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MAY 20, 1997 — Four-year Follow-up Study Shows 21 mg. Nicotine Patch Effective for Long-term Quitting

Of all the products on the market to help people quit smoking, the nicotine
patch still is among the best ways for smokers, especially heavy smokers,
to quit.

In 1991, one of the first major clinical trials for the nicotine patch
was held at nine sites around the country. Dave Daughton, a smoking cessation
researcher at the University of Nebraska Medical Center in Omaha, presented
findings of a four-year follow-up study conducted on the effectiveness
of various doses of the patch. His findings were presented at the 1997
International Conference of the American Lung Association and American
Thoracic Society in San Francisco.

The follow-up study looked at the effectiveness of the patch in 724
patients, average age 43, at seven of the original nine study sites across
the United States. Success rates, measured by permanent quitting, were
as follows: of 193 people on the 21 mg. patch, 20 percent remain non-smokers;
of 202 on the 14 mg., 10 percent remain non-smokers; and of the 127 people
on 7 mg., 12 percent remain non-smokers.

As part of the study, 202 people were given a placebo, and only seven
percent of these people were successful in quitting. Smokers also participated
in support groups, which contribute to successful quitting.

"The 20 percent success rate of the 21 milligram users of the patch
may not sound that great, but it’s excellent when you consider the chances
a person will quit smoking this year by cold turkey is only 2.5 percent,"
Daughton said. "The nicotine patch proved to be beneficial as a long-term
smoking cessation aid," Daughton said.

The follow-up study found 48 percent of those who weren’t smoking four
years after using the patch no longer crave cigarettes. Daughton said smokers
who succeed in quitting for six weeks on placebo patches have roughly the
same chance of quitting permanently as those on the nicotine patch.

The role of nicotine patches is to boost early quitting which leads
to increased long-term abstinence. After six weeks, the urge to smoke diminishes
and many of the physical symptoms such as anxiety, lack of concentration,
irritability and restlessness, subside greatly. The patch makes quitting
smoking more manageable because it provides sufficient levels of nicotine
which diminishes some of the nicotine withdrawal symptoms, Daughton said.

"The patch helps satisfy the body’s desire for nicotine while enabling
the quitter time to work on psychological and behavioral aspects of smoking."

The study also found smokers under age 30 didn’t do as well in long-term
quitting smoking (four or more years) as those older than 30. Daughton
believes this is because younger smokers are more likely to be exposed
to more people who smoke, and they have less experience with attempting
to quit smoking.

"Most people try to quit smoking three to four times before they
succeed," Daughton said. The most unexpected information in the follow-up
study is weight gain. After four years of not smoking, participants gained
an average of 20 pounds.

"This was a disturbing finding," Daughton said. "However,
it has to be looked at in the proper context. We don’t want to scare anyone
by saying they will gain 20 pounds if they quit smoking."

In the long run, Daughton said weight people gain after quitting is
not related to the method of quitting but is related to the number of cigarettes
smoked and to other factors such as age, lifestyle and physical activity.

"Weight gain after quitting is often associated with the number
of cigarettes smoked," Daughton said. "The subjects in this study
smoked on the average 30 or more cigarettes a day. Yet, even a few of them
lost weight. We know as we age, we tend to gain weight. Younger, more active,
lighter smokers won’t likely see that magnitude of weight change when they
quit smoking. My belief is that after a four-year period, what smokers
weigh after quitting is what they would have weighed had they never smoked."

Typically, smokers weigh less than non-smokers. However, smoking is
a weight-reduction method with potentially deadly side effects, Daughton
said. Of the estimated 46 million Americans who smoke (about 25 percent
of adults), 70 percent who would like to quit. An estimated 35 percent
of American smokers tried to quit in 1996.

In addition to the University of Nebraska Medical Center, other centers
involved in the study were: University of Minnesota, Minneapolis; Oregon
Research Institute, Eugene, Ore.; Pacific Medical Research Services, Redwood
City, Calif.; Pulmonary Drug Evaluation Program, Wheat Ridge, Colo.; Stanford
University School of Medicine, Center for Research in Disease Prevention,
Palo Alto, Calif.; and West Virginia University School of Medicine, Morgantown,
W.Va.