Dose-effect of fenfluramine use on the severity of valvular heart disease among fen-phen patients with valvulopathy.
OBJECTIVE
To determine whether the severity of valvulopathy was associated with the dosage of fenfluramine taken by fenfluramine-phentermine users with valvulopathy.


METHODS
Out of 105 suspected valvulopathy case reports received by the US Food and Drug Administration (FDA) among fenfluramine-phentermine users, 74 patients meeting FDA case definition for valvulopathy were included in this study. Patients with severe valvulopathy were classified as those either undergoing valve replacement surgery or having severe aortic or mitral regurgitation; all other patients were considered to have less severe valvulopathy.


RESULTS
The proportion with severe valvulopathy increased from 20-66% with increasing fenfluramine dosage from </=40 mg/d to >/=60 mg/d. Compared with patients taking<40 mg/d fenfluramine, patients taking >/=60 mg/d had an adjusted odds ratio of 9.2 (95% confidence interval=2.1-40.8) for severe valvulopathy.


CONCLUSIONS
Compared to patients with less severe valvulopathy, those with severe valvulopathy were substantially more likely to have taken >/=60 mg/d fenfluramine.
Li
R
R
Epidemic Intelligence Service, Epidemiology Program Office and Division of Nutrition and Physical Activity, Centers for Disease Control and Prevention, Atlanta, GA 30341-3717, USA. RIL6@CDC.GOV
Serdula
M K
MK
Williamson
D F
DF
Bowman
B A
BA
Graham
D J
DJ
Green
L
L
D000328:Adult; D001021:Aortic Valve; D001067:Appetite Depressants / Q000008:administration & dosage* / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D005260:Female; D005277:Fenfluramine / Q000008:administration & dosage* / Q000009:adverse effects*; D006349:Heart Valve Diseases / Q000139:chemically induced* / Q000473:pathology*; D006801:Humans; D016015:Logistic Models; D008297:Male; D008943:Mitral Valve; D010645:Phentermine / Q000008:administration & dosage / Q000009:adverse effects; D012720:Severity of Illness Index
D001067:Appetite Depressants; D004338:Drug Combinations; D005277:Fenfluramine; D010645:Phentermine