title: Impact of selective serotonin reuptake inhibitor therapy on heart valves in patients exposed to benfluorex: a multicentre study.
abstract: BACKGROUND
  Given the association between valvular heart disease and drugs that alter serotonin metabolism, concerns have been raised about the possibility of an association between selective serotonin reuptake inhibitor (SSRI) use and drug-induced valvular disease. In France, SSRI use has been suggested to be an important confounding factor in the development of heart valve lesions in patients exposed to benfluorex in the context of the 'Médiator scandal'.
  
  
  OBJECTIVE
  To address the relationship between SSRI use and valve regurgitation and morphology in a large cohort of patients exposed to benfluorex.
  
  
  METHODS
  Overall, 832 consecutive patients exposed to benfluorex prospectively referred to 10 centres underwent complete echocardiography examinations according to a standardized protocol. Echocardiograms were independently and blindly read off-line by two experts.
  
  
  RESULTS
  Ninety patients had been exposed to SSRIs for 3 months or more. The proportions of patients with no or trivial, mild, moderate or severe mitral regurgitation (MR) or aortic regurgitation (AR) were not different between SSRI patients and non-SSRI patients (P=0.63 and 0.58, respectively). The frequencies of AR ≥ mild (20 [22.2%] vs 145 [19.5%]; P=0.55) and MR ≥ mild (14 [15.6%] vs 118 [15.9%]; P=0.93) were similar in SSRI patients and non-SSRI patients. The frequencies of aortic and mitral valve abnormalities suggestive of drug-induced toxicity were also similar in the two patient groups. Multivariable logistic regression analysis confirmed the absence of any identifiable relationship between AR or MR and morphological abnormalities and SSRI use in the present cohort.
  
  
  CONCLUSIONS
  Exposure to SSRIs was not associated with an increased risk of heart valve regurgitation or morphological abnormalities suggestive of drug-induced toxicity in this large cohort of patients exposed to benfluorex.
authors.affiliation: Université Lille Nord de France, Groupement des Hôpitaux de l'Institut Catholique de Lille/Faculté Libre de Médecine, UC Lille, France.
authors.forename: Sylvestre
authors.initials: S
authors.lastname: Maréchaux
authors.forename: Antoine
authors.initials: A
authors.lastname: Jeu
authors.forename: Yannick
authors.initials: Y
authors.lastname: Jobic
authors.forename: Stéphane
authors.initials: S
authors.lastname: Ederhy
authors.forename: Erwan
authors.initials: E
authors.lastname: Donal
authors.forename: Patricia
authors.initials: P
authors.lastname: Réant
authors.forename: Shirley
authors.initials: S
authors.lastname: Abouth
authors.forename: Elise
authors.initials: E
authors.lastname: Arnasteen
authors.forename: Jacques
authors.initials: J
authors.lastname: Boulanger
authors.forename: Pierre-Vladimir
authors.initials: PV
authors.lastname: Ennezat
authors.forename: Thierry
authors.initials: T
authors.lastname: Garban
authors.forename: Catherine
authors.initials: C
authors.lastname: Szymanski
authors.forename: Christophe
authors.initials: C
authors.lastname: Tribouilloy
mesh_terms: D000328:Adult; D000368:Aged; D001021:Aortic Valve / Q000187:drug effects; D001022:Aortic Valve Insufficiency / Q000139:chemically induced; D001067:Appetite Depressants / Q000009:adverse effects*; D016009:Chi-Square Distribution; D018618:Echocardiography, Doppler, Color; D005260:Female; D005277:Fenfluramine / Q000009:adverse effects / Q000031:analogs & derivatives*; D005602:France; D006349:Heart Valve Diseases / Q000139:chemically induced* / Q000000981:diagnostic imaging / Q000503:physiopathology; D006351:Heart Valves / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000503:physiopathology; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000187:drug effects; D008944:Mitral Valve Insufficiency / Q000139:chemically induced; D015999:Multivariate Analysis; D015588:Observer Variation; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012017:Referral and Consultation; D015203:Reproducibility of Results; D018570:Risk Assessment; D012307:Risk Factors; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects*; D013997:Time Factors; D014261:Tricuspid Valve / Q000187:drug effects; D014262:Tricuspid Valve Insufficiency / Q000139:chemically induced
chemical_list: D001067:Appetite Depressants; D005277:Fenfluramine; D017367:Selective Serotonin Reuptake Inhibitors; C001584:benfluorex
keywords: 3,4-methylenedioxy-methamphetamine; 5-hydroxytryptamine; AR; Benfluorex; Drug-induced valvular disease; Echocardiography; HT; Inhibiteurs spécifiques de la recapture de la sérotonine; MDMA; MR; Maladies valvulaires induites par les médicaments; NYHA; New York Heart Association; PR; SSRI; Selective serotonin reuptake inhibitor therapy; TR; VHD; aortic regurgitation; mitral regurgitation; pulmonary regurgitation; selective serotonin reuptake inhibitor; tricuspid regurgitation; valvular heart disease; Échocardiographie