Tobacco use is a common practice

Smoking Cessation Therapy Considerations for Patients with Chronic Kidney Disease Continuing Nursing Education Harold J. Manley Nicole M. Stack obac...
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Smoking Cessation Therapy Considerations for Patients with Chronic Kidney Disease

Continuing Nursing Education

Harold J. Manley Nicole M. Stack obacco use is a common practice among Americans today. Nearly 47.5 million adults currently smoke, and this number has already increased from the estimated 46.2 million in 2001 (Centers for Disease Control and Prevention [CDC], 2002, 2003a,b). Tobacco use has numerous consequences and devastating health effects, but it also has large scale economic effects. Smoking leads to over 400,000 preventable deaths annually in addition to approximately $167 billion dollars lost annually in economic costs (CDC, 2005). According to the CDC, for every one person who dies, there are 20 individuals who also experience a serious illness secondary to smoking (CDC, 2002, 2003a,b). For each of the approximately 47 million smokers, more than $1,760 is lost in productivity, and $1,623 lost is in medical expenditures (CDC, 2005). The estimated annual economic costs of smoking are $75.5 billion in health care expenditures and $92 billion lost in productivity (CDC, 2005). Cigarette smoking is associated with significant morbidity and mortality, and it places individuals at risk for developing numerous diseases, including cardiovascular disease, cancers, osteoporosis, and respiratory disorders, in addition to detrimental effects during pregnancy and further nega-

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Harold J. Manley, PharmD, FASN, FCCP, BCPS, is Director of Clinical Pharmacy, DaVita VillageHealth Disease Management, Vernon Hill, IL, and a Member, the Albany Nephrology Pharmacy Group (ANephRx).

Cigarette smoking is a readily modifiable cardiovascular and chronic kidney disease (CKD) risk factor. Smoking cessation aids include nicotine replacement therapy (NRT), bupropion, and varenicline. Several reports suggest that patients with CKD who use tobacco products be encouraged to stop; however, very little is offered to the healthcare provider as to how to successfully prescribe and monitor smoking cessation therapy for this patient population. This article reviews NRT, bupropion, and varenicline pharmacokinetics and dosing literature for patients with CKD. Evidence for the benefit of smoking cessation in patients with CKD is also reviewed.

Goal: To increase awareness about smoking cessation therapy for patients with chronic kidney disease. Objectives 1. Explain how nicotine replacement therapy, bupropion, and varenicline are used as methods of smoking cessation therapy. 2. Describe the pharmacokinetics of bupropion and varenicline. 3. Discuss smoking cessation outcomes in patients with CKD.

tive consequences in adolescents who smoke (Okuyemi, Ahluwalia, & Harris, 2000). Cigarette smoking substantially increases the risk of cardiovascular disease, such as stroke, sudden death, and heart attack (Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults, 2001). Cigarette smoking is also associated with kidney disease and increases the risk and progression of chronic kidney disease (CKD) (Biesenbach & Zazgornik, 1996; Gambaro et al., 1998; National Kidney Foundation [NKF], 2002,

2003a; Orth, 2000; Yu, 2003). In the NKF’s Kidney Early Evaluation Program (KEEP), nearly half of KEEP participants had a smoking history; 14.0% were current smokers and 31.3% used to smoke. Of the current smokers, 23.6% had diabetes, 45% had hypertension, and 46% showed evidence of CKD (NKF, 2003a). CKD is estimated to affect over 11% of the U.S. population (Coresh et al., 2005). In addition to kidney disease, patients with CKD may present with comorbid conditions, such as left ventricular hypertrophy, diabetes

This offering for 1.9 contact hours is being provided by the American Nephrology Nurses’ Association (ANNA). ANNA is accredited as a provider of continuing nursing education (CNE) by the American Nurses Credentialing Center’s Commission on Accreditation.

Nicole M. Stack, PharmD, is an Assistant Professor, Albany College of Pharmacy, Albany, NY.

ANNA is a provider approved by the California Board of Registered Nursing, provider number CEP 00910.

Disclosure Statement: The authors reported no actual or potential conflict of interest in relation to this continuing nursing education article.

This CNE article meets the Nephrology Nursing Certification Commission’s (NNCC’s) continuing nursing education requirements for certification and recertification.

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mellitus, coronary heart disease, anemia, and hypertension (Brown et al., 2003; Keith, Nichols, Gullion, Brown, & Smith, 2004). Patients with CKD Stage 5 (those on dialysis) have a mean of 5 to 6 co-morbid conditions that often require complex therapeutic regimens of up to 12 different medications (Manley et al., 2004; United States Renal Data System [USRDS], 2000). The number and severity of the aforementioned cardiovascular risk conditions increase as CKD worsens (Anavekar et al., 2004; NKF, 2002; Rahman et al., 2004). Cardiovascular-related hospitalizations and mortality also increase with worsening kidney function (Go, Chertow, Fan, McCulloch, & Hsu, 2004). Once a patient reaches CKD Stage 5, approximately 50% of deaths are cardiovascular-related (USRDS, 2004). Since 1998, there has been a heightened awareness and call for research to reduce cardiovascular mortality in patients with CKD (Levey et al., 1998). Additionally, the NKF has published various clinical practice guidelines aimed at reducing the progression of kidney disease and cardiovascular mortality in patients with CKD through early detection and medical management of kidney disease, hyperphosphatemia, lipid abnormalities, anemia, hypertension, and cardiovascular disease (NKF, 2001, 2002, 2003b,c, 2004, 2005). Cigarette smoking is a readily modifiable cardiovascular and CKD risk factor. It is generally accepted that smoking cessation decreases cardiovascular mortality in the general population. Smoking cessation may also decrease the progression of CKD (Chuahiun et al., 2004; Halami et al., 2000; Schiffl, Lang, & Fischer, 2002). Despite several reports suggesting that patients with CKD who use tobacco should be encouraged to stop their tobacco use (Brown & Keane, 2001; NKF, 2002, 2003b, 2004, 2005; St. Peter, Schoolwerth, McGowan, & McClellan, 2003; Yu, 2003), little is offered to the healthcare provider as to how to successfully prescribe and monitor smoking cessation therapy for this patient population.

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Given the complexities of CKD and its affects on drug metabolism, distribution, and elimination, some clinicians may not be comfortable with or aware of the nuances of the medications prescribed for smoking cessation. In the context of CKD, this article reviews the dosing, pharmacokinetics, and side effect profiles of Food and Drug Administration-approved medications used in smoking cessation. It also reviews the literature of smoking cessation programs/clinics outcomes in patients with CKD. Nicotine use is an addiction, and therefore, requires behavioral or nonpharmacologic interventions in addition to pharmacologic options. Many smokers report the desire to quit, whether secondary to health concerns or economics reasons, but the difficulty to quit highlights the habitual and physiological addiction (Hymowitz et al., 1997; Okuyemi et al., 2000). Effective smoking cessation programs typically include patient support programs and rely on medications to increase success. Tobacco cessation can be treated with the use of behavioral modifications in addition to drug therapy, such as nicotine replacement therapies (NRTs) bupropion, or varenicline. Behavioral strategies can include support groups, relaxation techniques, and follow-up phone calls, in addition to regular face-toface visits with the patient’s tobacco cessation provider. The effectiveness of each of the behavioral and medication therapies has been studied, and it is reported that no one therapy is better than another (Bollinger et al., 2000; Hajak et al., 1999; Hays et al., 2001; Herrera et al., 1995; Hurt et al., 1997, 1998; Setter & Johnson, 1998; Shiffman et al., 2002). A patient’s preference is typically what defines the option the patient chooses.

Nicotine Replacement Therapy Nicotine is rapidly absorbed in the lung (Pomerleau & Pomerleau, 1998). On average, smokers absorb 1mg of nicotine per cigarette smoked; however, this can vary by the smoker and the level of inhalation. Nicotine then

enters the pulmonary and arterial circulation. Nicotine is a weak base and is non-ionized, leading to easier absorption in alkaline environments. Nicotine undergoes extensive first pass metabolism when ingested orally (for example, with gum or lozenge). Nicotine is largely metabolized by the liver, with renal excretion depending on urinary pH and flow. The half-life (t1/2) is approximately two hours. The main metabolites include cotinine and nicotine-N-oxide. The pharmacokinetics of intravenously administered nicotine (0.028 mg/kg) in nine healthy subjects (glomerular filtration rate [GFR], 84 to 143 mL/min/1.73m2), four patients with mild kidney failure (GFR, 63 to 73 mL/min/1.73m2), five patients with moderate kidney failure (GFR, 18 to 36 mL/min/1.73m2), and six patients with severe kidney failure (GFR, 1 to 10 mL/min/1.73m2) were reported (Pomerleau & Pomerleau, 1998). Three patients were on peritoneal dialysis. Nicotine and cotinine concentrations were measured in plasma, urine, and peritoneal dialysate from 0 to 24 hours after start of infusion. There were significant correlations between GFR and total clearance (p < 0.01, r = 0.79), and renal clearance (p = 0.047, r = 0.56) of nicotine. There were no differences between normal healthy subjects and those with mild renal insufficiency regarding nicotine total clearance and non-renal clearance. Nicotine total and non-renal clearances were reduced by 30% and 50% in patients with moderate and severe kidney failure, respectively, when compared to healthy patients. Non-renal clearance was 1,303 mL/minute in healthy subjects and 661 mL/minute in patients with severe kidney failure. Overall, the renal clearance of nicotine was 5% of total clearance in healthy patients, 2% in patients with mild kidney failure, 3% in patients with moderate kidney failure, and less than 1% in patients with severe kidney failure. Nicotine adverse effects, such as an increase in heart rate and blood pressure, were of the same magnitude in all groups. In trials evaluating the efficacy of

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Table 1 Smoking Cessation Medication Options for Patients with Chronic Kidney Disease Product

Formulation

Dose for Patients with CKD

Availability

Nicotine Containing Nicoderm CQ

Transdermal

7 to 21mg daily Regimen: 21mg daily x 6 weeks, then 14mg daily x 2 weeks, then 7mg daily x 2 weeks

OTC

Nicorette

Gum

2mg (for those that smoke less than 25 cigarettes per day) and 4mg (for those that smoke greater than 25 cigarettes per day) Regimen: 1 piece every 1-2 hours for first 6 weeks, then 1 piece every 2-4 hours for 3 weeks, then 1 piece every 4-8 hours for 3 weeks

OTC

Commit

Lozenge

2mg and 4mg Regimen: Frequency depends on level of nicotine dependence

OTC

Nicotrol

Inhaler

10mg cartridge that delivers 4mg of nicotine Regimen: up to 16 cartridges per day with continuous puffing over 20 minutes. Treat for 3 months then wean over 6-12 weeks

]

Nasal spray

0.5mg nicotine per spray Regimen: Initiate with 1 to 2 doses per hour as needed; maximum 40 doses per day

]

Transdermal

5-15mg daily for 16 hours; taper regimen: 15mg daily x 6 weeks; 10mg daily x 2 weeks; 5mg daily x 2 weeks

Buproprion (Zyban®)

Oral tablet

Renal Impairment: 150mg bupropion every day Hemodialysis: 150mg every 3 days

]

Varenicline (Chantix®)

Oral tablet

Renal Impairment (CrCl less than 30mL/minute) 0.5mg twice daily

]

Non-Nicotine Containing

Key: CKD – chronic kidney disease; OTC – over the counter; ] – prescription only; CrCI = creatine clearance.

NRTs, the appearance of cotinine in the blood, urine, or saliva is typically used as a measure of adherence to smoking cessation. In the United States, there are five NRT formulations currently available; these are the patch, gum, lozenge, inhaler, and nasal spray (Henningfield, Fant, Buchhalter, & Stitzer, 2005). Table 1 provides information on all available NRTs, the usual dose and the dose for patients with CKD, and the cost for a one-month supply. The most common adverse effects associated with NRT include dizziness, headache, and nausea. The patch is available over the counter without a prescription, and it provides patients with the

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option to “step-down” with the dose of their nicotine. Since it is a transdermal option, it leads to minimal stimulation (Henningfield et al., 2005). The typical dose available with the patch can vary with the brand or generic version, and it has minimal side effects, primarily local skin irritations. Gum and the lozenge NRTs are similar in their administration and dosage availability (2mg and 4mg) (see Table 1). They are also available without a prescription. The most common side effects include gastrointestinal discomfort, but these products are generally tolerated well (Molander et al., 2000). Gum and lozenge NRTs are also useful in targeting the “hand-

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to-mouth” routine of many smokers; the gum or lozenge provides patients with something to place in their mouths where they would normally place a cigarette. These products have also been shown to assist in reducing weight gain, which can be a concern or potential barrier for many smokers trying to quit (Eliasson, Taskinen, & Smith, 1996; Herrera et al., 1995; Shiffman et al., 2002; Thompson & Hunter, 1998). The NRT inhaler is another option that aims to target a patient’s “hand-tomouth” routine. The inhaler is available as a 10mg cartridge that delivers 4mg of nicotine. It also provides flexible dosing for patients, who typically

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use 6 to 16 cartridges per day based on their level of nicotine dependence (Bollinger et al., 2000; Hjalmarson, Nilsson, Sjostrom, & Wiklund, 1997; Okuyemi et al., 2000). The last NRT option is the nasal spray. The nasal spray is available as 0.5mg nicotine per spray. Patients are recommended to use 1 to 2 doses per hour (Henningfield et al., 2005). This formulation also provides flexible dosing and is the only NRT option that is closest to a cigarette in terms of the rapid rise in nicotine stimulation (Hurt et al., 1998; Okuyemi et al., 2000; Thompson & Hunter, 1998). Both the inhaler and nasal spray are well tolerated with mild side effects, such as coughing or nasal irritation, respectively.

Buproprion The first non-nicotine-containing medication approved by the Food and Drug Administration for smoking cessation is bupropion. Bupropion is indicated for the treatment of depression and also as an aide to smoking cessation (GlaxoSmithKline, 2007). This option focuses more on reducing a patient’s craving rather than supplementing the need for nicotine, such as an NRT (Hays et al., 2001; Hurt et al., 1997). Bupropion use is warranted in patients who are willing to quit and have tried the NRTs without success, are unwilling to use an NRT, and have a potential precaution that precludes them from using one of the NRTs (such as cardiac conditions, pregnancy). The purported mechanism of bupropion in assisting patients in smoking cessation is unknown, but is probably related to inhibition of noradrenergic or dopa-minergic neuronal uptake (GlaxoSmith-Kline, 2007). The resultant increase in norepinephrine and dopamine attenuates nicotine withdrawal symptoms and cravings, respectively. Bupropion should be started 1 to 2 weeks prior to the patient’s chosen “quit day” because the onset of activity usually occurs after the first week of initiation. Patients who have not stopped smoking after seven weeks of bupropion therapy are generally considered

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non-responsive to this treatment (Glaxo-SmithKline, 2007). The most common side effect with bupropion use is dry mouth and insomnia. Bupropion increases the risk of seizure. Doses should not exceed 300mg per day, and bupropion should not be prescribed in patients with seizure disorder or who are at risk for seizures (GlaxoSmithKline, 2007; Henningfield et al., 2005).

The Pharmacokinetics Of Bupropion Bupropion is rapidly absorbed after oral administration; however, only a small proportion of the oral drug reaches the systemic circulation intact. Bupropion is extensively protein bound (84%). The volume of distribution is 19 to 21 L/kg, and central nervous system concentrations are 10 to 25 times greater than in plasma concentrations (Findlay et al., 1981; Preskorn & Othmer, 1984). Buproprion undergoes extensive first-pass metabolism primarily by the CYP2B6 isoenzyme (GlaxoSmithKline, 2007). There are three active metabolites – hydroxybupropion, threohydrobupropion, and erythrohydrobupropion. The metabolite potentency, relative to bupropion, is estimated to be 50%, 20%, and 20% respectively (Glaxo-SmithKline, 2007). The kidney is responsible for 87% bupropion excretion; 10% is excreted via the feces (GlaxoSmithKline, 2007). With chronic administration, bupropion elimination half-life is 21 hours; metabolite elimination half-lives range from 20 to 37 hours. All half-lives are prolonged in patients with liver disease (GlaxoSmithKline, 2007). In the general population, the recommended dose is 150mg daily for 3 days then increasing to 150mg twice a day (GlaxoSmithKline, 2007; Henningfield et al., 2005). Common adverse effects include general gastrointestinal discomfort, agitation, and insomnia (Henningfield et al., 2005). Patients prescribed bupropion should be advised to take the second dose earlier in the evening to minimize any associated insomnia. The pharmacokinetics of bupropion and two of its major metabolites,

hydroxybupropion and threohydrobupropion, were studied in eight patients on hemodialysis (HD) following a single oral dose of 150 mg bupropion hydrochloride sustained-release (Worrall, Almond, & Dhillon, 2004). The bupropion results were similar to those for individuals with normal renal function. The metabolites demonstrated increased areas under the curve, indicating accumulation. Dialysis clearance of hydroxybupropion is unlikely. The results suggest significant accumulation of the metabolites in patients with renal failure. Due to the uncertainty of the clinical importance bupropion metabolite accumulation and potential associated toxic plasma levels, the authors recommend that a dose of 150mg bupropion every three days in patients receiving HD may be more appropriate than the current manufacturer’s recommendation (in renalimpaired patients) of 150 mg daily then increased to twice daily after 3 days. Further investigation of the safety and efficacy of this dosing recommendation is warranted.

Varenicline The latest non-nicotine containing medication approved and available for use in tobacco cessation is varenicline (Chantix®). Varenicline has a novel mechanism of action in targeting tobacco dependence. It works as a partial nicotinic receptor agonist selective for the α4β nicotinic receptor. By binding to α4β2 receptors, varenicline induces two results: 1) it signals the release of dopamine to create similar reinforcing effects due to its partial binding at the receptor, and 2) it acts as a physical antagonist by binding to the nicotine receptor to potentially block the effects of nicotine (Foulds, 2006; Pfizer, 2008). Varenicline’s dosing is 1mg twice daily for 12 weeks after a one-week dose titration. The recommended dosing titration is 0.5mg once daily for days 1 to 3, 0.5mg twice daily for days 4 to 7, and 1.0mg twice daily for day 8 through completion of treatment (Pfizer, 2008). Varenicline should be taken after eating and with a full glass of water to minimize possible side

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effects. The treatment duration may also be expanded to 24 weeks and has been shown increase efficacy and abstinence rates (Gonzales et al., 2006). The most common adverse effects associated with varenicline include nausea, headaches, insomnia, and abnormal dreams (Pfizer, 2008). Nausea has been reported as primarily mild to moderate (Gonzales et al., 2006; Jorenby et al., 2006; Tonstad et al., 2006) and can be minimized by using the recommended dose titration.

The Pharmacokinetics Of Varenicline Varenicline reaches maximum plasma concentrations within 3 to 4 hours after oral administration and typically achieves steady state within 4 days (Pfizer, 2008). Oral administration of varenicline has been shown to be unaffected by food or the time of administration (Faessel et al., 2006). Varenicline exhibits minimal metabolism with 92% of varenicline excreted unchanged in the urine and has a halflife of approximately 24 hours (Pfizer, 2008). Dosage adjustments have been recommended with varenicline in patients with severe renal impairment, which is defined as a creatinine clearance less than 30 mL/minute due to a 2-fold increase in varenicline levels (Pfizer, 2008). The recommended dosage adjustment is to titrate the patient from 0.5mg daily up to a maximum dose of 0.5mg twice daily. Currently, dosage adjustments have not been recommended for patients with hepatic impairment due to the minimal hepatic metabolism and are not recommended based on the age of the patient (Pfizer, 2008). Further data are still needed to evaluate the safety profile and potential for dosage adjustments in these special populations.

Smoking Cessation Outcomes In CKD: The Evidence To date, only three studies were identified via a MEDLINE search that investigate the effects of smoking cessation on preservation of kidney function (Chuahirun et al., 2004; Halimi et al., 2000; Schiffl et al.,

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2002). Unfortunately, the trials do not mention whether or not nicotine or bupropion therapy was used to facilitate smoking cessation. Smoking cessation effects on GFR decline in patients with type 2 diabetes with and without macroalbuminuria were reported (Chuahirun et al., 2004). All patients had a normal plasma creatinine, were prescribed an angiotensin-converting enzyme inhibitor, and had adequate blood pressure control. Non-smokers and smokers with normo-, micro-, and macroalbuminuria (n = 157) and a separate cohort (n = 80) with microalbuminuria, were followed for six months. Urine excretion of transforming growth factor beta-1 (UTGF-β1), measured as TGF-β1, is associated with in the development of scarring and fibrous cresents in the glomerulus via activation of myofibroblasts from glomerular parietal epithelial cells (El Nahas, 1996; Ng et al., 1999). UTGFβ1 increased in macroalbuminuric but not in nonmacroalbuminuric nonsmokers and UTGF-β1 rate was higher in smokers than nonsmokers within each albuminuria group. In the separate microalbuminuric cohort, the rate of UTGF-β1 change for quitting smokers was not different from nonsmokers (0.093 versus -0.123 ng/g of creatine/week, P = not significant) but for non-quitting smokers (0.970) was higher than non-smokers (P = 0.017). Patients with type 2 diabetes who are at high risk compared with low risk for nephropathy progression have progressive renal injury as measured by increasing UTGF-β1. Cigarette smoking exacerbates renal injury in type 2 diabetes despite blood pressure control and ACEI, but its cessation in those with microalbuminuria ameliorates the progressive renal injury caused by continued smoking. The second trial is a report of 45 patients with progressive primary nephropathies (glomerulonephritis or tubulointerstitial nephritis) and moderate renal failure (Schiffl et al., 2002). All patients were encouraged to stop cigarette smoking (1 to 2 packs per day); 26 patients refused to

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change their smoking habits (current smokers), and 16 successfully stopped (ex-smokers). Over a 24month study period, carboxyhemoglobin and creatinine clearance were measured every six months. The primary end-point of the study was endstage renal disease requiring dialysis. Current smokers and ex-smokers had similar rates of creatinine clearance decline in the preceding 24 months prior to the investigation. Compared to ex-smokers or matched non-smoking patients with CKD, individuals who continued to smoke had a significantly faster decline in creatinine clearance during the 24-month study period. Dialysis therapy was started in seven individuals (6 smokers; 1 exsmoker) over the study period. The authors concluded that smoking cessation slowed the progression of renal failure but did not reverse any renal function caused by previous smoking. Investigators determined creatinine clearance (Cockcroft-Gault formula) and proteinuria (dipstick) of an overnight urine sample in large observational trial (n = 28,409) in the general population of the la Sante region in France (Halimi et al., 2000). Adjusted creatinine clearance was higher in current smokers than in former smokers and never smokers (100.6 + 13.6 vs. 98.8 + 13.9 mL/min/1.73m2, P < 0.0001, and vs. 98.5 + 14.0 mL/min/1.73m2, P < 0.0001, respectively). This difference was predominant in men (HR and p value) and weak in women (HR and p value), and was associated with the number of cigarettes smoked daily (HR and p value). The slope of the projected age-related decline in the creatinine clearance accelerated with age, but it was similar in current smokers, former smokers, and never smokers. Current and former smokers had a marked risk of 2 or higher proteinuria (adjusted RR [95% CI], 3.26 [1.66 to 6.80], P = 0.0009, and 2.69 [1.24 to 5.99], respectively, P = 0.013, vs. never smoking), which was independent of the daily or cumulative cigarette consumption.

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Conclusion Increased efforts should be made to encourage patients with CKD to stop smoking in order to preserve kidney function and potentially delay dialysis therapy. Clinicians recommending smoking cessation pharmacotherapy should use reduced doses of bupropion and varenicline, and may use recommended doses of NRT. References Anavekar, N.S., McMurray, J.J.V., Velazquez, E.J., Solomon, S.D., Kober, L., Rouleau, J.L., et al. (2004). Relation between renal dysfunction and cardiovascular outcomes after myocardial infarction. New England Journal of Medicine, 351, 1285-1295. Biesenbach, G., & Zazgornik J. (1996). Influence of smoking on the survival rate of diabetic patients requiring hemodialysis. Diabetes Care, 19(6), 625-628. Bollinger, C.T., Zellweger, J.P., Danielsson, T., Van Biljon, X., Robidou, A., & Westin, A. (2000). Smoking reduction with oral nicotine inhalers: A doubleblind, randomized clinical trial of efficacy and safety. British Medical Journal, 321, 329-333. Brown, W.W., & Keane, W.K. (2001). Proteinuria and cardiovascular disease. American Journal of Kidney Diseases, 4, S8-S13. Brown, W.W., Peters, R.M., Ohmit, S.E., Keane, W.F., Collins, A., Chen, S.C., et al. (2003). Early detection of kidney disease in community settings: The kidney early evaluation program (KEEP). American Journal of Kidney Diseases, 42, 22-35. Centers for Disease Control and Prevention (CDC). (2002). Annual smoking-attributable mortality, years of potential life lost, and economic costs – United States, 1995-1999. Morbidity and Mortality Weekly Report (MMWR), 51(14), 300-303. Retrieved July 2, 2008, from www.cdc.gov/ mmwr/preview/mmwrhtml/mm511 4a2.htm Centers for Disease Control and Prevention (CDC). (2003a). Cigarette smokingattributable morbidity – United States, 2000. Morbidity and Mortality Weekly Report (MMWR), 52(1435), 842844. Retrieved July 2, 2008, from www.cdc.gov/tobacco/data_statistics/ MMWR/2003/mmwr5235a4.htm

Centers for Disease Control and Prevention (CDC). (2003b). Prevalence of current cigarette smoking among adults and changes in prevalence of current and some day smokingUnited States, 1996-2001. Morbidity and Mortality Weekly Report (MMWR), 52(14), 303-307. Retrieved July 2, 2008, from www.cdc.gov/mmwr/ preview/mmwrhtml/mm5214a2.htm Centers for Disease Control and Prevention (CDC). (2005). Annual smoking-attributable mortality, years of potential life lost, and productivity losses-United States, 1997-2001. Morbidity and Mortality Weekly Report (MMWR), 54(25), 625-628. Retrieved July 2, 2008, from http://www.cdc. gov/mmwr/preview/mmwrhtml/ mm5425a1.htm Chuahirun, T., Simoni, J., Hudson, C., Seipel, T., Khanna, A., Harrist, R.B., et al. (2004). Cigarette smoking exacerbates and its cessation ameliorates renal injury in type 2 diabetes. American Journal of Medical Science, 327(2), 57-67. Coresh, J., Byrd-Holt, D., Astor, B.C., Briggs, J.P., Eggers, P.W., Lacher, D.A., et al. (2005). Chronic kidney disease awareness, prevalence, and trends among U.S. adults, 1999 to 2000. Journal of the American Society of Nephrology, 16(1),180-188. El Nahas, A.M. (1996) Glomerulosclerosis: Intrinsic and extrinsic pathways. Nephrology Dialysis Transplantation, 11, 773-777. Eliasson, B., Taskinen, M.R., & Smith, U. (1996). Long-term use of nicotine gum is associated with hyperinsulinemia and insulin resistance. Circulation, 94, 878-881. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. (2001). Executive Summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III).

Journal of the American Medical Association, 285(19), 2486-2497. Faessel, H.M., Smith, B.J., Gibbs, M.A., Gobey, J.S., Clark, D.J., & Burstein, A.H. (2006). Single-dose pharmacokinetics of varenicline, a selective nicotinic receptor partial agonist, in healthy smokers and nonsmokers. Journal of Clinical Pharmacology. 46(9), 991-998. Findlay, J.W., Van Wyck Fleet, J., Smith, P.G., Butz, R.F., Hinton, M.L., Blum, M.R., et al. (1981). Pharmacokinetics of bupropion, a novel antidepressant agent, following oral administration to healthy subjects. European Journal of Clinical Pharmacology, 21, 127-135. Foulds, J. (2006). The neurobiological basis for partial agonist treatment of nicotine dependence: Varenicline. International Journal of Clinical Practice, 60(5), 571-576. Gambaro, G., Verlato, F., Budakovic, A., Casara, D., Saladini, G., Del Prete, D., et al. (1998). Renal impairment in chronic cigarette smokers. Journal of the American Society of Nephrology, 9, 562-567. GlaxoSmithKline. (2007). Prescribing Information: Zyban® oral sustained-release tablet. Retrieved July 2, 2008, from http://us.gsk.com/products/assets/us_ zyban.pdf Go, A.S., Chertow, G.M., Fan, D., McCulloch, C.E., & Hsu, C.Y. (2004). Chronic kidney disease and the risks for death, cardiovascular events, and hospitalizations. New England Journal of Medicine, 351, 1296-1305. Gonzales, D., Rennard, S.I., Nides, M., Oncken, C., Azoulay, S., Billing, C.B., et al. (2006). Varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs. sustained-release bupropion and placebo for smoking cessation: A randomized controlled trial. Journal of the American Medical Association, 296(1), 47-55 Hajek, P., West, R., Foulds, J., Nilsson, F., Burrows, S., & Meadow, A. (1999). Randomized comparative trial of

Nephrology Nursing Journal Editorial Board Statements of Disclosure In accordance with ANCC-COA governing rules Nephrology Nursing Journal Editorial Board statements of disclosure are published with each CNE offering. The statements of disclosure for this offering are published below. Paula Dutka, MSN, RN, CNN, disclosed that she is a consultant for Hoffman-La Roche and Coordinator of Clinical Trials for Roche. Patricia B. McCarley, MSN, RN, NP, disclosed that she is on the Consultant Presenter Bureau for Amgen, Genzyme, and OrthoBiotech. She is also on the Advisory Board for Amgen, Genzyme, and Roche and is the recipient of unrestricted educational grants from OrthoBiotech and Roche. Holly Fadness McFarland, MSN, RN, CNN, disclosed that she is an employee of DaVita, Inc. Karen C. Robbins, MS, RN, CNN, disclosed that she is on the Speakers’ Bureau for Watson Pharma, Inc.

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nicotine polacrilex, a transdermal patch, nasal spray, and an inhaler. Archives of Internal Medicine, 159, 20332038. Halimi, J.M., Giraudeau, B., Vol, S., Caces, E., Nivet, H., Lebranchu, Y., et al. (2000) Effects of current smoking and smoking discontinuation on renal function and proteinuria in the general population. Kidney International, 58(3), 1285-1292. Hays, J.T., Hurt, R.D., Rigotti, N.A., Niaura, R., Gonzales, D., & Durcan, M.J. (2001). Sustained-release bupropion for pharmacologic relapse prevention after smoking cessation. Annals of Internal Medicine, 35, 423433. Henningfield, J.E., Fant, R.V., Buchhalter, A.R., & Stitzer, M.L. (2005). Pharmacotherapy for nicotine dependence. CA – A Cancer Journal for Clinicians, 55(5), 281-299. Herrera, N., Franco, R., Herrera, L., Partidas, A., Rolando, R., & Fagerstrom, K.O. (1995). Nicotine gum, 2mg and 4mg, for nicotine dependence: A double-blind placebo controlled trial within a behavior modification support program. Chest, 108(2), 447-451. Hjalmarson, A., Nilsson, F., Sjostrom, L., & Wiklund, O. (1997). The nicotine inhaler in smoking cessation. Archives of Internal Medicine, 157, 1721-1728. Hurt, R.D., Dale, L.C., Croghan, G.A., Croghan, I.T., Gomez-Dahl, L.C., & Offord, K.P. (1998). Nicotine nasal spray for smoking cessation: Pattern of use, side effects, relief of withdrawal symptoms and cotinine levels. Mayo Clinical Proceedings, 73, 118-125. Hurt, R.D., Sachs, D.P., Glover, E.D., Offord, K.P., Johnston, J.A., Dale, L.C., et al. (1997). A comparison of sustained-release bupropion and placebo for smoking cessation. New England Journal of Medicine, 337(17), 1195-1202. Hymowitz, N., Cummings, K.M., Hyland, A., Lynn, W.R., Pechacek, T.F., & Hartwell, T.D. (1997) Predictors of smoking cessation in a cohort of adult smokers followed for five years. Tobacco Control, 6(Suppl 2), S57-S62. Jorenby, D.E., Hays, J.T., Rigotti, N.A., Azoulay, S., Watsky, E.J., Williams, K.E., et al. (2006). Efficacy of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist vs. placebo or sustained-release bupropion for smoking cessation: A randomized controlled trial. Journal of the American Medical Association, 296(1), 56-63. NEPHROLOGY NURSING JOURNAL

Keith, D.S., Nichols, G.A., Gullion, C.M., Brown, J., & Smith, D.H. (2004). Longitudinal follow-up and outcomes among a population with chronic kidney disease in a large managed care organization. Archives of Internal Medicine, 164, 659-663. Levey, A.S., Beto, J.A., Coronado, B.E., Eknoyan, G., Foley, R.N., Kasiske, B.L,, et al. (1998) Controlling the epidemic of cardiovascular disease in chronic renal disease: What do we know? What do we need to learn? Where do we go from here? American Journal of Kidney Diseases, 32(5), 853-906. Manley, H.J., Garvin, C.G., Drayer, D.K., Reid, G.M., Bender, W.L., Neufeld, T.K., et al. (2004). Medication prescribing patterns in ambulatory hemodialysis patients: Comparisons of USRDS to a large non-for-profit dialysis provider. Nephrology Dialysis Transplantation, 19, 1842-1848. Molander, L., Hansson, A., Lunell, E., Alainentalo, L., Hoffmann, M., & Larsson, R. (2000). Pharmacokinetics of nicotine in kidney failure. Clinical Pharmacology & Therapeutics, 68(3), 250-260. National Kidney Foundation (NKF). (2001). K/DOQI Clinical practice guidelines for anemia of chronic kidney disease: Update 2000. American Journal of Kidney Diseases, 37, S182238. Erratum in American Journal of Kidney Diseases, 2001, 38, 442. National Kidney Foundation (NKF). (2002). K/DOQI Clinical practice guidelines for chronic kidney disease: Evaluation, classification and stratification. American Journal of Kidney Diseases, 39, S1-S266. National Kidney Foundation.(2003a). K/DOQI clinical practice guidelines for managing dyslipidemias in chronic kidney disease. American Journal of Kidney Diseases, 41, S39-S58. National Kidney Foundation (NKF). (2003b). K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. American Journal of Kidney Diseases, 42, S1-S201. National Kidney Foundation (NKF). (2003c). Kidney early evaluation P program annual data report. American Journal of Kidney Diseases, 42, S1-60. National Kidney Foundation (NKF). (2004). K/DOQI clinical practice guidelines on hypertension and antihypertensive agents in chronic kidney disease. American Journal of Kidney Diseases, 43, S1-S290

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National Kidney Foundation (NKF). (2005). K/DOQI clinical practice guidelines for cardiovascular disease in dialysis patients. American Journal of Kidney Diseases, 45(3 Pt 2), 16-153. Ng, Y.Y., Fan, J.M., Mu, W., NikolicPaterson, D.J., Yang, W.C., Huang, T.P., et al. (1999). Glomerular epithelial-myofibroblast transdifferentiation in the evolution of glomerular crescent formation. Nephrology Dialysis Transplantation, 14, 2860-2872. Okuyemi, K.S., Ahluwalia, J.S., & Harris, K.J. (2000). Pharmacotherapy of smoking cessation. Archives of Family Medicine, 9(3), 270-281. Orth, S.R. (2000). Smoking: A renal risk factor. Nephron, 86,12-26. Pfizer. (2008). Package Insert: Chantix® Varenicline tablets. Retrieved July 2, 2008, from http://www.pfizer.com/ pfizer/download/uspi_chantix.pdf Pomerleau, O.F., & Pomerleau C.S. (1998). Nicotine replacement: A critical evaluation. New York: Alan R Liss, Inc. Preskorn, S.H., & Othmer, S.C. (1984). Evaluation of bupropion hydrochloride: The first of a new class of atypical antidepressants. Pharmacotherapy, 4, 20-34. Rahman, M., Brown, C.D., Coresh, J., Davis, B.R., Eckfeldt, J.H., Kopyt, N., et al. (2004). The prevalence of reduced glomerular filtration rate in older hypertensive patients and its association with cardiovascular disease: A report from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. Archives of Internal Medicine,164, 969-976. Schiffl, H., Lang, S.M., & Fischer, R. (2002). Stopping smoking slows accelerated progression of renal failure in primary renal disease. Nephrology, 15(3), 270-274. Setter, S.M., & Johnson, M.D. (1998). Transdermal nicotine replacement smoking cessation therapy. Annals of Pharmacotherapy, 32, 264-266. Shiffman, S., Dresler, C.M., Hajek, P., Gilburt, S.J.A., Targett, D.A., & Strahs, K.R. (2002). Efficacy of a nicotine lozenge for smoking cessation. Archives of Internal Medicine, 162, 12671276. St. Peter, W.L., Schoolwerth, A.C., McGowan, T., & McClellan, W.M. (2003). Chronic kidney disease: Issues and establishing programs and clinics for improved patient outcomes. American Journal of Kidney Diseases, 5, 903-924.

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Thompson, G.H., & Hunter, D.A. (1998). Nicotine replacement therapy. Annals of Pharmacotherapy, 32, 1067-1075. Tonstad, S., Tonnesen, P., Hajek, P., Williams, K.E., Billing, C.B., & Reeves, K.R. (2006). Effect of maintenance therapy with varenicline on smoking cessation: A randomized controlled trial. Journal of the American Medical Association, 296(1), 64-71 United States Renal Data System (USRDS). (2000). 2000 annual data report. Bethesda, MD: The National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases. United States Renal Data Systems (USRDS). (2004). 2004 annual data report. Bethesda, MD: National Institutes of Health, National Institute of Diabetes, Digestive, and Kidney Diseases. Worrall, S.P., Almond, M.K., & Dhillon, S. (2004). Pharmacokinetics of bupropion and its metabolites in haemodialysis patients who smoke. A single dose study. Nephron Clinical Practice, 97(3), 83-89. Yu, H.T. (2003). Progression of chronic renal failure. Archives of Internal Medicine, 163, 1417-1429.

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Smoking Cessation Therapy Considerations for Patients with Chronic Kidney Disease

ANNJ0810

ANSWER/EVALUATION FORM Smoking Cessation Therapy Considerations for Patients With Chronic Kidney Disease

Harold J. Manley, PharmD, FASN, FCCP, BCPS; Nicole M. Stack, PharmD 1.9 Contact Hours Expires: August 31, 2010 ANNA Member Price: $15 Regular Price: $25

Complete the Following: Name: ____________________________________________________________ Address: __________________________________________________________

Posttest Instructions • Select the best answer and circle the appropriate letter on the answer grid below. • Complete the evaluation. • Send only the answer form to the ANNA National Office; East Holly Avenue Box 56; Pitman, NJ 080710056; or fax this form to (856) 5897463. • Enclose a check or money order payable to ANNA. Fees listed in payment section. • If you receive a passing score of 70% or better, a certificate for the contact hours will be awarded by ANNA. • Please allow 2-3 weeks for processing. You may submit multiple answer forms in one mailing, however, because of various processing procedures for each answer form, you may not receive all of your certificates returned in one mailing.

__________________________________________________________________ Telephone: ______________________ Email: _____________________________ CNN: ___ Yes ___ No

CDN: ___ Yes ___ No

CCHT: ___ Yes ___ No

Payment: ANNA Member: ____ Yes ____ No Check Enclosed

Member #___________________________

American Express

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Total Amount Submitted: _________________ Credit Card Number: _______________________________ Exp. Date: _______ Name as it Appears on the Card: ______________________________________ Special Note Your posttest can be processed in 1 week for an additional rush charge of $5.00. ■ Yes, I would like this posttest rush processed. I have included an additional fee of $5.00 for rush processing.

Online submissions through a partnership with HDCN.com are accepted on this posttest at $20 for ANNA members and $30 for nonmembers. CNE certificates will be available immediately upon successful completion of the posttest. Note: If you wish to keep the journal intact, you may photocopy the answer sheet or access this posttest at www.annanurse.org/journal 1. What would be different in your practice if you applied what you have learned from this activity?

To increase awareness about smoking cessation therapy for patients with chronic kidney disease.

____________________________________________________________ ____________________________________________________________ ____________________________________________________________ ____________________________________________________________ ____________________________________________________________ ____________________________________________________________

Please note that this continuing nursing education activity does not contain multiple-choice questions. This posttest substitutes the multiple-choice questions with an open-ended question. Simply answer the open-ended question(s) directly above the evaluation portion of the Answer/Evaluation Form and return the form, with payment, to the National Office as usual.

Strongly disagree

Evaluation 2. By completing this offering, I was able to meet the stated objectives a. Explain how nicotine replacement therapy, bupropion, and varenicline are used as methods of smoking cessation therapy. b. Describe the pharmacokinetics of bupropion and varenicline. c. Discuss smoking cessation outcomes in patients with CKD. 3. The content was current and relevant. 4. This was an effective method to learn this content. 5. Time required to complete reading assignment: _________ minutes.

1 1 1 1 1

2 2 2 2 2

Strongly agree

3 3 3 3 3

4 4 4 4 4

5 5 5 5 5

I verify that I have completed this activity ________________________________________________________________________________ (Signature)

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