Université Lille Nord de France, Groupement des Hôpitaux de l'Institut Catholique de Lille/Faculté Libre de Médecine, UC Lille, France.
Arch Cardiovasc Dis. 2013 Jun-Jul;106(6-7):349-56. doi: 10.1016/j.acvd.2013.04.006. Epub 2013 May 31.
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'.
To address the relationship between SSRI use and valve regurgitation and morphology in a large cohort of patients exposed to benfluorex.
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.
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.
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.
鉴于瓣膜性心脏病与改变 5-羟色胺代谢的药物之间存在关联，人们对选择性 5-羟色胺再摄取抑制剂（SSRIs）的使用与药物引起的瓣膜疾病之间的可能关联表示担忧。在法国，有研究提示 SSRIs 的使用可能是氟苯丙胺暴露患者发生心脏瓣膜病变的一个重要混杂因素，这与“美多芭丑闻”有关。
在氟苯丙胺暴露的大样本患者中，评估 SSRIs 的使用与瓣膜反流和形态之间的关系。
共有 832 例连续氟苯丙胺暴露患者前瞻性地被转诊至 10 个中心，根据标准化方案进行了完整的超声心动图检查。超声心动图由两位专家独立和盲法离线读取。
90 例患者服用 SSRIs 的时间超过 3 个月。无或轻度、轻度、中度或重度二尖瓣反流（MR）或主动脉瓣反流（AR）的患者比例在 SSRIs 患者和非 SSRIs 患者之间无差异（P=0.63 和 0.58）。AR≥轻度（20 [22.2%] 例 vs 145 [19.5%] 例；P=0.55）和 MR≥轻度（14 [15.6%] 例 vs 118 [15.9%] 例；P=0.93）的频率在 SSRIs 患者和非 SSRIs 患者之间相似。两种患者组中，提示药物毒性的主动脉瓣和二尖瓣异常的频率也相似。多变量逻辑回归分析证实，在本氟苯丙胺暴露队列中，AR 或 MR 与形态异常之间不存在任何可识别的关系。
在本氟苯丙胺暴露的大样本患者中，SSRIs 的使用与心脏瓣膜反流或提示药物毒性的形态异常的风险增加无关。
