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Association between venous thromboembolism events and fibrates: A comparative study - 29/10/18

Doi : 10.1016/j.therap.2018.10.001 
Charles Dolladille a, b, , 1 , Xavier Humbert a, c, d, 1, Murielle Faucon e, Claire Tournilhac c, Marion Sassier a, Sophie Fedrizzi a, d, Paul Milliez b, d, Véronique Lelong-Boulouard a, Antoine Coquerel a, Paolo Emilio Puddu d, f, Jean-Jacques Parienti g, Joachim Alexandre a, d
a Department of pharmacology, CHU de Caen, 14000 Caen, France 
b Department of cardiology, CHU de Caen, 14000 Caen, France 
c Department of general medicine, université Caen Normandie, medical school, 14000 Caen, France 
d EA 4650, signalisation, électrophysiologie et imagerie des lésions d’ischémie-reperfusion myocardique, université Caen Normandie, medical school, 14000 Caen, France 
e Department of medical information, CHU de Caen, 14000 Caen, France 
f Department of cardiovascular, respiratory, nephrological, anesthesiological and geriatric sciences, Sapienza university of Rome, 000161 Rome, Italy 
g Department of biostatistics and clinical research, CHU de Caen, 14000 Caen, France 

Corresponding author. Department of pharmacology, CHU Caen, avenue de la Côte de Nacre, CS 30001, 14033 Caen cedex 9, France.Department of pharmacology, CHU Caenavenue de la Côte de Nacre, CS 30001Caen cedex 914033France
En prensa. Pruebas corregidas por el autor. Disponible en línea desde el Monday 29 October 2018
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Summary

Aim

Previous studies highlighted a significant association between fibrates and venous thromboembolism (VTE) events in dyslipidemia diabetic patients. Studies in non-diabetic patients are divergent. The present study investigated the association between VTE events and fibrates in diabetic and non-diabetic patients.

Methods

Two approaches were used: (1) a disproportionality analysis using the World health organization pharmacovigilance database VigiBase® was used to evaluate the reporting odds-ratio (ROR) of fibrates for VTE events. Clinical and demographic characterizations of patients with fibrates-related VTE reports are described; (2) a case control-study was performed using the Caen university hospital medical information database between January 2008 and December 2012. Cases were dyslipidemia patients who were hospitalized for VTE without an evident provoking factor. Up to four controls per case were selected in dyslipidemia patients hospitalized for a non-VTE event. Controls were matched to cases by age, gender, date of hospitalization, diabetes, chronic kidney disease and hospitalization department. A multivariate conditional logistic regression was performed.

Results

Disproportionality analysis: a total of 946 notifications were identified in VigiBase® (32.9% of diabetic patients). Fibrates were significantly associated with an increased report of VTE (ROR 1.14, CI 1.07–1.22). Case-control study: a total of 163 cases (21.5% of diabetic patients) and 514 matched controls were recruited. Fibrates were significantly associated with a higher risk of VTE events that required hospitalization in multivariate analysis (odds-ratio (OR) 3.67, CI 1.82–7.37, P=0.0003). The association was only significant for fenofibrate in both approaches.

Conclusion

Fenofibrate was associated with a higher incidence of VTE events in diabetic and non-diabetic patients.

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Keywords : Disproportionality analysis, Fibrates, Matched case-control study, Pharmacoepidemiology, Pharmacovigilance, Venous thromboembolism


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© 2018  Société française de pharmacologie et de thérapeutique. Publicado por Elsevier Masson SAS. Todos los derechos reservados.
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