BMJ 1999;318:285-289 ( 30 January )

Papers

Nicotine nasal spray with nicotine patch for smoking cessation: randomised trial with six year follow up

Thorsteinn Blondal, chest physician, ^a Larus Jon Gudmundsson, research physiotherapist, ^a Ingileif Olafsdottir, research nurse, ^a Gunnar Gustavsson, clinical research manager, ^b Ake Westin, biostatistician. ^b

^a Reykjavik Health Care Centre, Baronstigur 47, 101 Reykjavik and National University Hospital, Iceland, ^b Pharmacia and Upjohn, Box 941 S-251 09 Helsingborg, Sweden

Correspondence to: Dr Blondal thorsteinn.blondal{at}hr.is

Objective: To evaluate the efficacy of using a nicotine patch for 5 months with a nicotine nasal spray for 1 year.
Design: Placebo controlled, double blind trial.
Setting: Reykjavik health centre.
Subjects: 237 smokers aged 22-66 years living in or around Reykjavik.
Interventions: Nicotine patch for 5 months with nicotine nasal spray for 1 year (n=118) or nicotine patch with placebo spray (n=119). Treatment with patches included 15 mg of nicotine for 3 months, 10 mg for the fourth month, and 5 mg for the fifth month, whereas nicotine in the nasal spray was available for up to 1 year. Both groups received supportive treatment.
Main outcome measure: Sustained abstinence from smoking.
Results: The log rank test for 6 years (²=8.5, P=0.004) shows a significant association between abstinence from smoking and type of treatment. Sustained abstinence rates for the patch and nasal spray group and patch only group were 51% v 35% after 6 weeks (P=0.011 (²), 95% confidence interval 1.17% to 3.32%), 37% v 25% after 3 months (P=0.045, 1.01% to 3.08%), 31% v 16% after 6 months (P=0.005, 1.27% to 4.50%), 27% v 11% after 12 months (P=0.001, 1.50% to 6.14%), and 16% v 9% after 6 years (P=0.077, 0.93% to 4.72%).
Conclusions: Short and long term abstinence rates show that the combination of using a nicotine patch for 5 months with a nicotine nasal spray for 1 year is a more effective method of stopping smoking than using a patch only. The low percentage of participants using the nasal spray at 1 year, and the few relapses during the second year, suggest that it is not cost effective to use a nasal spray for longer than 7 months after stopping a patch.

Key messages Combined methods of nicotine replacement therapy have a potential advantage over one method because of high levels of substitution Nicotine patches release nicotine slowly, but nicotine nasal spray delivers nicotine more rapidly, enabling the smoker to respond quickly to any smoking urges Treatment with a patch and nicotine nasal spray was significantly more effective than patch and placebo from day 15 after stopping smoking Using a patch for 5 months with a nicotine nasal spray for 1 year provides a more effective means of stopping smoking than using a patch only It is not cost effective to use a nicotine nasal spray for longer than 7 months after stopping a patch

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