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OFFICE PRACTICE MODEL AND 16-HOUR NICOTINE PATCH YIELDS SIGNIFICANT QUIT RATES FOR SMOKERS

 PALO ALTO, Calif., Aug. 19 /PRNewswire/ -- A significant -- 25 percent -- quit rate will be reported here for patients in a one-year study of the nicotine patch's efficacy, with physician counseling, in aiding smoking cessation. One year sustained non-smoking rates were nearly three times higher for patients using the patch, (25 percent vs. 9 percent) versus those wearing a placebo, or dummy patch.
 The study was designed as a model for the stop-smoking therapy that a primary care physician could provide for patients in his or her private office. No special psychological or behavioral skills or services were used.
 The study, conducted by pulmonologist David P.L. Sachs, M.D., director of the Palo Alto Center for Pulmonary Disease Prevention, and his colleagues, cardiologist Urban Sawe, M.D., Ph.D., and behavioral pharmacologist Scott J. Leishow, Ph.D., was double-blind and placebo controlled. One year after their Target Quit Date, 28 of 113 (25 percent) patients treated with the 16-hour nicotine patch (Nicotrol(TM), Parke-Davis) had not smoked for the entire year, according to both self- reporting and objective validation (carbon monoxide and serum continue levels), compared with 10 of 107 (9 percent) patients who had worn a placebo patch. The difference between the 25 percent success in the treated group and 9 percent success in the placebo group is statistically significant: p < .0001.
 "The single-most important finding from this study," says Dr. Sachs, "is that 25 percent of those who used the active 16-hour patch refrained from smoking for an entire year, or 7-1/2 months after they had stopped using their nicotine patch, compared to only 9 percent of those who have been treated with the placebo patch. When you look at the few other studies that present either six-month or one year results, our results are almost twice as high as those."
 These results will be published in the Archives of Internal Medicine (vol. 153, pp. 1881-1890), the American Medical Association's specialty journal for internists and other primary care doctors.
 "The physician-office treatment approach (used in the study) is similar to that which a physician would use in medically managing any chronic medical disorder, such as asthma, insulin-dependent diabetes, angina or hypertension, and can be easily incorporated into any physician's standard office practice," Dr. Sachs and his two co-authors report in Archives.
 Subjects Recruited Through Ads
 Their subjects, healthy men and women from the San Francisco Bay Area and Santa Cruz County in California, were recruited through newspaper ads; they had smoked at least 10 cigarettes a day, for at least three years, and were motivated to quit. The three pre-quit office visits included a complete medical examination performed by a physician, routine lab work and the development of a personal plan to prepare the patient for stopping smoking.
 The subjects were seen thereafter by a nurse during seven brief, periodic follow-up visits to obtain fresh nicotine patches and report on side effects or other problems. The nurse's role was designed to approximate the level of care that can be provided in a private practice by an office nurse.
 Low Incidents of Side Effects
 The nurse monitored side effects by questioning the patients during each follow-up visit and by examining recent patch sites. "The patch was well-tolerated by patients and incidence of adverse reactions were low," according to Dr. Sachs. This is the first study to report skin irritation severity to no different for active than placebo patch wearers."
 The 30 cm(squared) patch with which therapy was initiated delivers approximately 15 milligrams of nicotine (average) through the skin over a 16-hour period. Smaller, step-down nicotine patches that were used for tapering the patients off to abstinence delivered less nicotine.
 No abnormal dreams were recorded using the 16-hour "waking-hours" patch. The 16-hour nicotine patch is not worn while sleeping, since smokers generally don't smoke while asleep. Previous studies with the 16-hour patch also reported low sleep disturbances (abnormal dreams), at a rate of less than one percent. "The `waking hours' patch seems to help avoid some of these potential patient concerns," according to Dr. Sachs.
 The 16-hour nicotine patch's major benefit, compared to placebo, in addition to greater efficacy in stopping smoking, was in reducing craving and other smoking-related withdrawal symptoms. Participants who successfully stopped smoking had gained weight at the end of six months. But those who quit while using the nicotine patch had significantly less weight gain (4.1 kilogram, average) than those who quit using the non- medicated, placebo patch (6.1 kg).
 Treatment Standardized
 Dr. Sachs attributed the 1 in 4 one year success rate among active nicotine patch wearers to integration of the nicotine patch into a standard treatment regimen that "can be provided easily by any primary care physician." The key elements, he and his colleagues write, are:
 -- An initial medical evaluation, including history and physical exam.
 -- Development of a treatment plan with the patient.
 -- Ongoing monitoring of compliance, effectiveness, and side effects of the medication.
 -- Slow, systematic tapering off of the nicotine.
 -- Scheduled office follow-up during active medication, tapering and post-nicotine phases.
 -- Appropriate medical counseling and advice by physician or nurse at each visit.
 "This trial is the first to show that the 16-hour nicotine transdermal patch can achieve effective long term smoking cessation in men and women when administered as part of a comprehensive behavioral smoking cessation program based around typical physician counseling, but without intensive behavior modification efforts such as group therapy and psychological intervention," Dr. Sachs and his co-authors conclude.
 -0- 8/19/93 R
 /CONTACT: Dr. David P. Sachs, director of the Palo Alto Center for Pulmonary Disease Prevention, 415-327-9494, or Brad Miles of Ted Klein & Co., 212-477-9007/


CO: Palo Alto Center for Pulmonary Disease Prevention ST: California IN: HEA SU: PDT

TM -- NY003 -- 4419 08/19/93 15:10 EDT
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Date:Aug 19, 1993
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