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568 results on '"Jolliet, Pascale"'

1. Clinical research and methodology What usage and what hierarchical order for secondary endpoints?

Author

Laporte, Silvy, Diviné, Marine, Girault, Danièle, Boutouyrie, Pierre, Chassany, Olivier, Cucherat, Michel, de Trogoff, Hervé, Dubois, Sophie, Fouret, Cecile, Hoog-Labouret, Natalie, Jolliet, Pascale, Mismetti, Patrick, Porcher, Raphaël, Rey-Coquais, Cécile, and Vicaut, Eric

Subjects
Statistics - Methodology
Abstract

In a randomised clinical trial, when the result of the primary endpoint shows a significant benefit, the secondary endpoints are scrutinised to identify additional effects of the treatment. However, this approach entails a risk of concluding that there is a benefit for one of these endpoints when such benefit does not exist (inflation of type I error risk). There are mainly two methods used to control the risk of drawing erroneous conclusions for secondary endpoints. The first method consists of distributing the risk over several co-primary endpoints, so as to maintain an overall risk of 5%. The second is the hierarchical test procedure, which consists of first establishing a hierarchy of the endpoints, then evaluating each endpoint in succession according to this hierarchy while the endpoints continue to show statistical significance. This simple method makes it possible to show the additional advantages of treatments and to identify the factors that differentiate them.

Published
2024
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10. Characterization of antipsychotic utilization before clozapine initiation for individuals with schizophrenia: an innovative visualization of trajectories using French National Health Insurance data

Author

Laforgue, Edouard-Jules, primary, Istvan, Marion, additional, Chaslerie, Anicet, additional, Artarit, Pascal, additional, Vallot, Geneviève, additional, Jolliet, Pascale, additional, Grall-Bronnec, Marie, additional, and Victorri-Vigneau, Caroline, additional

Published
2023
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16. Information and Communication on Risks Related to Medications and Proper Use of Medications for Healthcare Professionals and the General Public: Precautionary Principle, Risk Management, Communication During and in the Absence of Crisis Situations

Author

Molimard, Mathieu, Bernaud, Corine, Lechat, Philippe, Bejan-Angoulvant, Theodora, Benattia, Cherif, Benkritly, Amel, Braunstein, David, Cabut, Sandrine, David, Nadine, Fourrier-Réglat, Annie, Gallet, Benoit, Gersberg, Marta, Goni, Sylvia, Jolliet, Pascale, Lamarque-Garnier, Véronique, Le Jeunne, Claire, Leurs, Irina, Liard, François, Malbezin, Muriel, Micallef, Joelle, and Nguon, Marina

Published
2014
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17. Information et communication sur les risques liés au médicament et son bon usage auprès des professionnels de santé et du public : principe de précaution, gestion du risque, communication pendant et en dehors des situations de crise

Author

Molimard, Mathieu, Bernaud, Corine, Lechat, Philippe, Bejan-Angoulvant, Theodora, Benattia, Cherif, Benkritly, Amel, Braunstein, David, Cabut, Sandrine, David, Nadine, Fourrier-Réglat, Annie, Gallet, Benoit, Gersberg, Marta, Goni, Sylvia, Jolliet, Pascale, Lamarque-Garnier, Véronique, Le Jeunne, Claire, Leurs, Irina, Liard, François, Malbezin, Muriel, Micallef, Joelle, and Nguon, Marina

Published
2014
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25. Place des études post-AMM dans le suivi des risques du médicament : cahier des charges et méthodologies

Author

Auclert, Laurent, Bonnin, Marthe, Daudin, Magda, Dubois, Catherine, Francillon, Alain, Frauger, Elisabeth, Girault, Danièle, Gourlay, Marie-Laurence, Jolliet, Pascale, Jaïs, Carmen Kreft, Grimaldi, Lamiae, Lièvre, Michel, Maillère, Patricia, Maugendre, Philippe, Micallef, Joelle, Miranda, Sara, Pariente, Antoine, Bigot, Sylvie Paulmier, Pentel, Jonathan, Prestat, Laure, Pruvot, Fanny, Ferrer, Valérie Querol, Rocher, Fanny, Saussier, Christel, Zanetti, Laura, Tubach, Florence, Lamarque-Garnier, Véronique, and Castot, Anne

Published
2011
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26. Role of the Post-Marketing Authorisation Studies in Drug Risk Surveillance: Specifications and Methodologies

Author

Auclert, Laurent, Bonnin, Marthe, Daudin, Magda, Dubois, Catherine, Francillon, Alain, Frauger, Elisabeth, Girault, Danièle, Gourlay, Marie-Laurence, Jolliet, Pascale, Jaïs, Carmen Kreft, Grimaldi, Lamiae, Lièvre, Michel, Maillère, Patricia, Maugendre, Philippe, Micallef, Joelle, Miranda, Sara, Pariente, Antoine, Bigot, Sylvie Paulmier, Pentel, Jonathan, Prestat, Laure, Pruvot, Fanny, Ferrer, Valérie Querol, Rocher, Fanny, Saussier, Christel, Zanetti, Laura, Tubach, Florence, Lamarque-Garnier, Véronique, and Castot, Anne

Published
2011
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28. Définition des populations cibles des médicaments : comment anticiper au mieux la définition des populations cibles en vue du remboursement ?

Author

Alperovitch, Annick, Auquier, Pascal, Bamberger, Marion, Banzet, Marie-Noëlle, Boissel, Jean-Pierre, Borel, Thomas, Denis, Catherine, Flahault, Antoine, Gourlay, Marie-Laurence, Jolliet, Pascale, Joubert, Jean-Michel, Lièvre, Michel, Maison, Patrick, Meyer, Arlette, Moore, Nicholas, Prestat-Sledziewski, Laure, Rouby, Frank, Schmidely, Nathalie, Solesse, Anne, Teisseire, Bernard, Vasmant, Daniel, Veron, Didier, Villani, Patrick, Zanetti, Laura, Zureik, Mahmoud, Zylberman, Myriam, Homers, Françoise F., Massol, Jacques, and Maillère, Patricia

Published
2010
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29. How to Best Define Target Populations of Medicines in View of Their Coverage by the National Health Insurance Scheme?

Author

Alperovitch, Annick, Auquier, Pascal, Bamberger, Marion, Banzet, Marie-Noëlle, Boissel, Jean-Pierre, Borel, Thomas, Denis, Catherine, Flahault, Antoine, Gourlay, Marie-Laurence, Jolliet, Pascale, Joubert, Jean-Michel, Lièvre, Michel, Maison, Patrick, Meyer, Arlette, Moore, Nicholas, Prestat-Sledziewski, Laure, Rouby, Frank, Schmidely, Nathalie, Solesse, Anne, Teisseire, Bernard, Vasmant, Daniel, Veron, Didier, Villani, Patrick, Zanetti, Laura, Zureik, Mahmoud, Zylberman, Myriam, Hamers, Françoise F., Massol, Jacques, and Maillère, Patricia

Published
2010
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30. Poppers Use and High Methaemoglobinaemia: 'Dangerous Liaisons'

Author

Barrangou-Poueys-Darlas, Malcolm, Gerardin, Marie, Deheul, Sylvie, Istvan, Marion, Guerlais, Marylène, FAN, FAN, Jolliet, Pascale, Dejoie, Thomas, and Victorri-Vigneau, Caroline

Subjects
RS1-441, Pharmacy and materia medica, Medicine, methaemoglobinaemia, toxicity, poppers, Article, abuse
Abstract

Poppers are legal and largely used in France despite severe side effects, such as methaemoglobinaemia (MetHbia). Our work aimed to assess the prevalence of poppers consumers among patients with a MetHbia higher than or equal to 5% in French university hospitals and its evolution before and after the legalization of poppers in France. We conducted a national multicentre observational retrospective study. All patients for whom at least one MetHbia measurement was performed from 2012 to 2017 in university hospitals where the French addictovigilance network (FAN) is implanted were included. For each MetHbia measurement exceeding or equal to 5%, a return to the clinical file was made by the FAN to assess poppers consumption. We calculated the prevalence of MetHbia exceeding or equal to 5% and 25% and the prevalence of poppers consumption before and after the legalization. A total of 239 (0.14%) patients had a MetHbia level exceeding or equal to 5% with 25 (10.46%) cases of poppers consumption. Poppers consumption represented 68.4% (13 out of 19) of cases with MetHbia greater than or equal to 25%. Poppers consumption among patients with MetHbia exceeding or equal to 5% increased after the legalization from 4.76% to 11.67% (prevalence ratio PR = 2.45, 95% CI = [0.98–8.37], p-value = 0.190). The proportion of patients with a MetHbia level of 25% or more increased after the legalization from 4.76% to 8.63% (PR = 1.81, 95% CI = [0.68–6.82], p-value = 0.374). The use of poppers is very frequently reported by patients with MetHbia greater than or equal to 25%.

Published
2021

31. Change in the regulatory framework for zolpidem

Author

Istvan, Marion, Caillet, Pascal, Rousselet, Morgane, Guerlais, Marylène, Laforgue, Edouard-Jules, Gérardin, Marie, Jolliet, Pascale, Feuillet, Fanny, Victorri-Vigneau, Caroline, MethodS in Patients-centered outcomes and HEalth ResEarch (SPHERE), Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques, Université de Nantes (UN)-Université de Nantes (UN), and Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques

Subjects
MESH: Zolpidem, pharmacoepidemiology, MESH: Humans, MESH: Middle Aged, musculoskeletal, neural, and ocular physiology, state sequence analysis, [SDV]Life Sciences [q-bio], sedatives, MESH: Adult, hypnotics, MESH: Drug Prescriptions, MESH: Hypnotics and Sedatives, MESH: Benzodiazepines, benzodiazepines, MESH: Cohort Studies, psychological phenomena and processes, zolpidem
Abstract

International audience; In recent years, zolpidem has been the subject of numerous reports of misuse, abuse and dependence. In view of these risks, the French drug agency (ANSM) decreed in April 2017 the implementation of secure prescription pads. The objective of this study was to evaluate the impact of this regulatory measure on the prescription of zolpidem and other sedative medications (zopiclone, benzodiazepines and antihistamines) in long-term users of zolpidem and associated factors.

Published
2021
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36. Bénéfice médical réel estimé par comparaisons indirectes

Author

Barna, Alexandre, Cucherat, Michel, De Bels, Frédéric, de Sahb, Rima, Delonca, Jean, Izard, Valérie, Jolliet, Pascale, Joubert, Jean-Michel, Launois, Robert, Le Jeunne, Claire, Lièvre, Michel, Gaudin, Florence Mahlberg, Moser, Aurélie, Perles, Patricia, Pigeon, Martine, Coquais, Cécile Rey, Weisslinger, Nadine, Xerri, Bertrand, Falissard, Bruno, Zylberman, Myriam, and Meyer, François

Published
2009
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37. Real Medical Benefit Assessed by Indirect Comparison

Author

Barna, Alexandre, Cucherat, Michel, De Bels, Frédéric, de Sahb, Rima, Delonca, Jean, Izard, Valérie, Jolliet, Pascale, Joubert, Jean-Michel, Launois, Robert, Le Jeunne, Claire, Lièvre, Michel, Gaudin, Florence Mahlberg, Moser, Aurélie, Perles, Patricia, Pigeon, Martine, Coquais, Cécile Rey, Weisslinger, Nadine, Xerri, Bertrand, Falissard, Bruno, Zylberman, Myriam, and Meyer, François

Published
2009
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39. Descriptive analysis of sickle cell patients living in France

Author

Gerardin, Marie, Rousselet, Morgane, Couec, Marie-Laure, Masseau, Agathe, Guerlais, Marylène, Authier, Nicolas, Deheul, Sylvie, Roussin, Anne, Micallef, Joelle, Djezzar, Samira, Feuillet, Fanny, Jolliet, Pascale, Victorri-Vigneau, Caroline, MethodS in Patients-centered outcomes and HEalth ResEarch (SPHERE), Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques, Université de Nantes (UN)-Université de Nantes (UN), Institut de Neurosciences des Systèmes (INS), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques

Subjects
MESH: Adolescent, MESH: Aged, MESH: Humans, MESH: Middle Aged, MESH: Analgesics, MESH: Psychotropic Drugs, [SDV]Life Sciences [q-bio], MESH: Child, Preschool, MESH: Quality of Life, MESH: Adult, MESH: Pain Measurement, MESH: Male, MESH: France, MESH: Cross-Sectional Studies, MESH: Drug Prescriptions, MESH: Young Adult, MESH: Severity of Illness Index, MESH: Child, MESH: Pain, MESH: Anemia, Sickle Cell, MESH: Female, MESH: Pain Management, MESH: Treatment Outcome
Abstract

International audience; Background Sickle cell disease (SCD) induces chronic haemolytic anaemia and intermittent vaso-occlusion that results in tissue ischaemia causing acute, severe pain episodes that can lead to frequent hospitalizations. These consequences can have repercussions on family, social, school and/or professional life. Here, we present some of the results of the PHEDRE study (Pharmacodépendance Et DREpanocytose—drug dependence and sickle-cell disease), which is the largest study of patients with SCD in France. This paper intends to describe characteristics of the French SCD population. We also aimed to assess the impact of the disease on the lives of patients using objective and subjective variables. Methods The PHEDRE study was a national multicentric observational study. Adults, adolescents and children with a confirmed SCD diagnosis were included in the study by their referring doctor. Then, they were interviewed by phone about their socioeconomic status, about the impact of the disease on their lives and about their analgesic and psychoactive drug use. Results The study population consisted of 872 patients (28% were minors). Seventy-two percent of adults were active, and all minors were in school. Many patients presented criteria of severe SCD. Seventy-five percent were homozygous SS, 15% were double heterozygotes SC and 8% were heterozygotes Sβthal, 87% received specific treatment, 58% were hospitalized at least once for vaso-occlusive crisis in the past 12 months, and the number of analgesic drugs taken averaged 3.8. Seventy-five percent of patients reported academic or professional consequences related to their SCD, and 52% reported social consequences. Conclusions The impact of SCD on patients’ lives can be significant, nevertheless their social integration seems to be maintained. We highlighted respect of recommendations regarding analgesic treatments and only a few patients used tobacco, alcohol or cannabis. Trial registration Clinical Trials, NCT02580565 ; https://clinicaltrials.gov/ Registered 16 October 2015.

Published
2021
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40. A National Clinical Survey of Substance Use Disorder

Author

Victorri-Vigneau, Caroline, Laforgue, Edouard-Jules, Grall-Bronnec, Marie, Guillou-Landreat, Morgane, Rousselet, Morgane, Guerlais, Marylène, Feuillet, Fanny, Jolliet, Pascale, MethodS in Patients-centered outcomes and HEalth ResEarch (SPHERE), Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques, Université de Nantes (UN)-Université de Nantes (UN), and Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques

Subjects
MESH: Aged, MESH: Zolpidem, MESH: Humans, [SDV]Life Sciences [q-bio], MESH: Piperazines, MESH: Logistic Models, MESH: Male, MESH: Odds Ratio, MESH: Prospective Studies, MESH: Hypnotics and Sedatives, MESH: Risk Factors, MESH: Substance-Related Disorders, MESH: Benzodiazepines, MESH: Surveys and Questionnaires, MESH: Azabicyclo Compounds, MESH: Female, MESH: Prevalence
Abstract

International audience; Benzodiazepines and Z-drugs, zolpidem and zopiclone, (BZD/Z) are used longer than recommended in the elderly population. However, to date, very few attempts have been made to evaluate dependence on BDZ/Z among the elderly population. We conducted a national multicentric observational prospective study aimed at evaluating the prevalence of and risk factors for dependence among elderly adults. Patients aged 65 or older who were treated with BZD/Z for at least 3 months were evaluated through clinical interviews that conformed to official Diagnostic and Statistical Manual of Mental Disorders (DSM) dependence criteria. Among the 1,024 patients included in the survey, 442 of 976 (45.3%) met the dependence criteria. In the multivariate logistic regression model, dependent patients were categorized as follows: younger (odds ratio (OR) = 0.97), living mostly alone (OR = 1.45), showing psychiatric problems (OR = 2.22), having additional treatments (other than BZD/Z; OR = 1.37), having long-lasting treatment (OR = 1.04), exhibiting significant relationship difficulties (OR = 1.96), committing transgressional behaviors to procure BZD/Z (OR = 2.70), and wanting to stop their consumption of BZD/Z (OR = 7.60). A latent class analysis, which was applied to sort out subgroups within dependent patients, identified two profiles according to the prevalence of dependence items: profile 1 (73%), "withdrawal syndrome when BZD/Z is stopped" (100%) and "previous unsuccessful attempts to stop consumption" (82%); and profile 2 (27%), "tolerance" (76%) and "intake in larger amounts or over a longer period than intended" (86%). BZD/Z dependence is frequent in the elderly population, and among dependent patients, we found two profiles corresponding to positive and negative conditioning of the psychoactive effects of BZD/Z. This study is registered as NCT01920581.

Published
2021
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41. CYP1A2 and tobacco interaction: a major pharmacokinetic challenge during smoking cessation

Author

Barrangou-Poueys-Darlas, Malcolm, Guerlais, Marylène, Laforgue, Edouard-Jules, Bellouard, Ronan, Istvan, Marion, Chauvin, Pascale, Guillet, Jean-Yves, Jolliet, Pascale, Gregoire, Matthieu, Victorri-Vigneau, Caroline, MethodS in Patients-centered outcomes and HEalth ResEarch (SPHERE), Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques, Université de Nantes (UN)-Université de Nantes (UN), and Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques

Subjects
[SDV]Life Sciences [q-bio], addiction medicine, Cytochrome P450, drug interactions, pharmacokinetics, tobacco, smoking cessation
Abstract

International audience; Smoking cessation is underestimated in terms of drug interactions. Abrupt smoking cessation is common in cases of emergency hospitalization and restrictions of movement. Tobacco is a known cytochrome P450 1A2 (CYP1A2) inducer, its consumption and withdrawal can lead to major pharmacokinetic drug interactions. Nevertheless, references do exist, but may have different results between them. The objective of our work was to establish the broadest and most consensual list as possible of CYP1A2 substrates treatments and propose a pharmacological approach. We searched the widest possible list of CYP1A2 substrates based on various international references. We compared the references and defined probability and reliability scores of our results to sort the substances based on the scores. For the 245 substances identified as CYP1A2 substrates, we focused on the 63 CYP1A2 substrates with both probability and reliability scores >50%. Our work establishes adaptive pharmacological approaches for the management of patients initiating smoking cessation which must be integrated into the management of smoking cessation. Pharmacologists can now adopt adaptive pharmacological approaches to complement patient-specific clinical information about smoking cessation by considering pharmacokinetic risk. This work establishes an unprecedented list. It should guide in the care of patients initiating smoking cessation to prevent pharmacokinetic drug interactions.

Published
2021
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44. Le bon usage du médicament : définition, référentiels, périmètre et champ d’application

Author

Andrejak, Michel, Bader, Jean-Pierre, Bamberger, Marion, Bilbault, Pascal, Bordet, Régis, Brouard, Agnès, Burstin, Anne, Castaigne, Alain, Castot, Anne, Coulomb, Alain, Dahan, Muriel, DeBels, Frédéric, Duguay, Corinne, Dumarcet, Nathalie, Fender, Pierre, Brentano, Christian Funck, Giri, Isa-belle, Jolliet, Pascale, Pautrot, Murielle Jousselon, Leclerc, Florence, Gonidec, Patricia Le, Maillere, Patricia, Meyer, François, Defarges, Thierry Moreau, Obrecht, Olivier, Paintaud, Gilles, Petitcollot, Nicole, Samama, Marc, Sauterey, Julia, Schiavi, Pierre, Tcheng, Philippe, Villani, Patrick, Weber, Monique, Darmon, Nadine Weisslinger, Zylberman, Myriam, and Bergmann, Jean-François

Published
2008
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45. Good Medical Practice for Drugs. Definition, Guidelines, References, Field of Action and Applications

Author

Andrejak, Michel, Bader, Jean-Pierre, Bamberger, Marion, Bilbault, Pascal, Bordet, Régis, Brouard, Agnès, Burstin, Anne, Castaigne, Alain, Castot, Anne, Coulomb, Alain, Dahan, Muriel, DeBels, Frédéric, Duguay, Corinne, Dumarcet, Nathalie, Fender, Pierre, Brentano, Christian Funck, Giri, Isa-belle, Jolliet, Pascale, Pautrot, Murielle Jousselon, Leclerc, Florence, Gonidec, Patricia Le, Maillere, Patricia, Meyer, François, Defarges, Thierry Moreau, Obrecht, Olivier, Paintaud, Gilles, Petitcollot, Nicole, Samama, Marc, Sauterey, Julia, Schiavi, Pierre, Tcheng, Philippe, Villani, Patrick, Weber, Monique, Darmon, Nadine Weisslinger, Zylberman, Myriam, and Bergmann, Jean-François

Published
2008
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46. La consommation de cannabis chez les sujets présentant un abus, une pharmacodépendance ou sous traitement de substitution de la dépendance aux opiacés : données OPPIDUM 2006 et principales tendances depuis 2004 du réseau des Centres d’Évaluation et d’Information sur la Pharmacodépendance (CEIP)

Author

Frauger, Elisabeth, Vigneau, Caroline, Orléans, Véronica, Thirion, Xavier, Jolliet, Pascale, Micallef, Joëlle, and le Réseau des CEIP

Published
2008
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