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Efficacy and safety of brexpiprazole in patients with schizophrenia presenting with severe symptoms: Post-hoc analysis of short- and long-term studies.

ABSTRACT: BACKGROUND:The treatment of patients with severe schizophrenia symptoms can be complicated and expensive. AIMS:The purpose of this study was to evaluate the short- and long-term effects of brexpiprazole in patients with schizophrenia presenting with severe symptoms. METHODS:Data were pooled from three six-week, randomized, double-blind, placebo-controlled studies and two 52-week, open-label extension studies. In the short-term studies, 1405 patients received placebo or brexpiprazole 2-4 mg/day; 412 brexpiprazole-treated patients rolled over into the long-term studies and received brexpiprazole 1-4 mg/day. More severe symptoms were defined as a Positive and Negative Syndrome Scale Total score >95 (median score at baseline). Outcomes included change in Positive and Negative Syndrome Scale Total and Personal and Social Performance scale scores. RESULTS:Brexpiprazole improved Positive and Negative Syndrome Scale Total score over 6 weeks among more severely ill patients, with a least squares mean difference versus placebo of -6.76 (95% confidence limits: -9.80, -3.72; p<0.0001; Cohen's d: 0.43). Brexpiprazole also improved Personal and Social Performance scale score over 6 weeks in more severely ill patients (least squares mean difference: 4.38; limits: 2.14, 6.62; p=0.0001; Cohen's d: 0.38). Improvement of functioning was greatest in the 'Self-care' domain, followed by 'Personal and social relationships'. Among less severely ill patients, brexpiprazole was superior to placebo on Positive and Negative Syndrome Scale Total and Personal and Social Performance scale at Week 6. Improvements were maintained over 58 weeks. No new safety or tolerability concerns were observed. CONCLUSIONS:Brexpiprazole is an efficacious and well-tolerated treatment for schizophrenia in patients with more severe, and less severe, symptoms.

SUBMITTER: Meade N

PROVIDER: S-EPMC7383416 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Efficacy and safety of brexpiprazole in patients with schizophrenia presenting with severe symptoms: <i>Post-hoc</i> analysis of short- and long-term studies.

Meade Nicole N Shi Lily L Meehan Stine R SR Weiss Catherine C Ismail Zahinoor Z

Journal of psychopharmacology (Oxford, England) 20200710 8

<h4>Background</h4>The treatment of patients with severe schizophrenia symptoms can be complicated and expensive.<h4>Aims</h4>The purpose of this study was to evaluate the short- and long-term effects of brexpiprazole in patients with schizophrenia presenting with severe symptoms.<h4>Methods</h4>Data were pooled from three six-week, randomized, double-blind, placebo-controlled studies and two 52-week, open-label extension studies. In the short-term studies, 1405 patients received placebo or brex ...[more]

PMID: 32648810

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Project description:The successful treatment of schizophrenia entails improvement across a spectrum of symptoms. The aim of this post hoc analysis was to characterize the short- and long-term effects of brexpiprazole on Positive and Negative Syndrome Scale (PANSS) 'Marder factors.' Data were included from three 6-week, randomized, double-blind, placebo-controlled studies; a 52-week, randomized, double-blind, placebo-controlled maintenance treatment study; and two 52-week open-label extension (OLEx) studies-all in schizophrenia (DSM-IV-TR criteria). Patients receiving oral brexpiprazole were dosed at 2-4 mg/day (short-term studies) or 1-4 mg/day (long-term studies). At Week 6, least squares mean differences (LSMDs, with 95% confidence limits [CLs]) for brexpiprazole (n = 868) vs placebo (n = 517) were: Positive symptoms: -1.55 (-2.30, -0.80), P < .0001, Cohen's d effect size (ES) = 0.27; Negative symptoms: -1.12 (-1.63, -0.61), P < .0001, ES = 0.29; Disorganized thought: -1.26 (-1.78, -0.74), P < .0001, ES = 0.32; Uncontrolled hostility/excitement: -0.76 (-1.15, -0.37), P = .0002, ES = 0.26; Anxiety/ depression: -0.56 (-0.91, -0.22), P = .0014, ES = 0.22. At last visit of the maintenance study, LSMDs (95% CLs) for brexpiprazole (n = 96) vs placebo (n = 104) were: Positive symptoms: -3.44 (-4.99, -1.89), P < .0001, ES = 0.62; Negative symptoms: -1.23 (-2.52, 0.07), P = .063, ES = 0.27; Disorganized thought: -1.69 (-2.81, -0.56), P = .0035, ES = 0.42; Uncontrolled hostility/excitement: -1.26 (-2.12, -0.39), P = .0046, ES = 0.41; Anxiety/depression: -0.72 (-1.47, 0.03), P = .061, ES = 0.27. In the OLEx studies, improvements were maintained over 58 (6 + 52) weeks of brexpiprazole treatment. In conclusion, these data suggest that brexpiprazole treats the continuum of schizophrenia symptoms, in the short- and long-term. Trial Registration: Data used in this post hoc analysis came from ClinicalTrials.gov identifiers: NCT01396421, NCT01393613, NCT01810380, NCT01668797, NCT01397786, NCT01810783.

Project description:ObjectiveEpisodes of major depressive disorder (MDD) characterized by high levels of anxiety symptoms are less likely to respond to some forms of antidepressant treatment (ADT). This report examines the effects of adjunctive brexpiprazole on depressive symptoms among patients with MDD and anxiety symptoms.Materials and methodsThis was a post hoc analysis of 1,171 patients from the 6-week, randomized, double-blind phases of three studies in adults with MDD and inadequate response to ADTs (NCT01360645, NCT01360632, NCT02196506). Data were pooled for brexpiprazole 2-3 mg/day and for placebo (adjunct to ADT). Montgomery-Åsberg Depression Rating Scale Total score changes were assessed in subgroups of patients with and without anxious distress (based on proxies for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria) and anxious depression (defined as a Hamilton Depression Rating Scale Anxiety/somatization factor score of ?7). Safety was assessed by the incidence of treatment-emergent adverse events (TEAEs).ResultsBenefits were seen for adjunctive brexpiprazole (compared with adjunctive placebo) in both anxiety definition subgroups. For patients with anxious distress, the least squares mean difference (95% CI) at week 6 was -3.00 (-4.29, -1.71; P<0.0001) and, for those without anxious distress, was -1.38 (-2.71, -0.05; P=0.043). For patients with anxious depression, the difference was -2.19 (-3.60, -0.78; P=0.0023), compared with -2.34 (-3.58, -1.10; P=0.0002) for those without anxious depression. The most common TEAEs among patients with anxiety symptoms receiving ADT + brexpiprazole were akathisia, headache, restlessness, somnolence, and weight increase. There were no clinically meaningful differences in the rates of these TEAEs according to the presence or absence of anxiety symptoms.ConclusionAdjunctive brexpiprazole 2-3 mg/day may be efficacious in reducing depressive symptoms, and was well tolerated, in patients with clinically relevant anxiety symptoms.

Project description:BackgroundAneurysmal subarachnoid hemorrhage (aSAH) is a devastating stroke subtype with high morbidity and mortality. Although several studies have developed a prediction model in aSAH to predict individual outcomes, few have addressed short-term mortality in patients requiring mechanical ventilation. The study aimed to construct a user-friendly nomogram to provide a simple, precise, and personalized prediction of 30-day mortality in patients with aSAH requiring mechanical ventilation.MethodsWe conducted a post-hoc analysis based on a retrospective study in a French university hospital intensive care unit (ICU). All patients with aSAH requiring mechanical ventilation from January 2010 to December 2015 were included. Demographic and clinical variables were collected to develop a nomogram for predicting 30-day mortality. The least absolute shrinkage and selection operator (LASSO) regression method was performed to identify predictors, and multivariate logistic regression was used to establish a nomogram. The discriminative ability, calibration, and clinical practicability of the nomogram to predict short-term mortality were tested using the area under the curve (AUC), calibration plot, and decision curve analysis (DCA).ResultsAdmission GCS, SAPS II, rebleeding, early brain injury (EBI), and external ventricular drain (EVD) were significantly associated with 30-day mortality in patients with aSAH requiring mechanical ventilation. Model A incorporated four clinical factors available in the early stages of the aSAH: GCS, SAPS II, rebleeding, and EBI. Then, the prediction model B with the five predictors was developed and presented in a nomogram. The predictive nomogram yielded an AUC of 0.795 [95% CI, 0.731-0.858], and in the internal validation with bootstrapping, the AUC was 0.780. The predictive model was well-calibrated, and decision curve analysis further confirmed the clinical usefulness of the nomogram.ConclusionWe have developed two models and constructed a nomogram that included five clinical characteristics to predict 30-day mortality in patients with aSAH requiring mechanical ventilation, which may aid clinical decision-making.

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Efficacy and safety of brexpiprazole in patients with schizophrenia presenting with severe symptoms: Post-hoc analysis of short- and long-term studies.

Publications

Efficacy and safety of brexpiprazole in patients with schizophrenia presenting with severe symptoms: <i>Post-hoc</i> analysis of short- and long-term studies.

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