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Posted by OddipusRex on April 15, 2003, at 7:20:20
Part of an article in the NYTimes this morning. I'm not familiar with Zonegran. Is it used as a mood stabilizer too?
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April 15, 2003
Quest for Weight-Loss Drug Takes an Unusual Turn
By DENISE GRADY
...
Recently, in what might seem an odd twist, researchers have been studying weight loss in people taking two drugs already on the market, but approved for a completely different use, to treat epilepsy. Both drugs, Zonegran and Topamax, are also used to prevent migraine headaches. Zonegran is made by Elan Pharmaceuticals, and Topamax by Ortho-McNeil, a unit of Johnson & Johnson. The weight-loss potential of both drugs was discovered almost by accident, when people taking them for epilepsy or migraines noticed that they were dropping weight without trying.Scientists do not fully understand how these drugs make people lose weight. They appear to work on brain circuits that control hunger, cravings and feelings of fullness. Patients say they feel less hungry, fill up faster and lose the urge to gorge on things like chips, cookies and ice cream. In studies, people taking the drugs have lost an average of 6 percent to nearly 10 percent of their body weight: a respectable amount for any weight-loss drug, researchers say.
This is a subject that doctors and drug companies approach gingerly, almost as if they are afraid to talk about it. Drug companies fear that they will run afoul of the Food and Drug Administration, and doctors fear that they will become the agents of medical disaster by prescribing weight-loss drugs that turn out to cause unforeseen harm.
Neither Zonegran nor Topamax is approved for use in weight loss, and drug companies are not allowed to promote drugs for unapproved uses. Moreover, other weight-loss drugs have turned sour, casting a shadow on the entire field. Fen-phen, for instance, got promising results at first and became wildly popular, but was quickly abandoned when it was linked to heart-valve damage.
Topamax can have significant side effects, most notably difficulties with memory, attention and concentration. Some doctors jokingly call the drug "Dopeamax," and say it can make patients "skinny and stupid."
Carla Wolper, a dietitian in the obesity research center at St. Luke's-Roosevelt Hospital in New York, who worked on a weight-loss study with Topamax, said cognitive problems became apparent.
"A writer said a revision that should have taken her an hour took three hours," Ms. Wolper said. "A pianist had trouble remembering pieces. A graduate student had to read the same page over and over."
But all delayed reporting the problems, she said. "They were so happy to be losing weight that they sort of put up with it for a while before getting the dose lowered a bit," she said.
A Johnson & Johnson spokesman declined to discuss the side effects, but acknowledged that weight loss studies were suspended a year ago so that Topamax could be reformulated into a timed-release version that might be easier to tolerate and be effective at lower doses. The company plans to study the new version in people with obesity and Type 2 diabetes.
But in the meantime, obesity experts say some doctors are already prescribing the original version for weight loss, though it is not clear how common the practice is.
People are desperate to lose weight, and once a drug is on the market, doctors can prescribe it for any condition, regardless of what it was approved for. Such "off-label" use is common.
With regard to Topamax, Doug Arbesfeld, a spokesman for Johnson & Johnson, said, "Obviously, we're aware it's being used off label. That's not something we promote or encourage. Physicians are free to prescribe based on their own medical judgment."
As for Zonegran, the research has just begun, with only one study in a small number of patients. In the study, published last week in The Journal of the American Medical Association, a team led by Dr. Gadde found that Zonegran caused an average weight loss of about 20 pounds in obese people who took it for eight months. The loss approached 10 percent of body weight. By contrast, a placebo group lost only about three pounds. So far, the main side effect of Zonegran has been fatigue.
"We didn't expect to see this much weight loss," Dr. Gadde said. "If a drug can give patients a 10 percent weight loss at one year, and is tolerated well, with no serious side effects, that drug is going to be a winner."
Even so, he said it was too soon to recommend the drug to other doctors or the public. He said further studies should be done at more centers and in many more patients.
Elan, the maker of Zonegran, paid for the study, but, Dr. Gadde said, took no part in designing or interpreting it.
Dr. Ivan Lieberburg, chief scientific and medical officer at Elan, said, "We were extremely excited about these results." He said the company was considering applying to the F.D.A. to get Zonegran approved for weight.
Edna Parker, 48, has been taking Zonegran for about eight months, and has lost 47 pounds. She now weighs 202 and hopes to reach 175.
"When I step on the scale, it is so exhilarating to see the numbers go down instead of seeing them go up," she said.
Ms. Parker was in Dr. Gadde's study, in the placebo group. When the experiment was over, Dr. Gadde offered to treat her with Zonegran for free.
"To me, the drug is a godsend," she said. "I take can two or three spoons of food, and I'm full. When I eat, it's like the food swells up inside me. I'm just not hungry."
She has not felt any side effects from the drug, she said. But she hopes to stop taking Zonegran by the end of the year.
"I want to learn how to do it without the pills," she said. "They've helped me to restructure my eating habits and modify my lifestyle."
Though Ms. Parker said she thought she would be able keep the weight off on her own without the pills, she also said she would take them again if she began to regain weight.
Olivia Gatewood, 49, has lost 20 pounds after taking Zonegran for a year. She weights 150 now, and hopes to reach 143.
"It's not a miracle," she said. "It's been a gradual thing. It has curbed my appetite. More than anything, it's given me the boost I needed."
Another patient, who asked that her name not be used, lost 64 pounds in eight months on Zonegran. But her cravings for ice cream and other sweets came back when she stopped the drug, and she has regained about 25 pounds. She is struggling to avoid gaining more, but has not gone back on the drug because she hopes to become pregnant.
Dr. Louis Aronne, an obesity specialist at New York Hospital-Cornell Medical Center, said he had prescribed Topamax for some patients and would consider using Zonegran. But, he said: "Nobody thinks these are the miracle cures. No one thinks everybody loses weight."
But, Dr. Aronne said, the drugs may help some people who have not responded to other methods and will be one more weapon doctors and patients can use against obesity.
"To me," Dr. Aronne said, "what's important is that we just keep chipping away at this."
Copyright 2003 The New York Times Company |
Posted by Ritch on April 15, 2003, at 13:23:01
In reply to Zonegran and Topomax for weight loss, posted by OddipusRex on April 15, 2003, at 7:20:20
Part of an article in the NYTimes this morning. I'm not familiar with Zonegran. Is it used as a mood stabilizer too?
I was offered Zonegran as a possible switch from Depakote/Neurontin back when it came out. There was a slight risk of schizophreniform psychosis with it and it spooked me. The good thing about it from what I remember...were no life-threatening skin events, long half-life (can take it once at bedtime), low discontinuation rate during clinical trials (12%).
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