What would you recommend to this patient?A 55-year-old man comes into your office for follow-up of a chronic cough. He also complains of shortness of breath with activity. He reports that this has been getting worse over time. As you are interviewing the patient, you note that he smells of cigarette smoke. Upon further questioning, he reports smoking 1 pack of cigarettes per day for the past 35 years and denies ever being advised to quit. On examination, he is in no respiratory distress at rest, his vital signs are normal, and he has no obvious signs of cyanosis. His pulmonary examination is notable for reduced air movement and faint expiratory wheezing on auscultation.
What would you recommend to this patient?
What interventions are available to aid with smoking cessation?
Summary: A 55-year-old man with a 35-pack-year history of smoking presents with a chronic cough and progressively worsening dyspnea.
• Recommendations to this patient: This patient should be advised to quit smoking; one strategy, using the 5 As, is discussed below.
• Interventions available to help with smoking cessation: Counseling to quit smoking along with pharmacologic assistance with bupropion, varenicline, or nicotine replacement.
1. Know the many medical conditions and complications related to tobacco use.
2. Develop a framework for the discussion of tobacco use and promotion of smoking cessation.
3. Know the currently available pharmacologic agents that are used to aid in smoking cessation.
This is a 55-year-old man with a long history of smoking who presents with a chronic cough and worsening dyspnea. The most important first steps are to address the airway and breathing, and ensure that there is no respiratory emergency. Assessment of the patient’s air movement, oxygenation, and degree of respiratory distress are important. After evaluating his condition and ascertaining whether it is chronic lung disease or an exacerbation such as bronchitis superimposed on chronic obstructive pulmonary disease (COPD), therapy may be enacted. Bronchodilator therapy, antibiotic therapy depending on the character of the sputum and the chest radiograph findings are typically used. One critical component to therapy includes smoking cessation. Physician intervention is paramount, and the use of adjuvant therapies helps to increase the success.
PREGNANCY CATEGORY B: FDA (Food and Drug Administration) category for use of a medication in pregnancy in which animal studies have shown no harm to a fetus but human studies are not available or animal studies have shown harm to a fetus but studies in pregnant women have not shown harm.
PREGNANCY CATEGORY C: Animal studies have shown adverse fetal effects and there are no adequate studies in humans or no animal studies have been conducted and there are no adequate studies in humans.
PREGNANCY CATEGORY D: Human studies have shown potential adverse fetal effects; however, the benefits of therapy may outweigh the potential risks.
Tobacco use is the single greatest cause of preventable death. It is responsible for increased death rates from cancer, cardiac, cerebrovascular, and chronic pulmonary disease. Approximately 20% of the adult population reported smoking in 2010 and over 400,000 deaths per year are a result of tobacco use. Smoking also affects the health of those in close contact with people who smoke. Each year, 38,000 deaths from cancer and heart disease in nonsmokers are attributable to secondhand smoke. Smoking in pregnancy is associated with prematurity, intrauterine growth restriction, stillbirth, spontaneous abortion, and infant death. Smoking cessation reduces all of these risks. However, despite this evidence, it is difficult for smokers to quit. Health-care providers are important in the effort to reduce tobacco use and its related disease burden.
Research indicates that physician intervention, even in brief encounters, increases tobacco cessation rate. Furthermore, cessation rates increase with increased physician time and frequency of encounters to address tobacco use, but the optimal duration and frequency has not been defined. The process of discussing tobacco use and cessation involves several steps; one useful framework is the “five As”:
• Ask about tobacco use: Ask the patient at each visit about current tobacco use.
• Advise to quit through clear personalized messages: Let the patient know of his/her specific risks of tobacco use; in the sample case, talk to the patient about how the persistent cough and dyspnea can be related to the tobacco use and how cessation might be helpful.
• Assess willingness to quit: Find out the patient’s thoughts about quitting and if the patient is ready to proceed.
• Assist to quit: Including individual, group, or telephone counseling and pharmacologic treatment. For the patient that does not desire to quit, provide interventions that increase future quit attempts (motivational interviewing or the 5 Rs enhancing motivation strategy).
• Arrange follow-up and support.
Multiple factors may be part of a patient’s unwillingness to quit. A strategy to enhance motivation (5 Rs strategy) includes discussing the specific relevance to the patient of smoking cessation, risks of ongoing tobacco use, rewards to quitting (financial, health, social), roadblocks to quitting (withdrawal, discouragement because of failed past attempts, enjoyment of smoking), and repetition (readdressing the problem at each visit and reminding patients most people attempt to quit several times before being successful).
In pregnancy, it has been found to be helpful to discuss specific risks to the mother and fetus of continued tobacco use. While cessation prior to pregnancy is ideal, cessation at any time during pregnancy is associated with health benefits for patient and fetus, so ongoing discussions are encouraged. The pregnant patient will also need ongoing support after delivery to reduce the risk of remission after delivery.
In addition to counseling and reviewing the risks and benefits of quitting, the use of pharmacologic aids can increase the likelihood of successful smoking cessation when a patient has decided to quit. There are two broad modalities approved by the FDA to assist with smoking cessation: nicotine replacement and nonnicotine medications. Nicotine replacement products include gum, patch, inhaler, nasal spray, and lozenge. The approved nonnicotine medications are bupropion sustained release (brand name: Zyban) and varenicline (brand name: Chantix).
Bupropion was the first nonnicotine treatment for smoking cessation approved by the FDA. It is thought to work by blocking uptake of norepinephrine and/or dopamine. It is contraindicated in patients with eating disorders, monoamine oxidase (MAO) inhibitor use in the last 2 weeks, or a history of seizure disorder. The medication should be started 1 to 2 weeks before the quit date and the usual dose is 150 mg a day for 3 days then 150 mg twice a day. The usual course of treatment is 7 to 12 weeks, but it can be used for up to 6 months as maintenance therapy. This treatment can be used alone or in combination with nicotine-based treatments. In two studies comparing bupropion sustained release to placebo, the cessation rate for the bupropion group was 30%, compared to 17% in the placebo group. Common side effects include insomnia and dry mouth.
Varenicline is the newest agent approved for assistance with smoking cessation. It is a nicotinic receptor partial agonist that may reduce cravings for nicotine, reduce nicotine withdrawal symptoms, and block some of the binding of nicotine from cigarettes. Its efficacy at assisting with smoking cessation is similar to that of bupropion. It has not been studied for use with nicotine supplementation or with bupropion. The medication should be started 1 week before the quit date and the usual dose is 0.5 mg a day for 3 days, then 0.5 mg twice a day for 4 days, and then 1 mg a day for up to 6 months of treatment. Doses are reduced in patients on hemodialysis or with creatinine clearance <30 mL/min. Varenicline has been associated with neuropsychiatric symptoms including changes in behavior, agitation, depression, and suicidal behaviors. It should be used with caution in anyone with a history of psychiatric disorders and all persons using the medication should be monitored closely for these behaviors. Common side effects include nausea, trouble sleeping, and abnormal, vivid, or strange dreams.
Nicotine replacement therapies as a group increase smoking cessation rates over placebo. They can be used in combination therapy, which may increase cessation rates over monotherapy. Specifically, the combination of a daily nicotine patch and an as-needed nicotine replacement therapy (nicotine gum, inhaler, nasal spray, or lozenge) have been shown to be more effective than the patch alone.
Nicotine gum is available in 2 and 4 mg of nicotine per piece. The patient chews a piece of the gum until the patient feels a peppery taste in the mouth, “parks” the gum in a cheek until the sensation goes away, and then chews the gum again until the peppery sensation returns. The 4-mg dose is recommended for those who smoke more than 25 cigarettes per day and the 2-mg dose for those who smoke fewer than 25 cigarettes per day. Common pitfalls include not “parking” the gum (ie, chewing constantly) and not using enough pieces per day initially. Consider advising the patient to use the gum on a scheduled basis, rather than as needed, initially, and then slowly tapering the number of pieces per day. Common side effects, such as mouth soreness, hiccups, dyspepsia, and jaw ache, often are related to improper chewing technique.
The nicotine cartridge inhaler is available by prescription and has also been found to be effective in increasing smoking cessation rates. Each cartridge contains 4 mg of nicotine in 80 inhalations. The recommended dose is 6 to 16 cartridges per day. The inhaler can be used over several months, with a gradual tapering of the dose. For the gum, lozenge, and inhaler, acidic beverages (coffee, soda, or juices) can reduce absorption of the nicotine from the buccal mucosa, so the patient should avoid ingestion within 15 minutes of use of these products. Common side effects such as local irritation of the mouth and throat, coughing, and rhinitis usually declined with continued use.
Another therapeutic option is the nicotine nasal inhaler. The inhaler provides 0.5 mg of nicotine per inhalation and can be used at a starting rate of 1 to 2 doses per hour, for a maximum of 40 doses per day (5 doses per hour). The inhaler can also be used over months, with gradual tapering of the dose. Nasal irritation is the most common side effect. Of all the nicotine replacement products, the inhaler has the highest peak nicotine level and therefore also has the highest dependency potential.
The nicotine lozenge is available over the counter in 2 and 4 mg nicotine doses. The 4 mg nicotine lozenge is recommended for those who smoke their first cigarette within 30 minutes of waking and the 2 mg nicotine lozenge is for those who smoke their first cigarette more than 30 minutes after waking. The patient should allow the lozenge to dissolve in their mouth without swallowing or chewing. The recommended dose is 1 lozenge every 1 to 2 hours, not to exceed 20 lozenges a day, for the first 6 weeks and then a gradual 6 week taper for a total of 12 weeks of treatment. Common side effects include nausea, hiccups, and heartburn.
The nicotine patch is a passive nicotine replacement system, compared to the other methods outlined above. There are two common over-the-counter forms of the nicotine patch: Nicoderm CQ, which comes in multiple doses (21, 14, and 7 mg of nicotine per patch) and are meant to be worn for 24 hours a day, and Nicotrol, which has 15 mg of nicotine and is meant to be worn for 16 hours a day. The patch is replaced daily, and consideration should be given to starting with higher-dose patches in heavy smokers. Treatment with the patch for less than 8 weeks is as effective as longer treatment periods. The most common side effect is irritation of the skin at the site of the patch.
There is insufficient evidence to the effectiveness of pharmacologic therapy to aid in quitting in the populations of smokeless tobacco users, light smokers (<10 cigarettes/day), adolescents, and pregnant women. The nicotine inhaler, nasal spray, patch, and gum are pregnancy category D drugs. Pregnant smokers should be encouraged to quit without the use of any pharmacologic agents. However, these products can be considered for use in the pregnant smoker if counseling is insufficient to promote cessation, and if, in discussion with the patient, it is determined that the risks of continued smoking outweigh the risks of the medication. Bupropion and varenicline are pregnancy category C. They have not been studied in pregnancy and should only be used if the benefit justifies the potential risk to the fetus.
The United States Preventive Services Task Force (USPSTF) strongly recommends screening all adults and pregnant patients for tobacco use and offering cessation intervention for those who use tobacco products (Level A recommendation). Clinicians should ask pediatric and adolescent patients about tobacco use and provide a strong message against its use (Level C recommendation). For adolescent smokers, counseling has been shown to be effective and counseling interventions should be provided to aid in quitting (Level B recommendation).
7.1 A pregnant woman who smokes 1 pack of cigarettes a day asks for your advice regarding smoking cessation while she is pregnant. Which of the following statements is most appropriate?
A. Bupropion is pregnancy category C and relatively safe in pregnancy.
B. Varenicline is pregnancy category B and relatively safe in pregnancy.
C. Nicotine gum delivers a lower and safer dose of nicotine than the nasal spray.
D. The use of smoking cessation products during pregnancy frequently leads to adverse outcomes.
7.2 Which of the following statements regarding available treatments for smoking cessation is accurate?
A. Bupropion can be used in combination with nicotine supplements.
B. Nicotine gum is most effective if chewed continuously, to promote a constant release of the nicotine.
C. Nicotine supplements are most effective when used as needed for withdrawal symptoms.
D. All of the available agents are more effective when used in combinations with each other.
7.3 Which of the following counseling strategies is most likely to enhance your patients’ smoking cessation rates?
A. Discuss smoking cessation techniques only with patients who ask for your advice, as others will resent your suggestions.
B. Emphasize primarily the health risks of smoking.
C. Note in each patient’s chart that you have discussed cessation, so that you don’t repeat the message to the same patient at subsequent visits.
D. Ask about smoking cessation at each encounter.
7.1 A. Bupropion and varenicline are both pregnancy category C. Pregnant smokers should be encouraged to quit without the use of any pharmacologic agents. However, pharmacologic aids to increase the rate of smoking cessation during pregnancy can be used, after discussion with the patient of the risks and benefits of the medications and of continued smoking. Cessation of smoking at any time during the pregnancy is likely to provide health benefits for the mother and fetus. Nicotine gum delivers higher doses of nicotine than its nasal spray counterpart.
7.2 A. Bupropion can be used in combination with any of the nicotine supplementation products. The nicotine products can also be used in combination with each other. Varenicline has not been studied for use with other smoking cessation agents. Two common pitfalls in using nicotine supplementation are using supplementation only when having withdrawal symptoms and failing to use nicotine gum correctly. The gum should be chewed briefly and then parked in the cheek. It is less effective if chewed continuously.
7.3 D. Asking patients about tobacco use is a key to promoting cessation. It is important to ask each patient at each visit and to be prepared to provide advice and assistance at any time.
Most smokers require multiple attempts before successfully quitting for good. Remind your patients of this if they become discouraged in their efforts.
Use the five As—Ask, Advise, Assess, Assist, and Arrange follow-up—to help your patients quit smoking.
Fiore MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: US Department of Health and Human Services, Public Health Service; May 2008.
United States Preventive Services Task Force (USPSTF). Counseling and interventions to prevent tobacco use and tobacco-caused diseases in adults and pregnant women: USPSTF reaffirmation recommendation statement. Clinical Guidelines. Available at: http://www.uspreventiveservicestaskforce.org/uspstf09/tobacco/tobaccors2.pdf. Last accessed March 2010.