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PHARMACOTHERAPY

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Tobacco users have a physical dependence on nicotine, in addition to various reinforced psychological and social behaviors. The two-item Heaviness of Smoking Index (HSI) represents a reliable and valid way to assess the strength of someone’s nicotine dependence. Those who use tobacco more frequently every day and find a need to use tobacco first thing when they wake up in the morning are scored as more dependent. Table 61-1 shows a strategy for identifying smokers and determining readiness to quit as well as actions to be completed at that visit.

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Table 61-1.Simplified model for addressing tobacco use and dependence: ask and act.
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The use of pharmacotherapy doubles the effect of any tobacco cessation intervention. A recent Cochrane review has validated the importance of providing counseling support, in addition to pharmacotherapy, among smokers attempting to quit. Studies with four or more sessions showed the greatest impact; counseling can be delivered either in person or by telephone.

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The US PHS guideline on management of tobacco dependence recommends varenicline, sustained-release bupropion, and all forms of nicotine replacement (eg, resin or gum, inhaler, nasal spray, lozenges, and patch). Patients should be queried about experiences with prior use of cessation medications and asked if they are interested in a particular agent. Clinicians are encouraged to apply appropriate clinical judgment when assessing contraindications to the use of a particular agent. The use of pharmacotherapy to support smoking cessation is summarized in Table 61-2.

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Table 61-2.Chart aid for use of first-line adjunctive pharmacotherapy in smoking cessation.
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A. Nicotine Replacement Therapy (NRT)

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Nicotine patches, lozenges, and resin (gum) are available over the counter (OTC), whereas nicotine nasal sprays and the nicotine inhaler systems both require prescriptions. Reduced-dose regimens of nicotine replacement might be considered for patients consuming <10 cigarettes daily or those weighing <100 lb (~45 kg). Using two forms of nicotine replacement (eg, patch plus resin or lozenges) results in higher quit rates and should be recommended if other forms of nicotine replacement have not been effective alone. Quit rates with use of NRT range between 20% and 24%; use of NRT is recommended for a minimum of 6–8 weeks; however, some patients elect to continue nicotine-containing therapy for the long term.

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Nicotine medications appear to be safe for most people. Side effects of NRT mainly include local irritation (ie, mouth sores, skin rash, nasal and throat irritation) associated with the route of administration of the medication. Side effects are typically mild and transient. Studies show that only ~1 in 12 person reports discontinuing use of NRT because of side effects.

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Nicotine-containing products are not associated with the occurrence of acute cardiac events. This finding is consistent with the observation that NRT is rarely able to achieve blood levels of nicotine associated with smoking. Nonetheless, NRT should be approached cautiously among patients who are within 2 weeks of an acute myocardial infarction, are known to have significant arrhythmias, and have significant or worsening symptoms of angina.

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B. Bupropion (Zyban)

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Sustained-release bupropion is started at a dose of 150 mg daily for 3 days before increasing to 150 mg twice daily on day 4. Treatment with bupropion begins 1–2 weeks before the anticipated quit date; its use is contraindicated among patients with a history of seizure disorders, current substance abuse, or other conditions that may lower the seizure threshold. The standard treatment course of bupropion (Zyban) in 8 weeks yields quit rates of ~30%.

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C. Varenicline (Chantix)

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This agent binds to α4β2-nicotinic receptors in the central nervous system (CNS) to moderate symptoms of nicotine withdrawal, leading to reduced craving, decreased smoking satisfaction, and diminished psychological reward. Varenicline (Chantix) is started 1 week prior to the identified quit date, titrating up from a dose of 0.5 mg daily for 3 days, to 0.5 mg twice daily for days 4–7, then to 1 mg twice daily beginning on day 8. Rates of continuous abstinence are 44%. A full treatment course of 12 weeks is recommended, and those who are abstinent at 12 weeks may continue with another 12 weeks of treatment. The most commonly encountered side effects are nausea, insomnia, and abnormal dreams; these are generally rated as mild and often resolve within several days or may be managed with a dose reduction as needed. Varenicline is minimally metabolized and is essentially excreted in the urine. There are no known drug interactions. Dose modification is necessary only with severe renal disease.

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Cases of suicidal thoughts as well as aggressive and erratic behavior has been reported in some patients who have taken varenicline. There are also reports of drowsiness that affected patients’ ability to drive or operate machinery. Preliminary review by the FDA suggests that many of the cases may be newly identified mental illness in persons who experienced depressed mood, suicidal thoughts, and/or changes in emotion and behavior within days to weeks of starting on varenicline.

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Varenicline’s role in these cases has not been established. Trying to stop smoking, with or without treatment, is associated with nicotine withdrawal symptoms, including irritability and drowsiness; symptoms of existing mental illness may worsen with cessation. Not all of the cases reported to the FDA were known to involve patients with prior mental illness, and not all patients concerned had stopped smoking.

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According to information currently available, the potential benefits of varenicline greatly outweigh its risk. Clinicians are encouraged to screen for mental health issues prior to prescribing and to monitor patients for behavioral symptoms.

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Clinicians should remember to support patient quit attempts by placing a follow-up call within 1–2 weeks of the quit date. Instruct patients to contact your office if they experience unusual mood swings while using this medication. Remind patients that irritability, mood swings, and drowsiness result from nicotine withdrawal. These symptoms are most common immediately after a person stops smoking and typically lessen with time. In addition, patients should be counseled to use caution when driving or operating machinery until they know how quitting smoking with varenicline may affect them.

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Clinical experience with use of the pharmacotherapies for smoking cessation among pregnant women and adolescents is generally limited. Smokers with concurrent or prior depression may benefit from use of bupropion. Clinical judgment is advised regarding a comprehensive assessment of the risks and benefits associated with use of adjunctive pharmacotherapy in each of these settings.

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On the basis of the observation that the number of past quit attempts is predictive of future quit attempts, clinicians should encourage smokers to continue to try to quit ­smoking. However, studies show that while motivation to quit is important in predicting whether someone makes a quit attempt, it does not necessarily predict ability to remain smoke-free, which is more likely to be related to the strength of someone’s nicotine dependence. Clinicians play a pivotal role in not only motivating patients to make a quit attempt but also in offering evidence-based treatments to help them cope with craving and withdrawal symptoms that are the result of their nicotine addiction. Motivational interviewing can be used to enhance both level of motivation and the patient’s self-efficacy to cope with the uneasy feelings that typically accompany smoking abstinence.

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E-cigarettes
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Electronic cigarettes (ie, e-cigarettes) are battery-powered devices that deliver nicotine in an aerosol to the user. E-cigarettes initially emerged in China in 2003 and since have become widely available. E-cigarettes heat and vaporize a solution, often flavored, containing nicotine, and many are designed to outwardly resemble traditional tobacco cigarettes and have been touted by some as a smoking cessation aid for addicted smokers. At this time the evidence supporting the efficacy of e-cigarettes as a cessation treatment for nicotine addiction is limited, although clearly smoking e-cigarettes appears to be less risky than smoking conventional cigarettes.

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