1. Food and Drug Administration criteria for the diagnosis of drug-induced valvular heart disease in patients previously exposed to benfluorex: a prospective multicentre study
- Author
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Antoine Jeu, Stéphane Ederhy, Erwan Donal, Thierry Garban, Sylvestre Maréchaux, Yannick Jobic, Pierre-Vladimir Ennezat, Jacques Boulanger, Catherine Szymanski, Dan Rusinaru, Christophe Tribouilloy, Elise Arnalsteen, Patricia Reant, Groupement Hospitalier de l'Institut Catholique de Lille, Faculté Libre de Médecine-UC Lille, Mécanismes physiologiques et conséquences des calcifications cardiovasculaires: rôle des remodelages cardiovasculaires et osseux, Université de Picardie Jules Verne (UPJV)-Institut National de la Santé et de la Recherche Médicale (INSERM), Pôle cardiovasculaire et thoracique, CHU Amiens-Picardie, Département de Cardiologie (CHRU - Cardio), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Service de Cardiologie [CHU Saint-Antoine], CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service de cardiologie et maladies vasculaires [Rennes] = Cardiac, Thoracic, and Vascular Surgery [Rennes], CHU Pontchaillou [Rennes], Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM), Département de cardiologie, CHU Bordeaux [Bordeaux]-Hôpital Haut-Lévêque [CHU Bordeaux], CHU Bordeaux [Bordeaux], Service de Médecine Interne et Cardiologie, Centre Hospitalier de Beauvais, Service de Cardiologie, Centre Hospitalier de Compiègne, Hôpital Universitaire G et R Laennec, Service de cardiologie, Hôpital Cardiologique-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Faculté Libre de Médecine de Lille (FLM), Institut Catholique de Lille (ICL), Université catholique de Lille (UCL)-Université catholique de Lille (UCL)-Institut Catholique de Lille (ICL), Université catholique de Lille (UCL)-Université catholique de Lille (UCL)-UC Lille, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), and Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)
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Male ,Aortic valve ,medicine.medical_specialty ,Heart Valve Diseases ,Regurgitation (circulation) ,030204 cardiovascular system & hematology ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Risk Factors ,Internal medicine ,medicine.artery ,Mitral valve ,Appetite Depressants ,Fenfluramine ,Humans ,Medicine ,Radiology, Nuclear Medicine and imaging ,Prospective Studies ,030212 general & internal medicine ,health care economics and organizations ,Aged ,Benfluorex ,Aorta ,Mitral regurgitation ,United States Food and Drug Administration ,business.industry ,valvular heart disease ,Drugs ,General Medicine ,Middle Aged ,medicine.disease ,Valvular heart disease ,Echocardiography, Doppler ,United States ,3. Good health ,medicine.anatomical_structure ,chemistry ,Echocardiography ,Case-Control Studies ,Cohort ,cardiovascular system ,Cardiology ,Female ,[SDV.IB]Life Sciences [q-bio]/Bioengineering ,Cardiology and Cardiovascular Medicine ,business - Abstract
International audience; Aims The Food and Drug Administration (FDA) criteria for diagnosis of drug-induced valvular heart disease (DIVHD) are only based on the observation of aortic regurgitation ≥ mild and/or mitral regurgitation ≥ moderate. We sought to evaluate the diagnostic value of FDA criteria in a cohort of control patients and in a cohort of patients exposed to a drug (benfluorex) known to induce VHD. Methods and results This prospective, multicentre study included 376 diabetic control patients not exposed to valvulopathic drugs and 1000 subjects previously exposed to benfluorex. Diagnosis of mitral or aortic DIVHD was based on a combined functional and morphological echocardiographic analysis of cardiac valves. Patients were classified according to the FDA criteria [mitral or aortic-FDA(+) and mitral or aortic-FDA(−)]. Among the 376 control patients, 2 were wrongly classified as mitral-FDA(+) and 17 as aortic-FDA(+) (0.53 and 4.5% of false positives, respectively). Of those exposed to benfluorex, 48 of 58 with a diagnosis of mitral DIVHD (83%) were classified as mitral-FDA(−), and 901 of the 910 patients (99%) without a diagnosis of the mitral DIVHD group were classified as mitral-FDA(−). All 40 patients with a diagnosis of aortic DIVHD were classified as aortic-FDA(+), and 105 of the 910 patients without a diagnosis of aortic DIVHD (12%) were classified aortic-FDA(+). Older age and lower BMI were independent predictors of disagreement between FDA criteria and the diagnosis of DIVHD in patients exposed to benfluorex (both P ≤ 0.001). Conclusions FDA criteria solely based on the Doppler detection of cardiac valve regurgitation underestimate for the mitral valve and overestimate for the aortic valve the frequency of DIVHD. Therefore, the diagnosis of DIVHD must be based on a combined echocardiographic and Doppler morphological and functional analysis of cardiac valves
- Published
- 2014
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