Benfluorex and Unexplained Valvular Heart Disease: A Case-Control Study

BACKGROUND: Recent case reports suggest that benfluorex, a fenfluramine derivative used in the management of overweight diabetic patients and dyslipidemia, is associated with cardiac valve regurgitation. METHODS: We conducted a case-control study. Eligible patients were those admitted in the cardiology or the cardiac surgery units of our hospital between January, 1(st) 2003 and June 30(th) 2009, with mitral insufficiency diagnostic codes (ICD-10 I340 and I051). Patients with either a primary cause (degenerative, known rheumatic heart disease, infectious endocarditis, congenital, radiation-induced valvular disease, associated connective and/or vasculitis disease, trauma, tumor) or a secondary (functional) cause were considered as having an "explained" mitral regurgitation. Other patients were considered as having an "unexplained" mitral regurgitation and were included as cases. For each case, two controls were matched for gender and for the closest date of birth, among a list of patients with an "explained" mitral regurgitation. Drug exposures were assessed blindly regarding the case or control status, through contacts with patients, their family and/or their physicians. RESULTS: Out of the 682 eligible patients, 27 cases and 54 matched controls were identified. The use of benfluorex was reported in 22 patients: 19 of the 27 cases, versus 3 of the 54 controls, odds-ratio 17.1 (3.5 to 83), adjusted for body mass index, diabetes and dexfenfluramine use. CONCLUSION: The use of benfluorex is associated with unexplained mitral regurgitation

[Benfluorex (Mediator®), our vigilance in question].

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L'hypertension artérielle pulmonaire du sujet âgé

L'hypertension artérielle (HTAP) est une pathologie rare, sévère, décrite "classiquement" chez les sujets d'âge moyen. Il apparaît (données des registres et expérience de notre centre) qu'un tel diagnostic est de plus en plus fréquemment posé chez des sujets âgés. L'objectif de cette étude était de comparer les caractéristiques des sujets de plus de 65 ans aux sujets de moins de 65 ans. Méthode : il s'agit d'une étude rétrospective concernant des sujets porteurs d'HTAP diagnostiquée par cathétérisme cardiaque droit. Elle a porté sur des patients pris en charge au CHU de Brest entre février 1996 et novembre 2008. Les caractérisitiques étudiées concernaient l'âge, le sexe, la survie, l'étiologie de l'HTAP, les comorbidités, les critères de gravité clinique et hémodynamique et la prise en charge thérapeutique. Résultats : parmis les 66 patients étudiés, 24 avaient plus de 65 ans. Les sujets âgés avaient une survie nettement inférieure. Le tableau clinique était plus sévère, marqué par la fréquente présence de comorbidités respiratoires et cardiovasculaires. Conclusion : l'augmentation de la proportion de sujets âgés souffrant d'HTAP soulève de nombreux problèmes d'ordre diagnostique et thérapeutique. Ce constat nous pousse à encourager l'étude de cette population grâce à des registres prospectifs.BREST-BU Médecine-Odontologie (290192102) / SudocSudocFranceF

[About the settlement of litigations concerning the harm caused by benfluorex (Mediator®)].

International audienceSince September 1st 2011, the National Bureau for Compensation of Medical Accidents represents a unique portal for out-of-court settlement of litigations concerning the harm caused by benfluorex. In December 2012, its official record is as follows: 7627 patients files have been received, 1378 have been studied, 797 led to a recommendation, and compensation by the drug company Servier has been recommended for 46 cases. The large number of rejections raises a problem which needs to be examined in the light of the available evidence on benfluorex associated heart valve disease. This evidence concerns both the morphological characteristics of the disease and the epidemiology of its association with benfluorex. More than 90% of emergent double valve disease (aortic and mitral regurgitation), of emergent aortic valve regurgitation, and of prevalent grade 2 aortic valve regurgitation are attributable to benfluorex. The proportion of benfluorex-attributable disease is larger than 75% for prevalent double valve disease, or for prevalent aortic valve regurgitation of any grade. This probabilistic information, derived from the available epidemiological studies, needs to be considered as part of the evidence to establish or refute a causal link between benfluorex and valvular disease for a given patient, particularly if the patient has a low grade valvular insufficiency or no morphological anomaly

Chronic thromboembolic pulmonary hypertension: a tribute to pulmonary endarterectomy.

International audienc

Benfluorex withdrawal in France: Still be hiding somewhere in the world?

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[Letter on the article: "benfluorex and valvular heart disease"].

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