ROANOKE TIMES
Copyright (c) 1996, Roanoke Times
DATE: Tuesday, November 5, 1996 TAG: 9611050107
SECTION: EXTRA PAGE: 3 EDITION: METRO
COLUMN: Personal Health
SOURCE: JANE BRODY
Decades of medical wariness about using drugs for weight loss seem to have melted away with the introduction of two new prescription regimens that offer the appetite control of amphetamines but without the frightening side effects and addictive properties of these dangerous drugs.
One is a combination of two long-marketed weight-loss aids, fenfluramine and phentermine, commonly called ``fen/phen,'' and the other is a newly approved refinement, dexfenfluramine, sold under the trade name Redux. All three drugs work by changing the levels of brain chemicals that influence appetite and cravings.
While taking one or the other, hundreds of seriously overweight patients who had been unable to lose weight without battling constant cravings and nagging hunger are suddenly finding it quite easy to stick to a diet of modest portions.
But while clearly helpful to many people who have tried them, the new weight-loss medications are not magic bullets. Rather, as Dr. George Blackburn put it, they are one of ``three legs of a stool.'' The other two legs are learning how to choose a healthful, low-fat diet and adopting a regular regime of physical exercise.
``Without all three legs, you don't have a solid seat,'' said Blackburn, an obesity expert at Harvard Medical School. ``The drugs are truly an adjunct. They can help people stay on a healthful diet and not overeat.''
Drugs or no drugs, pounds can only be lost by taking in fewer calories and burning more. Furthermore, the drugs do not work for everyone, a fact that can be readily ascertained within a week because ``when they work, it's like night and day,'' Blackburn said. If no weight is lost in a month, he added, the medication should be stopped.
The drugs are not intended for casual use - for those who want to lose 10 or 15 pounds before a wedding, for example. They are approved only for patients whose weight is a health hazard: those who are 30 percent above their ideal weight or those who are 20 percent overweight and already have one or more other weight-related health problems, like diabetes or high blood pressure or elevated cholesterol.
The drugs should be prescribed only for patients who have been unable to achieve or maintain weight loss on a sensible diet and exercise program.
The medications are intended to help people with a biological basis for their weight problem. Not every overweight person has an uncontrollable appetite or insatiable cravings. Some put on pounds because they eat too much of the wrong foods or are too sedentary. The drugs are not for them.
Unfortunately, as was discovered by a few normal-weight decoy patients dispatched by ``American Journal,'' a syndicated television news magazine, some doctors were willing to prescribe the drugs for anyone who asked, regardless of their current weight or health status.
Weight-loss experts are concerned about the potential abuse of these medications by patients with eating disorders and by athletes trying to lose a few pounds fast.
Dr. Xavier Pi-Sunyer, an obesity expert at St. Luke's-Roosevelt Hospital in New York, pointed out that the drugs have side effects, though mostly temporary ones. Fenfluramine and dexfenfluramine can cause drowsiness, constipation, diarrhea, increased blood pressure and possibly confusion and some memory loss.
Phentermine is a stimulant that can cause insomnia, strange dreams, gastrointestinal disturbances and dry mouth. In addition, in rare cases, the fenfluramines have touched off a potentially fatal lung disorder called primary pulmonary hypertension. Anyone taking these medications should be examined regularly by the doctor who prescribes them.
How the drugs work
Fenfluramine and dexfenfluramine raise serotonin levels in the brain and seem to reduce cravings for fattening foods. Phentermine raises the level of noradrenaline, which signals satiety, and its stimulant effects counter the drowsiness that can be induced by fenfluramine.
The fen/phen combination was shown in a carefully done year-long study by Dr. Michael Weintraub, who is now with the Food and Drug Administration, to work better than either drug alone in fostering weight loss. But no one has yet completed a study of either regimen to test its long-term effectiveness and safety.
Neither has there yet been a head-to-head comparison of fen/phen and dexfenfluramine, so it is not possible to say which is more effective. Fenfluramine is a combination of dexfenfluramine, the active ingredient and only ingredient in Redux, and levofenfluramine, which has no effect on appetite.
Also, Redux was approved for use for up to one year, whereas the fen/phen combination has never been officially sanctioned, and approval of its individual drugs is limited to three months. Some doctors have nonetheless been keeping patients on fen/phen for a year or longer.
Blackburn, who is in the midst of a three-year fen/phen study, said that weight loss seemed to occur over a seven-month period and then level off, often well before a person had reached ``ideal'' weight. His recommendation: ``Stay on the medication for a year, then start to wean yourself to every other day, then one week off and one week on, and finally go off completely. If you start to gain weight, say five pounds, go back on the medication for one month and repeat the weaning process.''
Some patients have found that they do not need to take the full prescribed dose to hold the reins on their appetite. They do just as well taking the drugs every other day or dividing the capsules and taking a half dose daily. The cost savings can be considerable, since the full treatment can cost thousands of dollars a year.
Blackburn's study has thus far shown that about half of 375 patients lost more than 15 percent of their starting weight within a year. Half these patients have kept the weight off at the end of two years by taking the drugs every other day. A quarter have been able to keep the weight off without medication, and the remaining quarter dropped out, he said.
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