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1. A randomized clinical trial to evaluate the effect of post-intensive care multidisciplinary consultations on mortality and the quality of life at 1 year

Author

Sharshar, Tarek, Grimaldi-Bensouda, Lamiae, Siami, Shidasp, Cariou, Alain, Salah, Abdel Ben, Kalfon, Pierre, Sonneville, Romain, Meunier-Beillard, Nicolas, Quenot, Jean-Pierre, Megarbane, Bruno, Gaudry, Stephane, Oueslati, Haikel, Robin-Lagandre, Segolene, Schwebel, Carole, Mazeraud, Aurelien, Annane, Djillali, Nkam, Lionelle, and Friedman, Diane

Published
2024
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9. Clinical and economic burden of severe asthma: A French cohort study

Author

Aubier, M., Crestani, B., Taillé, C., Dombret, M.C., Pretolani, M., Berger, P., Bourdin, A., Vachier, I., Molinari, N., Chanez, P., Similowski, T., Didier, A., De Blay, F., Humbert, M., Garcia, G., Magnan, A., Maitre, B., Roche, N., Tsicopoulos, A., Chenivesse, C., Deslée, G., Marquette, C.H., Devouassoux, G., Nordon, Clementine, Grimaldi-Bensouda, Lamiae, Pribil, Celine, Nachbaur, Gaelle, Amzal, Billy, Thabut, Gabriel, Marthan, Roger, and Aubier, Michel

Published
2018
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10. Dronedarone, amiodarone and other antiarrhythmic drugs, and acute liver injuries: a case-referent study

Author

Andersen, Matthias, Berg, Thomas, Cordes, Hans-Jörg, Diepolder, Helmut, Fähndrich, Martin, Geier, Andreas, Göbel, Uwe, Grümmer, Harald, Jamali, Seyed Hamid, Kahl, Matthias, Krummenerl, Thomas, Lammertink, Jan, Langmann, Peter, Lohse, Ansgar W., Morgera, Ulrike, Niederau, Claus Ulrich, Pelster, Gregor, Plauth, Mathias, Reiser, Markus, Rufle, Walter, Schiefke, Ingolf, Schlenker, Thorsten, Schott, Eckart, Schwarze, Oliver, Schwerdtfeger, Michael, Seelhoff, Alexander, Spengler, Ulrich, Strohbach, Matthias, Tebbe, Johannes, Thomsen, Thomas, Treml, Oliver, von Aretin, Andreas, Wedemeyer, Heiner, Wiegand, Johannes, Wiese, Manfred, Wruck, Ullrich, Grimaldi-Bensouda, Lamiae, Benichou, Jacques, Rossignol, Michel, Larrey, Dominique, Abenhaim, Lucien, and Poynard, Thierry

Published
2018
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12. Risk of autoimmune diseases and human papilloma virus (HPV) vaccines: Six years of case-referent surveillance

Author

Abbas, Firas, Abdelmoumni, Abdelhakim, Hilliquin, Pascal, Requeda, Elisabeth, Adoue, Daniel, Brassat, David, Agard, Christian, Masseau, Agathe, Aladjidi, Nathalie, Clet, Johanna, Fernandes, Helder, Lemasson, Gwendal, Perel, Yves, Raymond, Isabelle, Richer, Olivier, Vital, Anne, Allain-Launay, Emma, Bru, Marie, Nicolino, Marc, Thomas, Caroline, Altman, Jean-Jacques, Amsallem, Daniel, Aras, Nazmiye, Boukari, Latifato, Dubrel, Marie, Fain, Olivier, Letellier, Edouard, Lucidarme, Nadine, Mekinian, Arsène, Morin, Anne-Sophie, Stirnemann, Jérôme, Atlan, Catherine, Audry, Dominique, Augustin, Jérôme, Bakir, Redouane, Bartolucci, Pablo, Chevalier, Xavier, Godeau, Bertrand, Guillaud, Constance, Khellaf, Mehdi, Limal, Nicolas, Lousteau, Valentine, Mahevas, Matthieu, Méliksetyan, Gayane, Michel, Marc, Roumier, Mathilde, Bayart, Sophie, Bonnet, Fabrice, Decaux, Olivier, Bekherraz, Amine, Brihaye, Benoit, Dachez, Roger, Daugas, Eric, Hayem, Gilles, Meyer, Olivier, Papo, Thomas, Pasqualoni, Elisa, Sacre, Karim, Travert, Florence, Bellon, Hélène, Beltrand, Jacques, Lefrere, François, Simon, Albane, Benhamou, Pierre-Yves, Benveniste, Olivier, Bolgert, Francis, Costedoat-Chalumeau, Nathalie, De Paz, Raphael, Demeret, Sophie, Fautrel, Bruno, Jacqueminet, Sophie, Louapre, Céline, Maillart, Elizabeth, Morel, Nathalie, Papeix, Caroline, Rigabert, Julie, Bensaid, Philippe, Berger, Claire, Berquin, Patrick, Le Moing, Anne-Gaëlle, Berroir, Stéphane, Besson, Gérard, Boutte, Célia, Casez, Olivier, Bonnotte, Bernard, Audia, Sylvain, Bossu-Estour, Cécile, Bourgarit, Anne, Dupuy, Alain, Keshmandt, Homa, Bourre, Bertrand, Brac, Aude, Perrin, Agnès, Pondarré, Corinne, Villar-Fimbel, Sylvie, Bruckert, Isabelle, Cosson, Anne, Magy-Bertrand, Nadine, Tisserand, Guillaume, Camu, William, Carlander, Bertrand, Morales, Raul Juntas, Cances, Claude, Pasquet, Marlene, Castilla Lievre, Maria Angela, Chabroux, Stephanie, Charif, Mamoud, Chatelus, Emmanuel, Sibilia, Jean, Chevrant-Breton, Jacqueline, Clavel, Sylvaine, Bille-Turc, Françoise, Cohen, Jacques, Courcoux, Marie France, Leverger, Guy, Machet, Laurent, Cuisset, Jean-Marie, Cony-Makhoul, Pascale, Darsy, Paul, Favre, Sandrine, Giraud, Pierrick, Leitenschenck, Laurence, Monteiro, Irène, Morati, Chafika, DeSeze, Jérôme, Dinulescu, Monica, Dhaoui, Taher, Dommange-Romero, Florence, Drevard, Elisabeth, Dupuis, Clémentine, Dumuis, Marie-Laure, Durand, Jean-Marc, Farad, Samia, Lecomte, Pierre, Pierre, Peggy, Fouyssac, Fanny, Gaudin, Philippe, Gautier, Alain, Gellen-Dautremer, Justine, Jarrin, Irène, Richette, Pascal, Georget, Emilie, Gras, Pierre, Moreau, Thibault, Giraud, Eric, Hacini, Maya, Mayer, Anne, Guillaumat, Cécile, Guillaume, Séverine, Guitton, Corinne, Kone-Paut, Isabelle, Marsaud, Céline, Rossi, Linda, Guyot, Marie-Hélène, Hassler, Patrick, Heimfert, Claude, Heinzlef, Olivier, Hillion, Brigitte, Hocquelet, Catherine, Husson, Helene, Ichai, Pierre, Jeziorski, Eric, Deslandre, Chantal Job, Le Guern, Véronique, Kamenov, Kamen, Kerlan, Véronique, Lemoine, Philippe, Misery, Laurent, Pan-Petesch, Brigitte, Krivitzky, Alain, Labauge, Pierre, Rodier, Michel, Lacade, Chadi, Razafimahefa, Berthe, Lachgar, Karim, Larmarau, Marie-Pierre, Leblanc, Thierry, Lebrun-Frenay, Christine, Lefèbvre, Patrick, Lejoyeux, Philippe, Leske, Charles, Ly, Kim, Magy, Laurent, Mansuy, Sylvie, Marechaud, Richard, Martin Negrier, Marie-Laure, Sole, Guilhem, Maupetit, Jean, Mazingue, Françoise, Mochon, Stéphanie, Moktar, Blidi, Morcamp, Donald, Morlet-Barla, Nathalie, Nicolas, Guillaume, Pautot, Vivien, Pellier, Isabelle, Verret, Jean-Luc, Outteryck, Olivier, Vermersch, Patrick, Pallot-Prades, Beatrice, Paquet, Jean Michel, Puechal, Xavier, Sortais, Annie, Pelletier, Jean, Rico, Audrey, Pez, Dominique, Stankoff, Bruno, Quittet, Philippe, Rémy, Claude, Roba, Eléna, Rosario, Hélène, Roudaut, Nathalie, Sonnet, Emmanuel, Ruel, Michel, Sebban, Samuel, Schaepelynck, Pauline, Simonin, Marie-Jeanne, Vial, Christophe, Viallard, Jean-Francois, Ladedan, Isabelle, Zenone, Thierry, Grimaldi-Bensouda, Lamiae, Rossignol, Michel, Koné-Paut, Isabelle, Courcoux, Marie-France, Viallard, Jean-François, Bourgault-Villada, Isabelle, Breart, Gerard, and Abenhaim, Lucien

Published
2017
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19. A case-control study to assess the risk of immune thrombocytopenia associated with vaccines

Author

Grimaldi-Bensouda, Lamiae, Michel, Marc, Aubrun, Elodie, Leighton, Pamela, Viallard, Jean-Francois, Adoue, Daniel, Magy-Bertrand, Nadine, Tisserand, Guillaume, Khellaf, Mehdi, Durand, Jean-Marc, Quittet, Philippe, Fain, Olivier, Bonnotte, Bernard, Morin, Anne Sophie, Limal, Nicolas, Costedoat-Chalumeau, Nathalie, Morel, Nathalie, Pan-Petesch, Brigitte, Decaux, Olivier, Mahevas, Matthieu, Ruel, Michel, Sacre, Karim, Lefrere, Francois, Abenhaim, Lucien, and Godeau, Bertrand

Published
2012
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28. Risk of breast cancer by individual insulin use: an international multicenter study

Author

Grimaldi-Bensouda, Lamiae, Cameron, David, Marty, Michel, Barnett, Anthony H., Penault-Llorca, Frederique, Pollak, Michael, Charbonnel, Bernard, Riddle, Matthew, Mignot, Laurent, Boivin, Jean-Francois, Khachatryan, Artak, Rossignol, Michel, Benichou, Jacques, Alperovitch, Annick, and Abenhaim, Lucien

Subjects
Eli Lilly and Co., Sanofi S.A., Oncology, Experimental -- Health aspects, Diabetes -- Risk factors -- Research -- Health aspects, Insulin -- Research -- Health aspects, Breast cancer -- Risk factors -- Research -- Health aspects, Cancer -- Research, Pharmaceutical industry -- Health aspects, Physicians (General practice) -- Health aspects, Health
Abstract

OBJECTIVE Several studies have been published in 2009 suggesting a possible association between insulin glargine and increased risk of malignancies, including breast cancer. The objective of this study was to [...]

Published
2014
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31. Valproic Acid as an Adjuvant Treatment for Generalized Convulsive Status Epilepticus in Adults Admitted to Intensive Care Units: Protocol for a Double-Blind, Multicenter Randomized Controlled Trial

Author

Sharshar, Tarek, primary, Ben Hadj Salem, Omar, additional, Porcher, Raphaël, additional, Grimaldi-Bensouda, Lamiae, additional, Heming, Nicholas, additional, Clair, Bernard, additional, Azabou, Eric, additional, Mazeraud, Aurélien, additional, Rohaut, Benjamin, additional, and Outin, Hervé, additional

Published
2021
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34. Autoimmune Disorders and Quadrivalent Human Papillomavirus Vaccination of Young Females: 415.

Author

Grimaldi-Bensouda, Lamiae, Guillemot, Didier, Godeau, Bertrand, Mahr, Alfred, Lambert, Paul-Henri, Benichou, Jacques, Lebrun-Frenay, Christine, Papeix, Caroline, Labauge, Pierre, Berquin, Patrick, Penfornis, Alfred, Benhamou, Pierre-Yves, Nicolino, Marc, Simon, Albane, Viallard, Jean-Francois, Costedoat-Chalumeau, Nathalie, Courcoux, Marie-France, Pondarre, Corinne, Hilliquin, Pascal, Chatelus, Emmanuel, Foltz, Violaine, Guillaume, Severine, Rossignol, Michel, and Abenhaim, Lucien

Published
2013

37. International cohort study on the effectiveness of dronedarone and other antiarrhythmic drugs for atrial fibrillation in real-world practice (EFFECT-AF).

Author

Khachatryan, Artak, Merino, Jose L, Abajo, Francisco Jose de, Botto, Giovanni L, Kirchhof, Paulus, Breithardt, Guenter, Stambler, Bruce, Abenhaim, Lucien, Grimaldi-Bensouda, Lamiae, and de Abajo, Francisco Jose

Subjects
ATRIAL fibrillation diagnosis, MYOCARDIAL depressants, ATRIAL fibrillation, AMIODARONE, RESEARCH funding, LONGITUDINAL method
Abstract

Aims: To evaluate the effectiveness and safety of dronedarone compared with other commonly used antiarrhythmic drugs (AADs) for preventing atrial fibrillation (AF) recurrences.Methods and Results: An international observational cohort study in Germany, Spain, Italy, and the USA enrolling patients with AF receiving AAD therapy. Patients with New York Heart Association (NYHA) Class IV heart failure were excluded. Participants were followed for up to 18 months, regardless of discontinuation or subsequent AAD switches. Atrial fibrillation recurrence was captured by hospitalization, emergency room visit, or electrocardiogram-based documentation of AF. Confounding bias was controlled for in the analysis of AF recurrence using multivariate models of 19 variables for adjustment. A total of 1009 participants [mean age 67.2 (10.8) years, male to female ratio 1.3] were recruited from 170 centres, 693 (69%) of which were from across Europe and the remaining 316 (31%) from the USA. At the time of enrolment, participants were taking dronedarone (51%) or other AADs (49%) [flecainide or propafenone (42%), sotalol (11%), and amiodarone (47%)]. No significant differences in the risk of first confirmed AF recurrence with dronedarone vs. other AADs [crude hazard ratio (HR) 1.10 (95% confidence interval 0.85-1.42); adjusted HR 1.16 (0.87-1.55)] were found, irrespective of whether univariate or multivariate models were used. Reported safety events were in accordance with the known safety profile of dronedarone.Conclusion: In this population of patients from either Europe or the USA receiving dronedarone or another AAD, the effectiveness of dronedarone was comparable to that observed for other AADs in preventing first AF recurrence. [ABSTRACT FROM AUTHOR]

Published
2022
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42. Valproic Acid as an Adjuvant Treatment for Generalized Convulsive Status Epilepticus in Adults Admitted to Intensive Care Units: Protocol for a Double-Blind, Multicenter Randomized Controlled Trial (Preprint)

Author

Sharshar, Tarek, primary, Ben Hadj Salem, Omar, additional, Porcher, Raphaël, additional, Grimaldi-Bensouda, Lamiae, additional, Heming, Nicholas, additional, Clair, Bernard, additional, Azabou, Eric, additional, Mazeraud, Aurélien, additional, Rohaut, Benjamin, additional, and Outin, Hervé, additional

Published
2020
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43. Who seeks primary care for musculoskeletal disorders (MSDs) with physicians prescribing homeopathic and other complementary medicine? Results from the EPI3-LASER survey in France

Author

Magnier Anne-Marie, Guillemot Didier, Duru Gérard, Massol Jacques, Bénichou Jacques, Rouillon Frédéric, Lert France, Bégaud Bernard, Avouac Bernard, Rossignol Michel, Grimaldi-Bensouda Lamiae, and Abenhaim Lucien

Subjects
Diseases of the musculoskeletal system, RC925-935
Abstract

Abstract Background There is a paucity of information describing patients with musculoskeletal disorders (MSDs) using complementary and alternative medicines (CAMs) and almost none distinguishing homeopathy from other CAMs. The objective of this study was to describe and compare patients with MSDs who consulted primary care physicians, either certified homeopaths (Ho) or regular prescribers of CAMs in a mixed practice (Mx), to those consulting physicians who strictly practice conventional medicine (CM), with regard to the severity of their MSD expressed as chronicity, co-morbidity and quality of life (QOL). Methods The EPI3-LASER study was a nationwide observational survey of a representative sample of general practitioners and their patients in France. The sampling strategy ensured a sufficient number of GPs in each of the three groups to allow comparison of their patients. Patients completed a questionnaire on socio-demographics, lifestyle and QOL using the Short Form 12 (SF-12) questionnaire. Chronicity of MSDs was defined as more than twelve weeks duration of the current episode. Diagnoses and co-morbidities were recorded by the physician. Results A total of 825 GPs included 1,692 MSD patients (predominantly back pain and osteoarthritis) were included, 21.6% in the CM group, 32.4% Ho and 45.9% Mx. Patients in the Ho group had more often a chronic MSD (62.1%) than the CM (48.6%) or Mx (50.3%) groups, a result that was statistically significant after controlling for patients' characteristics (Odds ratio = 1.43; 95% confidence interval (CI): 1.07 - 1.89). Patients seen by homeopaths or mixed practice physicians who were not the regular treating physician, had more often a chronic MSD than those seen in conventional medicine (Odds ratios were1.75; 95% CI: 1.22 - 2.50 and 1.48; 95% CI: 1.06 - 2.12, respectively). Otherwise patients in the three groups did not differ for co-morbidities and QOL. Conclusion MSD patients consulting primary care physicians who prescribed homeopathy and CAMs differed from those seen in conventional medicine. Chronic MSD patients represented a greater proportion of the clientele in physicians offering alternatives to conventional medicine. In addition, these physicians treated chronic patients as consulting rather than regular treating physicians, with potentially important impacts upon professional health care practices and organisation.

Published
2011
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44. Clinical and economic burden of severe asthma: A French cohort study

Author

Nordon, Clementine, primary, Grimaldi-Bensouda, Lamiae, additional, Pribil, Celine, additional, Nachbaur, Gaelle, additional, Amzal, Billy, additional, Thabut, Gabriel, additional, Marthan, Roger, additional, Aubier, Michel, additional, Aubier, M., additional, Crestani, B., additional, Taillé, C., additional, Dombret, M.C., additional, Pretolani, M., additional, Berger, P., additional, Bourdin, A., additional, Vachier, I., additional, Molinari, N., additional, Chanez, P., additional, Similowski, T., additional, Didier, A., additional, De Blay, F., additional, Humbert, M., additional, Garcia, G., additional, Magnan, A., additional, Maitre, B., additional, Roche, N., additional, Tsicopoulos, A., additional, Chenivesse, C., additional, Deslée, G., additional, Marquette, C.H., additional, and Devouassoux, G., additional

Published
2018
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45. Dronedarone, amiodarone and other antiarrhythmic drugs, and acute liver injuries: a case-referent study

Author

Grimaldi-Bensouda, Lamiae, primary, Wedemeyer, Heiner, additional, Wiegand, Johannes, additional, Lohse, Ansgar W., additional, Benichou, Jacques, additional, Rossignol, Michel, additional, Larrey, Dominique, additional, Abenhaim, Lucien, additional, Poynard, Thierry, additional, Schott, Eckart, additional, Andersen, Matthias, additional, Berg, Thomas, additional, Cordes, Hans-Jörg, additional, Diepolder, Helmut, additional, Fähndrich, Martin, additional, Geier, Andreas, additional, Göbel, Uwe, additional, Grümmer, Harald, additional, Jamali, Seyed Hamid, additional, Kahl, Matthias, additional, Krummenerl, Thomas, additional, Lammertink, Jan, additional, Langmann, Peter, additional, Morgera, Ulrike, additional, Niederau, Claus Ulrich, additional, Pelster, Gregor, additional, Plauth, Mathias, additional, Reiser, Markus, additional, Rufle, Walter, additional, Schiefke, Ingolf, additional, Schlenker, Thorsten, additional, Schwarze, Oliver, additional, Schwerdtfeger, Michael, additional, Seelhoff, Alexander, additional, Spengler, Ulrich, additional, Strohbach, Matthias, additional, Tebbe, Johannes, additional, Thomsen, Thomas, additional, Treml, Oliver, additional, von Aretin, Andreas, additional, Wiese, Manfred, additional, and Wruck, Ullrich, additional

Published
2018
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46. Effectiveness of new antiplatelets in the prevention of recurrent myocardial infarction

Author

Grimaldi-Bensouda, Lamiae, primary, Danchin, Nicolas, additional, Dallongeville, Jean, additional, Falissard, Bruno, additional, Furber, Alain, additional, Cottin, Yves, additional, Bonello, Laurent, additional, Morel, Olivier, additional, Leclercq, Florence, additional, Puymirat, Etienne, additional, Ghanem, Fahmi, additional, Delarche, Nicolas, additional, Benichou, Jacques, additional, and Abenhaim, Lucien, additional

Published
2018
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47. Risk of autoimmune diseases and human papilloma virus (HPV) vaccines: Six years of case-referent surveillance

Author

Grimaldi-Bensouda, Lamiae, primary, Rossignol, Michel, additional, Koné-Paut, Isabelle, additional, Krivitzky, Alain, additional, Lebrun-Frenay, Christine, additional, Clet, Johanna, additional, Brassat, David, additional, Papeix, Caroline, additional, Nicolino, Marc, additional, Benhamou, Pierre-Yves, additional, Fain, Olivier, additional, Costedoat-Chalumeau, Nathalie, additional, Courcoux, Marie-France, additional, Viallard, Jean-François, additional, Godeau, Bertrand, additional, Papo, Thomas, additional, Vermersch, Patrick, additional, Bourgault-Villada, Isabelle, additional, Breart, Gerard, additional, Abenhaim, Lucien, additional, Abbas, Firas, additional, Abdelmoumni, Abdelhakim, additional, Hilliquin, Pascal, additional, Requeda, Elisabeth, additional, Adoue, Daniel, additional, Agard, Christian, additional, Masseau, Agathe, additional, Aladjidi, Nathalie, additional, Fernandes, Helder, additional, Lemasson, Gwendal, additional, Perel, Yves, additional, Raymond, Isabelle, additional, Richer, Olivier, additional, Vital, Anne, additional, Allain-Launay, Emma, additional, Bru, Marie, additional, Thomas, Caroline, additional, Altman, Jean-Jacques, additional, Amsallem, Daniel, additional, Aras, Nazmiye, additional, Boukari, Latifato, additional, Dubrel, Marie, additional, Letellier, Edouard, additional, Lucidarme, Nadine, additional, Mekinian, Arsène, additional, Morin, Anne-Sophie, additional, Stirnemann, Jérôme, additional, Atlan, Catherine, additional, Audry, Dominique, additional, Augustin, Jérôme, additional, Bakir, Redouane, additional, Bartolucci, Pablo, additional, Chevalier, Xavier, additional, Guillaud, Constance, additional, Khellaf, Mehdi, additional, Limal, Nicolas, additional, Lousteau, Valentine, additional, Mahevas, Matthieu, additional, Méliksetyan, Gayane, additional, Michel, Marc, additional, Roumier, Mathilde, additional, Bayart, Sophie, additional, Bonnet, Fabrice, additional, Decaux, Olivier, additional, Bekherraz, Amine, additional, Brihaye, Benoit, additional, Dachez, Roger, additional, Daugas, Eric, additional, Hayem, Gilles, additional, Meyer, Olivier, additional, Pasqualoni, Elisa, additional, Sacre, Karim, additional, Travert, Florence, additional, Bellon, Hélène, additional, Beltrand, Jacques, additional, Lefrere, François, additional, Simon, Albane, additional, Benveniste, Olivier, additional, Bolgert, Francis, additional, De Paz, Raphael, additional, Demeret, Sophie, additional, Fautrel, Bruno, additional, Jacqueminet, Sophie, additional, Louapre, Céline, additional, Maillart, Elizabeth, additional, Morel, Nathalie, additional, Rigabert, Julie, additional, Bensaid, Philippe, additional, Berger, Claire, additional, Berquin, Patrick, additional, Le Moing, Anne-Gaëlle, additional, Berroir, Stéphane, additional, Besson, Gérard, additional, Boutte, Célia, additional, Casez, Olivier, additional, Bonnotte, Bernard, additional, Audia, Sylvain, additional, Bossu-Estour, Cécile, additional, Bourgarit, Anne, additional, Dupuy, Alain, additional, Keshmandt, Homa, additional, Bourre, Bertrand, additional, Brac, Aude, additional, Perrin, Agnès, additional, Pondarré, Corinne, additional, Villar-Fimbel, Sylvie, additional, Bruckert, Isabelle, additional, Cosson, Anne, additional, Magy-Bertrand, Nadine, additional, Tisserand, Guillaume, additional, Camu, William, additional, Carlander, Bertrand, additional, Morales, Raul Juntas, additional, Cances, Claude, additional, Pasquet, Marlene, additional, Castilla Lievre, Maria Angela, additional, Chabroux, Stephanie, additional, Charif, Mamoud, additional, Chatelus, Emmanuel, additional, Sibilia, Jean, additional, Chevrant-Breton, Jacqueline, additional, Clavel, Sylvaine, additional, Bille-Turc, Françoise, additional, Cohen, Jacques, additional, Courcoux, Marie France, additional, Leverger, Guy, additional, Machet, Laurent, additional, Cuisset, Jean-Marie, additional, Cony-Makhoul, Pascale, additional, Darsy, Paul, additional, Favre, Sandrine, additional, Giraud, Pierrick, additional, Leitenschenck, Laurence, additional, Monteiro, Irène, additional, Morati, Chafika, additional, DeSeze, Jérôme, additional, Dinulescu, Monica, additional, Dhaoui, Taher, additional, Dommange-Romero, Florence, additional, Drevard, Elisabeth, additional, Dupuis, Clémentine, additional, Dumuis, Marie-Laure, additional, Durand, Jean-Marc, additional, Farad, Samia, additional, Lecomte, Pierre, additional, Pierre, Peggy, additional, Fouyssac, Fanny, additional, Gaudin, Philippe, additional, Gautier, Alain, additional, Gellen-Dautremer, Justine, additional, Jarrin, Irène, additional, Richette, Pascal, additional, Georget, Emilie, additional, Gras, Pierre, additional, Moreau, Thibault, additional, Giraud, Eric, additional, Hacini, Maya, additional, Mayer, Anne, additional, Guillaumat, Cécile, additional, Guillaume, Séverine, additional, Guitton, Corinne, additional, Kone-Paut, Isabelle, additional, Marsaud, Céline, additional, Rossi, Linda, additional, Guyot, Marie-Hélène, additional, Hassler, Patrick, additional, Heimfert, Claude, additional, Heinzlef, Olivier, additional, Hillion, Brigitte, additional, Hocquelet, Catherine, additional, Husson, Helene, additional, Ichai, Pierre, additional, Jeziorski, Eric, additional, Deslandre, Chantal Job, additional, Le Guern, Véronique, additional, Kamenov, Kamen, additional, Kerlan, Véronique, additional, Lemoine, Philippe, additional, Misery, Laurent, additional, Pan-Petesch, Brigitte, additional, Labauge, Pierre, additional, Rodier, Michel, additional, Lacade, Chadi, additional, Razafimahefa, Berthe, additional, Lachgar, Karim, additional, Larmarau, Marie-Pierre, additional, Leblanc, Thierry, additional, Lefèbvre, Patrick, additional, Lejoyeux, Philippe, additional, Leske, Charles, additional, Ly, Kim, additional, Magy, Laurent, additional, Mansuy, Sylvie, additional, Marechaud, Richard, additional, Martin Negrier, Marie-Laure, additional, Sole, Guilhem, additional, Maupetit, Jean, additional, Mazingue, Françoise, additional, Mochon, Stéphanie, additional, Moktar, Blidi, additional, Morcamp, Donald, additional, Morlet-Barla, Nathalie, additional, Nicolas, Guillaume, additional, Pautot, Vivien, additional, Pellier, Isabelle, additional, Verret, Jean-Luc, additional, Outteryck, Olivier, additional, Pallot-Prades, Beatrice, additional, Paquet, Jean Michel, additional, Puechal, Xavier, additional, Sortais, Annie, additional, Pelletier, Jean, additional, Rico, Audrey, additional, Pez, Dominique, additional, Stankoff, Bruno, additional, Quittet, Philippe, additional, Rémy, Claude, additional, Roba, Eléna, additional, Rosario, Hélène, additional, Roudaut, Nathalie, additional, Sonnet, Emmanuel, additional, Ruel, Michel, additional, Sebban, Samuel, additional, Schaepelynck, Pauline, additional, Simonin, Marie-Jeanne, additional, Vial, Christophe, additional, Viallard, Jean-Francois, additional, Ladedan, Isabelle, additional, and Zenone, Thierry, additional

Published
2017
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48. Effect of an Institutional Medication Adherence Program for Long-Acting Injectable Risperidone on Adherence and Psychiatric Hospitalizations: Evidence From a Prospective Cohort Study

Author

Jalbert, Jessica J., primary, Rossignol, Michel, additional, Astruc, Bernard, additional, Bayle, Franck, additional, Nordon, Clementine, additional, Avouac, Bernard, additional, Rouillon, Frederic, additional, Abenhaim, Lucien, additional, and Grimaldi-Bensouda, Lamiae, additional

Published
2017
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49. The IMI PROTECT project: purpose, organizational structure, and procedures

Author

Reynolds, Robert F, Kurz, Xavier, de Groot, Mark C H, Schlienger, Raymond G, Grimaldi-Bensouda, Lamiae, Tcherny-Lessenot, Stephanie, Klungel, Olaf H, Reynolds, Robert F, Kurz, Xavier, de Groot, Mark C H, Schlienger, Raymond G, Grimaldi-Bensouda, Lamiae, Tcherny-Lessenot, Stephanie, and Klungel, Olaf H

Abstract

The Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium (PROTECT) initiative was a collaborative European project that sought to address limitations of current methods in the field of pharmacoepidemiology and pharmacovigilance. Initiated in 2009 and ending in 2015, PROTECT was part of the Innovative Medicines Initiative, a joint undertaking by the European Union and pharmaceutical industry. Thirty-five partners including academics, regulators, small and medium enterprises, and European Federation of Pharmaceuticals Industries and Associations companies contributed to PROTECT. Two work packages within PROTECT implemented research examining the extent to which differences in the study design, methodology, and choice of data source can contribute to producing discrepant results from observational studies on drug safety. To evaluate the effect of these differences, the project applied different designs and analytic methodology for six drug-adverse event pairs across several electronic healthcare databases and registries. This papers introduces the organizational structure and procedures of PROTECT, including how drug-adverse event and data sources were selected, study design and analyses documents were developed, and results managed centrally. Copyright © 2016 John Wiley & Sons, Ltd.

Published
2016

50. Calcium channel blockers and cancer: a risk analysis using the UK Clinical Practice Research Datalink (CPRD)

Author

Grimaldi-Bensouda, Lamiae, Klungel, Olaf, Kurz, Xavier, de Groot, Mark C H, Maciel Afonso, Ana S, de Bruin, Marie L, Reynolds, Robert, Rossignol, Michel, Grimaldi-Bensouda, Lamiae, Klungel, Olaf, Kurz, Xavier, de Groot, Mark C H, Maciel Afonso, Ana S, de Bruin, Marie L, Reynolds, Robert, and Rossignol, Michel

Abstract

OBJECTIVE: The evidence of an association between calcium channel blockers (CCBs) and cancer is conflicting. The objective of the present study was to evaluate the risk of cancer (all, breast, prostate and colon cancers) in association with exposure to CCB.METHODS: This is a population-based cohort study in patients exposed to CCBs from across the UK, using two comparison cohorts: (1) patients with no exposure to CCB (non-CCB) matched on age and gender and (2) unmatched patients unexposed to CCB and at least one other antihypertensive (AHT) prescription. Cancer incidence rates computed in the exposed and the two unexposed groups were compared using HRs and 95% CIs obtained from multivariate Cox regression analyses.RESULTS: Overall, 150 750, 557 931 and 156 966 patients were included, respectively, in the CCB, non-CCB and AHT cohorts. Crude cancer incidence rates per 1000 person-years were 16.51, 15.75 and 10.62 for the three cohorts, respectively. Adjusted HRs (CI) for all cancers comparing CCB, non-CCB and AHT cohorts were 0.88 (0.86 to 0.89) and 1.01 (0.98 to 1.04), respectively. Compared to the AHT cohort, adjusted HRs (CI) for breast, prostate and colon cancer for the CCB cohort were 0.95 (0.87 to 1.04), 1.07 (0.98 to 1.16) and 0.89 (0.81 to 0.98), respectively. Analyses by duration of exposure to CCB did not show excess risk.CONCLUSIONS: This large population-based study provides strong evidence that CCB use is not associated with an increased risk of cancer. The analyses yielded robust results across all types of cancer and different durations of exposure to CCBs.

Published
2016

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