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1. Safety of Inulin and Sinistrin: Combining Several Sources for Pharmacovigilance Purposes

Author

T-V. Bui, C. Prot-Bertoye, H. Ayari, S. Baron, J-P. Bertocchio, C. Bureau, P. Davis, A. Blanchard, P. Houillier, D. Prie, A. Lillo-Le Louet, M. Courbebaisse, Gestionnaire, Hal Sorbonne Université, Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Centre de Référence des Maladies Rénales Héréditaires de l'Enfant et de l'Adulte [CHU-Necker] (MARHEA), CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Paris Cité - UFR Médecine [Santé] (UPCité UFR Médecine), Université Paris Cité (UPCité), Physiologie rénale et tubulopathies = Renal Physiology and tubulopathies [CRC], Centre National de la Recherche Scientifique (CNRS)-Centre de Recherche des Cordeliers (CRC (UMR_S_1138 / U1138)), École pratique des hautes études (EPHE), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Université Paris Cité (UPCité)-École pratique des hautes études (EPHE), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Université Paris Cité (UPCité), Institut Necker Enfants-Malades (INEM - UM 111 (UMR 8253 / U1151)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité), Service d’explorations fonctionnelles [CHU Necker], Centre de Référence des Maladies Rénales Héréditaires de l'Enfant et de l'Adulte (MARHEA), Université de Paris - UFR Médecine [Santé] (UP Médecine), Université de Paris (UP), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Université de Paris (UP)-École pratique des hautes études (EPHE), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Université de Paris (UP), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Paris (UP)

Subjects
safety, medicine.medical_specialty, Fatal outcome, Inulin, RM1-950, 02 engineering and technology, sinistrin, inulin (PubChem CID: 16219508), 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Internal medicine, Pharmacovigilance, medicine, Pharmacology (medical), 030203 arthritis & rheumatology, Pharmacology, inulin, business.industry, Brief Research Report, 021001 nanoscience & nanotechnology, 3. Good health, [SDV.TOX] Life Sciences [q-bio]/Toxicology, Clinical trial, chemistry, pharmacovigilance, [SDV.SP.PHARMA] Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, [SDV.TOX]Life Sciences [q-bio]/Toxicology, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, Anaphylactic shock, Therapeutics. Pharmacology, hypersensitivity, 0210 nano-technology, business, Sinistrin
Abstract

Introduction: Inulin and its analog sinistrin are fructose polymers used in the food and pharmaceutical industries. In 2018, The French National Agency for the Safety of Medicines and Health Products (ANSM) decided to withdraw products containing sinistrin and inulin due to several reports of serious hypersensitivity reactions, including a fatal outcome.Objective: To assess the safety of inulin and sinistrin use in France.Methods: We searched multiple sources to identify adverse reactions (ARs) to inulin or sinistrin: first, classical pharmacovigilance databases including the French Pharmacovigilance (FPVD) and the WHO Database (VigiBase); second, data from a clinical trial, MultiGFR; third, data regarding current use in an hospital. All potential ARs to inulin or sinistrin were analyzed with a focus on hypersensitivity reactions and relationships to batches of sinistrin.Results: From 1991 to 2018, 134 ARs to inulin or sinistrin were registered in the FPVD or VigiBase. Sixty-three cases (47%) were classified as serious, and 129 cases (96%) were hypersensitivity reactions. We found an association between a batch of sinistrin and the occurrence of hypersensitivity reactions. During the MultiGFR clinical trial, 7 patients (7/163 participants) had an Adverse reaction; of these, 4 were hypersensitivity reactions including one case of grade 4 anaphylactic shock. In the hospital, no ARs were observed. In the literature, ARs to inulin and sinistrin are very rarely reported and mostly benign.Conclusion: Most ARs to inulin and sinistrin are hypersensitivity reactions that appear to be associated with sinistrin batches.

Published
2021

2. Can We Reduce Frame Rate to 15 Images per Second in Pediatric Videofluoroscopic Swallow Studies?

Author

Clement, Olivier, Dewachter, Pascale, Mouton-Faivre, Claudie, Nevoret, Camille, Guilloux, Laurence, Bloch Morot, Evelyne, Katsahian, Sandrine, Laroche, Dominique, Audebert, Martine, Benabes-Jezraoui, Béatrice, Benoit, Yves, Beot, Sylvie, Berard, Frédéric, Berthezene, Yves, Bertrand, Philippe, Bouffard, Juliette, Bourrain, Jean-Luc, Boyer, Bruno, Carette, Marie-France, Caron-Poitreau, Christine, Cavestri, Béatrice, Cercueil, Jean Pierre, Charpin, Denis-André, Collet, Evelyne, Crombe-Ternamian, Arielle, Dalmas, Jacques, Decoux, Eric, Defrance, Marie-France, Delaval, Yvonne, Demoly, Pascal, Depriester, Claude, Depriester, Pascale, Didier, Alain, Drouet, Martine, Dupas, Benoît, Dupre-Goetchebeur, Dominique, Dzviga, Charles, Fabre, Christine, Ferretti, Gilbert, Fourre-Jullian, Corinne, Girardin, Pascal, Giron, Jacques, Gouitaa, Marion, Grenier, Nicolas, Guenard Bilbault, Lydie, Guez, Stéphane, Gunera-Saad, Nathalie, Heautot, Jean-François, Herbin, Dominique, Hoarau, Cyrille, Jacquot, Claude, Julien, Christian, Laborie, Laurent, Lambert, Claude, Larroche, Pascal, Leclerc, Xavier, Lemaitre, Laurent, Leynadier, Francisque, Lillo-Le-Louet, Agnès, Louvel, Jean-Pierre, Louvier, Nathalie, Lucas, Marie-Madeleine, Meites, Geneviève, Mennesson, Nicolas, Metge, Liliane, Meunier, Yannick, Monnier-Cholley, Laurence, Musacchio, Mariano, Nicolie, Brigitte, Occelli, Gisèle, Oesterle, Hélène, Paisant-Thouveny, Francine, Panuel, Michel, Railhac, Nadine, Rety-Jacob, Frédérique, Rochefort-Morel, Cécile, Roy, Catherine, Sarlieve, Philippe, Sesay, Musa, Sgro, Catherine, Taourel, Patrice, Terrier, Patrick, Theissen, Odile, Topenot, Ingrid, Valfrey, Jocelyne, Veillon, Francis, Vergnaud, Marie-Claude, Veyret, Charles, Vincent, Denis, Wallaert, Benoit, Wessel, François, Zins, Marc, Layly, Julie, Marmouset, Franck, Chassagnon, Guillaume, Sirinelli, Dominique, Cottier, Jean-Philippe, Morel, Baptiste, Centre de recherche en neurosciences de Lyon - Lyon Neuroscience Research Center (CRNL), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Pathophysiology of the Vigilance States (SLEEP), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL), Groupe Hospitalier Universitaire Paris Seine-Saint-Denis (GHUPSSD), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Biomnis Laboratory, Service de Médecine Interne [CHU HEGP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Centre de référence des syndromes drépanocytaires majeurs, CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), CHU Amiens-Picardie, Hôpital Edouard Herriot [CHU - HCL], Hospices Civils de Lyon (HCL), Département d'allergie et d'immunologie clinique [CHU Lyon Sud], Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Immunologie de l'allergie cutanée et vaccination – Immunology of skin allergy and vaccination, Centre International de Recherche en Infectiologie (CIRI), École normale supérieure de Lyon (ENS de Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-École normale supérieure de Lyon (ENS de Lyon)-Université Claude Bernard Lyon 1 (UCBL), Hôpital de la Croix-Rousse [CHU - HCL], Éducation Éthique Santé EA 7505 (EES), Université de Tours (UT), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Institut de Cancérologie de Lorraine - Alexis Vautrin [Nancy] (UNICANCER/ICL), UNICANCER, CHU Tenon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Université Paris Cité (UPCité), Imagerie et cerveau (iBrain - Inserm U1253 - UNIV Tours ), Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Motricité, interactions, performance EA 4334 / Movement - Interactions - Performance (MIP), Le Mans Université (UM)-Centre hospitalier universitaire de Nantes (CHU Nantes)-Université de Nantes - UFR des Sciences et Techniques des Activités Physiques et Sportives (UFR STAPS), Université de Nantes (UN)-Université de Nantes (UN), Laboratoire Interuniversitaire de Biologie de la Motricité (LIBM ), and Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Université Savoie Mont Blanc (USMB [Université de Savoie] [Université de Chambéry])

Subjects
Male, medicine.medical_specialty, Adolescent, Pediatrics, Sensitivity and Specificity, [SHS]Humanities and Social Sciences, 030507 speech-language pathology & audiology, 03 medical and health sciences, Speech and Hearing, 0302 clinical medicine, Swallowing, Image Processing, Computer-Assisted, medicine, Humans, Child, ComputingMilieux_MISCELLANEOUS, Retrospective Studies, business.industry, Cineradiography, Gastroenterology, Reproducibility of Results, Frame rate, University hospital, Dysphagia, Deglutition, Pediatric Radiology, Otorhinolaryngology, Child, Preschool, Radiological weapon, Female, Radiology, medicine.symptom, Deglutition Disorders, 0305 other medical science, business, 030217 neurology & neurosurgery, Pediatric population
Abstract

Videofluoroscopic Swallow studies (VFSS) are useful radiological examinations to explore swallowing disorders but which require ionizing radiation. The aim of our study was to evaluate the comparability of pediatric VFSS at 15 frames per second (fps) with 30 fps. Fifty-five loops including 190 swallowings of VFSS at 30 fps performed on 32 consecutive pediatric patients in a University Hospital Center were retrospectively modified by a software to delete one image out of two to obtain secondary loops with a frame rate of 15 fps. An otorhinolaryngologist-phonatrician and a radiologist reviewed all swallowings blindly and randomly using the penetration and aspiration scale (PAS). In case of discordance, they concluded a consensual interpretation. Fifteen girls and seventeen boys were included. The median age was 4 years and 8 months (range = 4 months-16 yr.). 144 swallowings were normal. Swallowing disorder was confirmed in 46 swallowings, (23 supraglottic penetrations and 23 aspirations). Considering each swallowing at 15 fps, sensitivity and specificity were, respectively, 93% (CI 0.82-0.98) and 98% (CI 0.94-0.99). The Cohen'Kappa coefficient between each interpretation at 15 and 30 fps was "almost perfect" (κ = 0.95; CI 0.88-0.99). Considering each loop, conclusion was identical. Reducing frame rate at 15 fps during pediatric VFSS seemed to be acceptable with comparable diagnostic performances without clinical impact compared to 30 fps, while being an efficient way to reduce the ionizing radiation exposition in children. We would suggest reconsidering the possibility of using VFSS with a 15 fps in a pediatric population.

Published
2019

3. Clin Pharmacol Ther

Author

Mareva Faure, Yola Moride, Bernard Bégaud, Agnès Lillo-Le-Louet, Anne-Marie Castilloux, Bordeaux population health (BPH), and Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
Male, medicine.medical_specialty, MEDLINE, Comorbidity, 030226 pharmacology & pharmacy, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Recurrence, Risk Factors, Internal medicine, Secondary Prevention, Medicine, Humans, Pharmacology (medical), Aged, Proportional Hazards Models, Pharmacology, Aged, 80 and over, PharmacoEpi-Drugs, business.industry, Proportional hazards model, Hazard ratio, Age Factors, Anticoagulants, Cardiovascular Agents, Pharmacoepidemiology, Middle Aged, medicine.disease, Confidence interval, 3. Good health, Clinical trial, Stroke, 030220 oncology & carcinogenesis, Practice Guidelines as Topic, Female, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Guideline Adherence, business, Platelet Aggregation Inhibitors, Cohort study
Abstract

Using claims databases of a public healthcare program (Quebec) for the years 2010–2013, we conducted a cohort study of patients with acute ischemic stroke (AIS) to describe secondary prevention treatments and determine how they stood against practice guidelines. We compared the risk of death or AIS recurrence over 1 year in patients treated with anticoagulants, antiplatelets, and/or other cardiovascular drugs. In the month after discharge, 44.3% of the patients did not receive the recommended treatment and > 20% did not have any treatment. Untreated patients were younger, had less comorbidities, and a more severe AIS. Anticoagulants and antiplatelets were associated with a reduced risk of death or recurrence (hazard ratio (HR) 0.27; 95% confidence interval (CI) 0.20–0.36 and HR 0.25; 95% CI 0.16–0.38, respectively) compared with the untreated group. Effect size was similar for the other treatments. Findings confirm treatment benefits shown in clinical trials and emphasize the importance of AIS secondary prevention.

Published
2020

4. Diagnosis of Heparin-Induced Thrombocytopenia: Development and Validation of a Predictive Clinical Score Based on Objective Features Identified by a Multivariate Analysis of a Multinational Prospective Study

Author

Brigitte Tardy-Poncet, Emmanuel de Maistre, Claire Pouplard, Emilie Presles, Martine Alhenc-Gelas, Dominique Lasne, Marie-Hélène Horellou, Christine Mouton, Anne Serre-Sapin, Anne Bauters, Philippe Nguyen, François Mullier, Julien Perrin, Grégoire Le Gal, Pierre Morange, Lélia Grunebaum, Agnès Lillo-Le Louet, Ismail Elalamy, Yves Gruel, Andreas Greinacher, Thomas Lecompte, Bernard Tardy, and GFHT-HIT Study Group

Subjects
medicine.medical_specialty, Multivariate analysis, business.industry, Major trauma, medicine.disease, Intensive care unit, law.invention, Informed consent, law, Internal medicine, Heparin-induced thrombocytopenia, Good clinical practice, Medicine, Observational study, business, Prospective cohort study
Abstract

Background: Diagnosis of heparin-induced thrombocytopenia (HIT) is based on a composite of clinical likelihood and laboratory testing. We aimed to develop a diagnostic score derived from multivariate analysis of clinical features, including platelet count changes, prospectively recorded in patients with suspected HIT. Methods: This multinational observational study (ClinicalTrials.gov no. NCT00748839) included 2280 adult patients with suspected HIT: 1597 (derivation cohort) formed the basis for developing the scoring system, subsequently validated in 683 additional randomly selected patients (validation cohort). HIT was diagnosed by two independent adjudicators based on clinical features, local laboratory data, and the results of a centrally performed serotonin release assay (SRA). Findings: Overall, 56.7% of the patients were treated in an intensive care unit of whom 57.4% received unfractionated heparin; thromboembolism occurred in 12.3%. In the derivation and validation cohorts, 234 (14.7%) and 99 (14.5%) patients, respectively, were diagnosed with HIT. Eight features were positively associated with HIT diagnosis in a multivariate model (in brackets the value assigned for score calculation): unfractionated heparin use (1); therapeutic-dose heparin use (1); cardiac surgery with cardiopulmonary bypass (2); major trauma (3); 5- to 21-day interval from anticoagulant treatment initiation to suspicion of HIT (4); ≥ 40% decrease in platelet count over ≤ 6 days during the last 10 days of anticoagulation exposure (3); thrombotic event, either arterial (3) or venous (3). The C statistic of the model was 0.791 [0.76; 0.82] (p-value 0.70, Hosmer-Lemeshow test). In the validation cohort, the area under the ROC curve was 0.77 [95% CI 0.74-0.80], and HIT prevalence was 2.6% for a score ≤2; 6% for a score of 3–8; and 28.8% for a score >8: Interpretation: This study distinguishes validated clinical features of HIT, permitting improved estimation of its likelihood. Trial Registration: (ClinicalTrials.gov no. NCT00748839) Funding Statement: Programme Hospitalier de Recherche Clinique (French Health Ministry), Sanofi, LFB, Organon SA. Declaration of Interests: Dr. Mullier reports personal fees from Aspen, personal fees from Stago, grants from Werfen, outside the submitted work; Dr. Gruel reports personal fees from Sanofi, personal fees from LFB, other from Stago, personal fees from Aspen, outside the submitted work; . All other authors declare no conflict of interests. Ethics Approval Statement: The study was conducted in accordance with the ethical principles stated in the Declaration of Helsinki, Good Clinical Practice, and relevant French, Swiss and Belgian legal and regulatory requirements regarding data protection. The protocol was approved by French, Swiss and Belgian independent ethics committees. All patients received written information about the study, emphasizing their right to refuse participation or to withdraw at any time. As no experimental interventions were induced from the protocol, no written informed consent was required for inclusion.

Published
2019

5. Immediate Hypersensitivity to Contrast Agents: The French 5-year CIRTACI Study

Author

Dominique Herbin, Jacques Dalmas, Frédéric Berard, Jean-Luc Bourrain, Laurence Monnier-Cholley, Laurent Lemaitre, P. Girardin, Agnès Lillo-Le-Louet, Christian Julien, Lydie Guenard Bilbault, François Wessel, Jean Pierre Cercueil, Charles Veyret, Yvonne Delaval, Hélène Oesterle, Liliane Metge, Sylvie Beot, Béatrice Cavestri, Laurent Laborie, Philippe Bertrand, Arielle Crombe-Ternamian, Evelyne Collet, Evelyne Bloch Morot, Nicolas Mennesson, Claude Jacquot, Francis Veillon, Ingrid Topenot, Christine Caron-Poitreau, Brigitte Nicolie, Olivier Clément, Marie-Madeleine Lucas, Martine Audebert, Christine Fabre, Musa Sesay, Jacques Giron, Frédérique Rety-Jacob, Geneviève Meites, Francisque Leynadier, Xavier Leclerc, Pascal Larroche, Catherine Sgro, Claude Depriester, Alain Didier, Laurence Guilloux, Francine Paisant-Thouveny, Gisèle Occelli, Philippe Sarlieve, Sandrine Katsahian, Juliette Bouffard, Stéphane Guez, D. Laroche, Jean-Pierre Louvel, Corinne Fourre-Jullian, Claude Lambert, Yves Berthezene, Denis Vincent, Nicolas Grenier, Charles Dzviga, Cécile Rochefort-Morel, Yannick Meunier, Marie-France Defrance, Odile Theissen, Pascal Demoly, Michel Panuel, Eric Decoux, Cyrille Hoarau, Béatrice Benabes-Jezraoui, Marie-France Carette, Mariano Musacchio, Jean-François Heautot, Benoît Dupas, Benoit Wallaert, Denis-André Charpin, Gilbert Ferretti, Camille Nevoret, Pascale Dewachter, Marion Gouitaa, Patrice Taourel, Pascale Depriester, Yves Benoit, Bruno Boyer, Jocelyne Valfrey, Nadine Railhac, Martine Drouet, Nathalie Louvier, Claudie Mouton-Faivre, Catherine Roy, Marie-Claude Vergnaud, Nathalie Gunera-Saad, Marc Zins, Patrick Terrier, Dominique Dupre-Goetchebeur, Service de Radiologie [CHU HEGP], Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Paris-Centre de Recherche Cardiovasculaire (PARCC - UMR-S U970), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital Européen Georges Pompidou [APHP] (HEGP), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Biomnis Laboratory, Service de Médecine Interne [CHU HEGP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Centre de référence des syndromes drépanocytaires majeurs, CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), CHU Amiens-Picardie, Hôpital Edouard Herriot [CHU - HCL], Hospices Civils de Lyon (HCL), Service d'immunologie [Centre Hospitalier Lyon Sud - HCL], Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Hôpital de la Croix-Rousse [CHU - HCL], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), CHU Grenoble, Institut de Cancérologie de Lorraine - Alexis Vautrin [Nancy] (UNICANCER/ICL), UNICANCER, Service de dermatologie et allergologie [CHU Tenon], CHU Tenon [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Hôpital Albert Calmette, Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Service de radiologie et d'Imagerie médicale diagnostique et thérapeutique (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Hôpital Nord [CHU - APHM], Service de Dermatologie (CHU de Dijon), CH Martigues, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Centre hospitalier Saint-Joseph [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Pontchaillou [Rennes], Université de Montpellier (UM), Service de pneumologie [Toulouse], CHU Toulouse [Toulouse]-Hôpital Larrey [Toulouse], CHU Toulouse [Toulouse], Centre hospitalier universitaire de Nantes (CHU Nantes), Hôpital Morvan - CHRU de Brest (CHU - BREST ), Service de radiologie [Saint-Etienne], CHU Saint-Etienne-Université Jean Monnet [Saint-Étienne] (UJM), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Institut des Neurosciences de Montpellier - Déficits sensoriels et moteurs (INM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Service central de radiologie et d'imagerie médicale, CHU Grenoble-Hôpital Michallon, Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Hôpital Purpan [Toulouse], Hôpital Pellegrin, CHU Bordeaux [Bordeaux]-Groupe hospitalier Pellegrin, Service de radiologie et imagerie médicale [Rennes] = Radiology [Rennes], Centre Hospitalier Public du Cotentin (CHPC), Service de néphrologie et immunologie clinique [CHRU Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau-Université de Tours (UT), Clinique de réanimation médicale, Université Joseph Fourier - Grenoble 1 (UJF)-CHU Grenoble-Hôpital Michallon, CHU Saint-Etienne, Département de radiologie [Brest] (DR - Brest), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Services de neuroradiologie [Lille], Hôpital Roger Salengro [Lille]-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Hôpital Claude Huriez [Lille], CHU Lille, Service de Radiologie [CHU Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU), Centre Régional de Lutte contre le cancer Georges-François Leclerc [Dijon] (UNICANCER/CRLCC-CGFL), Hôpital de Rangueil, Service de réanimation médicale [CHU Rouen], Hôpital Charles Nicolle [Rouen]-CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Service de Radiologie [CHU Saint-Antoine], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Hôpital pasteur [Colmar], Centre Hospitalier Universitaire de Nice (CHU Nice), CHU Strasbourg, Laboratoire de Pharmacologie-Toxicologie [CHU de Dijon], Service de pneumologie, allergologie, mucoviscidose pédiatrique [Rouen], Service de radiologie [Strasbourg], CHU Strasbourg-Hôpital de Hautepierre [Strasbourg], Service de Médecine générale [CHU Caen], Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Service de pneumologie [Nantes], Université de Nantes (UN)-Centre hospitalier universitaire de Nantes (CHU Nantes), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Sorbonne Université-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Groupe hospitalier Paris Saint-Joseph - Hôpital, Centre Hospitalier Régional Universitaire [Besançon] (CHRU Besançon), Service de radiologie et imagerie médicale [Rennes], Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-CHU Pontchaillou [Rennes], Centre Hospitalier Public du Cotentin [Cherbourg-Octeville] (CHPC), Service de Néphrologie et d’Immunologie Clinique [CHRU Tours], Hôpital Bretonneau-Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Hôpital Jean Minjoz, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université-Sorbonne Université, Herrada, Anthony, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), CHU Saint-Etienne-Université Jean Monnet - Saint-Étienne (UJM), Institut des Neurosciences de Montpellier (INM), CH Centre Hospitalier Public du Cotentin (CHPC), Hôpital Charles Nicolle [Rouen], Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Centre de référence des syndromes drépanocytaires majeurs-Hôpital Européen Georges Pompidou [APHP] (HEGP), Service de néphrologie et immunologie clinique [CHRU Tours] (EA4245 UT), and Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau-Université de Tours

Subjects
medicine.medical_specialty, Allergy, Tryptase, Gastroenterology, Culprit, 030218 nuclear medicine & medical imaging, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Internal medicine, medicine, Clinical severity, lcsh:R5-920, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, biology, business.industry, General Medicine, medicine.disease, 3. Good health, 030228 respiratory system, chemistry, biology.protein, Intradermal test, Plasma histamine, lcsh:Medicine (General), business, Histamine, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Research Paper
Abstract

International audience; Background:Iodinated and gadolinium-based contrast media (ICM; GBCM) induce immediate hypersensitivity (IH) reactions. Differentiating allergic from non-allergic IH is crucial; allergy contraindicates the culprit agent for life. We studied frequency of allergic IH among ICM or GBCM reactors.Methods:Patients were recruited in 31 hospitals between 2005 and 2009. Clinical symptoms, plasma histamine and tryptase concentrations and skin tests were recorded. Allergic IH was diagnosed by intradermal tests (IDT) with the culprit CM diluted 1:10, "potentially allergic" IH by positive IDT with pure CM, and non-allergic IH by negative IDT.Findings:Among 245 skin-tested patients (ICM = 209; GBCM = 36), allergic IH to ICM was identified in 41 (19.6%) and to GBCM in 10 (27.8%). Skin cross-reactivity was observed in 11 patients with ICM (26.8%) and 5 with GBCM (50%). Allergy frequency increased with clinical severity and histamine and tryptase concentrations (p 50% of life-threatening ones. GBCM and ICM triggered comparable IH reactions in frequency and severity. Cross-reactivity was frequent, especially for GBCM. We propose considering skin testing with pure contrast agent, as it is more sensitive than the usual 1:10 dilution criteria.

Published
2018

6. Usefulness of initial plasma dabigatran concentration to predict rebound after reversal

Author

Nicolas Gendron, Juliette Gay, Marine Lemoine, Pascale Gaussem, Agnès Lillo-Le-Louet, and David M. Smadja

Subjects
Adult, Male, medicine.medical_specialty, 030232 urology & nephrology, Hemorrhage, 030204 cardiovascular system & hematology, Antibodies, Monoclonal, Humanized, Antithrombins, Dabigatran, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Internal medicine, medicine, Humans, Online Only Articles, Aged, Aged, 80 and over, business.industry, Hematology, Plasma, Middle Aged, Prognosis, Cardiology, Female, business, medicine.drug
Published
2018

7. Estimating the excess of inappropriate prescriptions of anti-dopaminergic anti-emetics during acute gastroenteritis epidemics in France

Author

Thomas Hanslik, Cécile Souty, Solen Kernéis, Thierry Blanchon, Bruno Lambert, Agnes Lillo-Le-Louet, Thomas Tritz, Clément Turbelin, Christophe Arena, and Victoire Roussel

Subjects
medicine.medical_specialty, Pediatrics, biology, Epidemiology, business.industry, Public health, Euros, Pharmacoepidemiology, Inappropriate Prescriptions, biology.organism_classification, Environmental health, Pharmacovigilance, medicine, Pharmacology (medical), Medical prescription, Adverse effect, business, health care economics and organizations
Abstract

Purpose Anti-dopaminergic anti-emetics (ADA) use for the treatment of nausea associated with gastroenteritis (GE) can be considered inappropriate, as their effects are not supported by evidence of clinical efficacy and can potentially induce serious adverse events. Objective This study quantifies the suboptimal consumption of ADA attributable to seasonal GE epidemics in France and its cost. Methods GE epidemiological data were collected and transmitted by the general practitioners (GPs) of Sentinelles network. Epidemic periods were identified by periodic regression. Drug sales data were obtained from pharmacies, and costs data were obtained from the French National Social Security. The ADA use and costs incurred by seasonal GE epidemics were calculated. Results During the epidemic periods considered in this study, the median age of patients seen by GPs for GE was 24 years old. During each epidemic, a sale increase by 14% for domperidone, by 15% for metoclopramide and 30% for metopimazine was observed. The average cost attributable to seasonal GE epidemic was 5 030 000 Euros, of which 2 160 000 Euros were incurred by the French National Social Security. Conclusion Linking epidemiological databases helped to identify and quantify inappropriate ADA prescriptions. GE treatment guidelines should be disseminated more widely. Copyright © 2013 John Wiley & Sons, Ltd.

Published
2013

8. Réintroduction de la clozapine chez les patients souffrant de schizophrénie résistante « super répondeurs », après neutropénie sous clozapine : à propos d’un cas

Author

Luc Darnige, H Loo, M O Krebs, A Lillo-Le Louet, and G Huguet

Subjects
Gynecology, Psychiatry and Mental health, medicine.medical_specialty, Arts and Humanities (miscellaneous), business.industry, Psychiatric status rating scales, medicine, Filgrastim, business, Martinique, medicine.drug
Abstract

Resume L’objectif de cet article est d’exposer une strategie de reintroduction de la clozapine associee au filgrastim apres un episode de neutropenie entrainant l’arret de la clozapine, autour d’un cas. B.N., âge de 35 ans, originaire de la Martinique, souffrant d’une schizophrenie resistante, pour laquelle il est « ultra repondeur » a la clozapine. En rupture de traitement, apres quatre annees de stabilite clinique sous clozapine, B.N. a presente lors de trois reintroductions de la clozapine (2008, 2010 et 2011), trois episodes de neutropenie. Nous avons donc realise une quatrieme reintroduction sous couverture de filgrastim (G-CSF) 0,6 mg/semaine. L’amelioration a ete notee des le huitieme jour. Apres huit semaines de traitement, le patient est stabilise sous clozapine 300 mg/j. L’evolution est clairement favorable, la PANNS est passee de 158 a 90. Il n’a pas ete constate de nouvel episode de neutropenie, avec au plus bas 1,9 G/L neutrophiles. La posologie de filgrastim a donc pu etre reduite a partir de la septieme semaine a 0,3 mg/semaine avec poursuite d’une surveillance hebdomadaire de la NFS pendant la duree du traitement. La tolerance est satisfaisante, avec amelioration des anomalies induites par le traitement anterieur, c’est-a-dire du bilan lipidique, de la glycemie, de la pression arterielle et de l’intervalle QT a l’ECG. Nous avons egalement souleve un biais de notoriete de la clozapine qui n’est souvent pas l’unique facteur etiologique a la neutropenie (autres medicaments hematotoxiques, rythme circadien, neutropenie transitoire, neutropenie ethnique).

Published
2013

9. Valganciclovir prophylaxis for cytomegalovirus infection in thoracic transplant patients: retrospective study of efficacy, safety, and drug exposure

Author

C. Charpentier, A. Lillo-Le Louet, Sandrine Lefeuvre, L. Havard, V. Boussaud, M. Benammar, Romain Guillemain, Eliane M. Billaud, R. Zekkour, Catherine Amrein, and P. Chevalier

Subjects
Ganciclovir, Transplantation, medicine.medical_specialty, business.industry, medicine.medical_treatment, Congenital cytomegalovirus infection, Valganciclovir, Retrospective cohort study, Neutropenia, medicine.disease, Gastroenterology, Surgery, Infectious Diseases, Internal medicine, Chemoprophylaxis, medicine, Lung transplantation, business, medicine.drug
Abstract

S. Lefeuvre, P. Chevalier, C. Charpentier, R. Zekkour, L. Havard, M. Benammar, C. Amrein, V. Boussaud, A. Lillo-Le Louet, R. Guillemain, E.M. Billaud. Valganciclovir prophylaxis for cytomegalovirus infection in thoracic transplant patients: retrospective study of efficacy, safety, and drug exposure. Transpl Infect Dis 2010: 12: 213–219. All rights reserved Abstract: Oral ganciclovir (GCV) was replaced by prodrug valganciclovir (vGCV) for cytomegalovirus (CMV) prophylaxis. We assessed retrospectively (2005–2007) vGCV effectiveness and safety during prophylaxis and 4 months after, in heart (HTx) and lung transplantation (LTx), including lung transplant for cystic fibrosis (CFTx). Patients with stable renal function received vGCV 900 mg daily during 3–6 and 8–12 months in HTx and LTx. Effectiveness was assessed by antigenemia (pp65Ag) and a GCV therapeutic drug monitoring to document exposure. A total of 32 patients (11 HTx, 7 LTx, and 14 CFTx) received vGCV for 106±67 days in HTx versus 270±85 days in LTx and CFTx. Doses were 700±225, 915±60, and 820±150 mg/24 h in HTx, LTx, and CFTx showing acceptable mean trough GCV 0.75±0.5 mg/L. Two of 9 cases of neutropenia were attributable to vGCV. Three CMV donor-positive/recipient-negative CFTx patients presented positive pp65Ag; 2 developed CMV disease (6%). We found that vGCV 900 mg, adapted to renal function, was effective and safe for long CMV prophylaxis together with efficient exposure in thoracic transplantation.

Published
2010

10. Detection of Drug–Drug Interactions Inducing Acute Kidney Injury by Electronic Health Records Mining

Author

Yannick Girardeau, Antoine Neuraz, Paul Avillach, Lillo-Le Louet Agnes, Christine Le Beller, P. Degoulet, Claire Trivin, Pierre Durieux, Centre de Recherche des Cordeliers (CRC), Université Pierre et Marie Curie - Paris 6 (UPMC)-École pratique des hautes études (EPHE), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Biomedical informatics and public health department, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Department of nephrology, Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Department of pharmacovigilance, Center for biomedical informatics, Harvard Medical School [Boston] (HMS), Children's hospital informatics program, Boston Children's Hospital, Centre de Recherche des Cordeliers ( CRC ), Université Paris Diderot - Paris 7 ( UPD7 ) -École pratique des hautes études ( EPHE ) -Université Pierre et Marie Curie - Paris 6 ( UPMC ) -Université Paris Descartes - Paris 5 ( UPD5 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), APHP, Hôpital Européen Georges Pompidou [APHP] ( HEGP ), Harvard Medical School [Boston] ( HMS ), Children's Hospital of Boston, Administateur, HAL Sorbonne Université, and Université Pierre et Marie Curie - Paris 6 (UPMC)-École Pratique des Hautes Études (EPHE)

Subjects
Adult, Male, [ SDV.MHEP.UN ] Life Sciences [q-bio]/Human health and pathology/Urology and Nephrology, Drug, medicine.medical_specialty, media_common.quotation_subject, Toxicology, Sensitivity and Specificity, [SDV.MHEP.UN]Life Sciences [q-bio]/Human health and pathology/Urology and Nephrology, chemistry.chemical_compound, Clarithromycin, Internal medicine, Data Mining, Electronic Health Records, Humans, Medicine, Drug Interactions, Pharmacology (medical), Rifle, Adverse effect, Intensive care medicine, Aged, Retrospective Studies, media_common, Aged, 80 and over, Pharmacology, Creatinine, business.industry, Acute kidney injury, Odds ratio, Acute Kidney Injury, Middle Aged, [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences, medicine.disease, [SDV.MHEP.UN] Life Sciences [q-bio]/Human health and pathology/Urology and Nephrology, Confidence interval, 3. Good health, [SDV.SP] Life Sciences [q-bio]/Pharmaceutical sciences, [ SDV.SP ] Life Sciences [q-bio]/Pharmaceutical sciences, chemistry, Female, business, Algorithms, medicine.drug
Abstract

International audience; Background and Objective : While risk of acute kidney injury (AKI) is a well documented adverse effect of some drugs, few studies have assessed the relationship between drug–drug interactions (DDIs) and AKI. Our objective was to develop an algorithm capable of detecting potential signals on this relationship by retrospectively mining data from electronic health records.Material and methods : Data were extracted from the clinical data warehouse (CDW) of the Hôpital Européen Georges Pompidou (HEGP). AKI was defined as the first level of the RIFLE criteria, that is, an increase ≥50 % of creatinine basis. Algorithm accuracy was tested on 20 single drugs, 10 nephrotoxic and 10 non-nephrotoxic. We then tested 45 pairs of non-nephrotoxic drugs, among the most prescribed at our hospital and representing distinct pharmacological classes for DDIs.Results : Sensitivity and specificity were 50 % [95 % confidence interval (CI) 23.66–76.34] and 90 % (95 % CI 59.58–98.21), respectively, for single drugs. Our algorithm confirmed a previously identified signal concerning clarithromycin and calcium-channel blockers (unadjusted odds ratio (ORu) 2.92; 95 % CI 1.11–7.69, p = 0.04). Among the 45 drug pairs investigated, we identified a signal concerning 55 patients in association with bromazepam and hydroxyzine (ORu 1.66; 95 % CI 1.23–2.23). This signal was not confirmed after a chart review. Even so, AKI and co-prescription were confirmed for 96 % (95 % CI 88–99) and 88 % (95 % CI 76–94) of these patients, respectively.Conclusion : Data mining techniques on CDW can foster the detection of adverse drug reactions when drugs are used alone or in combination.

Published
2015

11. Severe toxicity related to a pharmacokinetic interaction between docetaxel and ritonavir in HIV-infected patients

Author

Catherine Durdux, Jean-Paul Viard, Anne Langlois, Olivier Mir, Pierre Loulergue, Bernadette Dessard-Diana, Agnès Lillo-Le Louet, and Christine Le Beller

Subjects
Adult, Male, Mucositis, medicine.medical_specialty, Neutropenia, Phases of clinical research, Antineoplastic Agents, HIV Infections, Docetaxel, Pharmacology, Letter to the Editors, Gastroenterology, Seizures, Febrile, chemistry.chemical_compound, Internal medicine, medicine, Humans, Drug Interactions, Pharmacology (medical), Ritonavir, business.industry, virus diseases, HIV Protease Inhibitors, Exanthema, Middle Aged, medicine.disease, Paclitaxel, chemistry, Toxicity, Female, Taxoids, Liver function, business, Febrile neutropenia, medicine.drug
Abstract

The treatment of AIDS-related malignancies raises specific pharmacological issues in patients receiving highly active antiretroviral therapy (HAART), particularly when the regimen includes a ritonavir-boosted protease inhibitor. Ritonavir potently inhibits CYP3A4, the main enzyme involved in the metabolism of a number of anticancer agents, including docetaxel [1–3]. We have recently treated three patients receiving ritonavir-based HAART, who experienced severe haematological and skin toxicity shortly after the first infusion of docetaxel. We believe that this toxicity was directly triggered by ritonavir. Hence, despite normal baseline liver function and blood cell counts, our patients experienced early febrile neutropenia, grade 3 mucositis, skin rash and hand-foot syndrome (Table 1). None of the patients had other recognized risk factors for docetaxel-induced febrile neutropenia: albuminaemia and C-reactive protein were normal, and baseline lymphocyte count was >700 g l−1[2, 4]. Table 1 Severe toxicity following co-administration of docetaxel and ritonavir-based highly active antiretroviral therapy (HAART) Docetaxel is approved in the treatment of non-AIDS-defining malignancies such as breast, prostate and lung cancers, but also displays clinical activity in Kaposi's sarcoma [5]. In a Phase II study, docetaxel administered weekly was active and well tolerated in Kaposi's sarcoma patients, with moderate haematological toxicity [5]. However, patients included in this study received HAART without ritonavir pharmacoenhancement, and therefore did not experience toxicity in the same range as that observed in our case series. Preclinical reports indicate that ritonavir-induced inhibition of CYP3A4 causes a significant increase in exposure to docetaxel [6]. In a similar way, concomitant administration of docetaxel and ketoconazole, another potent inhibitor of CYP3A4, resulted in a major reduction in plasma clearance of docetaxel [7]. Therefore, we assume that ritonavir-induced inhibition of CYP3A4 may decrease the plasma clearance of docetaxel, and subsequently lead to severe docetaxel-related toxicity (mainly haematological and cutaneous). Another three cases [8, 9] of severe toxicity following co-administration of docetaxel and ritonavir were found in the literature (Table 1). As well, toxicity occurred after the first cycle of treatment, even with moderate doses of docetaxel (25–60 mg m–2). According to the drug interaction probability scale, the event–drug relationship was probable [10]. Among the above-described cases, paclitaxel was substituted for docetaxel in two patients, without recurrence of severe toxicity in the following cycles. However, two cases of severe haematological toxicity (including one fatal outcome) have been reported after the concomitant administration of paclitaxel and ritonavir [11]. Of note, paclitaxel is mainly metabolized by CYP2C8, and to a lesser extent by CYP3A4 [12]. Hence, it remains unclear whether inhibition of CYP3A4 by ritonavir could significantly decrease the plasma clearance of paclitaxel and cause severe haematological toxicity. In conclusion, these cases strongly support our hypothesis of a pharmacokinetic drug–drug interaction between ritonavir and docetaxel, even in patients treated with low doses of docetaxel. Clinicians should be aware that human immunodeficiency virus-infected patients receiving ritonavir-based HAART must receive anticancer drugs that are not metabolized by CYP3A4 instead of docetaxel.

Published
2010

12. Neuromuscular painful disorders: a rare side effect of voriconazole in lung transplant patients under tacrolimus

Author

N. Daudet, C. Le Beller, Catherine Amrein, Maud Berge, V. Boussaud, P. Chevalier, A. Lillo-Le Louet, Romain Guillemain, and Eliane M. Billaud

Subjects
Pulmonary and Respiratory Medicine, Adult, Graft Rejection, Male, medicine.medical_specialty, Side effect, Adolescent, Pain, Risk Assessment, Severity of Illness Index, Drug Administration Schedule, Tacrolimus, Cohort Studies, Pharmacotherapy, Postoperative Complications, Medicine, Aspergillosis, Humans, Drug Interactions, Retrospective Studies, Voriconazole, Transplantation, Lung, Dose-Response Relationship, Drug, business.industry, Retrospective cohort study, Neuromuscular Diseases, Middle Aged, Triazoles, Dermatology, Surgery, Calcineurin, surgical procedures, operative, medicine.anatomical_structure, Pyrimidines, Treatment Outcome, Drug Therapy, Combination, Female, Cardiology and Cardiovascular Medicine, business, medicine.drug, Follow-Up Studies, Lung Transplantation
Abstract

Voriconazole is an anti-fungal agent active against Aspergillus infection that is used for prophylaxis and curative treatment in lung transplant patients. We present nine cases of painful neuromuscular disorders, an unusual and rare side effect of high-dose voriconazole in association with tacrolimus.

Published
2007

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