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Tests show diet pill has wide-ranging benefits

Published November 10, 2004

NEW ORLEANS (AP) — An experimental pill that offers the
fairy-tale promise of helping people lose weight and quit smoking
has gathered even more stardust.

The biggest test yet of the drug found that it helped people not
only drop pounds, but also keep them off for two years —
longer than any other diet drug has been able to achieve.
Cholesterol and other health measures improved, too.

The impressive results from a study of more than 3,000 obese
people were presented at a medical conference yesterday, capping
months of anticipation about the new drug, Acomplia, made by the
French pharmaceutical firm Sanofi-Aventis.

Doctors called the research exciting and the company, which
funded the study, thinks the drug could have blockbuster potential
similar to cholesterol-lowering statin drugs.

In a study of 3,040 obese people throughout the United States
and Canada, those given the higher of two doses of the drug lost
more than 5 percent of their initial body weight, and a third of
them lost more than 10 percent.

“They achieved and maintained a weight loss of 19 pounds
as compared to 5.1 pounds in the placebo group,” said
F-Xavier Pi-Sunyer of Columbia University in New York, who led the
research and presented results at the American Heart Association
conference.

Those who quit taking the pill in the second year of the study
regained most of what they’d lost, suggesting that people
might have to take the drug indefinitely to maintain a lower
weight.

“We consider this to be a chronic problem. You don’t
cure obesity, you just improve it,” Pi-Sunyer said.

About two-thirds of American adults are overweight or obese,
raising their risk of everything from cancer and cardiovascular
disease to sore joints and snoring. About a fourth of American
adults smoke, which brings many of the same woes.

It’s been devilishly difficult to develop effective
treatments for either problem. Diet drugs in particular have a
checkered history, most notably the withdrawal from the market in
1997 of the popular “fen-phen” drug combination after
users developed heart valve problems.

Drugs now on the market either are designed for short-term use
or have distasteful side effects like bowel problems that make many
shy away from them.

Acomplia’s maker thinks it will avoid those problems by
attacking obesity in a novel way, and plans to seek federal
approval for it next year.

It’s the first diet drug aimed at blocking the
“pleasure center” of the brain and interfering with the
cycle of craving and satisfaction that drives many compulsive
behaviors and addictions. This same circuitry is activated when
people smoke pot.

“Weight regulation is really kind of an addictive
behavior,” said Robert Eckel, an expert on metabolism from
the University of Colorado Health Sciences Center who had no role
in the study.

It involved people who either were severely obese or were
moderately obese and also had another heart-related health problem
such as low “good” cholesterol, high blood pressure, or
high blood sugar.

They were given nutrition advice and urged to cut 600 calories a
day from their diet, and were randomly assigned to get either a 5-
or 20-milligram dose of Acomplia or fake pills. Neither they nor
their doctors knew who had received which.

After one year, those on the higher dose had lost an average of
19 pounds — the same result found in two smaller studies of
the drug reported earlier this year.

The new study went on to test whether staying on the drug kept
people from regaining weight. Those who took Acomplia during the
first year were redivided to either continue on it or get fake
pills for the second year.

At the end of the two years, 62.5 percent of people on the
higher dose had lost 5 percent of their body weight compared to
36.7 percent on the low dose and 33.2 percent on fake pills.

Waistlines shrank 3.1 inches with the higher dose, 1.9 inches
with the lower one and 1.5 inches for those on fake pills.

HDL or “good” cholesterol rose 24.5 percent on the
higher dose, 15.6 percent on the lower one and 13.8 percent on fake
pills. Triglycerides also fell according to dose.

“What we have here now is essentially a brand new
mechanism to treat an epidemic of staggering progression,”
said Douglas Greene, Sanofi’s vice president of regulatory
affairs.

Some people on the drug had nausea, but it usually was
short-lived. Rates of anxiety and depression were no greater for
those on Acomplia than those getting fake pills.

“There was no evidence this drug over two years had
something we had to worry about in the way of safety,”
Pi-Sunyer said.


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