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EPA-1546 - Paliperidone palmitate in non-acute but symptomatic patients with schizophrenia previously unsuccessfully treated with oral aripiprazole

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European Psychiatry 2014年第S1期29卷 1-1页

作者： Hargarter, L. Bergmans, P. Cherubin, P. Rancans, E. Bez, Y. Parellada, E. Carpiniello, B. Vidailhet, P. Schreiner, A. EMEA MAF Janssen- Cilag GmbH Neuss Germany Biostatistics & Programming Janssen Cilag Benelux Tilburg Netherlands EMEA MAF Janssen Cilag France Issy-les-Moulineaux France Psychiatry and Narcology Riga Stradins University Riga Latvia Psychiatry Dicle University Medical Faculty Diyarbakir Turkey Psychiatry Hospital Clinic de Barcelona Barcelona Spain Psychiatry Clinica Psichiatrica Universitá die Cagliari Cagliari Italy Psychiatry Centgre Hospitalier Régional Universitaire Strasbourg Strasbourg France EMEA MAF Janssen-Cilag GmbH Neuss Germany

Introduction To explore tolerability, safety and treatment response of flexibly dosed once-monthly paliperidone palmitate (PP) in adult nonacute patients with schizophrenia previously unsuccessfully treated with oral aripiprazole. Methods International prospective open-label 6-month study. Outcomes were change in Positive and Negative Syndrome Scale (PANSS), patient functioning (Personal and Social Performance Scale; PSP), disease severity (CGI-S and CGI-C), Extrapyramidal Symptom Rating Scale (ESRS) and treatment-emergent adverse events (TEAEs). Results 46 patients (73.9% male, mean age 34.4±9.4 years, 78.3% paranoid schizophrenia) were analyzed. The mean prior oral aripiprazole dose was 22.7±10.7 mg/day. 67.4% of patients completed the study. Mean PANSS total score decreased from 74.7±14.9 at baseline to 62.6±16.5 at LOCF endpoint (mean change -12.2±16.7; 95% confidence interval -17.1;-7.2; p<0.0001). 52.2% of patients showed a ≥20% improvement in PANSS total score, the percentage of patients rated mildly ill or less in CGI-S increased from 23.9% to 56.5% and 75.5% of patients were rated improved in CGI-C. Patient functioning in PSP improved from 58.9±13.4 to 62.9±15.2 (p=0.041). TEAEs reported in ≥5% were anxiety (n=6), injection site pain, bronchitis, insomnia and akathisia (n=4 each), and weight increase, depression and pain in extremities (n=3 each). Extrapyramidal symptoms measured by ESRS total scores improved significantly in completers from baseline to month 6 by -1.4±2.7 (p<0.007) and by -0.6±3.4 from baseline to LOCF endpoint (p=0.046). Conclusions Flexibly dosed paliperidone palmitate was well tolerated and associated with a clinically relevant symptomatic treatment response, improved functioning and less EPS in non-acute patients with schizophrenia previously unsuccessfully treated with oral aripiprazole.

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EPA-1545 - Functional outcomes with once-monthly paliperidone palmitate in acute and in non-acute patients with schizophrenia previously unsuccessfully treated with oral antipsychotics

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European Psychiatry 2014年第S1期29卷 1-1页

作者： Hargarter, L. Bergmans, P. Cherubin, P. Björner, A. Knegtering, R. Parellada, E. Carpiniello, B. Vidailhet, P. Mertens, C. Schreiner, A. EMEA MAF Janssen-Cilag GmbH Neuss Germany Biostatistics & Programming Janssen Cilag Benelux Tilburg Netherlands EMEA MAF Janssen Cilag France Issy-les-Moulineaux France Psychiatry Psykosmottagningen Mölndal Sweden Psychiatry University Medical Center of Groningen Groningen Netherlands Psychiatry Hospital Clinic de Barcelona Barcelona Spain Psychiatry Clininca Psichiatrica Università di Cagliari Cagliari Italy Psychiatry Centre Hospitalier Régional Universitaire Strasbourg Strasbourg France Psychiatry Neuro- Psychiatrische Kliniek St-Camillu Sint Denijs Westrem Belgium

Introduction Effective antipsychotic treatment of schizophrenia should, beyond symptom control, translate into meaningful functional improvements. This study explored functional outcomes in patients with schizophrenia switched from previous unsuccessful treatment with oral antipsychotics to flexible doses of paliperidone palmitate (PP). Methods Two groups of acute (N=212) and non-acute (N=593) patients from an international prospective open-label 6-month study. Outcomes were change in Positive and Negative Syndrome Scale (PANSS) total score, Personal and Psychosocial Performance scale (PSP) and Mini International Classification of Functionality, Disability and Health Rating for Activity and Participation Disorders in Psychological Illnesses (Mini-ICF-APP). Results Both groups significantly improved from baseline to endpoint in mean PANSS total score from 98.5±20.1 to 67.4±24.0 (mean change -31.0±29.0) in acute and from 71.5±14.6 to 59.7±18.1 (mean change -11.7±15.9) in non-acute patients (all p<0.0001). Patient functioning in PSP total score increased from 43.9±15.0 at baseline to 62.9±17.1 at endpoint (mean change 19.0±18.7; 95% confidence interval [CI] 16.4;21.6) in the acute and from 58.1±13.4 at baseline to 66.1±15.7 at endpoint (mean change 8.0±14.0; 95%CI 6.8;9.1) in the non-acute group (both groups p<0.0001). Illness-related disabilities of activity and participation within groups improved significantly in Mini-ICF-APP global score decreasing from 26.8±8.5 to 18.5±9.8 (mean change -8.0±10.4; 95%CI -9.5;-6.5) in acute and from 19.8±7.9 to 15.9±8.8 (mean change: -4.0±7.5; 95%CI - 4.6;-3.3) from baseline to endpoint in non-acute patients (both groups p<0.0001). Conclusions Symptom reduction in acute and non-acute patients with schizophrenia treated with PP after previous unsuccessful treatment with oral antipsychotics was associated with clinically meaningful functional improvements.

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Vitamin D intake and cardiovascular mortality in the NHANES i epidemiological follow-up study cohort

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Journal of Dietary Supplements 2012年第2期9卷 79-89页

作者： Fan, Chunpeng Nieto, F. Javier Bautista, Leonelo E. Fine, Jason P. Department of Biostatistics and Programming Sanofi U.S. Inc. Bridgewater NJ 08807 55 Corporate Drive United States Department of Population Health Sciences University of Wisconsin Madison WI United States Department of Biostatistics University of North Carolina Chapel Hill NC United States

The objective of the present study was to determine whether vitamin D intake is associated with CVD mortality in a general population sample. The association between vitamin D intake and CVD mortality (ICD-9 code 410414) rates was investigated using data from the the First National Health and Nutrition Examination Survey (NHANES I) Epidemiological Follow-up Study (NHEFS) 19711992. Overall, higher vitamin D intake was associated with lower CVD mortality. After adjustment for traditional risk factors for CVD, vitamin D intake showed mild but nonstatistically significant protective effects against CVD mortality with a hazard ratio for adequate as compared to low intake (with 95 confidence intervals) of 0.90 (0.74, 1.08). Hazard ratios were 0.95, 0.83, 0.88, and 1.02, in males, females, Whites, and Blacks, respectively (with 95 confidence intervals overlapping 1.0 in all cases). Thus, we did not find a statistically significant association between vitamin D intake and CVD mortality, although our findings are compatible with a mild protective effect, especially among females and Whites. © 2012 Informa Healthcare USA, Inc.

关键词： Dietary supplements ICD-9 Ischemic heart disease NHEFS

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Palmitate de palipéridone à doses flexibles chez des patients non-aigus atteints de schizophrénie après échec d’un autre traitement par antipsychotiques injectables à action prolongée

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European Psychiatry 2013年第8期28卷 107-108页

作者： Cherubin, P. Hargater, L. Bergmans, B. Bjorner, A. Knegtering, H. Parellada, E. Carpiniello, B. Vidailhet, P. Mertens, C. Schreiner, A. EMEA Medical Affairs Janssen Cilag Issy-lès-Moulineaux France EMEA Medical Affairs Janssen Cilag Neuss Allemagne Biostatistics & Programming Janssen Cilag Benelux Tilburg Pays-Bas 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 CHU de Strasbourg Strasbourg France Psychiatric Hospital Sint Camillus Sint-Denijs-Westrem Belgique

ObjectifsÉvaluer la tolérance, la sécurité d’emploi et la réponse à un traitement par palmitate de palipéridone (PP) à doses flexibles chez des patients non aigus atteints de s... 详细信息

ObjectifsÉvaluer la tolérance, la sécurité d’emploi et la réponse à un traitement par palmitate de palipéridone (PP) à doses flexibles chez des patients non aigus atteints de schizophrénie, après échec d’un traitement par un autre antipsychotique injectable à action prolongée : décanoate d’halopéridol (Déc-Hal), décanoate de flupentixol (Déc-Fpt), décanoate de fluphénazine (Déc-Flu), zuclopenthixol (Zuc) ou rispéridone à libération prolongée (RIS-LP).MéthodesÉtude internationale, prospective, ouverte, de six mois, chez des patients atteints de schizophrénie, non aigus mais insuffisamment contrôlés par d’autres antipsychotiques injectables à action prolongé***ères d’évaluationTaux de réponse (amélioration ≥ 20 % du score total à la PANSS [Positive and Negative Syndrome Scale]), score à la PSP (Personal and Social Performance scale), événements indésirables (EIs).RésultatsLes analyses ont été réalisées sur la population en intention de traiter de façon stratifiée pour chaque traitement : 53 patients Déc-Hal, 35 Déc-Fpt, 44 Déc-Flu, 42 Zuc, 56 RIS-LP. Les scores totaux moyens à la PANSS initiale variaient de 67,7 ± 20,3 [RIS-LP] à 75,7 ± 13,2 [Déc-Hal]. Entre 71,4 % [RIS-LP] et 85,7 % [Déc-Fpt] des patients ont terminé l’étude. À la fin de l’étude, 53,7 % [Zuc], 54,7 % [Déc-Hal], 59,1 % [Déc-Flu], 61,1 % [RIS-LP] et 61,8 % [Déc- Fpt] des patients ont vu leur score total à la PANSS diminuer d’au moins 20 %. Les scores moyens de PSP de base étaient de 48,7 [Déc-Hal], 59,6 [Déc-Fpt], 53,5 [Déc-Flu], 52,9 [Zuc] et 60,1 [RIS-LP], et le changement en fin d’étude était respectivement de : 5,2 ; 6,1 ; 6,0 ; 6,4 ; et 5,2 (p ≤ 0,0163 pour tous les traitements). Les EIs rapportés au moins une fois dans tous les sous-groupes : douleur au site d’injection, insomnie, trouble *** PP à doses flexibles a été bien toléré et a permis une réponse thérapeutique cliniquement significative chez des patients non aigus atteints de schizophrénie, après échec d’un traite

关键词： Schizophrénie Thérapeutique Antipsychotiques Palipéridone

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1100 – Safety, tolerability and treatment response with flexible doses of paliperidone palmitate in patients with an acute exacerbation of 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. EMEA Medical Affairs Janssen Cilag GmbH 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 with flexible doses of paliperidone palmitate in adult patients with an acute episode of schizophrenia. Methods Interim analysis of a prospective 6-month, open-label, multicenter study in adult patients with schizophrenia. Outcomes were change in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to endpoint, Clinical Global Impression-Severity Scale (CGI-S), patient functioning (Personal and Social Performance Scale; PSP), weight change and adverse events (AEs). Results Of the first 104 patients included (54.8% male, mean age 37.6±11.8 years, 81.7% paranoid schizophrenia, recommended paliperidone palmitate initiation regimen used in 89% of subjects), 65.4% completed the study. Most frequent reasons for discontinuation were AE (13.5%), subject choice (8.7%) and loss to follow-up (5.8%). Mean total PANSS score decreased from 99.5±15.5 at baseline to 71.0±26.9 at endpoint (mean change -28.6±26.2; 95% confidence interval [CI] -33.8; - 23.4; p< 0.0001) with 60.6% of the patients showing improvement of ≥30%. Mean CGI-S score changed from 5.0±0.8 at baseline to 3.6±1.3 at endpoint (95%CI -1.7; -1.1; p< 0.0001). Patient functioning improved from a mean PSP baseline score of 42.7±13.9 to 59.0±18.7 at endpoint (95% CI of change 12.7; 19.9; p< 0.0001). AEs reported in ≥5% were psychotic disorder (15.4%), insomnia (14.4%), injection site pain (13.5%), headache (8.7%), salivary hypersecretion (6.7%) and anxiety (6.7%). Conclusion These data support results from recent randomized controlled studies that flexibly dosed paliperidone palmitate is safe, well tolerated and associated with clinically meaningful treatment response in patients suffering from an acute episode of schizophrenia.

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Baseline Characteristics Of Patients With Chronic Myeloid Leukemia In a Prospective Observational Study (SIMPLICITY)

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BLOOD 2013年第21期122卷 4026-4029页

作者： Cortes, Jorge E. Hehlmann, Rudiger Gambacorti-Passerini, Carlo Goldberg, Stuart Khoury, H. Jean Mauro, Michael Michallet, Mauricette Paquette, Ron Simonsson, Bengt Foreman, Aimee Mohamed, Hesham Zyczynski, Teresa Hirji, Ishan Davis, Catherine Department of Leukemia The University of Texas MD Anderson Cancer Center Houston TX USA Department of Hematology/ Oncology University of Heidelberg Mannheim Germany Department of Internal Medicine and Clinical Research Unit University of Milano-Bicocca Monza Italy Division of Leukemia John Theurer Cancer Center at Hackensack University Medical Center Hackensack NJ USA Department of Hematology and Medical Oncology Winship Cancer Institute of Emory University Emory University Atlanta GA USA Memorial Sloan Kettering Cancer Center New York NY USA Centre Hospitalier Lyon Sud Pierre Benite France Ronald Reagan UCLA Medical Center University of California Los Angeles Los Angeles CA USA Department of Medical Sciences Hematology Uppsala University Hospital Uppsala Sweden ICON Clinical Research Biostatistics & Programming San Francisco CA USA Bristol-Myers Squibb Plainsboro NJ USA Global Health Economics and Outcomes Research Bristol-Myers Squibb Co. Princeton NJ USA Oncology Global Health Outcomes Bristol-Myers Squibb Co. Wallingford CT USA

Background Oral BCR-ABL tyrosine kinase inhibitors (TKIs), including imatinib (IM), dasatinib (DAS) and nilotinib (NIL), have improved survival in chronic-phase chronic myeloid leukemia (CP-CML). Few data are available that compare TKIs in daily clinical practice across multiple regions. Methods SIMPLICITY is an ongoing observational cohort study of adult patients with newly diagnosed CP-CML receiving first-line treatment with IM, DAS or NIL in the USA and Europe (Eu) outside of clinical trials (NCT01244750). The primary objective is to assess effectiveness of these TKIs in clinical practice. The study includes three ‘prospective' cohorts of patients treated with IM, DAS or NIL since 2010 (the study opened after first-line approval of all three TKIs) and a ‘historical' cohort treated with IM since 2008. Preliminary baseline demographics are presented for prospective cohorts. Results 860 prospective patients (Eu: 32%, USA: 68%) were enrolled through June 20, 2013, receiving IM (n=399), DAS (n=229) or NIL (n=232). Median age at initiation of first-line TKI was 56 years, with significant differences in pairwise comparisons between DAS and IM and NIL and IM (Table). Demographics were consistent across cohorts. Only 30% of patients had Hasford or Sokal scores recorded. ECOG performance status (PS) was available in 54% of patients. The number of baseline comorbidities per patient (mean: 3.2 + 2.7) was balanced across cohorts; 51% of patients presented with ≥3 comorbidities. Patients in the IM cohort had a higher prevalence of gastrointestinal comorbidities (P=.006 and .007 for DAS vs IM and NIL vs IM, respectively), and the NIL cohort had a higher prevalence of musculoskeletal comorbidities than the DAS cohort (P=.015). The proportions of patients with cardiovascular comorbidities were 38%, 36% and 42% in the DAS, NIL and IM cohorts, respectively, consisting primarily of hypertension (31%) and hyperlipidemia (17%) (P>.05 across cohorts). Coronary artery disease was p

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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.

关键词： FLOODS NUTRITION surveys MALNUTRITION -- Treatment ANTHROPOMETRY PUNJAB (Pakistan) -- Environmental conditions

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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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