Benfluorex and valvular heart disease;Benfluorex (Mediator®) et atteintes valvulaires

Presse Medicale

Volumn 40, Issue 11, 2011, Pages 1008-1016

  Tribouilloy, Christophe ^a   Jeu, Antoine ^a   Maréchaux, Sylvestre ^b   Jobic, Yannick ^c   Rusinaru, Dan ^a   Andréjak, Michel ^a  

^a AMIENS UNIVERSITY HOSPITAL   (France)

^b UNIVERSITÉ CATHOLIQUE DE LILLE   (France)

^c BREST UNIVERSITY HOSPITAL   (France)

Author keywords

[No Author keywords available]

Indexed keywords

BENFLUOREX; DRUG METABOLITE; NORFENFLURAMINE; ANOREXIGENIC AGENT; DRUG DERIVATIVE; FENFLURAMINE;

ADVERSE OUTCOME; AORTA VALVE DISEASE; DISEASE SEVERITY; DRUG EFFECT; DRUG EXPOSURE; DRUG MARKETING; DRUG MONITORING; DRUG SAFETY; FRANCE; HEART VALVE REGURGITATION; HUMAN; MITRAL VALVE DISEASE; SHORT SURVEY; VALVULAR HEART DISEASE; AORTA VALVE REGURGITATION; CHEMICALLY INDUCED DISORDER; COHORT ANALYSIS; CROSS-SECTIONAL STUDY; DRUG RECALL; ECHOCARDIOGRAPHY; FEMALE; FOLLOW UP; HEART VALVE; MALE; MIDDLE AGED; MITRAL VALVE REGURGITATION; PATHOLOGY; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW;

AORTIC VALVE INSUFFICIENCY; APPETITE DEPRESSANTS; COHORT STUDIES; CROSS-SECTIONAL STUDIES; ECHOCARDIOGRAPHY; FEMALE; FENFLURAMINE; FOLLOW-UP STUDIES; FRANCE; HEART VALVES; HUMANS; MALE; MIDDLE AGED; MITRAL VALVE INSUFFICIENCY; NORFENFLURAMINE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SAFETY-BASED DRUG WITHDRAWALS;

EID: 80755133677     PISSN: 07554982     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.lpm.2011.09.001     Document Type: Short Survey

References (28)

1. Bhattacharyya S., Schapira A.H., Mikhailidis D.P., Davar J. Drug-induced fibrotic valvular heart disease. Lancet 2009, 374:577-585.
2. Connolly H.M., Crary J.L., McGoon M.D., Hensrud D.D., Edwards B.S., Edwards W.D., et al. Valvular heart disease associated with fenfluramine-phentermine. N Engl J Med 1997, 337:581-588.
3. Abenhaim L., Moride Y., Brenot F., Rich S., Benichou J., Kurz X., et al. Appetite-suppressant drugs and the risk of primary pulmonary hypertension. International primary pulmonary hypertension study group. N Engl J Med 1996, 335:609-616.
4. Van Camp G., Flamez A., Cosyns B., Weytjens C., Muyldermans L., Van Zandijcke M., et al. Treatment of Parkinson's disease with pergolide and relation to restrictive valvular heart disease. Lancet 2004, 363:1179-1183.
5. Droogmans S., Cosyns B., D'haenen H., Creeten E., Weytjens C., Franken P.R., et al. Possible association between 3,4-methylenedioxymethamphetamine abuse and valvular heart disease. Am J Cardiol 2007, 100:1442-1445.
6. Roth B.L. Drugs and valvular heart disease. N Engl J Med 2007, 356:6-9.
7. Rothman R.B., Baumann M.H., Savage J.E., Rauser L., McBride A., Hufeisen S.J., et al. Evidence for possible involvement of 5-ht(2b) receptors in the cardiac valvulopathy associated with fenfluramine and other serotonergic medications. Circulation 2000, 102:2836-2841.
8. Droogmans S., Franken P.R., Garbar C., Weytjens C., Cosyns B., Lahoutte T., et al. In vivo model of drug-induced valvular heart disease in rats: pergolide-induced valvular heart disease demonstrated with echocardiography and correlation with pathology. Eur Heart J 2007, 28:2156-2162.
9. Droogmans S., Roosens B., Cosyns B., Degaillier C., Hernot S., Weytjens C., et al. Cyproheptadine prevents pergolide-induced valvulopathy in rats: an echocardiographic and histopathological study. Am J Physiol Heart Circ Physiol 2009, 296:H1940-H1948.
10. Levy R.J. Serotonin transporter mechanisms and cardiac disease. Circulation 2006, 113:2-4.
11. Mekontso-Dessap A., Brouri F., Pascal O., Lechat P., Hanoun N., Lanfumey L., et al. Deficiency of the 5-hydroxytryptamine transporter gene leads to cardiac fibrosis and valvulopathy in mice. Circulation 2006, 113:81-89.
12. Rafel Ribera J., Casañas Muñoz R., Anguera Ferrando N., Batalla Sahún N., Castro Cels A., Pujadas Capmany R. Valvular heart disease associated with benfluorex. Rev Esp Cardiol 2003, 56:215-216.
13. Noize P., Sauer M., Bruneval P., Moreau M., Pathak A., Bagheri H., et al. Valvular heart disease in a patient taking benfluorex. Fundam Clin Pharmacol 2006, 20:577-578.
14. Boutet K., Frachon I., Jobic Y., Gut-Gobert C., Leroyer C., Carlhant-Kowalski D., et al. Fenfluramine-like cardiovascular side-effects of benfluorex. Eur Respir J 2009, 33:684-688.
15. Gueffet J.P., Piriou N., Trochu J.N. Valvular heart disease associated with benfluorex. Arch Cardiovasc Dis 2010, 103:342-343.
16. Le Ven F., Tribouilloy C., Habib G., Gueffet J.P., Maréchaux S., Eicher J.C., et al. Valvular heart disease associated with benfluorex therapy: results from the French Multicentre Registry. Eur J Echocardiogr 2011, 12:265-271.
17. Frachon I., Etienne Y., Jobic Y., Le Gal G., Humbert M., Leroyer C. Benfluorex and unexplained valvular heart disease: a case-control study. PLoS One 2010, 5:e10128.
18. Tribouilloy C., Rusinaru D., Henon P., Tribouilloy L., Leleu F., Andréjak M., et al. Restrictive organic mitral regurgitation associated with benfluorex therapy. Eur J Echocardiogr 2010, 11:614-621.
19. Weill A., Païta M., Tuppin P., Fagot J.P., Neumann A., Simon D., et al. Benfluorex and valvular heart disease: a cohort study of a million people with diabetes mellitus. Pharmacoepidemiol Drug Saf 2010, 19:1256-1262.
20. Hill C. Mortalité attribuable au benfluorex (Mediator®). Presse Med 2011, 40:462-469.
21. Moulin P., Andre M., Alawi H., dos Santos L.C., Khalid A.K., Koev D., et al. Efficacy of benfluorex in combination with sulfonylurea in type 2 diabetic patients: an 18-week, randomized, double-blind study. Diabetes Care 2006, 29:515-520.
22. Boudes A, Lavoute C, Avierinos JF, Le Dolley Y, Villacampa C, Salem A, Loundou AD, Michel N, Renard S, Habib G. Valvular heart disease associated with benfluorex therapy: high prevalence in patients with unexplained restrictive valvular heart disease. Eur J Echocardiogr 2011; doi:10.1093/ejechocard/jer116.
23. http://www.afssaps.fr/var/afssaps_site/storage/original/application/d3586501cd588059288(37135191.pdf.
24. Droogmans S., Kerkhove D., Cosyns B., Van Camp G. Role of echocardiography in toxic heart valvulopathy. Eur J Echocardiogr 2009, 10:467-476.
25. Mast S.T., Jollis J.G., Ryan T., Anstrom K.J., Crary J.L. The progression of fenfluramine-associated valvular heart disease assessed by echocardiography. Ann Intern Med 2001, 134:261-266.
26. Dahl C.F., Allen M.R. Regression and progression of valvulopathy associated with fenfluramine and phentermine. Ann Intern Med 2002, 136:489.
27. Dahl C.F., Allen M.R., Urie P.M., Hopkins P.N. Valvular regurgitation and surgery associated with fenfluramine use: an analysis of 5743 individuals. BMC Med 2008, 6:34.
28. Vahanian A., Baumgartner H., Bax J., Butchart E., Dion R., Filippatos G., et al. Guidelines on the management of valvular heart disease: the task force on the management of valvular heart disease of the European Society of Cardiology. Eur Heart J 2007, 28:230-268.