A randomized controlled open comparative trial of varenicline vs nicotine patch in adult smokers: efficacy, safety and withdrawal symptoms (the VN-SEESAW study).
BACKGROUND
It has been suggested that anti-smoking therapy gives encouraging results, but this has not been verified by well-randomized study protocols. The present study was a randomized controlled trial of varenicline vs nicotine patch in adult smokers for comparison of efficacy, safety and withdrawal symptoms.


RESULTS
The 32 adult smokers were randomly divided into a varenicline group (VG, n=16) and a nicotine patch group (NG, n=16). The primary endpoints were the 12- and 24-week smoking-abstinence rates, safety and withdrawal symptoms including stress. No significant difference in abstinence rates was observed between the 2 groups over weeks 9-12 (71.4% vs 78.6% in the VG and NG, respectively), and weeks 9-24 (64.3% vs 71.4%, respectively). The frequencies of inability to concentrate at 2, 4, and 8 weeks, and wakeful nights at 2 weeks were higher in the VG than in the NG. Adverse side-effects associated with a gastrointestinal disorder occurred in 14 cases and 1 case in the VG and NG, respectively, and skin allergy was seen in 0 and 9 cases, respectively.


CONCLUSIONS
The selection of treatment depends on the balance of desired acuteness of cessation of smoking and side-effects, such as psychiatric and gastrointestinal problems or skin allergy.
Department of Clinical and Applied Science, Graduate School of Medical Sciences, Fukuoka University, Fukuoka, Japan.
Hitomi
H
Tsukahara
Keita
K
Noda
Keijiro
K
Saku
D000279:Administration, Cutaneous; D000328:Adult; D001552:Benzazepines / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D004644:Emotions; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D018722:Nicotinic Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D011810:Quinoxalines / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D012307:Risk Factors; D012907:Smoking / Q000188:drug therapy* / Q000523:psychology; D016540:Smoking Cessation / Q000379:methods*; D013315:Stress, Psychological; D013375:Substance Withdrawal Syndrome / Q000453:epidemiology* / Q000523:psychology; D016896:Treatment Outcome; D000068580:Varenicline
D001552:Benzazepines; D018722:Nicotinic Agonists; D011810:Quinoxalines; D009538:Nicotine; D000068580:Varenicline