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| |  Nicotine Substitution Does Not Reduce Intensity of Withdrawal Symptoms in Hospitalised Smokers: Presented at ERS By Evelyn Harvey VIENNA, Austria -- September 22, 2009 -- Offering nicotine substitution to smokers hospitalised for elective surgery does not have a significant effect on reducing cravings or other nicotine withdrawal symptoms, according to a phase 3 study presented here at the 19th Annual Congress of the European Respiratory Society (ERS). In addition, no further differences were seen in rates of smoking cessation 1 to 6 months following the study. “Hospitals have been smoke free by law since 2006 in Belgium, so we saw in-hospital smoking cessation as a teachable moment for patients,” explained Kris Nackaerts, MD, University Hospitals Leuven, Leuven, Belgium, on September 16. For the study, electively hospitalised patients at 4 academic hospitals were recruited between August 2006 and December 2008. All patients were aged 18 years and older and had smoked a minimum of 15 cigarettes per day for 3 years plus 10 per day in the week prior to admission. Patients were excluded for prior use of nicotine substitution (NS), drug use, or heavy alcohol use. Eligible patients (n = 296) were randomised to receive smoking-cessation counselling plus either NS patches of 15 mg/16 hours (n = 150) or placebo patches (n = 146) for a maximum of 7 days. Brief counselling (20-30 min) was given to each patient. The patients’ nicotine withdrawal symptoms were assessed using the Minnesota score and by measuring exhaled carbon monoxide (CO) levels. The study’s primary endpoint was the effects of short-term NS on withdrawal symptoms. There was no significant difference in Minnesota scores between NS and placebo patients at the end of the 7-day study period. There were no significant differences in quit rates between the NS group and the placebo group, and no reported side effects of NS. As expected, exhaled CO fell from 9.0-10.0 to 4.0-3.5 in both groups following hospitalisation and smoking cessation. The lack of significance observed in the study may be due to abnormally low baseline Minnesota scores. “If, in the future, inclusion criteria were restricted to patients with higher initial rates of withdrawal symptoms, an effect might be seen, but we wanted to include the whole smoking population,” commented Dr. Nackaerts. It is also possible that NS has no effects on nicotine withdrawal in electively hospitalised patients over short periods of time. Funding for this study was provided by Research Foundation Flanders and McNeil AB. [Presentation title: A Randomised, Double-Blind, Placebo-Controlled Phase 3 Study Investigating the Efficacy of Nicotine Substitution (NS) on Nicotine Withdrawal Symptoms (NWS) in Hospitalised Smokers (HS). Abstract 4632]
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