Varenicline (VAR) is a new selective α4β2 nicotine acetylcholine receptor partial agonist, available for nicotine dependence treatment in Italy as of July 2007. The aim of the present study is to evaluate the rate of smoking cessation among subjects enrolled in a Six-week Group Counseling Program for smoking cessation (SGCP) utilizing VAR and/or group counseling therapy through a 3-month follow-up period. From September 2007 to June 2008, 112 volunteers motivated to quit smoking (49 males and 63 females, average age 51.1±10.7 yrs and smoking an average of 22.8±8.8 cigarettes/day for a period of 33.8±11.2 yrs) were recruited by our Unit. After an individual motivational interview, subjects started the SGCP and were asked to begin a 12-week pharmacotherapy consisting of VAR 0.5 mg/d for days 1 to 3, 0.5 mg twice/d for days 4 to 7, then 1 mg twice/d through week 12. Exhaled CO levels were used as an index of abstinence; subjects came back after 3 months to check their smoking habit and to know if VAR treatment was completed. The majority of the subjects had a high school education and regular employment. Forty-eight subjects (42.9%) accepted VAR, with gender differences (53.1% males vs. 34.9 females p<0.05) and 17 subjects (35.4%) completed the 12-week therapy, whereas the remaining 64 subjects chose SGCP only. At enrollment subjects who chose VAR showed higher scores of nicotine dependence and drunk more coffee-cups/day. Thirty-one subjects (64.6%) that accepted VAR discontinued the drug after a median of 38.4±20.6 days. Nineteen subjects (39.6%) in the VAR group experienced nausea but only 5 (10.4%) for this reason discontinued VAR. Other main reasons they stopped VAR was because they felt that the drug did not help them to stop smoking (27.1%) or, vice versa, that they did not need more medication to maintain abstinence (8.3%). Subjects enrolled in a SGCP utilizing VAR showed a significative higher smoking cessation rate with respect to counseling alone: at the end of SGCP (83.3% vs. 62.5% respectively), at the three-month follow-up (68.8% vs. 53.1% respectively), at the six-month follow-up (62.5% vs. 39.1% respectively) and at the one-year follow-up (56.3%vs. 35.90% respectively). All the subjects that completed VAR maintained their abstinence during the follow-up period. Our data suggest that VAR could ameliorate the outcome of a program for smoking cessation. However the percentage of subjects that discontinued VAR is higher (64.6%) with respect to that we observed using Bupropion Therapy (46.4%) in a SGCP. Then in order to improve compliance with the therapeutical treatment, VAR pharmacological profile, including its side effects, must be throughly explained to subjects that begin a SGCP.
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