Treatment with the synthetic human growth hormone-releasing factor, tesamorelin, resulted in a significant loss of visceral adipose tissue—deep belly fat—compared with a placebo in people with lipodystrophy, according to a new article published in the December 6 issue of the New England Journal of Medicine (NEJM).
The tesamorelin study is a 52-week trial involving 412 patients with lipodystrophy. During the first 26 weeks, 273 patients received tesamorelin and 137 received a placebo. During the second 26 weeks of the study, those who’d originally received placebo switched to tesamorelin, while those who originally received tesamorelin either stayed on the drug or were switched to placebo.
In the NEJM article, Julian Falutz, MD, of the Montreal General Hospital at the McGill University Health Centre, and his colleagues report the results from the first 26 weeks of the study. At week 26, those who’d received tesamorelin had a 15.2 percent decrease in visceral adipose tissue, compared with a 5 percent increase in those who received a placebo. Moreover, people in the tesamorelin group had greater improvements in cholesterol and insulin function than those who received a placebo.
There was no difference in the incidence of serious side effects between those receiving tesamorelin or placebo. However, those taking tesamorelin were more likely to discontinue the drug due to side effects than those in the placebo group.
Preliminary data from the second half of the study were reported at the 2007 European AIDS Conference in Madrid. Final results from the 52-week study have not yet been published in a peer-reviewed medical journal.
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ELFRIEDE ORTEGA, spring, tx., 2008-02-21 11:17:03
my life is very affected for the visceral fat of my belly.
Marc Gold, Austin, 2008-01-22 00:30:41
My quality of life has been tremendously affected by lipo....I would take the risk to try anything
Jim Schumacher, , 2007-12-26 13:21:52
I participated in this study and am anxoiusly awaiting the approval of tesamorlin. Any guess when this may happen.
steve, minnesota, 2007-12-17 18:02:28
There is a currenty recruting trial, study # NCT00435136 at clinicaltrials.gov for a list of the 63 centers that are participating
Ray VEra, , 2007-12-16 22:54:35
PLese keep me inform about this new drug tesamorelin,thanks.
Charlie Baltz, Honolulu, 2007-12-16 09:27:01
Regarding Andrew Werner's inquiries about "insurance reimbursement", I know in some cases it is difficult to breath w/too much belly fat from lipodystrophy;therefore, I would see it as "therapeutical" as long as you inform your physician you are experiencing breathing difficulties. I would also be interested in test trials of this drug in the U.S.
luv, NY, 2007-12-15 17:59:51
Speaking for myself, I would give anything to rid tis lipo; if people stopped because of the side effects then those affects must be pretty bad. What are the side-effects?
Dutchie, Providence/Boston, 2007-12-13 22:12:37
I'd liek to participate in a study in either Providence or Boston. Too bad they couldn't take the belly fat and put it where my behind used to be.
Stuart, Palm Beach, Fl, 2007-12-13 11:27:29
I did contact the pharm. Mfg. today in China to find out about clinical trials in the United States. If they do get back to me, I will post their response!
Stuart, Palm Beach, Fl, 2007-12-13 11:09:48
If anyone does turn up any information please feel free to share it with me. My email address is FRSCatComcast.net
I can't seem to find any info either!
Ron, st louis MO, 2007-12-13 00:38:20
where can I get in a belly fat trial ? I jumped to 300 pounds all in the tummy (Lipo)
HELP !
Michael, Indianapolis, 2007-12-12 21:16:49
I would like to know where I might be able to enroll in a trial. I've tried a Google search with no success. I live in Indianapolis, IN.
PARKER, Los Angeles, 2007-12-12 16:11:33
Yeah, I'm wondering the same thing as to study details. Does anyone have any perinent infrmation?
Steven Holcomb, Louisville, 2007-12-12 15:56:32
I would love to get involved in the study. Slowly, but surely, the study of AIDS belly fat will surface so that many people can understand why so many sick people gain so much weight. Please send me info if I can sign up for a study close to home. I live near Knoxville, TN Thank you, Steve Holcomb
Jeff Underwood, Durham, NC, 2007-12-12 12:11:11
Does anyone know how I can get in a study? I live and work at Duke University Hospital and would hope to find a study there. And, are there any open studies going on now?
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