| アブストラクト | INTRODUCTION: Several studies have investigated the occurrence of venous thromboembolic events (phlebitis and pulmonary embolism) [VTE] and fibrates. Fibrates could be associated with VTE although published data are contradictory. The objective of this study is to confirm the link between VTE and fibrates. MATERIALS AND METHODS: Retrospective disproportionality analysis (case/non-case method) from observations recorded consecutively in the French pharmacovigilance database between 1985 and 2016. Cases were defined as embolic and thrombotic events, thrombophlebitis; Non-cases were other adverse events reported over the same period. We measured the disproportionality of exposure to each fibrate among cases and no-cases. The analysis was validated with a positive control (drospirenone) and a negative control (paracetamol). RESULTS: We compared 19,436 cases (including 161 mentioning fibrates) to 563,310 non-cases (including 3228 fibrates). Reports of VTE were significantly associated with fenofibrate (ROR=1.83; 95% CI=[1.53; 2.2]) but not with other fibrates: bezafibrate (ROR=0.44; 95% CI=[0.2; 0.99]), ciprofibrate (ROR=1.15; 95% CI=[0.76; 1.73]) and gemfibrozil (ROR=0.91; 95% CI=[0.45; 1.84]). CONCLUSION: With this study, we confirm the link between VTE and fenofibrate. It is therefore advisable to remain cautious when prescribing fenofibrate, in particular in case of past history of VTE and to declare systematically any venous thromboembolic adverse events observed with these drugs. |
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| 投稿者 | Humbert, Xavier; Dolladille, Charles; Sassier, Marion; Valnet-Rabier, Marie-Blanche; Vial, Thierry; Guitton, Emmanuelle; Page, Annabelle; Sole, Elodie; Auriche, Pascal; Coquerel, Antoine; Alexandre, Joachim; Fedrizzi, Sophie |
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| 組織名 | Service de pharmacologie clinique, centre regional de pharmacovigilance de Basse;Normandie, CHU Cote-de-Nacre, CHU de Caen, avenue de la Cote-de-Nacre, 14000;Caen, France; UFR de medecine, departement de medecine generale, Normandie;universite, 14000 Caen, France. Electronic address: humbertxavier@yahoo.fr.;Service de cardiologie, CHU de Caen, 14000 Caen, France.;Caen, France.;Centre regional de pharmacovigilance de Franche Comte, 25030 Besancon, France.;Centre regional de pharmacovigilance de Rhone-Alpes, 69424 Lyon, France.;Centre regional de pharmacovigilance de Midi-Pyrenees, 31000 Toulouse, France.;Agence nationale de securite du medicament et des produits de sante, 93285;Saint-Denis, France.;Caen, France; Service de cardiologie, CHU de Caen, 14000 Caen, France. |
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