Study Suggests That Nicotine Inhaler Can Help
Achieve Sustained Smoking Reduction
Possible First Step to Cessation in Patients
Unwilling or Unable to Quit Completely
BASEL, Switzerland, Aug. 7 /PRNewswire-AsiaNet/ -- The following press release was issued by Pharmacia Corporation:
A new study published in the August 5th issue of the British Medical Journal suggests that a nicotine inhaler effectively and safely achieved sustained smoking reduction over 24 months in patients who were unable or unwilling to quit completely. The study concluded that smoking reduction may be a feasible first step towards smoking cessation in subjects who are not willing or able to abruptly stop.
The Swiss study, which included 400 adult smokers, found that 26 percent of smokers using a nicotine inhaler who were unable or unwilling to quit smoking achieved at least 50 percent reduction in daily cigarettes after four months. This was in contrast to 9 percent of their counterparts in the placebo group. At the two-year mark, sustained smoking reduction was seen in 9.5 percent of the nicotine inhaler group and 3 percent of the placebo group.
"These results are important because, for some patients, reducing the number of cigarettes smoked is believed to be a critical first step to eventually achieving cessation," said study lead author Chris T. Bolliger, MD, Respiratory Division, Department of Internal Medicine, University Hospital, Basel, Switzerland. "Other studies have shown that heavy smokers typically have the highest relapse rates when they abruptly try to quit smoking. By using a nicotine inhaler to curtail the amount of tobacco consumed, as we did in this study, we are putting these smokers in a much better position to achieve their ultimate goal of abstinence."
Tobacco is the single most preventable risk to human health, accounting for 3.5 million deaths annually -- one every nine seconds.(1) By the year 2020, it is predicted that tobacco-related deaths annually will exceed deaths from AIDS, auto accidents, murder, suicide, illegal drugs, and alcohol combined.(2) Of the 1.1 billion smokers in the world, 2 approximately 70 percent say they want to quit.(3)
Study Design and Findings
The study investigated whether long-term smoking reduction can be achieved through the use of a nicotine inhaler and whether concomitant use of nicotine replacement therapy (NRT) and smoking is safe. The two-center, double-blind, randomized, placebo-controlled study enrolled healthy smokers who were unwilling or unable to quit, but interested in reducing their smoking. Patients included 400 adults, at least 18 years of age, who smoked 15 or more cigarettes per day for three or more years, and had an expired carbon monoxide level of 10 parts per million (ppm) or greater. Subjects had failed in at least one serious attempt to quit within the past 12 months, but wanted to reduce smoking as much as possible with the help of the nicotine inhaler (an initial reduction of 50 percent was suggested to participants.) People currently using NRT, any other behavioral or pharmacological smoking cessation/reduction program, or other nicotine products were excluded from the study.
The 200 patients in the active treatment group received nicotine inhalers, while the remaining 200 patients received placebo inhalers. After the initial telephone screening and baseline assessment, subjects were reassessed at the clinic after 1, 2, 3, and 6 weeks, and after 3, 4, 6, 12, 18, and 24 months. Information on the health implications of smoking was initially distributed, and smoking reduction counseling was provided at each visit. The primary measure of success for the study was self-reported reduction of daily cigarette smoking by at least 50 percent compared to baseline from week 6 to month 4.
The results suggested that sustained long-term smoking reduction with the nicotine inhaler could be achieved and maintained. From week 6 onward, the success rates were significantly higher for the active group compared to the placebo group: at 4 months (26 percent vs. 9 percent; p<0.001), 12 months (13 percent vs. 4 percent, p=0.002), and 24 months (9.5 percent vs. 3 percent, p=0.012). A reduction in the exhaled carbon monoxide concentration among daily inhaler users was seen in both the active an placebo groups.
One hundred and fourteen subjects in the placebo group reported 193 adverse events, and 113 subjects in the active group reported 227 adverse events. Fifty-three serious events occurred, none of which was treatment-related. Two local symptoms were significantly more common in the active group than the placebo group: throat irritation (7 percent vs. 2 percent), and coughing (6.5 percent vs. 2 percent). The total number of adverse events related to symptoms usually associated with nicotine overdose (nausea, vomiting and palpitation) were evenly distributed between the groups; nausea or nausea/vomiting was reported by 9 of 200 in the active group and by 8 of 200 in the placebo group, while palpitation was 2 of 200 and by 1 of 200, respectively.
The study was co-authored by Xandra van Biljon, RN, and Andre P. Perruchoud, MD, Respiratory Division, Department of Internal Medicine, University Hospital, Basel, Switzerland; Jean-Pierre Zellweger, MD, and Annik Robidou, RN, University Medical Policlinic, CHUV, Lausanne, Switzerland; and by Tobias Danielsson, BSc, Ake Westin, MSc, and Urbain Sawe, MD, PhD, Pharmacia Corporation, Helsingborg, Sweden. It was supported by a grant from the Consumer Healthcare division of Pharmacia Corporation.
References
1. World Bank Development Practice Series. Curbing the Epidemic:
Governments and the Economics of Tobacco Control. 1999.
www.worldbank.org/html/extpb/epidemic.htm
2. World Health Organization. Leave the Pack Behind. Geneva,
Switzerland: World Health Organization, 1999.
3. New Public Health Service Guideline Calls on Health Professionals to
Make Treating Tobacco Dependence a Top Priority. Press Release,
June 27, 2000. Department of Health and Human Services.
http://www.surgeongeneral.gov/tobacco/hhssmokpr.htm
SOURCE Pharmacia Corporation
CONTACT: CONTACT: Mary-Frances Faraji of Pharmacia, 908-306-8361, or [email protected]; or Kim Diamond of Edelman Healthcare, 212-704-4535, or [email protected]/
