Portal de Periódicos da CAPES

Fibrates et risques thrombo-emboliques veineux : étude cas/non-cas dans la base nationale de pharmacovigilance

2017; Elsevier BV; Volume: 72; Issue: 6 Linguagem: Inglês

10.1016/j.therap.2017.07.002

1958-5578

Xavier Humbert, Charles Dolladille, Marion Sassier, Marie‐Blanche Valnet‐Rabier, Thierry Vial, Emmanuelle Bondon‐Guitton, A Page, Elodie Solé, Pascal Auriche, Antoine Coquerel, Joachim Alexandre, Sophie Fédrizzi,

Biosimilars and Bioanalytical Methods

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.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).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: bézafibrate (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]).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.