Abstract | OBJECTIVE: RESEARCH METHODS AND PROCEDURES: 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. CONCLUSION: 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.
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Authors | D S Bach, A M Rissanen, C M Mendel, G Shepherd, S P Weinstein, F Kelly, T B Seaton, B Patel, T A Pekkarinen, W F Armstrong |
Journal | Obesity research
(Obes Res)
Vol. 7
Issue 4
Pg. 363-9
(Jul 1999)
ISSN: 1071-7323 [Print] United States |
PMID | 10440592
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Appetite Depressants
- Cyclobutanes
- sibutramine
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Topics |
- Adult
- Aged
- Aortic Valve Insufficiency
(chemically induced, diagnostic imaging, epidemiology)
- Appetite Depressants
(adverse effects, therapeutic use)
- Body Mass Index
- Cyclobutanes
(adverse effects, therapeutic use)
- Diabetes Mellitus, Type 2
(physiopathology)
- Double-Blind Method
- Echocardiography, Doppler, Color
- Female
- Humans
- Incidence
- Male
- Middle Aged
- Mitral Valve Insufficiency
(chemically induced, diagnostic imaging, epidemiology)
- Obesity
(drug therapy, physiopathology)
- Prevalence
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