NEW YORK (Reuters Health) - Nicotine lozenges may join the ranks of patches, nasal spray and gum in helping smokers to kick their habit, researchers say.

After nearly one year, 15% to 18% of smokers had quit after using the lozenges for 6 months, compared with 6% to slightly more than 9% of those who were given a placebo or inactive treatment.

Nearly two thirds of smokers reported at least one side effect of the lozenges, including anger, frustration, depression, headache, insomnia or nausea, and about 17% of this group reported a severe side effect, according to the report. GlaxoSmithKline, a manufacturer of nicotine replacement products, funded the study.

Nonetheless, the results show that lozenges can provide cigarette smokers with another option for reducing their dependence on nicotine and possibly quitting smoking over the long term, according to Dr. Saul Shiffman from the University of Pittsburgh in Pennsylvania and colleagues.

"Increasing the reach and appeal of nicotine replacement therapy and enhancing the use of smoking cessation treatment is a matter of public health urgency," Shiffman and his team write in the June 10th issue of the Archives of Internal Medicine.

Smoking, they note, is the leading preventable cause of death and illness in Western nations. While nicotine replacement therapies such as patches and nasal sprays may help lower smoking rates, only 28% of US smokers and 11% of European smokers have tried such therapies, possibly because they can be irritating and inconvenient.

The study included nearly 2,000 smokers aged 18 and older living in the US and UK who received nicotine lozenges or placebo. All smokers wanted to quit and had not tried other nicotine replacement therapies within the past 30 days.

Smokers who usually had their first cigarette of the day within 30 minutes of waking were defined as "high dependence" and received lozenges containing 4 milligrams (mg) of nicotine. All other smokers received lozenges containing 2 mg of nicotine. The treatment released nicotine over 30 minutes after it dissolved in the mouth.

The smokers used 9 to 20 lozenges a day for 6 weeks. They gradually decreased their lozenge use for the next 6 months, and then stopped using the lozenges. Individuals receiving the active medication were more likely to report heartburn, hiccups and nausea than those taking the placebo.

After 6 weeks of treatment, smokers who received the nicotine lozenges were up to four times more likely to have quit than their peers who received the placebo. Although some of these individuals started smoking again, the results show that "the new nicotine lozenge is an effective and safe treatment for smoking," Shiffman and colleagues conclude.

"Physicians should counsel smokers to quit and suggest the nicotine lozenge as an option," they add.

SOURCE: Archives of Internal Medicine 2002;162:1267-1276.

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