Extended treatment for some addicted smokers

Sunday, July 06, 2008

Jonathan Foulds, MA, MAppSci, PhD

The brand new US Public Health Service Guideline on the Treatment of Tobacco Use and Dependence was written after an extremely thorough review of all the randomized controlled smoking cessation trials in the literature with at least 6 months follow-up.
http://www.surgeongeneral.gov/tobacco/
The guideline was also written by a large group of experts on tobacco treatment and healthcare. That guideline stated,
“For some patients it may be appropriate to continue medication treatment for periods longer than is usually recommended. Although weaning should be encouraged for all patients using medications, continued use of such medications is clearly preferable to a return to smoking with respect to health consequences.” (p126).

So what is meant by extended or “long term” treatment for tobacco dependence?

Most pharmacological tobacco dependence treatments (e.g. bupropion/Zyban, nicotine patch, nicotine gum) last for 7-12 weeks. Most non-pharmacological treatment is even shorter, e.g. the number of counseling sessions reimbursed by Medicare is 4 (>10 minutes) and group treatment most commonly consists of 6 weekly sessions. So in the field of tobacco dependence treatment, any treatment lasting longer than 12 weeks is considered “long term”. So is there any evidence that treatment lasting longer than 12 weeks may be safe and effective?

Williams et al (1) randomized patients to 52 weeks of varenicline (Chantix) or placebo. They found that varenicline was safe for a year of treatment and produced significantly higher quit rates at one year than placebo.

Tonstad and colleagues (2) treated 1927 smokers with the typical 12 weeks of varenicline and the 1236 who were not smoking at 12 weeks were then randomized to a further 12 weeks of varenicline or placebo (double blind). The question was, “does longer term treatment with varenicline prevent relapse over the next 12 weeks? By week 24, 30% of those who had varenicline had smoked, compared with 50% of those who had placebo for the last 12 weeks. So longer term varenicline resulted in more people succeeding in quitting smoking. When the participants were followed up at 12 months (i.e. at least 6 months off-drug for everyone) there were still more non-smokers among those who had varenicline for 24 weeks as compared to those who had it for 12 weeks.

But the added effects of longer duration treatment do not just apply to varenicline, or even just pharmacotherapy. Hall and colleagues (2004) (3) randomized smokers to standard 12 weeks of counseling and 8 weeks of nicotine patches plus either another 9 months of counseling, or 12 months of nortriptyline (an antidepressant that helps people quit smoking) or 12 months of placebo. At the one year follow-up, those who had nortriptyline and counseling for a year had a quit rate of 50%, as compared with only 18% for those who had nortiptyline but only 12 weeks of counseling, 30% for those who had 12 weeks of counseling and placebo, and 42% for those who had a year of counseling and placebo. The authors concluded that, “Comprehensive extended treatments that combine drug and psychological interventions can produce consistent abstinence rates that are substantially higher than those in the literature.” But as can be seen from the numbers, it was primarily the extended counseling that contributed to the unusually high one-year quit rates.

This study by Hall and colleagues was one of the first to really adopt the “chronic disease” model for smoking cessation, and it is also the one study to achieve the highest one year quit rates (50%).

The reality is that most smokers are not seeking extended (i.e. over 12 weeks) counseling or extended pharmacotherapy as a way to stop smoking. And many will not need it. The point is that those patients who have made a choice that they are willing to do whatever is necessary to save their life and become healthier by stopping smoking, and who appear likely to benefit from it, should be provided with extended treatment that appears likely to increase their chances. When 12 weeks of treatment have not succeeded in controlling hypertension, diabetes or asthma, we don’t expect our doctors to say, “oh well, never mind, it didn’t work and I won’t try to help you any more.” The same should go for tobacco dependence treatment. And when a patient has had 12 weeks of treatment but still feels vulnerable to relapse then there is evidence to suggest that the extended treatment may help them to remain smoke-free. The evidence is certainly not clear enough to recommend this to all patients, but it is sufficient to support it as an option for some.

(1) Williams KE, Reeves KR, Billing CB Jr, Pennington AM, Gong J. A double-blind study evaluating the long-term safety of varenicline for smoking cessation. Curr Med Res Opin. 2007 Apr;23(4):793-801.
(2) Tonstad S, Tønnesen P, Hajek P, Williams KE, Billing CB, Reeves KR;Varenicline Phase 3 Study Group. Effect of maintenance therapy with varenicline on smoking cessation: a randomizedcontrolled trial. JAMA. 2006 Jul 5;296(1):64-71.
http://www.ncbi.nlm.nih.gov/pubmed/16820548?ordinalpos=10&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum

(3) Hall SM, Humfleet GL, Reus VI, Muñoz RF, Cullen J. Extended nortriptyline and psychological treatment for cigarette smoking. Am J Psychiatry. 2004 Nov;161(11):2100-7.
http://www.ncbi.nlm.nih.gov/pubmed/15514412?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_Discovery_RA&linkpos=3&log$=relatedarticles&logdbfrom=pubmed

Some additional references supporting this rationale can be found at:
http://www.annals.org/cgi/content/full/148/7/554?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=Foulds+&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT

Note: Jonathan Foulds has done paid work for pharmaceutical companies (Novartis, GSK, Celtic Pharma and Pfizer). This has included advising on potential new medicines, training health professionals, advising on clinical trial design, discussing barriers to quitting and reviewing applications for research grants. His main funding sources are mentioned in a funding statement on the bio page.

Labels: cessation, cigarette smoking, dependence, extended, jonathan foulds

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Are Americans Switching to Smokeless Tobacco?

Monday, June 09, 2008

Jonathan Foulds, MA, MAppSci, PhD

A recent paper by Professor Brad Rodu of University of Louisville, School of Medicine and Dr Carl Phillips if the University of Alberta suggested that switching to smokeless tobacco is a viable smoking cessation option for American smokers.

The paper, published in the online Harm Reduction Journal, used data from the year 2000 National Health Interview Survey (NHIS) which asked 3622 male smokers and 3653 male former smokers about the methods used and outcome of their most recent attempt to quit smoking. Because the NHIS survey is administered to a fairly representative sample of the US population, Rodu and Phillips then used the results of the survey to estimate the total number of male smokers in the US using each quit rate and quitting smoking in the United States. So far this all sounds fairly sensible. However, the authors then took that fairly simple data and made rather far-reaching claims without critically examining the quality (and quantity) of data.

For example, the main conclusions drawn in the paper and its abstract (summary) were that a reasonably large number of smokers in the US (261,000) have quit smoking by switching to smokeless tobacco on their latest quit attempt. It is also claimed that the quit rate among those trying to quit smoking by switching to smokeless tobacco is higher than among those trying other methods (e.g. nicotine replacement therapy). However, examination of the data tables in the paper revealed that a total of only 33 people in the survey claimed to have quit smoking by switching to smokeless tobacco. Unfortunately this is too small a number to provide reliable estimates of numbers using this as a quit method nationally. The ubsurdity of using such very small samples to estimate national numbers is even clearer when one looks at the figures for those using the nicotine nasal spray (NNS). Only 3 people in the survey claimed to have used the nicotine nasal spray on their last quit smoking attempt, and none remained free of smoking at the time of the survey. Despite this extremely small sample, the authors went ahead and used it to estimate that at a national level,14,000 smokers used the NNS on their latest quit attempt and none (0%) succeeded.

One other issue with this study stems from the fact that the various smoking cessation aids differed in the time periods in which they were available. For example, while smokeless tobacco has been available for over 100 years, the pharmacological aids only became available in the 1980s and 1990s. So 48% of those who quit by using smokeless tobacco quit at least 10 years ago, compared to 11% of those who quit with the patch. In some ways this may make those quits on smokeless more impressive in that they are longer term quits, but it also serves to underline that in some ways these comparative figures are not comparing like with like. Smokers who quit 20-20 years ago may differ from those trying to quit in recent years, and memory for more distant events maybe less accuarate.

But overall, the biggest weakness of this study was the very small sample of participants who used smokeless tobacco in their quit attempt and then the inappropriate use of these very small numbers to estimate national numbers. Perhaps the main thing that can be concluded from this study report is that the vast majority of smoking cessation attempts in the United States do not involve the use of a proven smoking cessation aid, and a small but measurable proportion of smokers succeed in quitting smoking by switching to smokeless tobacco. If the NHIS survey uses similar questions in future it may be interesting to see how the pattern of use of smoking cessation aids changes over time.

I’d encourage smokers to use smoking cessation treatments that have been demonstrated to be safe and to increase your chances of success. These include counseling from a trained healthcare provider, nicotine replacement therapy, bupropion and varenicline.

The paper by Rodu and Philips is available at:
http://www.harmreductionjournal.com/content/5/1/18

Labels: cessation, cigarette smoking, comprehensice tobacco control, jonathan foulds, nicotine regulation reduction smoking smokeless

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Chantix (varenicline) Safety

Wednesday, May 28, 2008

Jonathan Foulds, MA, MAppSci, PhD

Last week a report was released by an organization called the “Institute for Safe Medication Practices” (ISMP) which claimed to have safety concerns about Chantix (varenicline, also marketed as Champix outside the United States). The Executive Summary of the report made two main recommendations:

1. Chantix should be avoided or used with caution by persons operating aircraft, motor vehicles or other machines (e.g. power stations) where a lapse in alertness or motor control could have serious consequences.
2. Patients and doctors should excercise caution in the use of Chantix (generally) and “consider the use of alternative approaches to smoking cessation.”

Given that most of us drive a vehicle, the report is basically suggesting that varenicline is such an unsafe drug that it should be avoided. These are strong recommendations, and have immediately resulted in the Federal Aviation Authority (FAA) and Federal Motor Carrier Safety Administration (FMCSA) adding varenicline to their list of drugs that should not be used by pilots or truck drivers. The report itself has not been published in a peer-reviewed journal and so it is reasonable to assess the quality of the data on which it was based, and to evaluate whether the recommendations are warranted on the basis of that data.

The ISMP report was based on an analysis of the frequency and type of serious adverse events that have been reported to the US Food and Drug Administration (FDA) about Chantix, in comparison to other drugs. In particular, the report noted that by the 4th quarter of 2007 Chantix “accounted for more reports of serious adverse events in the United States than any other drug.” This amounted to 988 reports about Chantix in the 4th quarter, as compared with 372 (Oxycodone) to 640 (Interferon Beta) reports about the next 5 most reported drugs.

The report then selected a sample (3063) of the total reports (excluding foreign or unclear reports) for slightly more detailed analysis. It noted that a much larger proportion of the reports about Chantix came from consumers (57%) than is typical of other drugs (26%) for which health professionals are the predominant source. The report also noted that a lower proportion of the reports about Chantix (2.5%) reported deaths, as compared with 17% of reports about other drugs.

The report summarized the most frequent medical terms included in the reports about Chantix. By far the most common term used was nausea (593), which was more than twice as common as any other reported symptom. It was also noteable that among the most commonly reported medical symptoms mentioned in the adverse event reports, many are also recognized nicotine withdrawal symptoms (i.e symptoms known to increase when smokers quit smoking, particularly without any treatment medication), such as depression (287), insomnia (242), anxiety (217), and weight increase (141).

Problems with the ISMP report and its conclusions

There are a number of fundamental problems with the quality of the data, analysis and interpretation in the ISMP report. Before discussing some of these, it is worth discussing the way that reports of serious adverse events are delivered to the FDA. There are 4 main sources of reports.

1. Members of the public can send reports directly to FDA, either by mail or via an on-line reporting system (and I have provided the link on previous posts on this blog about Chantix to ensure that reports reach FDA).
2. Health professionals can report adverse events to FDA.
3. Lawyers sometimes report adverse events to FDA.
4. The manufacturer is required to report to FDA any reports that are brought to its attention directly. Those adverse events that are already mentioned on the product labeling are reported on a quarterly basis, and novel symptoms must be reported within 15 days (expedited).

Reports from the first 3 of these sources are entirely voluntary and are made in a rather haphazard way. The ISMP report estimated that typically between 1 and 10% of serious adverse events are actually reported to FDA. It is commonly found that AE reports peak around two years after the launch of a drug, even if the drug becomes used more often thereafter. The purpose of the FDA’s reporting and monitoring system is to facilitate post-marketing surveillance and enable detection of patterns of adverse events that could potentially be caused by a medicine but were not detected in the initial placebo-controlled trials leading to drug approval. The main point here is that these reports are not made in a systematic way, and the frequency of reports can be influenced by factors such as (a) the frequency of use of the drug (b) the novelty of the drug (c) media coverage of the drug and (d) efforts by the company to interact with users in a manner that will lead to them hearing of and therefore being required to report on AEs.

With these factors in mind, here are some of the problems with the ISMP report:

1. The report fails to consider the frequency of the use of the drug when considering the number of adverse events being reported. Since its launch in August 2006 (i.e. less than 2 years), Chantix has been used by an estimated 5.5 million smokers in the United States. In 2007 alone it was used by 3.8 million new patients in the U.S. (6.2 million prescriptions). This is many times more than the other drugs listed in the ISMP report. For example, Etanercept (Enbrel, the drug with the 3rd largest number of adverse event reports to FDA) was launched in 1998, and has been used by a total of 450,000 patients WORLDWIDE in those 10 years. Comparing frequency of adverse events without adjusting for the frequency of drug use is so obviously inappropriate as to cast doubt on the reliability of the report as a whole.
As mentioned briefly in the ISMP report, many factors can affect the frequency of reporting of adverse events to FDA. In the case of Chantix, the widely publicized death of a rock musician (who was tragically shot by a neighbor in Texas) which his partner felt could have been related to Chantix, sparked off widespread media speculation about potential side effects. The manufacturer also offers a number of direct to consumer quit smoking services, including a free telephone hotline called “Get Quit”. Because this hotline is run by the manufacturer, whenever a caller mentions a symptom, they are immediately transferred to the medical department, the details are noted and the information reported to FDA. These events and procedures can have a large effect of increasing the number of serious adverse events reported and this was not adequately considered in the ISMP report. It is noteworthy that 92% of the events analyzed in the ISMP report came via the manufacturer.

2. The report fails to adequately consider the possibility that some of the reported adverse events may have been caused by nicotine withdrawal. The vast majority of those using Chantix were attempting to quit smoking, which itself is known to cause a range of nicotine withdrawal symptoms, including many of the symptoms most commonly reported to FDA and mentioned in the ISMP report (depression, insomnia, anxiety, weight increase). It is entirely plausible that many of these reported symptoms were caused by nicotine withdrawal rather than Chantix. In fact in the placebo-controlled trials of Chantix, withdrawal symptoms were REDUCED in those using Chantix.

3. The report doesn't adequately consider the serious health effects of tobacco dependence. The ISMP report characterizes the other comparison drugs as being “intended for serious illness in patients and have benefits that are accompanied by substantial risks. In comparison, varenicline is intended for use in healthy people to help stop smoking.” Unfortunately this statement indicates a misunderstanding of the nature of tobacco dependence as a serious illness causing the premature death of 50% of continuing smokers, and of the fact that a high proportion of patients using smoking cessation medications are already suffering from or at very high risk for smoking-caused illnesses, including some mentioned as adverse events in the report (e.g. cardiac arrhythmias).

4. The report inaccuratley characterizes the relative efficacy of varenicline versus other treatments. The ISMP report states that Chantix has similar long term quit rates to nicotine gum. This statement contradicts the findings of the new US Public Health Service Clinical Practice Guideline on Treating Tobacco Use and Dependence, which found a mean quit rate of 13.8% with placebo, 19% with nicotine gum and 33.2% with varenicline (p109) and that quit rates with varenicline are significantly greater than with the nicotine patch (p121). This Guideline, written after the recent labeling changes for varenicline, concluded that, “Varenicline is an effective smoking cessation treatment that patients should be encouraged to use.” (p113).

Probably the most basic problem with the ISMP report is its failure to consider the frequency of use of the medicines as a factor influencing the interpretation of the frequency of adverse events reported. It therefore remains unclear whether any of these serious adverse events were caused by varenicline. When added to the other problems of interpretation mentioned above, I prefer to rely on the recommendation of the US Clinical Practice Guideline, which resulted from a very thorough review of the available scientific evidence.

So what does this mean for patients considering quitting smoking? As always, rely on the advice of your own doctor rather than on reports in the media or the internet (including this one!).

The complete ISMP report can be found at:
Strong Safety Signal Seen for New Varenicline Risks
http://www.ismp.org/docs/vareniclineStudy.asp

Previous posts on this blog that are relevant to this issue are:
What is nicotine withdrawal syndrome? 3/6/07http://www.healthline.com/blogs/smoking_cessation/2007/03/what-is-nicotine-withdrawal-syndrome.html
Ten tips for coping with nicotine withdrawal. 3/7/07http://www.healthline.com/blogs/smoking_cessation/2007/03/ten-tips-on-coping-with-tobacco.html
Chantix: how does this new stop smoking medicine work? 4/15/07http://www.healthline.com/blogs/smoking_cessation/2007/04/chantix-how-does-this-new-quit-smoking.html
Can quitting smoking trigger depression? 6/16/07http://www.healthline.com/blogs/smoking_cessation/2007/06/can-quitting-smoking-trigger-depression.html
Chantix and mental illness. 08/12/07http://www.healthline.com/blogs/smoking_cessation/2007/08/chantix-and-mental-illness.html
Two new studies of Chantix (varenicline). 08/19/07http://www.healthline.com/blogs/smoking_cessation/2007/08/two-new-studies-of-chantix-varenicline.html
Does Chantix cause mental health problems? 9/20/07http://www.healthline.com/blogs/smoking_cessation/2007/09/does-chantix-cause-mental-health.html
Chantix (varenicline) safety being reviewed by FDA. 11/21/07http://www.healthline.com/blogs/smoking_cessation/2007/11/chantix-varenicline-safety-being.html
New study of Chantix in comparison with NRT. 11/28/07http://www.healthline.com/blogs/smoking_cessation/2007/11/new-study-of-chantix-in-comparison-with.html
Smoking and suicide. 4/22/08 http://www.healthline.com/blogs/smoking_cessation/2008/04/smoking-and-suicide.html

Full reports on the largest placebo-controlled trials of varenicline can be found via:
http://jama.ama-assn.org/cgi/content/full/296/1/47

Labels: cessation, champix, Chantix, cigarette smoking, jonathan foulds, Nicotine Replacement, safety, varenicline

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Become an Ex

Wednesday, April 30, 2008

Jonathan Foulds, MA, MAppSci, PhD

On previous posts I’ve talked about good websites for helping smokers quit:

Can smoking cessation internet sites help you to quit? 4/21/07
http://www.healthline.com/blogs/smoking_cessation/2007/04/can-smoking-cessation-internet-sites.html

There are quite a few good ones, and so far my favorite is at www.quitnet.com .

But I recently checked out a fairly new one and was very impressed. Its at www.becomeanex.org . It has been funded by a coalition on public health agencies, and appears to have been really well put together and is really easy to use. One of its main selling points is its emphasis on quitting smoking as a process, and its recognition that it is not all over in a month. So this site presents quitting as a process, provides loads of useful tips and advice, and is particularly good at helping you link with networks of other smokers for added support. The site makes good use of new technologies to make it easy to register, easy to communicate with other smokers trying to quit, and fairly easy to ask a question not just of others trying to quit, but also of recognized experts, like Dr Richard Hurt of the Mayo Clinic.

I found it very simple to register. You can set up your own profile, add your photo and details if you want (or not if you don’t), and there are plenty of subgroups you can join, made up of people with a particular thing in common (e.g. living in Texas, or using Chantix). The only slight problem I had was that when I clicked on some of the video components they didn’t all run smoothly. That may have just been a problem with my PC as I’m a bit technologically challenged. I believe this site is fairly new, (launched March, 2008) but I think it looks like it could be very helpful to tobacco users thinking about quitting.

Check it out and let me know what you think.
www.becomeanex.org

Labels: becomeanex, cessation, cigarette smoking, jonathan foulds, website

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New study compares Chantix to the nicotine patch

Monday, February 11, 2008

Jonathan Foulds, MA, MAppSci, PhD

We have already talked about the studies showing that Chantix (varenicline or Champix outside the US) is more effective than both placebo pills and Zyban (bupropion) for smoking cessation. There has also been one study comparing smoking cessation outcomes before and after Chantix was available (by John Stapleton and colleagues in the UK).

Today a new study has been published comparing the effects of a standard course of Chantix (12 weeks) with a normal course of the nicotine patch (10 weeks) for stopping smoking. This was a randomized “open-label” study, meaning that neither the participants nor the researchers were able to choose which participants got which treatment, (they were allocated to treatment on the basis of random numbers), but that everyone new which treatment they got (i.e. there were no placebo or dummy patches or pills).

The study by Aubin and colleagues was carried out across 5 countries (Europe and USA), with 376 smokers being assigned to Chantix and 370 to the patch. All the participants smoked at least 15 cigarettes per day (average = 23 per day). The participants were required to be relatively healthy with no unstable illnesses within the previous 6 months (including psychological problems or substance dependence). None had used nicotine replacement therapy in the previous 6 months. About half (48%) had previously tried the nicotine patch, and almost 90% had previously tried to quit. The average age of participants was 43, and they had smoked for around 26 years. 93% of the participants were white.

Participants attended weekly appointments for the first 12 weeks, then had 7 further appointments up to the one year follow-up, as well as 5 telephone contacts.

3 months after the target quit date, 56% of those treated with Chantix had not used any tobacco during the prior month, as had 42% of those treated with the nicotine patch. This advantage for Chantix treatment was statistically significant. At the one year follow-up (i.e. after about 9 months without treatment medications) 26% of those allocated Chantix treatment remained remained quit, as did 20% of those treated with the patch (also a statistically significant difference). During the first 7 weeks of treatment, those treated with Chantix reported significantly lower craving, negative affect (bad mood) and restlessness.

About twice as many patients treated with Chantix (8%) as the patch (4.3%) had to discontinue the medicine due to an adverse event. The most frequent adverse events were nausea (37% on Chantix versus 10% on the patch), insomnia (around 20% in both groups) and headache (19% Chantix, 10% patch).

There has been some recent concern (discussed on this forum) about Chantix potentially causing depression and suicidal thoughts. In this trial, one person became depressed and it was believed to be caused by Chantix, and another person had suicidal thoughts (causing hospitalization) 11 days after completing Chantix treatment. These low rates of serious depression (<1%) in association with Chantix treatment are consistent with prior reports. It is interesting that ratings of “negative affect” were significantly lower among those taking Chantix than the patch during the first 7 weeks (meaning that Chantix users experienced, on average less bad moods/depressive thoughts than those wearing the patch). So the etiology of depression while taking Chantix remains a mystery. One possibility is that Chantix, because it is slightly more effective than prior medications, enables some people to successfully quit who would not otherwise have succeeded, and some of those people may be more prone to depression in association with quitting smoking.

Overall, the results from this study are consistent with previous studies in showing that Chantix is probably the most effective single medicine for smoking cessation, that it frequently causes mild side effects (e.g. transient nausea) and that serious adverse events are uncommon.

Ref:
Aubin HJ et al. Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomized, open-label trial. Thorax published online Feb 8, 2008.

Labels: cessation, Chantix, cigarette smoking, jonathan foulds, Nicotine Replacement, patch, varenicline

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Planning to quit smoking with Chantix

Wednesday, December 19, 2007

Jonathan Foulds, MA, MAppSci, PhD

We are currently approaching the peak “New Year” season for quitting smoking – also a time when people are very busy finishing off their year-end work and participating in the holiday season. As Chantix is the newest medication designed to help people quit, and will likely be heavily advertised by Pfizer – its manufacturer, I expect hundreds of thousand of people will use it for the first time over the coming months.

However, as we have discussed at length on this forum, some concerns have emerged regarding potential adverse events relating to use of this medicine: depressive or suicidal thoughts, aggressive or erratic behavior and drowsiness.
See link for prior discussions: http://www.healthline.com/blogs/smoking_cessation/2007/11/chantix-varenicline-safety-being.html

So is this a good drug that may help save your life or a dangerous drug that may harm you? As we’ve discussed before, the evidence is clear that Chantix is effective at helping smokers quit and is typically accompanied by fairly mild side-effects (e.g. mild nausea). The concerns are over the possibility that a very small minority of Chantix users (perhaps between 0.1 and 1%) may experience the more serious side-effects mentioned above. At the moment the FDA is investigating this, but so far there is no conclusive evidence that these side effects are caused by Chantix (rather than being rarely occurring effects of stopping smoking). I therefore recommend that smokers interested in quitting should not be scared to try Chantix as the drug really does help smokers quit. But I strongly recommend that smokers planning to use Chantix should ensure that they have organized a proper quit plan, utilizing a number of support networks (e.g. telephone quitline, family etc) but very much involving the family doctor also. By this I mean that rather than simply calling in to the doctor for a prescription (or ordering it on a website), you arrange an appointment with your doctor to discuss the use of the medicine, and its potential side-effects, and that you also arrange at least one follow-up appointment with him/her within the first two weeks of starting on the medicine. If a doctor who knows you and your medical history is supporting your quit attempt and monitoring your progress it is far less likely you will be seriously affected by these potential side effects, and more likely you will succeed in quitting.

This model of quitting smoking is also precisely what is recommended by the Clinical Pratice Guideline your doctor should be following (advising doctors on the “5 As”: Ask, Advise, Assess, Assist, Arrange)
http://www.tobaccoteacher.com/5As.html

So my recommendation for people thinking of trying Chantix in the near future is that you should start planning now. This would involve making an initial appointment to see your doctor, planning a target quit date (just over a week after your doctors appointment) AND arranging an additional follow-up appointment shortly after your quit date, so your doctor can monitor progress and give advice. These steps should be taken in addition to using other assistance such as telephone quitlines and internet sites for smoking cessation, enlisting the support of family and friends, and taking other sensible behavioral steps (e.g. throwing out all your remaining tobacco the night before your quit date).

Best of luck, and have a great holiday season.

Labels: cessation, Chantix, cigarette smoking, holidays, jonathan foulds, new year

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Helping Latino Smokers To Quit

Friday, November 16, 2007

Jonathan Foulds, MA, MAppSci, PhD

Spanish speakers, primarily originating in Central and South America, are the fastest growing segment of the U.S. population. In the city where I work, (New Brunswick, New Jersey, USA) approximately 50% of the population is Latino – from a number of countries with Mexico being the largest subgroup. For various reasons, Latino smokers have been less inclined to make use of treatment services to help them quit. Here in New Brunswick we have worked at making our service more culturally competent, with the help of funding from the Robert Wood Johnson Foundation. This has included adding basic features (e.g. Spanish speaking staff), and doing more systematic outreach into the Latino community. In so doing the proportion of our patients who are Latino has increased from 3% in 2001 to over 15% in 2006. The website for this project includes resources for both smokers and clinicians at: http://proyectovidanofume.org/

Latino smokers are also even less inclined to use medication (like nicotine patches or Zyban) than the rest of the population, even when factors like health insurance coverage are the same. It seems that this is because some of the common misconceptions are even more prevalent in Latino smokers (e.g. “I should be able to quit on my own” or “These medicines may be as harmful as smoking”). In order to try to help remedy this situation we have translated guidance for consumers on the use of nicotine replacement therapy to Spanish. This and other documents are available at:
http://proyectovidanofume.org/espanol/publication-span.htm

Whether you live in Mexico, Manchester or Minneapolis, the message for smokers is the same: “The single best thing you can do for your health is to quit smoking. Help is available from your doctor, your pharmacist, and online and you should do whatever it takes to succeed in becoming tobacco free.”

Labels: cessation, cigarette smoking, latino, proyectovida

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Its Great American Smokeout

Wednesday, November 14, 2007

Jonathan Foulds, MA, MAppSci, PhD

Tomorrow (November 15th, 2007) is the Great American Smokeout 2007 – a day on which smokers across the country are encouraged to try to go the whole day without using any tobacco - and then to consider staying that way.

There is usually a reasonable amount of media activity encouraging people to quit smoking and there is a national peak in quit attempts on this day. It is therefore an excellent day for smokers who have been contemplating quitting to have a go. If you are a regular reader of this blog, you’ll know that we’ve previously given a lot of advice on methods for stopping smoking. Some of the links are provided here to help you recap:

How bad is smoking for your health? 2/18/07
http://www.healthline.com/blogs/smoking_cessation/2007/02/how-bad-is-smoking-for-health.html

Ten tips for coping with nicotine withdrawal. 3/7/07
http://www.healthline.com/blogs/smoking_cessation/2007/03/ten-tips-on-coping-with-tobacco.html

Nicotine addiction: how it can trick you into “absent-minded” smoking. 4/13/07
http://www.healthline.com/blogs/smoking_cessation/2007/04/nicotine-addiction-how-it-can-trick.html

How to tell if a smoking cessation aid works. 4/29/07
http://www.healthline.com/blogs/smoking_cessation/2007_04_01_smoking_cessation_archive.html

Get rid of all your tobacco. 6/16/07
http://www.healthline.com/blogs/smoking_cessation/2007/06/get-rid-of-all-your-tobacco.html

Is nicotine replacement therapy effective in the “real world”? 6/21/07
http://www.healthline.com/blogs/smoking_cessation/2007/06/is-nicotine-replacement-therapy.html

When is the best time to quit smoking? 6/29/07
http://www.healthline.com/blogs/smoking_cessation/2007/06/when-is-best-time-to-quit-smoking.html

A year of smoking takes 3 months off your life. 7/9/07
http://www.healthline.com/blogs/smoking_cessation/2007/07/last-friday-july-6th-new-paper-was.html

The American cancer Society Website for Great American Smokeout is also worth a visit at: http://acsf2f.com/gaso/

I’d like to encourage all smokers out there to really have a go at lasting the whole of tomorrow without a smoke, whether you use a smoking cessation aid or not. Then if you can do it for one day, why not another?
I’d also love to hear from those who are going to try, what method you used, and how it went. Feel free to post your stories on this site for others to learn from. Best of luck.

Labels: cessation, cigarette smoking, great american smokeout

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Finding out about smoking and health

Monday, October 01, 2007

Jonathan Foulds, MA, MAppSci, PhD

Labels: cessation, cigarette smoking, health

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Effects of smoking during pregnancy

Friday, September 28, 2007

Jonathan Foulds, MA, MAppSci, PhD

The harmful effects of smoking during pregnancy have been known for many years and in 2001 the US Surgeon General summarized the effects as follows:

-Smoking during pregnancy is associated with increased risk for premature rupture of membranes, abruptio placentae (placenta separation from the uterus), and placenta previal (abnormal location of the placenta, which can cause massive hemorrhaging during delivery). Smoking is also associated with a modest increase in risk for preterm delivery.

-Women who smoke may have a modest increase in risks for ectopic pregnancy and spontaneous abortion.

-Infants born to women who smoke during pregnancy have a lower average birth weight and are more likely to be small for gestational age than infants born to women who do not smoke. Low birth weight is associated with increased risk for neonatal, perinatal, and infant morbidity and mortality. The longer the mother smokes during pregnancy, the greater the effect on the infant’s birth weight.

-The risk for perinatal mortality, both stillbirths and neonatal deaths, and the risk for sudden infant death syndrome (SIDS) are higher for the offspring of women who smoke during pregnancy.

Most relevant studies suggest that infants of women who stop smoking by the first trimester have weight and body measurements comparable with those of nonsmokers’ infants. Studies also suggest that smoking in the third trimester is particularly detrimental.

Although less well known, there is also fairly good evidence of harmful effects on the child’s psychological development of smoking in pregnancy. A study published by Button and colleagues in the journal, “Early Human Development” this past week concluded that, “There is strong evidence for an association between maternal smoking in pregnancy and psychological problems in offspring. The problems most frequently associated are attention problems, hyperactivity, and conduct problems.” Although there are a number of explanations for this association, animal studies confirm a direct causal effect of toxin exposure on brain development during pregnancy.

The implications are very clear: there are massive benefits to the health of the mother and the baby of quitting smoking before or during pregnancy. The following link provides some good structured advice on quitting smoking in pregnancy:

http://www.surgeongeneral.gov/tobacco/prenatal.htm

Labels: cessation, cigarette smoking, pregnancy

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Does Chantix Cause Mental Health Problems?

Thursday, September 20, 2007

Jonathan Foulds, MA, MAppSci, PhD

The issue of Chantix effects on mental health gained national attention yesterday when the ABC News program “Good Morning America” covered the story of the bizarre and tragic death of the Texas musician, Carter Albrecht. http://www.abcnews.go.com/GMA/OnCall/Story?id=3623085&page=2

Some of the details of this tragedy can be found online via the ABC news story but the key points were that Mr Albrecht was actually killed by being shot in the head by a neighbor as he banged on the neighbor’s door, but that his girlfriend felt that his bizarre behavior may have been caused by the Chantix he was taking at the time.

Regular readers of this blog will know that this issue has come up before – see:
“Chantix: how does this new stop smoking medicine work?” 4/15/07
http://www.healthline.com/blogs/smoking_cessation/2007/04/chantix-how-does-this-new-quit-smoking.html

“Chantix and mental illness: what are the facts?” 08/12/07
http://www.healthline.com/blogs/smoking_cessation/2007/08/chantix-and-mental-illness.html

“Two new studies of Chantix (varenicline)”. 08/19/07
http://www.healthline.com/blogs/smoking_cessation/2007/08/two-new-studies-of-chantix-varenicline.html

There have been a number of comments from people who experienced frightening dreams, anxiety attacks, depression and suicidal thoughts while on the medicine, as well as the suicide of a family member. The number and pattern of these comments were sufficient to cause me some concern and so I decided to take another look at the published reports of the clinical trials of Chantix and also speak to a number of colleagues who treat many patients with Chantix, in order to try to get a sense of whether these experiences may be caused by Chantix, rather than other potential causes (including nicotine withdrawal effects).

On looking at the evidence from the clinical trials, it is more consistent with the idea that Chantix reduces depressive thoughts, rather than increases them. For example, one large study was published in JAMA on July 2006 comparing the outcomes of 352 smokers treated with Chantix (varenicline), 329 people treated with Zyban (bupropion) and 344 people treated with identical placebo pills. This was a randomized double-blind trial meaning that no-one knew which type of pills they received until the end. 22% quit completely for a year on Chantix, as did 16% on Zyban and 8% on placebo. The paper reported on changes in “negative affect” (a combination of unpleasant mood symptoms including depression and irritability). Patients on Chantix reported a significantly SMALLER increase in these symptoms than patients taking placebo. Zyban had a similar effect of reducing negative affect compared with placebo pills. The paper also listed adverse events reported by participants. The main symptom that was clearly reported more frequently by Chantix users was nausea, reported by 28% of Chantix users, compared with 13% on Zyban and 8% on placebo. Of the psychiatric disorders mentioned, only “abnormal dreams” appeared to be more common on Chantix (10%), compared with 6% on Zyban and 6% on placebo. There was no clear difference in reports of serious irritability (6%, 5%, 6%) and fewer patients on Chantix reported insomnia (14%) than did patients on Zyban (22%). In terms of “serious” adverse events, these were no more common for Chantix than placebo and the single case of a serious psychiatric event (acute exacerbation of schizophrenia) occurred in a patient taking placebo pills.

Another almost identical trial was reported by Jorenby and colleagues in the same issue of JAMA, with very similar results (i.e. higher quit rates with Chantix, along with lower reported negative affect [mood] than placebo, but higher rates of nausea.). Serious adverse events again were rare and scattered evenly across the different types of pills with little clear pattern, but there was one report of “acute psychosis, emotional lability” in the Chantix group (out of 344 taking Chantix). This study did, however, find a higher rate of “abnormal dreams” on Chantix (13%) than Zyban (6%) or placebo (4%). The earlier studies designed to identify the best dose of Chantix also had similar findings (dose-dependent increase in nausea and abnormal dreams) but no real evidence of other mental health symptoms. For example, Nides and colleagues found 10% on placebo and 12% on the high dose of Chantix reported serious “irritability’, and that “depression was not observed as an adverse event with varenicline (Chantix) treatment.”

The data sheet for prescribers of Chantix notes that 4500 people were exposed to Chantix during its premarketing development and that discontinuation of treatment due to adverse events was rare. The most frequent reason was nausea (3% for Chantix versus 0.5% for placebo). 0.3% reported discontinuing Chantix because of abnormal dreams as did 0.2% on placebo pills. As with all medications, the data sheet has a long list of symptoms experienced by participants in the trials, including “Psychotic disorder, suicidal ideation” as “rare”. Note – this does not imply that the drug caused these events – just that they occurred rarely in people taking the drug. Overall, the pattern of results from trials of Chantix suggest that with the exception of abnormal or vivid dreams, psychiatric symptoms such as depression or negative affect are LESS likely to occur in people taking Chantix to quit smoking, than in people taking placebo pills while quitting smoking.

However, one has to bear in mind that early clinical trials typically exclude patients currently being treated for mental health and other serious health problems. So the possibility remains that the drug may cause problems in types of patients that were not included in the initial trials. That’s where post-marketing surveillance is important. This is something that the pharmaceutical companies and doctors routinely carry out. For my part, I simply asked a large group of colleagues who are experienced in treating “real patients” with Chantix and other treatments, whether they had noticed any signs of worsening mental health associated with Chantix use. The clinicians I spoke to estimated that they had been involved in the treatment of over 2000 patients with Chantix, including patients with co-occurring serious mental health and other medical problems. There was a pretty clear consensus that while there were a few isolated cases (a couple) of patients reporting mental health problems, these were not noticeably more frequent than one normally encounters with other treatments (e.g. nicotine replacement or Zyban, or counseling with no medication).

So overall I am somewhat reassured that Chantix is a safe medicine that is effective at helping smokers to quit. But why the rash of reports on the internet of depression and bizarre behavior? Firstly, I don’t doubt that these people’s experiences are real and in some cases, very serious. I also think it is plausible that some (probably a minority) could be directly linked to Chantix. In some cases it could be an unusual interaction between the individual, the medicine and maybe another drug (including alcohol) they are taking. But for most, I suspect the serious behavioral/psychiatric problems experienced are unlikely to be caused by Chantix. Here are my reasons:
1. For highly addicted smokers, mood disturbance and altered thinking is common when quitting smoking, even without taking any medication.
2. The evidence described above, indicates that with the exception of abnormal dreams, Chantix reduces the severity of mood/psychological disturbance experienced while trying to quit smoking.
3. Around 3 million Americans have taken Chantix to try to quit smoking. Among that many smokers trying to quit for a month or two, one would expect a few thousand or more to have serious symptoms of depression etc even if they were not taking a medicine to help them. But when someone has these symptoms while taking a new drug, it is perfectly natural to conclude that the drug may have caused the symptom. In these days of widespread internet access, chat-rooms etc, that easily turns into a few hundred patients reporting similar symptoms on the internet while taking the same drug.

It therefore appears that if Chantix causes any serious mental health problems at all (which remains unproven), it is extremely rare (perhaps in the order of one per thousand). So my advice is that if you are considering quitting smoking and are interested in taking an FDA-approved medicine, whether it be nicotine replacement therapy, bupropion or Chantix, then you should not be put off by relatively isolated reports of side effects. The highest quality of evidence (from randomized placebo-controlled trials) demonstrates that these medicines are safe and will roughly double your chances of successfully quitting smoking. However, everyone reacts to medicines differently, and if you start to experience a worrying symptom that you believe may be caused by the medicine you should consult your doctor immediately. Even better, when you see your doctor to obtain a prescription, you should arrange a follow-up visit within a week or so of starting the medicine in order to discuss your progress, side-effects etc. If you have any concerns between appointments, call your doctor. It is also wise to get as much additional support from friends, family, telephone quitlines etc as possible. There is a national (US) toll-free number for telephone counseling (1-877-448-7848) and in the case of Chantix users in the US, there is additional support available via http://www.chantix.com/ .

Finally, anyone who believes there to be a causal link between use of a medication and a severe adverse event (e.g. depression, suicidal ideation, suicide, or any other serious adverse event), whether it be in yourself, your patient or a family member, should report it to the MedWatch program at: http://www.fda.gov/medwatch/how.htm . This is one of the main mechanisms of post-marketing surveillance that can help identify rare or previously unknown risks from medicines.

Labels: cessation, Chantix, cigarette smoking, varenicline

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Stopping smoking effects on drug metabolism

Sunday, September 16, 2007

Jonathan Foulds, MA, MAppSci, PhD

It is widely known that smoking speeds up basal metabolic rate (by around 10%) and so stopping smoking slows down the basal metabolic rate. This is one of the reasons people tend to put on weight when they stop smoking (the other reason is increased appetite resulting from the loss of nicotine’s mild appetite suppressant effects).

However, it is less widely known that cigarette smoking increases the activity of several liver enzymes that are responsible for metabolizing a number of drugs/medicines. This means that smokers frequently require a larger dose of these medicines than non-smokers, and may require the dose to be reduced after they quit smoking. One of the drugs whose metabolism is affected by smoking is caffeine. So when someone who drinks 6 cups of caffeinated coffee per day stops smoking, those 6 cups will produce blood caffeine levels up to 50% higher and so they will therefore feel as if they had about 9 cups of coffee. In the case of caffeine this could cause the person to feel anxious, restless and jittery and may also make it harder to get to sleep.

Many of the medicines that are affected by smoking are medicines used to treat psychiatric problems. These include some members a class of antianxiety drugs known as, “benzodiazepines” (e.g. diazepam), a number of anti-psychotic medicines (including some of the newer “atypical” anti-psychotic medicines e.g. olanzapine (Zyprexa), as well as older ones like haloperidol [Haldol]). Metabolism of some antidepressants is also affected in a similar way as are some other (non psychiatric) medicines. So, as with caffeine, when people who are already taking these medicines on a regular basis then quit smoking, the blood levels of these medicines may well increase by 10-40%. So depending on the medicine, this may also cause an increase in some of the side-effects caused by the medicine.

All of this serves to underline that it is a good idea to speak to your family doctor around the time you plan to quit. The family doctor should be able to identify the medicines whose metabolism is affected by tobacco, and also identify the likelihood that any new side effects that begin after ceasing smoking may be due to the effects on drug metabolism.

A list of drugs whose metabolism is known to be affected by smoking (and therefore smoking cessation) may be found at: http://smokingcessationleadership.ucsf.edu

Labels: cessation, cigarette smoking, drugs, metabolism

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Two new studies of Chantix (varenicline)

Sunday, August 19, 2007

Jonathan Foulds, MA, MAppSci, PhD

Two new trials of the smoking cessation medicine varenicline (Chantix) were published this past weekend. One reported the results in 515 nicotine-dependent Japanese smokers (mainly men) and the other reported the results in 250 Korean and Taiwanese smokers.

The Japanese study compared the outcomes across various doses of varenicline, with participants taking the pills for 12 weeks, and then being followed up for a further 40 weeks off drug. As in previous studies, the 1mg dose (twice daily) achieved slightly higher quit rates than lower doses, albeit with higher reported side-effects. The 1mg dose achieved abstinence rates of 65% at 12 weeks, as compared with 40% among those using placebo pills. At one year follow up, 35% of those who were given 1mg pills for the first 12 weeks remained abstinent, compared with 23% of those who had taken placebo pills. So this study in Japan confirmed the safety and efficacy of Chantix, but the “effect size” – the degree to which the drug performed better than placebo, was not quite as impressive as previous studies. This was partly because a relatively large proportion of Japanese smokers in this study succeeded in quitting while using placebo pills.

Another study based in Korea and Taiwan directly compared 12 weeks of 1mg varenicline with 12 weeks of placebo in 250 smokers (mainly men). After 12 weeks, 60% of those using varenicline were not smoking, compared with 32% of those using placebo pills. After 24 weeks (i.e. another 12 weeks “off drug”) the quit rate was 47% among those who had used varenicline, versus 22% among those who had used placebo. As in previous studies, those taking varenicline were more likely to report some nausea, constipation and abnormal dreams, but these were generally mild in nature. Also like prior studies, those on Chantix were not less likely to report an increased appetite. This is noteworthy as most previous smoking cessation medicines (such as nicotine replacement therapy or bupropion) tend to reduce appetite compared with placebo, and suggests that Chantix works via a slightly different mechanism.

So far, the placebo-controlled trials of varenicline have been remarkably consistent in finding that it approximately doubles quit rates compared with placebo, and that this increased quit rate is maintained even after up to 40 weeks off drug. The early studies suggested that Chantix may result in higher quit rates than other pharmacological treatments for smoking. Whether this ultimately turns out to be the case will require additional studies directly comparing different treatments.

The take-home message for smokers interested in trying to quit is that this new medicine continues to demonstrate that it is safe and effective in increasing smokers’ chances of successfully quitting, with the most frequent side-effect being mild nausea (16-42% of users). The nausea is less marked at lower doses, and also appears less when taking the pill along with food and water. Most people using Chantix are able to continue using it and the initial nausea subsides. Those continuing to take Chantix for the full course (up to 24 weeks) tend to have higher quit rates than those discontinuing early.

Labels: addiction, cessation, Chantix, cigarette smoking, nicotine, tobacco, varenicline

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Health insurance coverage for nicotine dependence treatment

Sunday, July 22, 2007

Jonathan Foulds, MA, MAppSci, PhD

Last night I went to see the Michael Moore movie “SiCKO” which is an expose of the problems with the U.S. healthcare system, focusing particularly on the problems with health insurance and so-called “Health Maintenance Organizations (HMOs)”. No matter what you think of Michael Moore, if you have any interest at all in your health or that of your family, and particularly if you have any interest in this nation’s health, then you should definitely see this movie.

The movie points out some of the worst aspects of the health insurance system and then compares it to the situation in countries like Canada, the UK, Cuba and France. As someone who has been both a patient and a provider in the UK and US healthcare systems I have to say I found the portrayal in the movie to be very accurate. The United States is a great country with tremendous wealth both financially and in terms of the resilience and hard work of its people. But to my mind its healthcare s

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New study compares Chantix to the nicotine patch

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Effects of smoking during pregnancy

Does Chantix Cause Mental Health Problems?

Stopping smoking effects on drug metabolism

Two new studies of Chantix (varenicline)

Health insurance coverage for nicotine dependence treatment