Obesity101.com THE LATEST IN OBESITY RESEARCH AND WEIGHTLOSS DRUG DEVELOPMENT Join our list More information Phen/fen heart valve survey results LETTER FROM THE EDITOR. I consider myself the eternal optimist, so I always see the glass as half full instead of half empty. And that phrase has never been more appropriate than this month. On May 13 the FDA granted Roche Pharmaceuticals approvability status for Xenical, and the very next day the FDA Endocrinologic and Metabolic Drugs advisory committee unanimously rejected the type-2 diabetes medication Ergoset. While Ergoset was not under consideration for obesity treatment at this time, Ergo Science is conducting human testing on Ergoset and weight loss. Questions regarding Xenical and breast cancer remain, and Roche will need to provide the FDA with more information before it goes to market. Nonetheless, the drug is expected to gain final approval, possibly because it has already been approved in several other countries, and is likely to be approved in still more countries in the very near future. Notwithstanding the rejection of Ergoset, Obesity-news has summarized the only two published human studies in this month's edition along with recent abstracts from a recent Roche symposium on Xenical. This month you will also see several summaries of newly published studies on phentermine and fenfluramine to accompany the results of the Obesity-news heart valve survey. I had planned to report final results in this month's newsletter, but realized that the information I have is not sufficient. While many patients gave Obesity-news an exact diagnosis in the survey, some gave answers like "leaky valves". Some didn't remember what dose of medication they took. Last October when I composed the survey, like most non-cardiologists, I had no idea that some amount of leakage in heart valves was normal. In any event, I have written all the respondents who reported any diagnosis and will give you a final report if and when I have some more answers. In the meantime, here is some preliminary data. General profile of respondents. There were 135 respondents who gave usable data. Anonymous surveys were excluded without review. Some respondents used the survey form to send comments and other unrelated information. Those surveys were excluded as well. Of the 135 usable surveys, 113 were from women and 22 from men. The age range was 18 to 66 and length of treatment 4 - 208 weeks. The dose range was 20 to 80 mg for fenfluramine, and 15 to 30 mg. for dexfenfluramine. The profile of the respondents to this survey was unusual in many ways. In the first place, 42 of them had been treated with phen/fen, fenfluramine or dexfenfluramine for more than 52 weeks, and 5 for more than 150 weeks. Having an echocardiogram was not a requirement of the survey, but any kind of follow-up exam. However, of the 135 respondents, 85 had echos, 17 had echos both before and after treatment. RESPONDENTS WITH CONFIRMED OR PROBABLE HEART VALVE DAMAGE Age/ Sex Fen/ dexfen dose Length of treatment (in weeks) Baseline abnormal Follow-up diagnosis 33-F unk 29 no MR, TR 38-F 20 f 42 MVP valve regurg MR, TR, AR, PPH 42-F 40 f 52 no AR 45-F 40 f 52 no TR, PPH 47-F unk 85 murmur AR 50-F 15 d 60 no AR, TR Key:MVP=mitral valve prolapse, MR=mitral regurgitation, TR=tricuspid regurgitation, AR=aortic regurgitation, PPH=pulmonary hypertension. Preexisting heart conditions. 7 heart murmurs, 4 baseline mitral valve prolapse, 2 congenital heart defects (one of these patients had a shunt in her heart) and 1 patient with an aortic valve replacement. The patient with the shunt who had been taking fenfluramine (20 mg) for 51 weeks reported no further damage. The respondent with the mechanical valve replacement reported no damage, and the second patient with a congenital heart defect reported trace leakage. All three were followed up with echocardiography. Reported follow-up exam results. 7 previously undiagnosed heart murmurs, 7 trace leaks, 3 previously undiagnosed mitral valve prolapse (but no leakage), 1 cardiomyopathy. 13 other patients reported valve leaks. Of the 13, 4 have damage by the FDA echocardiography guidelines and 2 look like they probably do. 2 of the 4 patients with confirmed damage also have PPH. Of the 4 cases of clinically significant heart valve damage, 2 had baseline heart abnormalities. Of the 2, one had a baseline heart murmur and the other, who was also diagnosed with PPH, had preexisting mitral valve prolapse. From the comments, it looks like this respondent might have preexisting valve damage as well. Her doctor said he could not confirm that the new valve problems were caused by phen/fen. With the information on hand it is impossible to tell if the other 7 have any diagnosis other than trace leakage. Since 3 out of 4 patients have trace leakage, it's probable that at least some of those reports were not clinically significant. Conclusions. It is difficult to reach any hard conclusions with the information on-hand. The 6 cases of confirmed/probable heart valve damage comprise 4 percent of the sample. If all 13 turn out to have clinically significant disease, the percentage would jump to 9.6 percent. However, not all the patients had echocardiography. If you exclude the surveys without echos then the current six cases would comprise 7 percent of the sample and all 13 would comprise 15 percent, although this would skew the results. Closing comments. I will endeavor to get additional information from all respondents reporting damage. However, it is very possible that no more information will be made available. If this is the case, the data here will be the only report Obesity-news will make on this survey. Home|Subscribe|Archives|Drug info|Contact|Media & Links|Site index|FAQs|Doctors/meetings|Admin Obesity-news is a publication of Hirsch Communications. An on-line subscription is $104.00 per year, payable in advance by check, money order, American Express, Discover, VISA or Mastercard. Subscribing is simple using our secure on-line subscription form. Obesity-news also accepts fax orders at 703/960-7462 and mail orders at PO Box 19316, Alexandria, VA 22320-0316. Copyright 1997-2008, all rights reserved. IMPORTANT: All information in this publication is believed to be accurate and true. Publisher is not liable for omissions or inaccuracies. Information in this newsletter is for educational purposes only and should not be construed as medical advice, or be used in lieu of consultation with a health care provider.