Real-world efficacy of prescription and over-the-counter nicotine replacement therapy.
OBJECTIVE
To assess smoking cessation rates achieved with nicotine gum and patch in simulated over-the-counter (OTC) and actual prescription (Rx) settings.


METHODS
Separate open-label studies with gum and patch in OTC and Rx settings.


METHODS
There were multiple samples: OTC gum: 2981 smokers; OTC patch: 2367; Rx gum: 324; Rx patch: 669.


METHODS
All smokers received active nicotine replacement. In the OTC setting, smokers self-selected doses of nicotine gum (2 or 4 mg Nicorette) or patch (21, 14 or 7 mg NicoDerm CQ). No intervention was provided. In the Rx setting, smokers were prescribed gum or patch by their physician.


METHODS
Biochemically verified continuous smoking abstinence was assessed at 6 weeks (28-day abstinence) and 6 months.


RESULTS
OTC success rates were consistently higher than Rx rates: differences were significant at 6 weeks for both patch [OR = 1.45 (1.05-1.98)] and gum [OR 2.92 (1.58-5.40)], and remained significant at 6 months for patch [OR = 3.63: (1.74-7.61)] but not gum [OR = 1.37: (0.73-2.58)]. Among OTC gum users. 16.1% were abstinent at 6 weeks and 8.4% at 6 months. For Rx gum users, abstinence rates were 7.7% at 6 weeks and 7.7% at 6 months. With OTC patch, 19.0% were abstinent at 6 weeks and 9.2% at 6 months. With Rx patch. abstinence rates were 16.0% at 6 weeks and 3.0% at 6 months.


CONCLUSIONS
Smoking cessation rates achieved with nicotine gum and patch under OTC conditions were as good as those under real-world prescribing conditions.
Shiffman
Saul
S
Pinney Associates, Inc, Pittsburgh, PA 15213, USA. shiffman@pinneyassociates.com
Rolf
Clyde N
CN
Hellebusch
Stephen J
SJ
Gorsline
Jane
J
Gorodetzky
Charles W
CW
Chiang
Yu-Kun
YK
Schleusener
Debra S
DS
Di Marino
Michael E
ME
D000328:Adult; D000368:Aged; D011307:Drug Prescriptions; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000008:administration & dosage*; D004366:Nonprescription Drugs; D016540:Smoking Cessation / Q000379:methods*; D014029:Tobacco Use Disorder / Q000534:rehabilitation
D004366:Nonprescription Drugs; D009538:Nicotine