Download
Upcoming SlideShare
Loading in...5
×
 

Download

on

  • 2,213 views

 

Statistics

Views

Total Views
2,213
Views on SlideShare
2,213
Embed Views
0

Actions

Likes
0
Downloads
27
Comments
0

0 Embeds 0

No embeds

Accessibility

Categories

Upload Details

Uploaded via as Microsoft PowerPoint

Usage Rights

© All Rights Reserved

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Processing…
Post Comment
Edit your comment
  • It has been well documented in the literature that secondhand smoke (environmental tobacco smoke exposure) is associated with increased number of deaths from lung cancer; cardiac-related illnesses; sudden infant death syndrome, low birth-weight newborns and pre-term deliveries (maternal exposure); childhood asthma (both new cases and exacerbations), lower respiratory infections and middle ear infections in children. Second hand smoke increases the relative risk of chronic obstructive pulmonary disease by 55%. Passive cigarette smoke confers a doubling of risk for stroke approaching that of active smoking, and an "exposure threshold" rather than a dose-response relationship is observed. There is a synergistic effect of smoking on stroke risk in women using oral contraceptives. It is clear that even nonsmokers face significant health risks from exposure to secondhand smoke. References CDC. Surgeon General’s Report. The Health Consequences of Involuntary Exposure to Tobacco Smoke; Executive Summary . 2006. Eisner MD, Balmes J, Katz PP, et al. Lifetime environmental tobacco smoke exposure and the risk of chronic obstructive pulmonary disease. Environ Health . 2005 May 12;4(1):1-8. Goldstein LB, Adams R, Alberts MJ, et al. Primary Prevention of Ischemic Stroke. A Guideline from the American Heart Association/American Stroke Association Stroke Council. Cosponsored by the Outcomes Research Interdisciplinary Working Group Physical Activity, and Metabolism Council; and the Quality of Care and Cardiovascular Nursing Council; Clinical Cardiology Council; Nutrition, Atherosclerotic Peripheral Vascular Disease Interdisciplinary Working Group. Stroke . 2006;37;1583-1633.
  • Striving for total abstinence is essential. Not even a single puff after the quit date. Identify what helped and what hurt in previous quit attempts. Build on past success. Discuss challenges/triggers and how the patient will successfully overcome them. Because alcohol is associated with relapse, the patient should consider limiting/abstaining from alcohol while quitting. Quitting is more difficult when there is another smoker in the household. Patients should encourage housemates to quit with them, or to not smoke in their presence.
  • Analyses of smoking cessation rates for the All Subjects population showed that varenicline was significantly more efficacious than placebo in all measures of abstinence, both at the end of the 12-week treatment period and during the non-pharmacologic treatment follow-up through Week 24 and Week 52. The 9-12 week Continuous Abstinence Rate is defined as the percentage of randomized subjects who abstained from smoking (not even a puff) from Week 9 through 12 of the study as confirmed by both subject self-report and by end-expiratory CO measurement of ≤10 parts per million at each clinic visit. The primary endpoint, which was abstinence from even a single puff of a cigarette (patient reported and CO-confirmed at study visits) during weeks 9, 10, 11, and 12, was nearly identical in the two studies. This Continuous Abstinence Rate was 44% in the varenicline groups. Each of the comparisons were statistically significant. Varenicline also showed significantly greater response rates vs.bupropion SR in these analyses. The studies above correspond to Study 4 and Study 5 in the Chantix full prescribing information. The most frequently reported adverse events (>10%) with Chantix were nausea, headache, insomnia, and abnormal dreams. Nausea was reported by approximately 30% of patients treated with Chantix 1 mg bid, with approximately a 3% discontinuation rate during 12 weeks of treatment. Nausea was generally described as mild or moderate and often transient. For some subjects, it was persistent over several months. References Gonzalez D, Rennard SI, Billing CB, et al. Varenicline, an  4  2 Nicotinic Acetylcholine Receptor Partial Agonist, vs Sustained-Release Bupropion and Placebo for Smoking Cessation. JAMA. 2006;296:47-55. Jorenby DE, Hays JT, Rigotti MD, et al. Efficacy of Varenicline, an  4  2 Nicotinic Acetylcholine Receptor Partial Agonist, vs Placebo or Sustained-Release Bupropion for Smoking Cessation. JAMA . 2006;296:56-63. Chantix  Prescribing Information. Pfizer Inc, New York, NY. (May 2006)
  • The results of the double blind randomized phase of the study showed that 70.5% of subjects (Chantix quitters in the open-label run-in) who received varenicline for an additional 12 weeks were continuously abstinent during weeks 13 to 24 versus 49.6% of patients treated with 12 weeks of varenicline followed by placebo. At week 52, 43.6% of subjects that had received varenicline versus 36.9% of subjects that had received placebo were continuously abstinent. At both weeks 24 and 52, the results were statistically significant 1 . Continuous abstinence was defined as no smoking (not even a puff) recorded on multiple occasions throughout that defined period. Continuous abstinence is based upon subject self-report and confirmed by end-expiratory CO measurement of ≤10 parts per million at each clinic visit. The study above corresponds to Study 6 in the Chantix full prescribing information. The most frequently reported adverse events (>10%) with Chantix were nausea, headache, insomnia, and abnormal dreams. Nausea was reported by approximately 30% of patients treated with Chantix 1 mg bid, with approximately a 3% discontinuation rate during 12 weeks of treatment. Nausea was generally described as mild or moderate and often transient. For some subjects, it was persistent over several months. References Tonstad S, Tonnesen P, Hajek P, et al. Effect of Maintenance Therapy With Varenicline on Smoking Cessation. JAMA. 2006;296:64-71. Chantix  Prescribing Information. Pfizer Inc, New York, NY. (May 2006)
  • Striving for total abstinence is essential. Not even a single puff after the quit date. Identify what helped and what hurt in previous quit attempts. Build on past success. Discuss challenges/triggers and how the patient will successfully overcome them. Because alcohol is associated with relapse, the patient should consider limiting/abstaining from alcohol while quitting. Quitting is more difficult when there is another smoker in the household. Patients should encourage housemates to quit with them, or to not smoke in their presence.
  • Striving for total abstinence is essential. Not even a single puff after the quit date. Identify what helped and what hurt in previous quit attempts. Build on past success. Discuss challenges/triggers and how the patient will successfully overcome them. Because alcohol is associated with relapse, the patient should consider limiting/abstaining from alcohol while quitting. Quitting is more difficult when there is another smoker in the household. Patients should encourage housemates to quit with them, or to not smoke in their presence.
  • Striving for total abstinence is essential. Not even a single puff after the quit date. Identify what helped and what hurt in previous quit attempts. Build on past success. Discuss challenges/triggers and how the patient will successfully overcome them. Because alcohol is associated with relapse, the patient should consider limiting/abstaining from alcohol while quitting. Quitting is more difficult when there is another smoker in the household. Patients should encourage housemates to quit with them, or to not smoke in their presence.
  • Figure 1. The Actions of Nicotine and Varenicline in the Brain. The principal site of nicotine action in the brain is the mesolimbic system (Panel A). Nicotine stimulates dopaminergic neurons located in the ventral tegmental area, increasing dopamine release in the nucleus accumbens. Nicotine interacts with nicotinic acetylcholine receptors, which are pentameric ion channels located in the mesolimbic system and elsewhere (Panel B). The highest-affinity nicotinic acetylcholine receptors consist of two{alpha} 4 subunits and three {beta}2 subunits. Nicotine binds to and causes a conformational change in the{alpha} 4{beta}2 nicotinic acetylcholine receptor, increasing sodium (Na+) influx. Varenicline is a partial agonist of the{alpha} 4{beta}2 nicotinic acetylcholine receptor that causes partial stimulation while it competitively inhibits nicotine binding.
  • Double the quit rate if look at 20mg dose
  • Camel, late 1940s. As new evidence of the serious harms of smoking accrued, this prominent advertising campaign claimed that Camels were the preferred cigarette of American physicians. From the Collection of Stanford University (tobacco.stanford.edu)
  • The most common adverse events from 12-week fixed-dose studies are listed in this chart. These figures represent adverse events reported as both >5% and twice the rate seen in placebo-treated patients Reference Chantix  Prescribing Information. Pfizer Inc, New York, NY. (May 2006)
  • Instructions for presribing Chantix: Patients should be started on Chantix for 12 weeks. For those who have quit smoking at 12 weeks on Chantix, an additional 12 weeks of Chantix is recommended to further increase the likelihood of long-term abstinence. Patients should first set a target quit date. Dosing should begin 1 week before this date. This provides the patient time to titrate up to the recommended dose prior to his quit date. Chantix should be taken after eating and with a full glass of water. Encourage adjunctive behavior modification therapy and enrollment in the GETQUIT  Support Plan. Some patients will not succeed at quitting on their first attempt or will relapse after treatment. They should be encouraged to make another attempt once factors contributing to the failed attempt have been identified and addressed. The most frequently reported adverse events (>10%) with Chantix were nausea, headache, insomnia, and abnormal dreams. Nausea was reported by approximately 30% of patients treated with Chantix 1 mg bid, with approximately a 3% discontinuation rate during 12 weeks of treatment. Nausea was generally described as mild or moderate and often transient. For some subjects, it was persistent over several months. Dose adjustment with Chantix is recommended in subjects with severe renal impairment. Patients who cannot tolerate the adverse effects of Chantix may have the dose lowered temporarily or permanently. Reference Chantix  Prescribing Information. Pfizer Inc, New York, NY. (May 2006)

Download Download Presentation Transcript

  • Smoking: The Talk You’ve Never Heard Michael B. Honan, MD CardioVascular Associates, PC Brookwood Medical Center December 30, 2008
  • Disclosures
    • None
  • Objectives
    • I want to convince you that smoking cessation is:
      • Far and away the most impactful thing smokers can do to help their long-term health and life expectancy.
        • “ This is much more important to how long you live and how healthy you are than whether we open your artery or not.”
    • I want you to have the information needed to give you the greatest chance of success in this endeavor . Motivation is the single biggest factor determining whether or not someone will quit smoking.
  • Approaches to the Discussion
    • Be sure they know that you understand that:
      • This is their decision,
      • that your role is only to give them the information that you have that they might benefit from, and
      • that you will do what you can for them regardless of what they choose to do.
      • Your message might not resonate until the 6 th or 7 th time you have this conversation, but it is your role to allow them the opportunity to reconsider their decision to smoke.
      • They may not succeed in quitting until their 6 th or 7 th attempt.
  • Public Health Service Guidelines – The 5A Model
    • A sk about smoking.
    • A dvise one to quit.
    • A ssess willingness to quit.
    • A ssist those willing to quit.
    • A rrange for follow-up.
    Fiore MC, et al. Treating tobacco use and dependence: clinical practice guideline. Rockville (MD): US Dept Health Human Svcs Public Health Svc; 2000. Also 2008 Update.
  • Approaches to the Discussion
    • Help them to understand that they can quit.
      • There are more former than current smokers in the US.
      • Up to 85% of smokers after MI have quit smoking.
    • It’s never “too late” to quit smoking.
    • The older the smoker and the longer the smoking duration, the greater the chances of quitting.
    • Encourage them to have this conversation with themselves.
      • “ List the reasons you want to continue to smoke, and the reasons you might not want to start back.”
  • Individualize your discussion for each patient.
  • Smoking and Mortality
    • In 1928, smoking linked to lung cancer 1 .
    • In 1938, smoking linked to mortality overall 2 .
    • The first Surgeon General’s Report labeled smoking “the single most important source of preventable morbidity and premature mortality.” in 1964.
    • Lombard HL, Doering CR. N Engl J Med 1928;198:481-7.
    • Pearl R. Science 1938;87:216-7.
  • Surgeon General’s Report May 2004
    • 438,000 deaths per year- still the #1 cause of preventable death in the US .
      • 19% of all deaths!!!
    • Reduces lifespan of the average smoker by:
      • 13.2 years for males
      • 14.5 years for females
    • 5,522,257 years of potential life lost in the US in 2001.
  •  
  • Deaths Attributed to Smoking Morbid Mortal Wkly Rep 2003;52:842-4.
  • Risk Factors
    • Unmodifiable
      • Age
      • Family history of early CAD
      • Male gender
      • Genetic factors
      • African-American
    • Modifiable
      • Cigarette smoking
      • Hypertension
      • Cholesterol-HDL, LDL,
      • Triglycerides
      • Diabetes
      • Overweight
      • Poor diet
      • Lack of regular exercise
      • Cocaine/crack use
  • Cardiovascular Risk Factors
    • Smoking > 1 ppd
    • Smoking > 1 ppd
    • Weight > 129% ideal vs < 112%
    • Cholesterol > 268 vs < 219
    • Systolic BP > 150 vs < 130
    • Diastolic BP > 94 vs < 80
    Relative Risk of Major Coronary Events 8422 Men Age 40-64 Followed for 72,011 person-years The Pooling Project Research Group. J Chron Dis 1978;31:201-306. There are also interactions between risk factors.
  • Cardiovascular Effects
    • Impairs endothelial function – vasoconstriction.
    • Pro-thrombotic
      • Increases fibrinogen, hs-CRP, and homocysteine levels.
      • Reduces anti-thrombin III.
      • Increases platelet aggregation.
    • Causes catecholamine release.
      • Increases lipolysis, fatty acid release, VLDL levels.
      • Lowers HDL cholesterol.
    • Reduces the oxygen content of blood.
      • Carbon monoxide binds irreversibly to hemoglobin.
      • Impaired pulmonary function – raises A-a gradient.
    Bazzano LA. Ann Intern Med 2003;138:891-7.
  • Cardiac Effects
    • Atherosclerosis
      • Promotes coronary plaque formation.
      • Promotes plaque rupture/ acute coronary syndromes.
      • Promotes premature coronary bypass closure and restenosis.
    • Reduces coronary blood flow and promotes coronary vasospasm – cath lab demos 1,2 .
    • Nicotine increases oxygen utilization and demand by increasing heart rate & BP – increases ischemia 3 .
    • Arrhythmias-PVCs, APCs, atrial fib, MAT, VT, V-fib.
    • Cardiomyopathy independent of atherosclerosis 4 .
    • Kaijser L, Berglund B. Clin Physiol 1985;5:541-52. 2. Maouad J, et al. Catheter
    • Cardiovasc Diagn 1986;12:366-75. 3. Wolk R. J Amer Coll Cardiol 2005;45:910-4.
    • 4. Hartz AJ, et al. N Engl J Med 1984;311:1201-6.
  • Cardiovascular Effects
    • 33.5% of smoking-related deaths 1 .
    • Coronary artery disease (X 2.5) 2 – angina, myocardial infarction, arrhythmias, sudden death, heart failure.
    • Cerebrovascular disease – stroke (X 3), 3 hemorrhagic stroke (X 3.29) 4 , and TIA.
    • Peripheral vascular disease (X 7.3 )5 – claudication, leg ulcers, impaired wound healing, gangrene, aneurysms of aorta and other vessels, venous insufficiency (X 2.4). 6
    • Interaction with other risk factors – diabetes, lipids, hypertension, estrogen, genetics.
    • Morbid Mortal Wkly Rep 2003;52:842-4. 2. The Pooling Project Research Group.
    • J Chron Dis 1978;31:201-306. 3. Hankey GJ. J Cardiovasc Risk 1999;6:207-11.
    • 4. Kurth T, et al. Stroke 2003;34;2792-5. 5. Fowler B, et al. Aust NZ J Publ Health
    • 2002;26:26:291-24. 6. Gourgo S, et al. Am J Epidemiol 2002;155:1007-15.
  • Relative Risk Cardiovascular http://apps.nccd.cdc.gov/sammec/edit_risk_data.asp
  • Smoking Cessation after MI
    • Occurred in 56.2% at 6 months and 56.8% at a year among 19 hospitals in the Premier Registry. 1
    • Results in a 36-46% reduction in mortality. 2,3
    • Reduction in recurrent nonfatal MI.
    • Better control of other cardiovascular risk factors.
    • Better functional status.
    • Thus smoking cessation counseling a CMS, JCAHO performance measure.
    1. Reeves GR, et al. Arch Intern Med 2008;168:2111-7. 2. Critchley, et al. Cochrane Database Syst Rev. 2003:CD003041.doi:10.1002/14651858CD003041. 2. Wilson K, et al. Arch Intern Med 2000;160:939-44.
  • ACC/AHA 2007 STEMI Guidelines Secondary Prevention
    • Ask, advise, assess, and assist patients to stop smoking – I (B)
    • Clopidogrel 75 mg daily:
      • PCI – I (B)
      • no PCI – IIa (C)
    • Statin goal:
      • LDL-C < 100 mg/dL – I (A)
      • consider LDL-C < 70 mg/dL – IIa (A)
    • Daily physical activity 30 min 7 d/wk, minimum 5 d/wk – I (B)
    • Annual influenza immunization – I (B)
  • Predictors of Smoking Cessation after MI
    • PREMIER Registry- 19 centers, 639 smokers
      • Discharge prescription for cardiac rehab: OR=1.80 (1.17-2.75).
      • Treated at a facility that offered an inpatient smoking cessation program with at least one month of support after discharge: OR=1.71 (1.03-2.83).
      • Depressive symptoms: OR=0.57 (0.36-0.90).
    Dawood N, et al. Arch Intern Med 2008:168:1961-7.
  • Deaths Attributed to Smoking Morbid Mortal Wkly Rep 2003;52:842-4.
  • Respiratory Tract Effects
    • Causes peribronchiolar inflammation and fibrosis, bronchospasm, increases mucosal permeability, impairs mucociliary clearance, changes pathogen adherence, disrupts respiratory epithelium, impairs immune response, carcinogenic.
    • Acute and chronic sinusitis
    • Acute and Chronic Obstructive Pulmonary Dis (X 13.1)
      • Asthma, emphysema (24%) chronic bronchitis (49%), pneumonia, interstitial lung disease, bronchiolitis, pulmonary hypertension, respiratory failure, tuberculosis (X 4.5)
    Arcavi L. Arch Intern Med 2004;164:2206-16.
  • Relative Risk - Respiratory http://apps.nccd.cdc.gov/sammec/edit_risk_data.asp
  • Lung Cancer
    • About 28% of smoking-attributable deaths.
    • In 2000
      • in US, 87% of the 184,000 new cases of lung cancer 1
      • 850,000 lung cancer deaths worldwide 2 .
    • 3000 US lung cancer deaths attributed to secondhand smoke 3 .
    • 10-year risk for a 68yo man with a 100-pack-yr history is 15%.
    • Continued smoking shortens survival time 5 .
    • Ctrs Dis Contr. Morbid Mortal Wkly Rep 2003;52;842-4. 2. Ezrati M. Lancet
    • 2003;362:847-52. 3. Amer Heart Assn 2005. 5. Bach PB, et al. J Natl Cancer Inst
    • 2003;95:470-8.
  • Lung Cancer – Dose Effect Wynder EL, Stellman SD. J Natl Cancer Inst 1979;62:471-7.
  • Cancer Effects
    • Carcinogenic – 60 chemical carcinogens
      • Responsible for a third of all cancer deaths in western countries.
      • Incidence of lung cancer deaths in the US has been steeply declining over the past ten years, first in men, and now in women as well.
    Sacco AJ, et al. Lung Cancer 2004;Suppl 2:S3-9.
  • Relative Risk - Cancer http://apps.nccd.cdc.gov/sammec/edit_risk_data.asp
  • Gastrointestinal Effects
    • Chronic destructive periodontal disease – the main risk factor. Relative risk X 5-20 vs never smoker 1 .
    • Increased risk and severity, slower healing and greater recurrence of gastritis, gastroesophageal reflux, peptic ulcer disease (X 3.4-4.1 )2.
    • Increased Crohn’s Disease (X 2.0) and ischemic bowel.
    1. Bergstrom J. Odontology 2004;92(1):1-8. 2. Mallamapalli A, et al. Med Clin N Amer 2004;1431-51.
  • Smoking and Infection
    • Cause structural changes in the respiratory tract and a decrease in immune response.
        • 30% increased WBC, increased CD8 + counts, reduced IgG, IgA, IgM.
        • reduced CD4 + counts in bronchoalveolar fluid.
        • Inhibition of PMN chemotaxis and migration, NK cell activity.
        • Decreases release of IL-1, IL-2, IL-6, TNF-α, IFN-γ.
      • 2- to 5-fold increased risk of invasive pneumococcus.
      • 1.5- to 2.2-fold risk of common cold.
      • 1.4- to 2.4- fold influenza risk and more severe.
      • Varicella, HPV, HIV prevalence and severity increased
      • Increased risk of tuberculosis, especially important in underdeveloped countries.
      • Increased risk of meningococcal disease, bronchitis, and otitis media in children exposed to secondhand smoke.
    Arcavi L. Arch Intern Med 2004;164:2206-16.
  • Women and Smoking
    • Smoking reduces the average life expectancy 1 by:
      • 14.5 years for females.
      • 13.2 years for males.
    • Facilitates the metabolism of estrogen, increasing risk of cardiovascular disease, osteoporosis (80% higher fracture risk), cervical cancer, and wrinkles.
    • Increased susceptibility of women to develop lung cancer in response to smoking which is more virulent and at an earlier age than in men 2 . In 2000, exceeded breast, uterine, and ovarian cancer death combined in women. ¼ of all cancer deaths in women.
    • Doubles the risk of DVT and PTE among OCP users 3 .
    1. US Surgeon General May 2004. 2. Reuters January 31, 2005. 3. Reichert VC, et al. Med Clin N Amer 2004;88:1467-81.
  • Women and Smoking The Nurses’ Health Study
    • 104,519 nurses age 30-55 followed 1980-2004.
    • At baseline (1980),
      • 45.7% never smoked
      • 26.0% past smokers
      • 28.3% current smokers
    • In 2002, only 8% of those alive were current smokers.
    • Among current smokers, 64% of all deaths were directly attributable to smoking . Among former smokers, 28% of deaths attributable to smoking.
    Kenfield SA, et al. JAMA 2008;299:2037-47.
  • Mortality Among Women Nurses’ Health Study Smoking Status Cigarettes per Day Kenfield SA, et al. JAMA 2008;299:2037-47.
  • Causes of Death in Women Cardiovascular & “Unrelated Cancer” Kenfield SA, et al. JAMA 2008;299:2037-47.
  • Causes of Death in Women Respiratory & “Related Cancer” Kenfield SA, et al. JAMA 2008;299:2037-47. Lung, AML, bladder, kidney, cervix, esophagus, lip, mouth, pharynx, pancreas, stomach, larynx
  • Smoking and Pregnancy
    • Increased infertility (X 1.36), spontaneous abortions, ectopic pregnancies (X 1.9).
    • Increases prematurity and fetal death.
    • Low birth weight doubles.
    • Increased risk of placenta previa, pre-eclampsia.
    • Sudden Infant Death Syndrome – 10% of all infant deaths.
    • Negative toddler behavior –cranky, restless, sick more often, learning problems.
    Morbid Mortal Wkly Rep 2002;51:i-iv,1-13.
  • Pregnancy & Long-Term Vascular Damage to Children
    • Atherosclerosis in Young Adults study-births from 1970-1973, follow-up at 28.4 years.
    • At birth offspring lighter and shorter at birth
    • Heavier (p=.001) and higher SBP (p=.02) as adolescents.
    • Heavier (p=.004), shorter (p=.02), more likely to smoke (p=.006) as adults.
    • At age 28, Carotid IMT
      • 13.4 μ m greater if mother smoked (p=0.001)
      • 12.4 μ m greater if father smoked (p=.002)
      • Greater if both smoked (p=.001)
    Geerts C, et al. Arterioscler Thromb Vasc Biol 2008: DOI: 1161/ATVBAHA.108.173229.
  • Drug Metabolism
    • Enhanced clearance of:
      • theophyllline, tacrine, propranolol, diazepam, chlordiazepoxide, estrogen
    • Reduces the metabolism of drugs by the cytochrome P450 pathway:
      • warfarin
    • Reduces levels of fluvoxine, imipramine.
    • Increases levels of clozapine.
    Metz CN, et al. Med Clin N Amer 2004;1399-1413.
  • Other Medical Problems
    • Increases the risk of:
      • Dementia & Alzheimer’s (X 2) and cognitive dysfunction (X 1.5).
      • Insulin resistance and risk (X 1.45-1.94) and severity of diabetes.
      • Grave’s Disease and ophthalmopathy.
      • Cataracts.
      • Severity of rheumatoid arthritis.
      • Impotence (X 2.5).
      • Psoriasis.
    Sundaram R, et al. Med Clin N Amer 2004;1391-7. Mallamapalli A, et al. Med Clin N Amer 2004;1431-51. Sabia S, et al. Arch Intern Med 2008:168:1165-73.
  • Smokeless Tobacco
    • Snuff, chewing, or “spit” tobacco.
    • Used by 5 million adults and more than 750,000 adolescents.
    • Increases risk of oral cancer, dental problems such as receding gums, bone loss, and bad breath.
    • Increased heart rate by 16 bpm, blood pressure by 10 mm Hg, and epinephrine by 50% among 16 healthy young men.
    Wolk R. J Amer Coll Cardiol 2005;45:910-4.
  • Secondhand Smoke
    • Secondhand smoke exposure is responsible for 38,000 deaths including 3000 lung cancer deaths annually in the US 1 .
    • Living with a smoker increases the risk of ischemic heart disease death by 30-57% 3-5.
    • www.americanheart.org . 3. Bartecchi, C, et al. Circulation 2006;114:1490-6. 4. Taylor AE, et al. Circulation 1992;86:699-702. 5. Barnoya J, et al. Circulation 2005; 111:2684-98.
  • Secondhand Smoke
    • May rapidly precipitate atherothrombotic events.
    • Increases CRP, fibrinogen, and ox-LDL similar in magnitude to smokers.
    • Increases platelet aggregation, augments MMP activity, thus plaque destabilization
    • Decreases HDL, causes mitochondrial damage, insulin resistance.
    • 30 minutes SHS impairs coronary endothelial function and increases aortic stiffness similar to smokers.
    • Reduces heart rate variability.
    Barnoya J, et al. Circulation 2005;111;2684-98
  • Clean Indoor Air & Acute Coronary Syndromes
    • In Helena, MT, there was a 40% reduction in the number of heart attacks with a clean indoor air policy, that returned to prior levels when it was overturned. 2
    • In Pueblo, CO, there was a 27% reduction in heart attacks over the 18-month period after a comprehensive public Smoke-Free Air Act = a reduction by 70/100,000/year vs. no change in Colorado Springs during the same period. 3
    • In Scotland, in the year after smoke-free legislation in March 2006 there was a 17% reduction in hospital admissions for acute coronary syndromes (95% CI 16-18%) vs a 4% reduction in England. This was a reduction of 14% among smokers, 19% among former smokers, and 21% among never smokers.
    1. Ritter J. USA Today March 9, 2005:7D. 2. Bartecchi, C, et al. Circulation 2006;114:1490-6. 3. Pell JP, et al. N Engl J Med 2008;359:482-91.
  • Secondhand Smoke
    • Pre-school age children exposed to their parents’ smoke are 20% more likely to get middle ear infections.
    • Maternal smoking ½ ppd increases COPD risk 70% in their children 2 .
    • March 8, 2005 California Air Resources Board links passive smoking to a 26-90% increased risk of breast cancer 3 .
    2. Reichert VC, et al. Med Clin N Amer 2004;88:1467-81. 3. Ritter J. USA Today March 9, 2005:7D.
  •  
  • States with Restrictions as of 12/31/07
    • Restrictions in private-sector worksites in 37 (39) states.
    • Restrictions in restaurants in 41, but not in: AL. Smoke-free in 21 states.
    • Restrictions in bars in only 20. Smoke-free in 13 states.
    • As of 2003, 77% of US workers in a smoke-free workplace.
    MMWR 2008 57(20):549-52.
  • American Cancer Society Alabama Survey
    • Of 500 registered Alabama voters who participated:
    • 78% responded in favor of a law making all Alabama workplaces smoke-free.
    • 95% viewed secondhand smoke as at least some kind of health hazard.
    • 92% agreed no one should be exposed to secondhand smoke in the workplace.
    • 79% responded that it is the government's responsibility to promote and protect public health.
    • 81% said they were likely to vote in the next election.
    Performed by Little rock-based Opinion Research Associates January 2008
  • Coalition for a Tobacco-Free Alabama
    • Alabama Academy of Family Physicians
    • Alabama Citizens Action Program (ALCAP)
    • Alabama Department of Public Health
    • Alabama Faith United Against Tobacco
    • Alabama Sports Festival
    • Alabama State Nurses Association
    • American Academy of Pediatrics - Alabama Chapter
    • American Cancer Society
    • American College of Cardiology - Alabama Chapter
    • American Heart Association
    • Alabama Lung Association
    • Blue Cross Blue Shield
    • DuBois Institute
    • Medical Association for the State of Alabama
  • Other Impacts Personal Expense
    • Cigarettes- At $3.27/pack, 1ppd X 50 years will cost $59,677 in 2005 dollars.
    • Duke economist Frank Sloan estimates at $40/pack or $220,000 for a 24YO man in The Price of Smoking .
      • Cost of cigarettes + excise taxes.
      • Life and property insurance.
      • Medical care for the smoker and his family.
      • Lost earnings due to acute illness and disability.
      • Lost receipt from private pensions, social security and Medicare due to early death.
      • Reduced quality of life due to illness and disability.
      • Lost retirement (life expectancy about 67 years).
    WalMart April 5, 2005. Duke Magazine 2005;91:17. Sloan FA, et al. The Price of Smoking 2004. The MIT Press, Cambridge, MA.
  • Other Impacts Societal Expense
      • $76 billion societal medical expense:
        • $27 billion ambulatory
        • $19 billion nursing home
        • $17 billion hospital
        • $6.4 billion prescription drugs
        • $5.4 billion other
      • $98 billion in lost productivity costs annually.
      • $204 billion total cost.
    http://apps.nccd.cdc.gov/sammec/computations.asp
  • Smoking and Health-Related Quality of Life in Old Age
    • 1658 healthy white men in Helsinki Businessman Study 40-55 YO enrolled 1974, surveyed 2000
    • Never smokers lived ten years longer, and their extra years were of better quality.
    • Health-related quality of Life (HRQoL) measured with Rand 36-Item Health Survey
    Strandberg AY, et al. Arch Intern Med 2008: 168:1968-74
  • . Strandberg, A. Y. et al. Arch Intern Med 2008;168:1968-1974. The unadjusted association of smoking status and the number of cigarettes smoked daily at baseline in 1974 and mortality during the 26-year follow-up period
  • Strandberg, A. Y. et al. Arch Intern Med 2008;168:1968-1974. The age-adjusted association of smoking status at baseline in 1974 and health-related quality of life as RAND 36-Item Health Survey (RAND-36) scores in 2000
  • Other Impacts - Social
    • Hygiene and odor distasteful to others
    • Wrinkles (X 2.3-4.7) and smokers’ nails
    • Loss of credibility with one’s children:
      • “You’re doing something you know is bad for you!”
      • Learned lack of self-control increases children’s chances of addiction to cigarettes and other substances as well as other behavior patterns.
  • Prevalence of Smoking > 18yo National Health Interview Survey 45.3 million current smokers in the US 45.7 million former smokers MMWR 2007;56(44)1157-61. 23.9% 20.8% 18.0%
  • Smoking in Alabama
    • The percentage of Alabamians who smoked has gone down from 30.6% in 1990 to 25.3% in 2002 to 23.2% in 2006.
    • We receive $100,000,000 a year from the $206 billion Master Settlement Agreement. Only a few hundred thousand dollars go to tobacco prevention and cessation programs.
    • In 2005, national tobacco-industry marketing expenditures were 13.1 billion dollars.
    Birmingham News November 23, 2004. MMWR 2007;56(44):1157-61.
  • Smoking and Children
    • 80% of adult smokers began before age 18.
    • Every day
      • Nearly 4000 children under age 18 try their first cigarette.
      • 2000 children under age 18 become regular smokers.
    American Heart Association 2005. CDC April 1, 2005. MMWR 2008;57(25):689-91.
  • Smoking Frequency Among High School Students MMWR 2008;57(25):689-91. -school-based tobacco-use prevention policies and procedures -higher price + excise tax -reduced parental and societal prevalence -restricted advertising -counter-advertising -less in movies and videos -smoke-free ordinances -reduced availability
  • Cigarette Use - Age The World Almanac 2003. MMWR 2007;56(44):1157-61.
  • Global Cigarette Consumption World Health Organization. http://www.who.int.tobacco/en/atlas8.pdf This is 50 packs of cigarettes for every man, woman, and child on the planet!!
  • Worldwide Tobacco Use
    • 1 billion male smokers and ¼ billion female smokers 1 .
    • The average Chinese man smokes 16 cigarettes/day 2 .
    • In developed countries, 35% of men and 22% of women smoke; whereas in developing countries, 58% of men and only 9% of women smoke 1 .
    • 4.83 million deaths attributed to smoking in 2000 3 .
    1. Mackay J and Eriksen MP. The Tobacco Atlas . Geneva:WHO;2002. 2. Knight E, et al. CRS Report for Congress; 1998. 3. Ezrati M and Lopez AD. Lancet 2003;362:847-52.
  • Benefits of Quitting
    • People who quit smoking before age 50 have half the risk of dying over the next 15 years of those who continue to smoke 1 .
    • Within a year of quitting the excess risk of a heart attack is reduced 80%. 2.
    • Within 2 wks of quitting platelet aggregation is reduced 3 .
    • Smoking cessation improves pulmonary function 20-30% within 2 to 3 months 4 .
    • Ten years after quitting the risk of lung cancer is reduced 50% 4.
    • Ctrs for Dis Contr Prev. Morbid Mortal Wkly Rep 1990;39:2-10. 2. Wilhelmsson C, et al. Lancet 1975;1:415-20. 3. Morita H. Circulation 2005;45:589-94.
    • 4. Jorenby DE. Circulation 2001;104:e51-2.
  • Smoking Cessation
    • “ Stopping smoking is easy. I’ve done it a thousand times.”
    Mark Twain
  • Smoking Cessation
    • In 2000 1
      • 68% of smokers wanted to quit (US and Europe)
      • 40% tried to quit
      • 5% succeeded in quitting
    • Personal Motivation is the most important factor as to whether someone will quit smoking. Hospitalization, especially with a heart attack, is the most susceptible period that people have to be successful recipients of smoking cessation counseling.
    • After a heart attack 71% of people in an aggressive smoking cessation program will quit smoking 2 .
    • In the Medicare database, those who received smoking cessation counseling prior to discharge post-MI were 20% more likely to survive 30 days, as well as 60 days, and one year 3 .
    • American Heart Association. 2. Taylor CB, et al. Ann Intern Med 1990;113;
    • 118-23. 3. Houston TK. Am J Med 2005;118:269-75.
  • Medicare and Smoking
    • 9.3% of those over 65 smoke. 10% quit each year.
    • Elderly account for 300,000 of the 440,000 deaths each year from smoking.
    • Smoking costs HHS 14.2 billion dollars/year, 10% of its total budget.
    • 1-800-QUIT-NOW and www.smokefree.gov
  • Alabama Tobacco Quitline 1-800-QUITNOW
    • Set up by CDC for any interested Alabamians.
    • Telephone counseling service.
    • Referral to local smoking cessation services.
    • Educational materials.
    • Consultation for implementation and training on the USPHS Clinical Practice Guidelines for Treating Tobacco Use and Dependence.
    • Provide nicotine replacement therapy coupons.
    Alabama MD 2005;41:1-3 .
  • Quitting Smoking
    • A recommendation by a health care provider will increase chances of success by 30%.
    • Behavioral treatment increases chances of success by 50%.
      • Identification of and avoidance or coping with smoking triggers.
      • Social support by a clinician, family, friends, co-workers.
    Zbikowski SM, et al. Med Clin N Amer 2004;88:1453-65.
  • Public Health Service Guidelines – The 5A Model
    • A sk about smoking- every patient every visit.
    • A dvise one to quit- in a clear, strong personalized manner.
    • A ssess willingness to quit.
    • A ssist those willing to quit.
      • If willing, offer medication, and provide or refer for counseling or additional treatment. (1-800-QUITNOW.)
      • If unwilling, provide interventions designed to increase future quit attempts.
    • A rrange for follow-up- if willing, at a week and a month. If unwilling, address again at next visit.
    Fiore MC, et al. Treating tobacco use and dependence: clinical practice guideline. Rockville (MD): US Dept Health Human Svcs Public Health Svc; 2008 Update.
  • Assist those willing to quit.
    • S et a quit date, ideally within two weeks.
    • T ell family, friends, and co-workers about quitting, and request understanding and support.
    • A nticipate challenges such as nicotine withdrawal, particularly during the first few critical weeks.
    • R emove tobacco products from your environment. Prior to quitting, avoid smoking in places where you spend a lot of time such as home, work, car. Make your home smoke-free.
    • Recommend the use of medications to reduce withdrawal symptoms.
    Fiore MC, et al. Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: USDHHS. PHS. May 2008.
  • Assist those willing to quit.
    • Total abstinence.
    • Past quit experience.
    • Anticipate triggers/ alter routines:
      • alcohol, morning cup of coffee, weekly poker game.
    • Other smokers in the household.
    • Provide a supportive clinical environment.
    • Provide other sources of help.
      • 1-800-QUIT-NOW, www.smokefree.gov,
    Fiore MC, et al. Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: USDHHS. PHS. May 2008.
  • Quitting and Medications
    • Nicotine supplements – gum, patches, lozenges, inhalers, nasal spray
    • Anti-depressants
      • Buproprion SR (Wellbutrin SR or Zyban)
      • Nortryptilline and clonidine (not approved for this use, listed as second-line in the guidelines)
    • Varenicline (Chantix) -nicotine-receptor partial agonist
    • Rimonabant (not available) –cannabanoid receptor blocker
    • NicVax* and Ta-Nic* trigger the production of antibodies that bind to nicotine molecules and prevent them from reacting with receptors in the brain.
    • Should all be used in combination with counseling
    *Currently in clinical trials
  • Transdermal Nicotine + Nortryptiline vs Placebo 18/79 (23%) vs 8/79 (10%); p=0.052 Nicotine Nortryptiline Prochazka A, et al. Arch Intern Med 2004;164:2229-33. Clonidine also listed as second-line treatment in the guidelines.
  • Buproprion SR 12-Month Abstinence Rate Jorenby DE, et al: NEnglJMed 1999;340:685-91. p<.001 p<.001
    • 150 mg po qd X 3 days, then 150 mg po bid.
  • Varenicline - Chantix
    • After inhalation, nicotine predominantly binds to the nicotinic aceylcholine (nACh) receptors located in the mesolimbic-dopamine system of the brain within a matter of seconds. Nicotine specifically activates  4 β 2 nicotinic receptors in the Ventral Tegmental Area (VTA) causing an immediate dopamine release at the Nucleus Accumbens 1 (nAcc). The dopamine release is believed to be a key component of the reward circuitry associated with cigarette smoking 1 .
    • Varenicline is a selective α4β2 nicotinic receptor partial agonist.
    • Reduces the rewarding and reinforcing effects of nicotine.
    Picciotto MR, et al. Nicotine Tob Res. 1999; Suppl 2:S121-125.
  •  
  •  
  • Varenicline vs Placebo
        • Hays JT, and Ebbert JO. N Engl J Med 2008:359:2018-24 .
    *vomiting, constipation, diarrhea, flatulence, dyspepsia. 8.1 12.0 Stop due to AE 11.8 22.5 Other GI effects* 14.3 16.8 Headache 5.0 14.4 Abnormal dreams 12.7 22.0 Insomnia 11.2 35.8 Nausea % of subjects Adverse Effect Placebo Varenicline
  • Varenicline
    • Essentially no metabolism, 80% excreted unchanged in urine.
    • No meaningful drug-drug interactions.
    • Start at 0.5 mg/day for 3 days, 0.5 bid for 4 days, then 1.0 mg bid for 3-6 months.
    • Can reduce dosage to 1.0 mg daily for nausea.
    • Can reduce to 0.5 mg daily for Cr Clearance < 30 cc per min or dialysis patients. Removed with dialysis.
    • Use with GETQUIT Support Program, 1-800-QUIT-NOW, www.smokefree.gov.
        • Hays JT, and Ebbert JO. N Engl J Med 2008:359:2018-24.
  • Assist those unwilling to quit. Motivational Interviewing
    • Express empathy.
    • Develop discrepancy.
    • Roll with resistance.
    • Support self-efficacy.
    Fiore MC, et al. Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: USDHHS. PHS. May 2008.
  • Assist those unwilling to quit. Enhancing motivation to quit- The 5 R’s
    • Relevance-personalize to disease states, family situation.
    • Risks-
      • Acute- SOB, asthma flares, sinusitis, ulcers, pregnancy.
      • Long-term- MI, CVA, COPD, cancer.
      • Environmental- spouse, infants, children.
    • Rewards- health, taste, smell, money, self-image, impact on children’s habits, health of family, SOB, nails, teeth, wrinkles, quality of life, life expectancy, retirement.
    • Roadblocks- withdrawal, “reduced stress” myth, fear of failure, weight gain, lack of support- do for yourself.
    • Repetition every visit- most people make repeated quit attempts.
    Fiore MC, et al. Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: USDHHS. PHS. May 2008.
  • Arrange follow-up.
    • Contact within the first week, and again within the first month, then as needed.
    • Identify problems encountered, and anticipate challenges in the future. Assess medication use and problems. Remind of Quitline/support.
    • Congratulate them on their successes, and encourage complete abstinence.
    • Continue to assess use at every visit, and provide feedback.
    Fiore MC, et al. Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: USDHHS. PHS. May 2008.
  • Summary
    • Smoking is far and away the most important behavior affecting life expectancy and long-term health of smokers. 64% die as a result.
    • Educate and Motivate your patient: “If you smoke, carefully consider what reasons you use to commit yourself to continuing to smoke, and what factors about your health and future relationships might motivate you to quit.”
    • “ You can quit! I would love to assist you!”
    • Use the 5 A’s, medications, and other resources.
  •  
  •  
  • Conclusion
    • “ Sparing a few minutes for tobacco cessation: if only half of all nurses helped one patient per month quit smoking, more than 12 million smokers would overcome their addictions every year.” Bialous SA, Sarna L. Am J Nurs . 2004;104(12):54-60.
  • Atherosclerosis
    • A process that builds up plaque inside the walls of arteries or blood vessels that carry blood to the organs of the body.
      • May reduce the blood flow to these organs gradually.
      • May form blood clots which rapidly reduce blood flow.
      • May cause spasm in these arteries.
  • Atherosclerosis Major Organs Affected
    • Heart - coronary artery disease
      • Angina or chest discomfort, shortness of breath
      • Myocardial infarction
      • Congestive heart failure
      • Arrhythmias and sudden death
    • Brain – cerebrovascular disease
      • Stroke and transient ischemic attack
    • Peripheral vascular disease
      • Claudication, skin ulcers, wound healing, gangrene, aneurysms
  • Atherosclerosis Risk Factors
    • Factors that increase the risk and severity of atherosclerosis:
    • Modifiable and un-modifiable
  • Cigarette Use By Gender http://www.cdc.gov/nchs. 45.4 million smokers in the US.
  • Cigarette Use - Education MMWR 2007;56(44):1157-61.
  •  
  • Nicotine
    • Pleasurable effects:
      • Arousal
      • Relief of anxiety
    • Nicotine withdrawal:
      • Irritability, frustration, anger
      • Dysphoric or depressed mood
      • Anxiety
      • Difficulty concentrating
      • Restlessness
      • Increased appetite or weight gain
      • Decreased heart rate
      • Insomnia
    DSM-IV . Washington, DC.:American Psychiatric Association. 1994 .
  • Nicotine pharmacokinetics
    • Rapid absorption from smoke due to large pulmonary capillary surface area
    • Rapid transit directly to the brain undiluted
    • Immediate rapid rise in nicotine levels
    • Binding and conformational change in pentameric nicotinic acetylcholine receptors in
      • Nucleus accumbens
      • Mesolimbic system-reward center of the brain- highest concentrations of high affinity  4  2
      • Ventral tegmental area
    Henningfield JE, et al. Drug Alcohol Depend 1993:33:23-9. Watkins SS, et al. Nicotine Tob Res 2000:2:19-37.
  • Hays J and Ebbert J. N Engl J Med 2008;359:2018-2024 The Actions of Nicotine and Varenicline in the Brain
  • Varenicline - Chantix
    • A selective α4β2 nicotinic receptor partial agonist developed by Pfizer.
    • Reduces the rewarding and reinforcing effects of nicotine.
    • A randomized placebo-controlled trial of Varenicline 0.5 mg bid (N=253) vs Varenicline 1.0 mg bid (N=253) vs Placebo (N=121)
    Oncken C. American College of Cardiology Meeting, March 8, 2005.
  • Varenicline - Quit Rate All values p <0.0001 vs placebo Oncken C. American College of Cardiology Meeting, March 8, 2005.
  • Treating Tobacco Use and Dependence: 2008 Update
    • Tobacco use presents a rare confluence of circumstances:
      • A highly significant health threat;
      • A disinclination among clinicians to intervene consistently;
      • The presence of effective interventions.
    • Indeed it is difficult to identify any other condition that presents such a mix of lethality, prevalence, and neglect, despite effective and readily available interventions.
    Fiore MC, et al. Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: USDHHS. PHS. May 2008.
  • Why should a busy clinician consider making treatment of tobacco use a priority?
    • Clinicians make a difference with even a minimal (<3 minute) intervention.
    • A relation exists between the intensity of intervention and tobacco cessation outcome.
    • Even when patients are not willing to make a quit attempt at this time, clinician-delivered brief interventions enhance motivation and increase the likelihood of future quit attempts.
    • Tobacco users are being primed to consider quitting by a wide range of societal and environmental factors (e.g., public health messages, family members).
    Fiore MC, et al. Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: USDHHS. PHS. May 2008 .
  • Why should a busy clinician consider making treatment of tobacco use a priority?
    • There is growing evidence that smokers who receive clinician advice and assistance with quitting report greater satisfaction with their health care than those who do not.
    • Tobacco use interventions are highly cost-effective.
    • Tobacco use has a high case fatality rate (>50% of long-term smokers will die of smoking related disease.
    Fiore MC, et al. Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: USDHHS. PHS. May 2008.
  • Abstinence Rates by # Treatment Sessions Meta-analysis 46 studies Fiore MC, et al. Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: USDHHS. PHS. May 2008. 24.7 (21.0-28.4) 2.3 (2.1-3.0) 51 >8 sessions 20.9 (18.1-23.6) 1.9 (1.6-22) 23 4-8 sessions 16.3 (13.7-19.0) 1.4 (1.1-1.7) 17 2-3 sessions 12.4 1.0 43 0-1 session Estimated Abstinence Rate (95% CI) Estimated Odds Ratio (95% CI) Number of arms Number of Sessions
  • Secondary Prevention and Long Term Management
    • Status of tobacco use should be asked at every visit.
    • Every tobacco user and family member who smoke should be advised to quit at every visit.
    • The tobacco user’s willingness to quit should be assessed.
    • The tobacco user should be assisted by counseling and developing a plan for quitting.
    • Follow-up, referral to special programs, or pharmacotherapy (including nicotine replacement and pharmacological rx) should be arranged.
    • Exposure to environmental tobacco smoke at home and work should be avoided.
    Smoking 2007 Goal: Complete cessation. No exposure to environmental tobacco smoke. Goals Class I Recommendations NEW NEW
  • Prolonged Abstinence N=261 N=261 N=262 N=189 N=183 N=188 16.1 20.6 15.6 20.2 27.6 36.2 0 5 10 15 20 25 30 35 40 ITT Completers Percent Abstinent (%) p=0.004 p=0.002 OR=2.0 - 95%CI=[1.296;3.046] OR=2.2 - 95%CI=[1.374;3.456] STRATUS-US Study. American College of Cardiology Meeting, March 2004. Placebo Rimonabant 5mg Rimonabant 20mg
  • Camel late 1940s Brandt, AM. N Engl J Med 2008;359;445-8.
  • “ Reports of serious drug reactions hit record”
          • The FDA should forcefully warn patients taking Chantix that they may have blackouts and other problems that could lead to accidents, the report said. The current warnings say that patients may be too impaired to drive or operate heavy machinery, but such language is standard for many medications.
          • The report found 15 cases of Chantix patients who appeared to have been involved in traffic accidents, and 52 additional cases involving blackouts or loss of consciousness. The FDA received 1,001 reports of serious injuries possibly linked to Chantix, more than for the ten best-selling brand name drugs combined.
          • Chantix &quot;continued to provide a striking signal of safety issues that require investigation and action,&quot; the report said. The authors acknowledged Pfizer's concern that publicity may be driving up the number of reports, but nonetheless concluded that there are enough to warrant further action by the FDA.
          • Pfizer said the total sum of its data on Chantix, including results from clinical trials, show that the drug's benefits clearly outweigh its risks.
          • &quot;We stand by the efficacy and safety profile of Chantix,&quot; the company said in a statement. &quot;There are few things that provide greater health benefits than quitting smoking. Pfizer is committed to reducing the prevalence of smoking globally. As part of that mission, we want to increase peoples' understanding of the dangers of smoking and the benefits of quitting.&quot; 
    Alonso-Zaldivar R. The Boston Globe. 10/22/08
  • Restrictions on use of Varenicline
    • Monitor patients closely if adverse behavioral effects are noted by patient or family. Report if suspected.
    • Package insert: safety concerns wile operating heavy machinery.
    • FAA: pilots and air-traffic controllers may not use varenicline.
    • ..also by the organization overseeing interstate commercial truck and bus drivers.
    Hays JT, and Ebbert JO. N Engl J Med 2008:359:2018-24
  • States with Restrictions as of 12/31/07
    • Restrictions in private-sector worksites in 37, but not in: AK, IN, KS, KY, (MD), (MI), MS, NC, SC, TX, VA, WV, WY.
    • Restrictions in restaurants in 41, but not in: AL, IN, KY, MS, NC, SC, TX, WV, WY. Smoke-free in 21 states.
    • Restrictions in bars in only 20. Smoke-free in 13 states.
    • As of 2003, 77% of US workers in a smoke-free workplace.
    MMWR 2008 57(20):549-52.
  •  
  •