Absence of cardiac valve dysfunction in obese patients treated with sibutramine.
OBJECTIVE
Serotonin-releasing agents prescribed as weight-loss medications have been implicated as a cause of acquired aortic and mitral valve abnormalities. Sibutramine hydrochloride (MERIDIA) is a serotonin and norepinephrine reuptake inhibitor with proven efficacy of weight reduction. The purpose of this study was to determine the incidence of cardiac valve disease in sibutraminetreated patients.


METHODS
Obese patients with type 2 diabetes mellitus enrolled in an ongoing double-blind, placebo-controlled, parallel-arm, 12-month study of sibutramine (followed by a 12-month open label extension) underwent transthoracic echocardiographic imaging and color Doppler interrogation for assessment of cardiac valve anatomy and function.


RESULTS
A total of 210 patients were evaluated. Of these, 133 were receiving sibutramine (72 in the double-blind period), and 77 were receiving placebo. The mean+/-Standard Deviation age was 54+/-9 years, and the mean duration of treatment was 229+/-117 days (approximately 7.6 months). The prevalence of left-sided cardiac valve dysfunction was low and similar for the two treatment groups (sibutramine 3/133, or 2.3%; placebo 2/77, or 2.6%). All five cases were cases of aortic insufficiency; four were mild, one was severe (in a placebo patient). All three sibutramine cases were patients over age 50; two had a history of systemic hypertension.


CONCLUSIONS
The prevalence of left-sided cardiac valve dysfunction was not higher than background in obese patients treated with sibutramine for an average of 7.6 months.
Bach
D S
DS
Department of Medicine, University of Michigan, Ann Arbor 48109, USA.
Rissanen
A M
AM
Mendel
C M
CM
Shepherd
G
G
Weinstein
S P
SP
Kelly
F
F
Seaton
T B
TB
Patel
B
B
Pekkarinen
T A
TA
Armstrong
W F
WF
D000328:Adult; D000368:Aged; D001022:Aortic Valve Insufficiency / Q000139:chemically induced* / Q000000981:diagnostic imaging / Q000453:epidemiology; D001067:Appetite Depressants / Q000009:adverse effects / Q000627:therapeutic use*; D015992:Body Mass Index; D003503:Cyclobutanes / Q000009:adverse effects / Q000627:therapeutic use*; D003924:Diabetes Mellitus, Type 2 / Q000503:physiopathology; D004311:Double-Blind Method; D018618:Echocardiography, Doppler, Color; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D008944:Mitral Valve Insufficiency / Q000139:chemically induced* / Q000000981:diagnostic imaging / Q000453:epidemiology; D009765:Obesity / Q000188:drug therapy / Q000503:physiopathology*; D015995:Prevalence
D001067:Appetite Depressants; D003503:Cyclobutanes; C058254:sibutramine