title: Natural history of valvular regurgitation using side-by-side echocardiographic analysis in anorexigen-treated subjects.
abstract: In 1997, the US Food and Drug Administration (FDA) reported valvular regurgitation (aortic regurgitation [AR] mild or greater and/or mitral regurgitation [MR] moderate or greater) in 32.8% of patients treated with anorexigens. This study sought to determine the natural history of valvular regurgitation in patients who were included in the FDA's original report. This was a nonrandomized, natural history study of these subjects. Cohort I consisted of 155 of 186 patients (83%) who were reported to the FDA. Cohort II consisted of a similar group of 311 patients who were not included. Initial echocardiograms were obtained for medical indications before the study initiation, and study echocardiograms were standardized and obtained at 3-month intervals. Level III echocardiographers performed blinded, side-by-side comparison of the first and last study echocardiograms at a core laboratory. Cohorts I and II consisted of predominantly female, middle-aged, obese subjects. At enrollment, patients in cohorts I and II had mild or greater AR (17.9%, 13.5%) and moderate or greater MR (3.3%, 4.0%), respectively, which was less than in the FDA's report. At follow-up, there were no statistically significant changes in the degree of valvular regurgitation in either cohort when the first and last study echocardiograms were read side by side. In conclusion, this natural history follow-up study demonstrates that MR and AR in long-term anorexigen-treated patients was less than reported to the FDA, did not progress, and remained echocardiographically stable during the 10-month duration of the study.
authors.affiliation: Department of Cardiovascular Medicine, The Cleveland Clinic Foundation, Cleveland, Ohio, USA. kleina@ccf.org
authors.forename: Allan L
authors.initials: AL
authors.lastname: Klein
authors.forename: Brian P
authors.initials: BP
authors.lastname: Griffin
authors.forename: Richard A
authors.initials: RA
authors.lastname: Grimm
authors.forename: L Leonardo
authors.initials: LL
authors.lastname: Rodriguez
authors.forename: John A
authors.initials: JA
authors.lastname: Sallach
authors.forename: Annitta J
authors.initials: AJ
authors.lastname: Morehead
mesh_terms: D001067:Appetite Depressants / Q000627:therapeutic use*; D001783:Blood Flow Velocity / Q000502:physiology; D018450:Disease Progression; D018618:Echocardiography, Doppler, Color / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000000981:diagnostic imaging*; D008944:Mitral Valve Insufficiency / Q000150:complications / Q000000981:diagnostic imaging* / Q000503:physiopathology; D009765:Obesity / Q000150:complications / Q000188:drug therapy*; D011379:Prognosis; D011446:Prospective Studies; D013318:Stroke Volume / Q000502:physiology
chemical_list: D001067:Appetite Depressants