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1096 – Safety, tolerability and treatment response with flexible doses of paliperidone palmitate in non-acute patients with schizophrenia

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European Psychiatry 2013年第S1期28卷 1-1页

作者： Schreiner, A. Hargarter, L. Bergmans, P. Cherubin, P. Janssen-Cilag Medical Affairs EMEA EMEA Medical Affairs Janssen-Cilag Medical Affairs EMEA Neuss Germany Biostatistics & Programming Janssen Cilag Benelux Tilburg The Netherlands EMEA Medical Affairs Janssen Cilag France Issy-les-Moulineaux France

Objective To explore tolerability, safety and treatment response of flexible doses of paliperidone palmitate in adult non-acute patients with schizophrenia previously unsuccessfully treated with oral antipsychotics. Methods Interim analysis of a prospective 6-month, open-label study. Outcomes were change in the Positive and Negative Syndrome Scale (PANSS) score, Clinical Global Impression-Severity Scale (CGI-S) and patient functioning (Personal and Social Performance Scale; PSP) from baseline to endpoint, weight change and adverse events (AEs). Results Of the first 403 patients enrolled (63.3% male, mean age 39.4±12.0 years). 74.4% completed the study. Most frequent reasons for discontinuation were subject choice (10.7%), and AE (5.5%). The recommended initiation regimen was administered in 94.0% of subjects. Mean PANSS total score decreased from 71.9±15.2 at baseline to 60.8±18.4 at endpoint (mean change -11.1±15.4; 95% confidence interval [CI]-12.6;-9.6; p< 0.0001); 61.2% of the patients showed an improvement of ≥20% in PANSS total score. The percentage of patients rated mildly ill or less in CGI-S increased from 33.2% to 62.1%. Patient functioning improved from a mean PSP baseline score of 57.9±13.7 to 65.2±15.3 at endpoint (95%CI of change 6.0; 8.7; p< 0.0001). AEs reported in ≥5% were injection site pain (13.9%), insomnia (7.9%), anxiety (6.9%), psychotic disorder (5.7%) and somnolence (5.2%). Mean weight change from baseline to endpoint was 1.4±5.2kg (95%CI 0.8; 1.9). Conclusion These data support results from recent randomized controlled studies that flexibly dosed paliperidone palmitate is safe, well tolerated and associated with a clinically relevant treatment response in non-acute patients with schizophrenia previously unsuccessfully treated with oral antipsychotics.

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Evaluation of Nutrition Surveys in Flood-affected Areas of Pakistan: Seeing the Unseen!

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IDS BULLETIN-INSTITUTE OF DEVELOPMENT STUDIES 2013年第3期44卷 10-20页

作者： Hossain, S. M. Moazzem Talat, Mah Boyd, Erin Chowdhury, Shamim Rafique Soofi, Sajid Bashir Hussain, Imtiaz Ahmed, Imran Salam, Rehana Abdus Bhutta, Zulfiqar A. Chief of Health and Nutrition in UNICEF Afghanistan having previously worked in UNICEF Pakistan Sri Lanka and the New York Headquarters. Certified Master Trainer with expertise in facilitation skills monitoring and programme management. Emergency Nutrition Specialist at the United Nations Children's Fund (UNICEF) Headquarters with over ten years of experience in humanitarian response and policy related to emergency nutrition programming and data analysis. Has Been the Director General of the Bureau of Statistics (BOS) Planning and Development Department Government of Punjab Pakistan since 2007. Pediatrician and researcher. He is a Fellow of Pediatrics and has a long affiliation with the Department of Pediatrics and Child Health at the Aga Khan University Karachi where he is currently working as an Assistant Professor and Coordinator. Presently holds the position of Senior Social Scientist at the Aga Khan University Karachi. Working as Data Manager at the Department of Paediatrics Aga Khan University Karachi. Has been a Senior Instructor (Research) at the Aga Khan University Karachi since November 2012 and holds a master's degree in Epidemiology and Biostatistics from the university. Professor and founding chair of the Division of Maternal and Child Health Aga Khan University Karachi.

In 2010 Pakistan experienced the worst floods recorded in its history;millions of people were affected and thousands lost their lives. Nutrition assessment surveys led by UNICEF were conducted in flood-affected areas of Punjab and Sindh provinces to assess the nutrition status of children between 659 months while Aga Khan University (AKU) undertook a parallel assessment including micronutrient status in their project areas within Balochistan, Sindh and Punjab. Standardised Monitoring and Assessment of Relief and Transition (SMART) methodology was used. 881 children from Sindh, 1,143 from Punjab and 817 from AKU project areas were measured for anthropometry and their households were interviewed. The findings indicated that while immediate life-saving interventions were essential, there was also an urgent need to address chronic malnutrition. Through high-level dissemination of the survey results, treatment and prevention of malnutrition has become a priority for the provincial and federal government in Pakistan and for donors.

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Réponse thérapeutique, tolérance et sécurité d’emploi du palmitate de palipéridone à dose flexible : une étude prospective chez des patients adultes non-aigus atteints de schizophrénie, après échec d’un traitement par antipsychotiques oraux

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European Psychiatry 2013年第8期28卷 107-107页

作者： Vidailhet, P. Schreiner, A. Bergmans, P. Cherubin, P. Rancans, E. Bez, Y. Parellada, E. Carpiniello, B. Hargater, L. CHU de Strasbourg Strasbourg France EMEA Medical Affairs Janssen Cilag Neuss Allemagne Biostatistics & programming Janssen Cilag Benelux Tilburg Pays-Bas EMEA medical affairs Janssen Cilag Issy-lès-Moulineaux France Department of Psychiatry et Narcology Riga Stradins University RIGA Lettonie Dicle University Medical Faculty Diyarbakir Turquie Hospital Clínic de Barcelona Barcelone Espagne Clinica Psichiatrica Università di Cagliari Cagliari Italie

ObjectifsÉvaluer la tolérance, la sécurité d’emploi et la réponse à un traitement mensuel par palmitate de paliperidone (PP) à doses flexibles chez des patients adultes atteints de schizophrénie, non-aigus mais symptomatiques, après échec d’un traitement par antipsychotiques oraux.MéthodesAnalyse d’un groupe de patients atteints de schizophrénie, non-aigus mais symptomatiques, inclus dans une étude internationale, ouverte, prospective de six mois, évaluant la symptomatologie clinique : PANSS (Positive and Negative Syndrome Scale) et CGIS-S (Clinical Global Impression-Severity Scale), les événements indésirables (EIs) et le changement de poids.RésultatsCinq cent quatre-vingt-treize patients (population en intention de traiter) : 63,1 % d’hommes, âge moyen 38,4 ± 11,8 ans, 78,6 % souffrant de schizophrénie paranoïde. La principale raison de la substitution d’un antipsychotique oral par le PP était un manque d’efficacité (24,3 %). 74,5 % des patients ont terminé l’étude de six mois. Les raisons les plus fréquentes d’arrêt précoce étaient : le choix du patient (9,3 %), des effets indésirables (EIs) (6,1 %), les perdus de vue (3,0 %) et le manque d’efficacité (2,5 %). Le score total moyen à l’échelle PANSS a diminué de 71,5 ± 14,6 à l’inclusion à 59,7 ± 18,1 à la fin de l’étude (soit une différence de −11,7 ± 15,9 points ; 95 % IC 95 % [−13,0 ; −10,5] ; p <0,0001). 64,0 % des patients ont eu une amélioration supérieure ou égale à 20 % du score total à la PANSS et le pourcentage de patients légèrement malades ou moins (CGI-S) est passé de 31,8 à 63,2 %. Les EIs touchant plus de 5 % des patients sont : douleur au site d’injection (12,3 %), insomnie (8,6 %), anxiété (6,7 %), trouble psychotique (6,1 %) et céphalées (5,6 %). Le changement moyen de poids a été de 1,2 ± 5,0 kg (IC 95 % [0,7 ; 1,6]).ConclusionsCes résultats confirment la bonne tolérance et l’efficacité thérapeutique du PP à doses flexibles chez des patients non aigus atteints de schizophrénie, après échec d’un

关键词： Schizophrénie Thérapeutique Antipsychotiques Palipéridone

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Palmitate de palipéridone à doses flexibles – Réponse thérapeutique, tolérance et sécurité d’emploi: une étude prospective chez des patients en période d’exacerbation aiguë d’un trouble schizophrénique après échec d’un traitement par antipsychotiques oraux

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European Psychiatry 2013年第8期28卷 107-107页

作者： Schreiner, A. Bergmans, P. Cherubin, P. Rancans, E. Bez, Y. Parellada, E. Carpiniello, B. Vidailhet, P. Hargater, L. EMEA Medical Affairs Janssen Cilag Neuss Allemagne Biostatistics & Programming Janssen Cilag Benelux Tilburg Pays-Bas EMEA Medical Affairs Janssen Cilag Issy-lès-Moulineaux France Dpt. Psychiatry et Narcology Riga Stradins University Riga Lettonie Dicle University Medical Faculty Diyarbakir Turquie Hospital Clínic de Barcelona Barcelone Espagne Clinica Psichiatrica Università di Cagliari Cagliari Italie CHU de Strasbourg Strasbourg

ObjectifsÉvaluer la tolérance, la sécurité d’emploi et l’efficacité de doses flexibles de PP chez des patients adultes en période d’exacerbation aiguë d’une schizophrénie, après échec d’un traitement par antipsychotiques oraux.MéthodesÉtude internationale, prospective, ouverte, de six ***ères d’évaluationPositive and Negative Syndrome Scale (PANSS), Clinical Global Impression-Severity (CGI-S), événements indésirables (EI), changement de poids.RésultatsDeux cent douze patients (population en intention de traiter) : âge moyen 36,4 ± 12,1 ans, 59,0 % d’hommes, 85,4 % souffrant de schizophrénie paranoïde ont été inclus. La principale raison de la substitution d’un antipsychotique oral par le PP était un manque d’efficacité (45,8 %). 70,3 % des patients ont terminé l’étude de six mois. Les raisons les plus fréquentes d’arrêt précoce ont été : le choix du patient (9,4 %), des EI (9,0 %), les perdus de vue (4,7 %), le manque d’efficacité (2,8 %). Le score total moyen à la PANSS initiale (98,5 ± 20,1) a diminué, et ce dès j8, pour atteindre 67,4 ± 24,0 à la fin de l’étude (diminution de −31,0 ± 29,0, p < 0,0001). 66,7 % des patients ont eu une amélioration de plus de 30 % du score PANSS total et le pourcentage de patients jugés manifestement malades ou pire (CGI-S) a diminué de 75,1 % à 20,5 %. Les EIs (≥ 5 % patients) : douleur au site d’injection (13,7 %), insomnie (10,8 %), trouble psychotique (10,4 %), céphalées (6,1 %) et anxiété (6,1 %). Le changement moyen de poids a été de 2,6 ± 5,6 kg (IC 95 % [1,8; 3,4]).ConclusionsCes résultats confirment que le PP à doses flexibles est bien toléré et permet une réponse clinique précoce et cliniquement significative chez des patients en période d’exacerbation aiguë de leur trouble schizophrénique, après échec d’un traitement par antipsychotiques oraux.

关键词： Schizophrénie Thérapeutique Antipsychotiques Palipéridone

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Amélioration fonctionnelle sous palmitate de paliperidone à doses flexibles chez des patients aigus ou non aigus atteints de schizophrénie, après échec d’un traitement par antipsychotiques oraux

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European Psychiatry 2013年第8期28卷 108-108页

作者： Hargarter, L. Bergmans, B. Cherubin, P. Bjorner, A. Knegtering, H. Parellada, E. Carpiniello, B. Vidailhet, P. Mertens, C. Schreiner, A. EMEA Medical Affairs Janssen Cilag Neuss Allemagne Biostatistics & Programming Janssen Cilag Benelux Tilburg Pays-Bas EMEA Medical Affairs Janssen Cilag Issy-lès-Moulineaux Psykosmottagningen MÖLNDAL Suède Lentis Mental Health and University Medical Center of Groningen Groningen Pays-Bas Hospital Clínic de Barcelona Barcelone Espagne Clinica Psichiatrica Università di Cagliari Cagliari Italie Psychiatric Hospital Sint Camillus CHU de Strasbourg Strasbourg Sint-Denijs-Westrem Belgique

ObjectifsÉvaluer l’amélioration fonctionnelle chez des patients atteints de schizophrénie sous palmitate de paliperidone (PP) à doses flexibles après échec d’un traitement par antipsychotiques oraux.MéthodesAnalyse menée dans deux sous-groupes de patients atteints de schizophrénie : aigus (n = 202) et non aigus (n = 593) après échec d’un traitement par antipsychotiques oraux, inclus dans une étude internationale, prospective, de six ***ères d’évaluationChangement du score total à la PANSS (Positive and Negative Syndrome Scale), à la PSP (Personal and Psychosocial Performance scale), et à la Mini-ICF-APP (Mini International Classification of Functionality, Disability and Health Rating for Activity and Participation Disorders in Psychological Illnesses).RésultatsLes deux sous-groupes ont présenté une amélioration significative du score total à la PANSS : de 98,5 ± 20,1 à l’inclusion à 67,4 ± 24,0 à la fin de l’étude (diminution moyenne = −31,0 ± 29,0) chez les patients aigus et de 71,5 ± 14,6 à 59,7 ± 18,1 (diminution moyenne = −11,7 ± 15,9) chez les patients non aigus. Cette réponse thérapeutique était associée à une augmentation significative du score total à la PSP de 43,9 ± 15,0 à 62,9 ± 17,1 (amélioration moyenne = 19,0 ± 18,7, p <0,0001) chez les patients aigus, et de 58,1 ± 13,4 à 66,1 ± 15,7 (amélioration moyenne =8,0 ± 14,0, p < 0,0001) chez les patients non aigus. Il existait une amélioration significative du score à la Mini-ICF-APP qui diminuait de 26,8 ± 8,5 à 18,5 ± 9,8 (diminution moyenne = −8,0 ± 10,4, p < 0,0001) chez les patients aigus et de 19,8 ± 7,9 à 15,9 ± 8,8 (diminution moyenne = −4,0 ± 7,5, p < 0,0001) chez les patients non ***’amélioration symptomatique sous PP à doses flexibles chez des patients aigus ou non-aigus atteints de schizophrénie après échec d’un traitement par antipsychotique oral s’est accompagnée d’une amélioration fonctionnelle cliniquement significative.

关键词： Schizophrénie Thérapeutique Antipsychotiques Palipéridone

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1736 – Long-acting injectable risperidone and oral antipsychotics in patients with schizophrenia - a prospective one-year non-interventional study (inors)

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European Psychiatry 2013年第S1期28卷 1-1页

作者： Schreiner, A. Svensson, A. Wapenaar, R. Cherubin, P. Princet, P. Serazetdinova, L. Starostina, N. Zink, M. EMEA Medical Affairs Janssen-Cilag Medical Affairs EMEA Neuss Germany EMEA Medical Affairs Janssen-Cilag AB Sollentuna Sweden Biostatistics & Programming Janssen Cilag B.V. Tilburg The Netherlands EMEA Medical Affairs Janssen Cilag France Issy-les-Moulineaux Centre Hospitalier Spéchialisé de Fains-Véel Fains-Véel France Federal Institution of Healthcare Psychoneurologic Dispensary No.5 Saint Petersburg Federal Institution of Healthcare Psychiatric Hospital No.2 Nizhni Novgorod Russia Zentralinstitut für Seelische Gesundheit Klinik für Psychiatrie und Psychotherapie Mannheim Germany

Introduction and objectives To explore safety, tolerability, treatment response and hospitalizations in adult patients with schizophrenia treated with long-acting injectable risperidone (RLAI) or oral antipsychotic standard of care (oAP) in routine clinical practice. Methods Prospective one-year open-label non-interventional study exploring flexible doses of RLAI and oAPs. Primary outcome was the number of hospitalizations from baseline to endpoint. Additional outcomes were changes in the Clinical Global Impression of Schizophrenia (CGI-SCH), patient functioning (Global Assessment of Functioning) and treatmentemergent adverse events (TEAEs). Results The intent-to-treat analysis included 561 patients on RLAI and 522 patients on oAPs (44% female gender, mean age (±SD) 42.2±13.1 years). Demographics and baseline characteristics were comparable, yet RLAI-treated patients had higher disease severity, lower baseline functioning and more substance abuse. The number of hospitalizations did not differ between the two groups while median duration of hospitalization was significantly shorter with RLAI (12.3 vs 20.6 days). Positive, negative, cognitive symptoms, disease severity, patient functioning and medication satisfaction improved significantly better with RLAI than oAPs. The most frequently reported TEAEs (=2% in any group) for RLAI and oral APs were increase of body weight (5.0%; 5.6%), psychotic disorder (2.7%; 4.0%), schizophrenia (2.5%; 3.1%), anxiety (2.3%; 2.7%), insomnia (0.9%; 3.1%) and somnolence (0.4%; 2.5%), respectively. Conclusion This one-year non-interventional study supports results of recent randomized controlled trials that treatment with RLAI is associated with less days spent in hospital, better symptomatic and functional outcomes and higher patient satisfaction with medication compared to oral APs.

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High-dimensional Cell Image Data Analysis in Drug Discovery

High-dimensional Cell Image Data Analysis in Drug Discovery

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The Third IMS-China International Conference on Statistics and Probability(第三届国际数理统计学会中国分会年会)

作者： Donghui Zhang Xianhong Xie Sanofi Aventis Global Biostatistics and Programming 200 Crossing Blvd Bridgewater NJ 08807 USA

In high-content screening (HCS) assay, the cell images in each well of multi-well plates are captured and multiple cell features (i.e., cell counts, size, shape, intensity,texture, overlap of colors) are extracted from *** high-dimensional features/parameters provide more representatives of biological models that allow phenotype definition and pathway analysis for both compound and target screenings,and for analysis of mechanisms of actions,

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Sample Size Calculation for Thorough QT/QTc Study Considering Various Factors Related to Multiple Time Points

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Journal of Biopharmaceutical Statistics 2010年第3期20卷 563-577页

作者： Zhaoling Meng zhaoling.meng@*** Kringle, Robert Xun Chen Peng-Liang Zhao Biostatistics and Programming Sanofi-Aventis Bridgewater New Jersey USA

The sample size requirement in a thorough QT/QTc study is discussed under a balanced parallel or crossover study design. First, we explore the impacts of various factors on the study power, including the mean effect profile across time and correlation among time points. Then we estimate the variability parameters needed based on multiple historical studies. Different baseline usage is illustrated to have a significant impact on the analysis variability in the parallel studies. Finally, the sample size calculations and recommendations are given for demonstrating a “negative” drug effect and the study assay sensitivity, respectively. [ABSTRACT FROM AUTHOR]

关键词： False positive IUT test Multiple test correction Positive control Power

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Sequential Monitoring of Conditional Randomization Tests: Generalized Biased Coin Designs

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Sequential Analysis 2008年第3期27卷 234-253页

作者： Yanqiong Zhang Yanqiong.Zhang@*** Rosenberger, William F. Department of Biostatistics and Programming Sanofi-Aventis Malvern Pennsylvania USA Department of Statistics George Mason University Fairfax Virginia USA

For the generalized biased coin class of randomization procedures, Smythe (1988) proved asymptotic normality of the conditional linear rank test. Clinical trialists often undertake interim analysis to determine whether to stop the trial early for a substantial treatment effect. In this article, we will set up one interim analysis using a conditional randomization test. The joint asymptotic distribution of the interim test statistic and the final test statistic will be explored. We also define the concept of conditional information under a randomization model. [ABSTRACT FROM AUTHOR]

关键词： Conditional information fraction Joint asymptotic normality Linear rank test Spending functions

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Sequential monitoring of conditional randomization tests: Generalized biased coin designs

Sequential monitoring of conditional randomization tests: Ge...

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作者： Zhang, Yanqiong Rosenberger, William F. Department of Biostatistics and Programming Sanofi-Aventis Malvern PA United States Department of Statistics George Mason University Fairfax VA United States Sanofi-Aventis 9 Great Valley Parkway Malvern PA 19355 United States

关键词： Statistics

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