Valvular abnormalities and cardiovascular status following exposure to dexfenfluramine or phentermine/fenfluramine

JAMA

Volumn 283, Issue 13, 2000, Pages 1703-1709

  Gardin, Julius M ^a,b   Schumacher, Donald ^c   Constantine, Ginger ^d   Davis, Kelly D ^d   Leung, Cyril ^b   Reid, Cheryl L ^b  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c Center for Nutrition and Preventative Medicine   (United States)

^d WYETH AYERST RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DEXFENFLURAMINE; FENFLURAMINE; PHENTERMINE;

ADULT; AORTA VALVE REGURGITATION; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE ASSOCIATION; DRUG EXPOSURE; DRUG INDUCED DISEASE; DRUG SAFETY; ECHOCARDIOGRAPHY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OBESITY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; VALVULAR HEART DISEASE;

EID: 0034607394     PISSN: 00987484     EISSN: None     Source Type: Journal    
DOI: 10.1001/jama.283.13.1703     Document Type: Article

References (26)

1. Redux [package insert]. Philadelphia, Pa: Wyeth-Ayerst Laboratories; 1998.
2. Pondimin [package insert]. Philadelphia, Pa: Wyeth-Ayerst Laboratories; 1998.
3. Connolly HM, Crary JL, McGoon MD, et al. Valvular heart disease associated with fenfluramine-phentermine. N Engl J Med. 1997;337:581-588.
4. Kurz X, Van Erman A. Valvular heart disease associated with fenfluramine-phentermine [letter]. N Engl J Med. 1997;337:1772-1773.
5. Rasmussen S, Corya B, Glassman RD. Valvular heart disease associated with fenfluramine-phentermine [letter]. N Engl J Med. 1997;337:1773.
6. Graham DJ, Green L. Further cases of valvular heart disease associated with fenfluramine-phentermine [letter]. N Engl J Med. 1997;337:635.
7. Cannistra LB, Davis SM, Bauman AG. Valvular heart disease associated with dexfenfluramine [letter]. N Engl J Med. 1997;337:636.
8. Jick H, Vasilakis C, Weinrauch LA, et al. A population-based study of appetite-suppressant drugs and the risk of cardiac-valve regurgitation. N Engl J Med. 1998;339:719-724.
9. Khan MA, Herzog CA, St Peter JV, et al. The prevalence of cardiac valvular insufficiency assessed by trans-thoracic echocardiography in obese patients-treated with appetite-suppressant drugs. N Engl J Med. 1998;339:713-718.
10. Burger AJ, Sherman HB, Charlamb MJ, et al. Low prevalence of valvular heart disease in 226 phentermine-fenfluramine protocol subjects prospectively followed for up to 30 months. J Am Coll Cardiol. 1999;34:1153-1158.
11. Weissman N, Tighe J, Gottdiener J, Gwynne J. An assessment of heart-valve abnormalities in obese patients taking dexfenfluramine, sustained-release dexfenfluramine or placebo. N Eng J Med. 1998;339:725-732.
12. Akasaka T, Yoshikawa J, Yoshida K, et al. Age-related valvular regurgitation. Circulation. 1987;76:262-265.
13. Choong CY, Abascal VM, Weyman J, et al. Prevalence of valvular regurgitation by Doppler echocardiography in patients with structurally normal hearts by two-dimensional echocardiography. Am Heart J. 1989;117:636-642.
14. Klein AL, Burstow DJ, Tajik AJ, et al. Age-related prevalence of valvular regurgitation in normal subjects. J Am Soc Echocardiogr. 1990;2:54-63.
15. Shively B, Roldan C, Gurule F, Simon T. Agerelated changes in cardiac function by color Doppler echocardiography. J Am Coll Cardiol. 1990;15:187A.
16. Aronow WS, Ahn C, Kronzon I. Prevalence of echocardiographic findings in 554 men and in 1,243 women aged >60 years in a long-term health care facility. Am J Cardiol. 1997;79:379-380.
17. Biava G, Delfino M, Lagana B, et al. Prevalence of valvular regurgitation in structurally normal hearts. Coron Artery Dis. 1997;8:559-563.
18. Singh J, Evans J, Levy D, et al. Obesity and valvular regurgitation: is there an association [abstract]? J Am Soc Echocardiogr. 1998;11:509.
19. Gardin JM, Wong ND, Bommer W, et al. Echocardiographic design of a multicenter investigation of free-living elderly subjects: the Cardiovascular Health Study. J Am Soc Echocardiogr. 1992;5:63-72.
20. Perry GJ, Helmcke F, Nanda NC, et al. Evaluation of aortic insufficiency by Doppler color flow mapping. J Am Coll Cardiol. 1987;9:952-959.
21. Helmcke F, Nanda NC, Hsiung MC, et al. Color Doppler assessment of mitral regurgitation with orthogonal planes. Circulation. 1987;75:175-183.
22. Yock PG, Popp RL. Noninvasive estimation of right ventricular systolic pressure by Doppler ultrasound in patients with tricuspid regurgitation. Circulation. 1984;70:657-662.
23. Food and Drug Administration. FDA analysis of cardiac valvular dysfunction with use of appetite suppressants. Available at: http://www.fda.gov/cder /news/slides/sld001.htm. Accessed February 17, 1998.
24. Centers for Disease Control and Prevention. Cardiac valvulopathy associated with exposure to fenfluramine or dexfenfluramine: US Department of Health and Human Services interim public health recommendations, November, 1997. MMWR Morb Mortal Wkly Rep. 1997;46:1061-1066.
25. Bonow RO, Picone AL, McIntosh CL, et al. Survival and functional results after valve replacement for aortic regurgitation from 1976 to 1983. Circulation. 1985;72:1244-1256.
26. Reid C, Gardin J, Yunis C, et al. Prevalence and clinical correlates of aortic and mitral regurgitation in a young adult population [abstract]. Circulation. 1994;90:1-282.