Diagnosis of Predominant Negative Symptoms: Post-hoc Analyses of a Phase 3 Clinical Trial with Cariprazine Monotherapy and Risperidone

2017 ◽  
Vol 41 (S1) ◽  
pp. S270-S270
Author(s):  
I. Laszlovszky ◽  
Á. Barabássy ◽  
E. Szalai ◽  
B. Szatmári ◽  
J. Harsányi ◽  
...  
Keyword(s):  
Patient Population ◽  
Negative Symptoms ◽  
Social Performance ◽  
Dose Range ◽  
Patient Characteristics ◽  
Phase 3 ◽  
Double Blind ◽  
Parallel Group ◽  
Baseline Values ◽  
Post Hoc

ObjectiveTo present, post hoc analyses from a controlled, prospective study of predominant negative symptoms (PNS) of schizophrenia on baseline patient characteristics, severity of symptoms and their variability among participating countries.MethodsData were analyzed from a phase 3, randomized, double-blind, active-controlled, parallel-group study in adult PNS patients with schizophrenia (EudraCT Number 2012-005485-36). Subjects with a PANSS factor score for negative symptoms (PANSS-FSNS) ≥ 24 and no pseudo-specific factors (e.g. high positive symptoms, extrapyramidal symptoms, depression) were randomized to cariprazine 4.5 mg/d (dose range: 3–6 mg/d) or risperidone 4 mg/d (dose range: 3–6 mg/d) for 26 weeks. Baseline values of PANSS-FSNS, individual PANSS items, personal and social performance (PSP), and clinical global impression of severity (CGI-S) were analyzed based on the data gained from 11 European participating countries.ResultsAverage PANSS-FSNS of patients was 27.6 ± 2.48, reflecting severe negative symptoms. Patients were moderately ill (CGI-S 4.2 ± 0.75), with marked difficulties (PSP 48.4 ± 10.78) predominantly in social functioning. The investigated patient population was fairly homogeneous as shown by small variability in all three scores. Moreover, baseline values in the 11 countries presented low variability while number of enrolled patients per country showed high variance (n = 7–118). Narrative description of symptoms and individual PANSS items rated as most severe and prominent were in high correlation.ConclusionPost hoc evaluation of this predominant negative symptom study showed that, this patient population can be identified reliably by psychiatrist. Additional training on the judgment of personal and social relationships can increase the diagnostic accuracy.Disclosure of interestEmployee of Gedeon Richter Plc.

Day-to-day and Social Functioning of Patients with Negative Symptoms of Schizophrenia: Post-hoc Analyses of a Phase 3 Clinical Trial with Cariprazine Monotherapy and Risperidone

2017 ◽  
Vol 41 (S1) ◽  
pp. S270-S270
Author(s):  
Á. Barabássy ◽  
I. Laszlovszky ◽  
B. Szatmári ◽  
E. Szalai ◽  
J. Harsányi ◽  
...  
Keyword(s):  
Social Functioning ◽  
Negative Symptoms ◽  
Social Performance ◽  
Controlled Study ◽  
Phase 3 ◽  
Double Blind ◽  
Substantial Impact ◽  
End Of Treatment ◽  
Number Of Patients ◽  
Post Hoc

IntroductionNegative symptoms have substantial impact on day-to-day functioning of patients with schizophrenia affecting their ability to perform activities of daily living and to maintain personal relationships.ObjectiveTo present post hoc data on day-to-day and social functioning of patients with predominant negative symptom (PNS) of schizophrenia, treated with cariprazine versus risperidone.MethodsData from 26 weeks, phase 3, randomized, double-blind, active-controlled study in PNS patients were analyzed (EudraCT 2012-005485-36). Subjects with PNS (PANSS factor score for negative symptoms ≥24) were randomized to cariprazine 4.5 mg/d or risperidone 4 mg/d. Change from baseline to end of treatment on the personal and social performance scale (PSP) and PANSS prosocial subscale (P3, P6, N2, N4, N7, G16) was analyzed.ResultsSignificantly greater improvements were seen with cariprazine compared to risperidone in the change from baseline to end of treatment on the PSP (LSMD + 4.632 [2.71, 6.56]; P < 0.001) from week 10 onwards (effect size 0.48); in the PSP subdomains of self-care (LSMD −0.2 [−0.3; −0.1]; P = 0.004), personal and social relationships (LSMD −0.2 [−0.4;−0.1]; P < 0.001) and socially useful activities (LSMD −0.4 [−0.5; −0.2]; P < 0.001); in the number of patients who improved at least 10 points on the PSP (OR 2.1; P = 0.001) or shifted to a higher category (OR 2.2; P = 0.001); and on the PANSS prosocial subscale (LSMD −0.8 [−1.41, −0.16]; P = 0.014).ConclusionPost hoc evaluation of this study showed that cariprazine treatment is associated with a clinically relevant improvement in patient functioning and social competence compared to risperidone.Disclosure of interestEmployee of Gedeon Richter Plc.

Monotherapy treatment with cariprazine for the treatment of predominant negative symptoms of patients with schizophrenia: A double-blind, active comparator-controlled trial

2016 ◽  
Vol 33 (S1) ◽  
pp. s256-s257 ◽  
Author(s):  
G. Németh ◽  
M. Debelle ◽  
I. Laszlovszky ◽  
E. Szalai ◽  
B. Szatmári ◽  
...  
Keyword(s):  
Negative Symptoms ◽  
Partial Agonist ◽  
Social Performance ◽  
Controlled Trial ◽  
Dose Range ◽  
Treatment Change ◽  
Double Blind ◽  
Preferential Binding ◽  
Competing Interest ◽  
Risperidone Group

ObjectiveTo examine the effect of cariprazine, a dopamine D3/D2 receptor partial agonist with preferential binding to D3 receptors, on predominant negative symptoms of schizophrenia.MethodsSubjects with schizophrenia and PANSS factor score for negative symptoms (PANSS-FSNS) ≥ 24 and no pseudospecific factors (e.g. extrapyramidal symptoms, depression) were randomized to cariprazine 4.5 mg/d (dose range: 3-6 mg/d) or risperidone 4 mg/d (dose range: 3-6 mg/d) for 6 months.ResultsFour hundred and sixty-one patients were randomized 1:1 to double-blind risperidone (n = 231) or cariprazine (n = 230) treatment. Change from Baseline (CfB) at week 26 in the primary parameter, PANSS-FSNS, was larger in the cariprazine group than in the risperidone group (LSMD = −1.47; 95% CI: [−2.39, −0.53]; P = 0.002) significant from week 14 onwards. CfB at week 26 in the functional parameter, Personal and Social Performance (PSP) total score, showed similarly greater improvement with cariprazine than risperidone (LSMD = 4.63; 95% CI: [2.71, 6.56]; P < 0.001) significant from week 10 onward. Statistically significant differences in favor of cariprazine at week 26 were shown in the PSP areas of self-care, socially useful activities and personal and social relationships. Most patients tolerated the study treatment well, as reflected by low discontinuation rates due to adverse events (AEs). Adverse event profiles of cariprazine and risperidone were similar. The most common AEs during study treatment were insomnia (10.0%), and headache (10.4%), both in the risperidone group.Conclusion26-week cariprazine treatment, given as antipsychotic monotherapy, was significantly more effective on negative symptoms and on functioning than risperidone in patients with predominant negative symptoms of schizophrenia.Disclosure of interestThe authors have not supplied their declaration of competing interest.

scholarly journals Effect of the Nonsteroidal Mineralocorticoid Receptor Blocker, Esaxerenone, on Nocturnal Hypertension: A Post Hoc Analysis of the ESAX-HTN Study

2020 ◽  
Author(s):  
Kazuomi Kario ◽  
Sadayoshi Ito ◽  
Hiroshi Itoh ◽  
Hiromi Rakugi ◽  
Yasuyuki Okuda ◽  
...  
Keyword(s):  
Older Patients ◽  
Target Organ Damage ◽  
Organ Damage ◽  
Effective Treatment Option ◽  
Double Blind ◽  
Nocturnal Hypertension ◽  
Post Hoc Analysis ◽  
Nocturnal Dipping ◽  
Parallel Group ◽  
Post Hoc

Abstract BACKGROUND Nocturnal hypertension is an important phenotype of abnormal diurnal blood pressure (BP) variability and a known risk marker for target organ damage and cardiovascular events. This study aimed to assess the differential BP-lowering effects of esaxerenone vs. eplerenone on nocturnal BP in hypertensive patients with different nocturnal dipping patterns. METHODS This was a post hoc analysis of the “Esaxerenone (CS-3150) Compared to Eplerenone in Patients with Essential Hypertension” study (NCT02890173), which was a phase 3, multicenter, randomized, controlled, double-blind, parallel-group clinical study conducted in Japan. Ambulatory BP monitoring data were collected. RESULTS Patients (n = 1,001) were randomized to esaxerenone 2.5 mg/day (n = 331) or 5 mg/day (n = 338), or eplerenone 50 mg/day (n = 332). Reductions in nighttime systolic BP (95% confidence interval) were significantly greater with 2.5 and 5 mg/day esaxerenone vs. eplerenone (−2.6 [−5.0, −0.2] and −6.4 mm Hg [−8.8, −4.0], respectively). Esaxerenone significantly reduced nighttime BP from baseline compared with eplerenone in non-dippers with previously uncontrolled BP. In addition, esaxerenone did not markedly alter nighttime BP in extreme dipper patients. In the esaxerenone 5 mg/day group, esaxerenone-induced decreases in nighttime BP were greater than eplerenone-induced decreases in older patients. CONCLUSIONS Esaxerenone may be an effective treatment option for nocturnal hypertension, especially in older patients and those with a non-dipper pattern of nocturnal BP.

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