Nicotine replacement before quitting cigarettes?

Normally, nicotine replacement therapy (NRT) -- including nicotine patches, gum, lozenges and nasal sprays -- is begun once a smoker quits. But some recent studies have looked at whether "pre-quitting" NRT, begun a few weeks before a smokers' scheduled quit date, can help boost success rates.

In theory, this tactic could help by familiarizing smokers with NRT before they quit, by curbing their desire to smoke due to nicotine "saturation," or by separating the reward of nicotine from the act of smoking itself. However, study results so far have been mixed.

For the new study, published in the journal Addiction, New Zealand researchers recruited 1,100 smokers who had called the country's national Quitline for help in giving up the habit.

Normally, people who register with the program are mailed vouchers for heavily-subsidized nicotine patches or gum (to be used for eight weeks after the quit date, as manufacturers suggest). They also receive phone calls from their Quitline "adviser" for support.

In this study, half of the participants were randomly assigned to follow the usual Quitline procedure, while the other half began their NRT two weeks before their scheduled quit date.

Six months later, the researchers found, there was no significant difference in quitting success between the pre-quitting NRT group and the standard-care group. In the former group, 23 percent said they had been abstinent over the past week, versus 21 percent of those in the standard-care group.

A sub-group of study participants also had their abstinence verified through tests that detect cotinine, a metabolic byproduct of nicotine, in the saliva. Again, there was no difference between the two treatment groups in long-term quit rates.

However, when the researchers combined their results with those of the previous studies on pre-quitting NRT, they found that there was an overall benefit of the tactic -- roughly a one-quarter increase in the chances of staying abstinent in the longer term.

That latter finding suggests there may be a "small-to-moderate" benefit to pre-quitting NRT, write the researchers, led by Dr. Chris Bullen of the University of Auckland.

Still, the current study was designed to simulate as closely as possible the way that many smokers' quit in the "real world," rather than the research setting. The lack of any benefit from pre-quitting NRT leaves the question of how effective the approach would be for the typical smoker.

As far as the safety of using NRT while still smoking, the rates of side effects were nearly identical in the two study groups -- affecting roughly 45 percent of participants in each group, according to Bullen's team.

One side effect -- "unspecified" chest pain -- was more common in the pre-quitting NRT group; nine people reported the problem, versus one in the usual-care group. But none of those instances of chest pain was severe, the researchers note.

In general, some of the most common side effects of nicotine-replacement therapy include headache, dizziness, upset stomach, sleep problems and increased heartbeat. More research is still needed to see whether any of those effects are more common with pre-quitting NRT.

The current study was funded by the Health Research Council and the Heart Foundation of New Zealand. Two of the co-researchers on the work have served as consultants to manufacturers of NRT products.

Star Scientific applies to FDA to market new tobacco product

Star Scientific Inc. said yesterday that it has filed an application with the Food and Drug Administration for approval to market Stonewall-BDLT as a modified-risk tobacco product under the Family Smoking Prevention and Tobacco Control Act of 2009.

It is the company's second such application to the Tobacco Products Center of the FDA. The first, for ARIVA-BDLT, was filed by Star on Feb. 19. The company believes that these are the only applications for modified-risk products that have been filed with the FDA to date.

Stonewall-BDLT, like ARIVA-BDLT, is a dissolvable tobacco lozenge with wintergreen flavoring. The product is made with flue-cured tobacco, don't mix with free tobacco, that contains levels of tobacco-specific nitrosamines that are below detectable limits by most current standards of measure.

Just Being Overweight Shortens Life: Effects of Excess Weight may Match Smoking

A study conducted in Sweden spanning almost four decades has suggested that overweight persons, and not just those who were obese, may also be subjected to increased risk of premature death. It also suggested that the adverse effects of excess weight on mortality may be as significant as smoking cigarettes.

Details and Findings of Study

Published in the British Medical Journal, the study had been conducted using data from Sweden's military service conscription register, census as well as cause of death register. In all, after excluding certain persons due to incomplete data, 45,920 men were tracked for a period of 38 years; the average age of the men at the start of the study was 18.7 years. During the period, 2,897 of the men passed on.

Body Mass Index and Mortality

Having accounted for age, socioeconomic status, muscle strength and smoking, the researchers found that men who were overweight (body mass index, or BMI, from 25.0 to 29.9) during adolescence at the point they joined the Swedish military in 1969 and 1970 had a 33% higher rate of mortality during the study period, as compared with their counterparts in the normal weight range (BMI from 18.5 to 24.9). Obese men (BMI of 30 or more) had even higher risk - a whopping 114% elevated likelihood of death during the period. Similar relative estimates were obtained when smokers and non-smokers were analyzed separately. Figures also did not differ by much when smoking was not adjusted for.

Underweight men (BMI less than 18.5) did okay, although those who were extremely underweight (BMI less than 17) had 33% increased mortality, too, similar to overweight men.

Smoking and Mortality

The study subjects had declared their smoking habits when they attended mandatory military conscription tests back in 1969 and 1970. Using this information, and after adjusting for age, socioeconomic status, muscular strength and BMI, the study team also found that, compared with their non-smoking counterparts, light smokers (1 to 10 sticks of cigarettes per day) experienced 54% increased rate of mortality during the period. Not surprisingly, heavy smokers (more than 10 sticks of cigarettes each day) fared worse, suffering heightened mortality rate of 111%. Again, the figures were similar even when BMI was not adjusted for. Although the magnitude of risk increase differed across BMI categories, they featured in the same direction.

Combined Effects of Smoking and Weight

Using normal-weight non-smokers as the reference group, the relative risks of mortality of almost all the other groups were large (at least 31% higher) and highly significant. Only two groups were spared - moderately underweight non-smokers and extremely underweight non-smokers. Overweight heavy smokers experienced heightened risk of 155%, while obese heavy smokers suffered the worst, having a risk close to 5 times (4.74) that of normal weight non-smokers.

Significance of Findings - Discussion

These findings are significant in two main ways. Firstly, they suggest that persons who are overweight but not obese could also be subject to increased risk of dying early; other recent studies had been divided on whether overweight people may experience such elevated risk as compared to their healthy-weight counterparts.

According to Martin Neovius, a postdoctoral fellow at Stockholm's Karolinska Institute and the leader of the study, his team's findings confirm the discoveries of the Nurse's Health Study conducted at Harvard. With one study having looked at women and one having covered men, the two studies complement each other. "We find exactly the same in men as they did in women," he said.

The team's findings also suggest that the impact on mortality of excess weight could be as significant as smoking, a big assertion considering that smoking is widely believed to be the single most important factor for many diseases and premature death. "What we show is that for the overweight, there is a significantly increased risk of premature death, similar to smoking one to ten cigarettes a day," said Neovius.

It is possible, however, that the study exaggerates the impact of being overweight. A major limitation of the analysis is that the study subjects' weight was only known at the start of the study period, or the point at which they joined the military. Generally speaking, people put on weight as they grow older, and some of those who were overweight during adolescence may have "graduated" to obesity in adulthood. If that were the case, their increased risk of premature death would be attributable to obesity, and not to merely being overweight during their younger years. This point was raised by David F Williamson, a visiting professor at the Rollins School of Public Health at Emory University.

Conclusion

Obesity has become an epidemic worldwide, with rates of the condition soaring in recent decades, in particular among children. Together with smoking, these two are the major behavioral risk factors for chronic degenerative diseases and premature death in developed nations today. Neovius feels that policy makers should take note of the findings of his team's study and work towards raising awareness of the dangers of being too heavy, as well as being severely underweight.

"Anti-smoking campaigns have been very successful. But we don't have any good preventative programmes for overweight and obesity," he said, in reference to his native Sweden, although things are not very different in other countries.

"We know that health behaviors are established early on in life," he also said. This tells us that adolescents must be targeted in educational efforts. Adults, too, should note that smoking and excess weight are dangerous factors, and even more deadly when put together.