Ionamin online research references
cceb.med.upenn.edu
Although several studies have reported on valve abnormalities among users of fenfluramine or dexfenfluramine, detailed information on these subjects has not been provided, limiting the ability to understand who may be at risk for valve abnormalities and to generate hypotheses about the etiology and pathogenesis of these abnormalities. This study was a detailed medical record review of 18 previously reported users of fenfluramine and phentermine, all with valve abnormalities on echocardiogram and 2 with surgical pathology. Both clinical characteristics and medication use were recorded by trained abstracters using a standardized data collection form. Two subjects (11%) had other possible etiologies of valve disease: a history of rheumatic fever and prescribed ergotamine. Three subjects (17%) had a history of migraine headaches and 4 (22%) had murmurs noted before using fenfluramine. Use of medications that may affect serotonin receptors was common: ergotamine (1 subject, 5%), selective serotonin reuptake inhibitors (6, 33%), sumatriptan (2, 11%), and mirtazapine (1, 5%). Prior medication and nonmedication allergies were recorded in 6 (33%) and 3 (17%) subjects, respectively. All subjects had symptoms possibly due to fenfluramine or phentermine side effects. This study raises the hypotheses that valvular heart disease among fenfluramine users may be less common than previously estimated, that serotonin excess may play a role in valve pathology, and that a patient's response to anorexigens and other medications may serve as a marker for increased risk. Further study is needed to test these hypotheses.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10496440&dopt=Abstract
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Obes Res. 1999 Sep;7(5):469-76.
Beneficial effects of pharmacotherapy on weight loss, depressive symptoms, and eating patterns in obese binge eaters and non-binge eaters.
Alger SA, Malone M, Cerulli J, Fein S, Howard L.
Division of Clinical Nutrition, Albany Medical College and Albany College of Pharmacy, NY 12208, USA.
OBJECTIVE: The purpose of this study was to compare the impact of drug therapy on weight loss, Beck Depression Inventory (BDI) scores, and binge eating patterns (BES) between obese binge eaters and non-binge eaters. RESEARCH METHODS AND PROCEDURES: 22 severe binge eaters, 17 moderate binge eaters, and 16 non-binge eaters received phentermine resin 15mg/day and dl-fenfluramine 20mg three times daily over a 6 month period for weight loss. All data are reported as mean+/-S. RESULTS: The percent weight loss compared to baseline within the 3 groups ranged from 8.9% to 11.3% at 3 months and 10.6% to 14.9% at 6 months. After 6 months, 73% of the severe binge eaters, 59% of moderate binge eaters and 69% of non-binge eaters had experienced more than 10% weight loss. BDI scores were significantly higher in the severe group at baseline when compared to non-binge eaters (p<0.006). After 3 and 6 months BDI scores improved in all groups but remained significantly different between the severe and non-binge eaters until the 6-month assessment. BES scores declined in all groups over the 6-month period. Echocardiograms were performed in 35 of 55 subjects following reports of a possible association between fenfluramine and valvular changes. Fifteen (43%) of subjects had no abnormal findings and 20 (57%) had evidence of valvular insufficiency occurring in one or more valves. Seven patients (20%) had significant valve damage according to the DHHS and FDA criteria. CONCLUSION: After 24 weeks of treatment severe binge eaters improved their eating pattern, depression scores, and achieved weight loss similar to non-binge eaters. These data suggest that pharmacologic intervention for weight loss and subsequent weight maintenance can be as successful in binge eaters as non-binge eaters. A relationship was seen between duration of drug treatment and valvular insufficiency in subjects treated for an average of 52 weeks. These findings validate the FDA requirement for studies of at least 1 year duration to evaluate both the safety and efficacy of pharmacologic treatment for obesity.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10509604&dopt=Abstract
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caregroup.harvard.edu
OBJECTIVES: This investigation sought to determine the effect of phentermine-fenfluramine (phen-fen) on the prevalence of valvular heart disease in 226 obese subjects enrolled in a prospective, strict weight loss, research protocol. BACKGROUND: Early reports have suggested that the use of phen-fen for weight loss may be associated with increased valvular heart disease. Such reports were based on small numbers of patients, limited data on dose and duration of phen-fen therapy, and no correlation with matched controls. METHODS: All subjects underwent transthoracic echocardiography for significant valvular lesions within a mean of 97 days from the manufacturer's announcement of the voluntary withdrawal of fenfluramine and dexfenfluramine. All echocardiograms were interpreted by two independent readers. RESULTS: The study population included 183 women and 43 men with a mean age of 46.9 +/- 8.9 years and mean starting body mass index of 39.8 +/- 7.7 kg/m2. Using the Food and Drug Administration criteria, significant aortic regurgitation was detected in 15 subjects (6.6%) and mitral regurgitation in 3 subjects (1.3%). Only one patient had significant regurgitation of both aortic and mitral valves. No valves had severe regurgitation. Significant valvular disease did not correlate with the dose or duration of phen-fen therapy. Furthermore, the prevalence of valvular regurgitation is comparable to the normal offspring in the Framingham Heart Study, who are similar in age, gender, and geographical location. CONCLUSIONS: Phen-fen therapy is associated with a low prevalence of significant valvular regurgitation. Valvular regurgitation in our subjects may reflect age-related degenerative changes.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10520805&dopt=Abstract
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