400 resulted in significant improvements from baseline in PANSS and CGI scores over 24 weeks. In Study 291, AOM 400 resulted in significantly greater improvements from baseline in PANSS and CGI scores vs placebo at all post-baseline timepoints. In post hoc analyses, AOM 400 showed similar efficacy in symptom improvement in adult patients aged ≤35 years and >35 years, with some evidence of a larger treatment effect on PANSS negative symptoms among younger patients in the acute treatment setting. Conclusion: In acute treatment and maintenance therapy settings, AOM 400 was effective in the rapid stabilization and long-term maintenance of symptoms in patients with schizophrenia.

Dataset Information

Efficacy and safety of once-monthly Risperidone ISM^® in schizophrenic patients with an acute exacerbation.

Publications

Efficacy and safety of once-monthly Risperidone ISM<sup>®</sup> in schizophrenic patients with an acute exacerbation.

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