Obesity Study Evaluates Long-Term Use of Diet Drug Duo

By Starr, Cynthia | Drug Topics, August 3, 1992 | Go to article overview

Obesity Study Evaluates Long-Term Use of Diet Drug Duo


Starr, Cynthia, Drug Topics


For those veteran dieters whose ample bodies wax and wane with almost predictable regularity, the notion of maintained weight loss may seem like, pardon the expression, so much pie in the sky. Yet, the tantalizing results of a recent study indicate that one requirement for successful treatment of obesity may simply be a different point of view.

FOUR-YEAR TRIALS: In a complex four-year series of trials, researchers from the University of Rochester School of Medicine and Dentistry evaluated a multidisciplinary approach to weight loss that included prolonged use of a combination of two old diet drugs, fenfluramine and phentermine. Instead of using the drugs for a period of weeks, as is currently recommended, participants took the two agents for up to three and one-half years.

In the first part of the investigation, a daily drug regimen of 60 mg of fenfluramine and 15 mg of phentermine was pitted against placebo in 121 enrollees. When used alone, fenfluramine is given in total daily doses ranging from 60 mg to 120 mg per day; phentermine in doses of 15 mg to 37.5 mg per day.

Because the two drugs influence different chemical messenger systems in the brain, the researchers hoped that pairing them would enhance weight loss and diminish adverse reactions. Phentermine, which mainly affects the norepinephrine network, has stimulatory properties, while the serotonergic agent fenfluramine, is a mild depressant.

The participants, who weighed in at 130% to 180% of ideal body weight, also took part in a program of diet, exercise, and behavior modification. Still, after seven months, it was clear that the group taking the active agents had the edge. Those receiving the two drugs had lost an average of 14.3 kg or a little more than 30 pounds. The placebo group was down 4.6 kg or 10 pounds.

In the ensuing couple of years, all remaining participants received the two drugs and continued to adhere to the additional weight-control tactics. However, the researchers altered the dosing schedules. Some patients took the drugs on a continuous basis, while others took them only during the seasons that most try dieters' souls--October to January and April to June.

Doses were also modified. Those patients who had not lost more than 10% of their initial weight despite treatment began taking a 30-mg daily dose of phentermine along with fenfluramine. Later, the participants could choose to have their dosages raised or lowered. In the last year of the study, the researchers followed the patients' progress as they stopped taking the drugs.

The bottom line: Despite diet, exercise, and behavior modification, people gained weight whenever they weren't on medication. Those who took the two drugs reached a plateau several months into the study. But, they were able to maintain a degree of weight loss as long as they were treated. Those who regained some pounds while taking the two drugs, still gained less than those who were not receiving drug therapy.

What's more, patients found adverse reactions, such as dry mouth or sleep disturbances, more bothersome when they took the drugs on an intermittent rather than continuous basis. In addition, those who were "poor losers" when taking the initial doses didn't do much better when dosage was increased.

'A REGULATORY PROBLEM': "I think it's becoming clearer and clearer that obesity is a regulatory problem in much the same way that high blood pressure is a blood pressure regulatory problem and diabetes is a sugar regulatory problem," Frank Greenway, a member of the clinical faculty at the University of California-Los Angeles and a private practitioner in Marina Del Rey, told Drug Topics. …

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