Smoking Cessation Handout 1 pp Fall 2024 PDF

Smoking Cessation Pharmacotherapy Whitney Maxwell, PharmD, MBA, BCPS [email protected]...

Smoking Cessation Pharmacotherapy Whitney Maxwell, PharmD, MBA, BCPS [email protected] Office phone: (803)777-4715 http://medicalxpress.com/news/2013-06-reveals-undertreated-chronic-conditions.html Objectives  Appreciate epidemiology of tobacco use & smoking cessation  Assesstobacco use & intervene using a patient-centered approach  Apply pharmacologic and clinical principles for pharmacotherapy selection  Provideappropriate smoking cessation interventions and pharmacotherapy in both community and clinic settings  Epidemiology of Tobacco Use Leading cause of preventable death and morbidity in U.S.  ~14% of the U.S. population (~30 m) smokes  ~440,000 premature deaths annually  $96 billion/yr in direct medical expenses 2018 ACC Tobacco Cessation Consensus Decision Pathway. JACC 2018;72(25):3332-3365. Treating Tobacco Use and Dependence: 2008 Update. U.S. Department of Health and Human Services. 2008. Epidemiology of Smoking Cessation  70% of smokers want to quit  44% attempt to quit each year  10 cigarettes/day Nicotine patch 6 weeks: 14 mg/24 hours 6 weeks: 21 mg/24n=6 (12%) hours 2 weeks: 7 mg/24 hours 2 weeks: 14 mg/24 hours 2 weeks: 7 mg/24 hours JAMA 2012;308:1573-1580. NEJM 2011;365:1222-1231. http://rxforchange.ucsf.edu/curricula/teaching_materials.php Nicotine Replacement Therapy  Nicotine Transdermal Patch  Adverse Effects:  Local skin reactions  Insomnia  Vivid dreams  Headache  Disadvantages:  Cannot titrate dose to control cravings/withdrawal  Advantages:  Slowrelease of nicotine  Once daily dosing/adherence JAMA 2012;308:1573-1580. NEJM 2011;365:1222-1231. http://rxforchange.ucsf.edu/curricula/teaching_materials.php Nicotine Replacement Therapy  Nicotine Lozenges  Directions  Do not use within 15 minutes of eating/drinking  Do not chew or swallow  Do not exceed 20 lozenges per day  Dosing Regimen: Weeks 1-6 Weeks 7-9 Weeks 10-12 1 lozenge Q 1-2 hrs 1 lozenge Q 2-4 hrs 1 lozenge Qn=6 4-8 (12%) hrs  Lozenge dose:  High dependence: (smoking < 30 min of waking) = 4mg  Low dependence: (smoking ≥ 30 min of waking) = 2mg JAMA 2012;308:1573-1580. NEJM 2011;365:1222-1231. http://rxforchange.ucsf.edu/curricula/teaching_materials.php Nicotine Replacement Therapy  Nicotine Lozenges  Adverse Effects:  Nausea  Insomnia  Headache  Hiccups  Cough  Heartburn  Flatulence  Disadvantages:  Frequent dosing required  Advantages:  Easy to use and titrate to control cravings  Can be used in smokers with poor dentition/dentures  May delay weight gain JAMA 2012;308:1573-1580. NEJM 2011;365:1222-1231. http://rxforchange.ucsf.edu/curricula/teaching_materials.php Nicotine Replacement Therapy  Nicotine Gum  Directions:  Do not use within 15 minutes of eating/drinking  Chew slowly until tingling or peppery taste, then “park”  Do not exceed 24 pieces of gum per day Weeks 1-6 Weeks 7-9 Weeks 10-12  Dosing Regimen: 1 piece Q 1-2 hours 1 piece Q 2-4 hours 1 piece Q 4-8 hours  Gum dose: n=6 (12%)  High dependence: 4mg  Low dependence: 2mg JAMA 2012;308:1573-1580. NEJM 2011;365:1222-1231. http://rxforchange.ucsf.edu/curricula/teaching_materials.php Nicotine Replacement Therapy  Nicotine Gum  Adverse Effects:  Mouth soreness  Hiccups  Upset stomach (ulcers, reflux)  Jaw muscle ache  Disadvantages:  Frequent dosing required  May stick to dental work  Proper chewing technique required to limit side-effects  Advantages:  Easyto use and titrate to control cravings  Might delay weight gain JAMA 2012;308:1573-1580. NEJM 2011;365:1222-1231. http://rxforchange.ucsf.edu/curricula/teaching_materials.php Nicotine Replacement Therapy  Nicotine Inhaler  Directions:  Do not use within 15 minutes of eating  Inhale into back of throat or puff in short breaths  Inhaler will last for about 20 minutes of puffing  Open cartridge remains potent for ≤ 24 hours  Do not exceed 16 cartridges/day  Dosing Regimen: Weeks 1-12 Weeks 12-18 n=6 (12%) 6 cartridges/day initially, titrate PRN Gradually reduce the # doses/day  Inhaler dose:  Each 10 mg cartridge has 4 mg of nicotine JAMA 2012;308:1573-1580. NEJM 2011;365:1222-1231. http://rxforchange.ucsf.edu/curricula/teaching_materials.php Nicotine Replacement Therapy  Nicotine Inhaler  Adverse Effects:  Mild irritation in mouth or throat (initially)  Unpleasant taste or cough (initially)  Runny nose  Upset stomach  Hiccups  Headache  Disadvantages:  Need for frequent dosing & frequent puffing  Visible during use  Advantages:  Easy to use and titrate to control cravings  “Hand-to-mouth” ritual mimicry  Device assembly can be difficult JAMA 2012;308:1573-1580. NEJM 2011;365:1222-1231. http://rxforchange.ucsf.edu/curricula/teaching_materials.php Nicotine Replacement Therapy  Nicotine Nasal Spray  Directions:  Do not use within 5 minutes of driving  Prime, tilt head back, spray while mouth breathing  Do not inhale, do not blow nose within 2-3 minutes  Do not exceed 5 doses/hour or 40 doses/day  Dosing Regimen: Weeks 1-6 (or 8) Weeks 9-12 (or 14) 1-2 doses/hr initially, titrate PRN n=6 (12%) Attempt to reduce the # doses/day  Nasal spray dose:  1 dose = 2 sprays (1 spray per nostril @ 0.5 mg/spray)  1 mg of nicotine per dose JAMA 2012;308:1573-1580. NEJM 2011;365:1222-1231. http://rxforchange.ucsf.edu/curricula/teaching_materials.php Nicotine Replacement Therapy  Nicotine Nasal Spray  Adverse Effects: (usually lessen after a few days to 1 week)  Hot peppery feeling in back of throat or nose  Sneezing/nasal mucosa irritation  Coughing  Watery eyes  Runny nose  Disadvantages:  Addiction potential due to rapid nicotine delivery  Need for frequent dosing  Advantages:  Easy to use and titrate to control cravings  Rapid nicotine delivery  Less insomnia compared to other formulations JAMA 2012;308:1573-1580. NEJM 2011;365:1222-1231. http://rxforchange.ucsf.edu/curricula/teaching_materials.php Nicotine Replacement Therapy - Recap NRT Type Advantages Disadvantages Patch Slow release of Cannot titrate dose to control nicotine cravings/withdrawal Once daily dosing/adherence Gum Easy to use and titrate Frequent dosing required to control cravings May stick to dental work Might delay weight Proper chewing technique gain required to limit side-effects Lozenge Easy to use and titrate Frequent dosing required to control cravings Can be used in smokers with poor dentition May delay weight gain Nasal Spray Easy to use and titrate Addiction potential due to rapid to control cravings nicotine delivery Rapid nicotine delivery Need for frequent dosing Inhaler Easy to use and titrate Need for frequent dosing/puffing to control cravings Visible during use “Hand-to-mouth” ritual Device assembly can be difficult mimicry JAMA 2012;308:1573-1580. NEJM 2011;365:1222-1231. http://rxforchange.ucsf.edu/curricula/teaching_materials.php Varenicline (Chantix ) ®  Contraindications /Cautions/Warnings  Hypersensitivity  Serious skin reactions  Angioedema  Accidental injury (somnambulism)  Severe renal impairment  Pregnancy Category C  ↑ effects of alcohol , seizure risk (3/2015 FDA Safety communication)  Serious or unstable psychiatric disorders  Suicidal, homicidal, or assaultive behavior in last 12 months  Cardiovascularevents (6/2011 FDA safety communication)  Neuropsychiatric Adverse Events JAMA 2012;308:1573-1580. NEJM 2011;365:1222-1231. Chantix Package Label. http://rxforchange.ucsf.edu/curricula/teaching_materials.php  ® Varenicline (Chantix )  Contraindications /Cautions/Warnings  Cardiovascular events  (6/2011 FDA safety communication; caution statement remains on package label)  “…several larger meta-analyses, a large retrospective cohort study and a clinical trial among smokers with ACS [acute coronary syndrome] found no increases in CV risk with varenicline.”  CATS trial (>6,000 smokers enrolled) indicated no significant increase in CV events with varenicline compared to placebo or NRT  Some observational studies with conflicting results  “Given the overall data, the committee considered varenicline to be safe for use in stable CVD and, with caution, in patients with ACS…” 2018 ACC Tobacco Cessation Consensus Decision Pathway. JACC 2018;72(25):3332-3365 JAMA Intern Med 2018;178(5):622-626.  ® Varenicline (Chantix )  Contraindications /Cautions/Warnings  Black box warning for serious neuropsychiatric events removed in 2016 (Caution statement remains on package label)  EAGLES trial (multi-national, multi-center, randomized, double-blind, placebo-controlled) published in 2016 indicated no significant increase in neuropsychiatric adverse events with varenicline compared to placebo or nicotine patch 2018 ACC Tobacco Cessation Consensus Decision Pathway. JACC 2018;72(25):3332-3365. Lancet 2016;387:2507-2520.  Varenicline (Chantix ) ®  Directions  Take with a full glass of water after meals  Stop varenicline & notify healthcare provider of any agitation, hostility, depressed mood, atypical behavior/thinking, suicidal ideation, or suicidal behavior occur.  Use caution when operating heavy machinery  Dosing Regimen: 7 days before Quit Date Quit Date Day 1-3 Day 4-7 Thereafter 0.5 mg daily 0.5 mg twice daily 1 mg twice daily  End-organ dysfunction Renal: CrCl 6,000 smokers enrolled) indicated no significant increase in CV events with bupropion compared to placebo or NRT 2018 ACC Tobacco Cessation Consensus Decision Pathway. JACC 2018;72(25):3332-3365. JAMA Intern Med 2018;178(5):622-626.  Bupropion SR (Zyban ) ®  Directions:  Take doses >8 hrs apart, but do not take PM dose at bedtime to reduce insomnia  Do not crush, divide, or chew tablets  Stop bupropion & notify healthcare provider of any agitation, hostility, depressed mood, atypical behavior/thinking, suicidal ideation, or suicidal behavior occur.  Dosing Regimen: 7 days before Quit Date Quit Date Day 1-3 Day 4-7 Thereafter 150 mg daily in AM 150 mg twice daily 150 mg twice daily  End-organ dysfunction  Renal: no adjustment; Hepatic: max dose is 150 mg QOD JAMA 2012;308:1573-1580. NEJM 2011;365:1222-1231. Zyban Package Label. http://rxforchange.ucsf.edu/curricula/teaching_materials.php Bupropion SR (Zyban ) ®  Side Effects:  Insomnia (35-40%)  Tremor (rare)  Rash (rare)  Constipation  Seizure (0.1%)  Disadvantages  Drug interactions (CYP 2B6 substrate, CYP 2D6 inhibitor)  Advantages  Easeof use, BID dosing  May delay weight gain  FDA approved for combination with nicotine patch JAMA 2012;308:1573-1580. NEJM 2011;365:1222-1231. Zyban Package Label. http://rxforchange.ucsf.edu/curricula/teaching_materials.php  Combination Therapy Consider combination therapy when single-agent therapy does not provide adequate efficacy: Varenicline + single NRT product or Bupropion + single NRT product 2018 ACC Tobacco Cessation Consensus Decision Pathway. JACC 2018;72(25):3332-3365 Pharmacotherapy 3rd Line Options Nortriptyline Pharmacotherapy Future Option? Cytisine (Tabex®) Cytisine (Tabex®)  Precautions/contraindications/warnings  Contraindications: severe hypertension & atherosclerosis  May exacerbate psychosis in patients with schizophrenia New Engl J Med. 2014;371:25:2353-2362. https://www.tabex.net/patient-details.php Cytisine (Tabex®)  Directions  Initiatetherapy 5 days prior to quit date while tapering smoking  Dosing Regimen:  1.5 – 9 mg daily x 25 days  1st-3rd day: 1 tablet (1.5 mg) Q 2 hours (6 tabs daily)  4th to 12th day: 1 tablet Q 2.5 hours (5 tabs daily)  13th to 16th day: 1 tablet Q 3 hours (4 tabs daily)  17th to 20th day: 1 tablet Q 5 hours (3 tabs daily)  21st to 25th day: 1 - 2 tabs daily New Engl J Med. 2014;371:25:2353-2362. LexiComp https://www.tabex.net/patient-details.php Cytisine (Tabex®)  Adverse Effects:  N/V  Sleep disorders  Disadvantages:  Not currently approved by the FDA  Internet sales: counterfeit or low quality risk  Same theoretical concerns in patients with mental health disorders as varenicline  t½ = 4.8 hours, so multiple doses required  Advantages:  Has been shown to be superior to NRT (patch + gum or lozenge)  Low cost (currently) ~$30 for 100 tablets (1.5 mg) New Engl J Med. 2014;371:25:2353-2362. Special Considerations Pharmacotherapy for Patients with CVD Preference Stable CVD Inpatient with ACS (Unstable CVD) 1st line: Varenicline In-hospital: or Nicotine patch Combo NRT or Combo NRT Discharge: Varenicline or Combo NRT 2nd line: Bupropion Discharge: or Single NRT product Single NRT product 3rd line: Nortriptyline Bupropion Single Varenicline + single NRT product n/a Agent or Ineffective: Varenicline + Bupropion or Bupropion + single NRT product 2018 ACC Tobacco Cessation Consensus Decision Pathway. JACC 2018;72(25):3332-3365  Gradual Reduction & Medication Preloading  Strategiesfor patient who are open, but not willing to set a quit date within 30 days  Gradual reduction:  Quitrate may be similar to abrupt cessation  Varenicline assisted gradual reduction (3 months) has been studied and ↑ quit rates  Preloading pharmacotherapy  Initiatingpharmacotherapy while still smoking  Goal: reducing satisfaction from smoking, ↓ # cigarettes/day 2018 ACC Tobacco Cessation Consensus Decision Pathway. JACC 2018;72(25):3332-3365 Duration of Smoking Cessation Therapies Therapy option Suggested duration Nicotine patch ≤ 3 months Nicotine gum ≤ 3 months Nicotine lozenges 3-6 months Nicotine inhaler ≤ 6 months Nicotine nasal spray 3-6 months Bupropion SR (Zyban®) 3-6 months Varenicline (Chantix®) 3-6 months  2008 Guidelines:  “The Lung Health Study of almost 4,000 smokers…reported that approximately one-third of long-term quitters still were using nicotine gum at 12 months, and some for as long as 5 years , with no serious side-effects” JAMA 2012;308:1573-1580. NEJM 2011;365:1222-1231. Rx For Change Website. Treating Tobacco Use and Dependence: 2008 Update. U.S. Department of Health and Human Services. 2008. NRT duration & use while smoking  April 2013 FDA Update  Recommended changes to labeling of OTC NRT:  Remove: warning against use of NRT while smoking or using other nicotine-containing products  Remove: specific durations of OTC NRT products  Replace with: instructions for patients to contact a healthcare provider if they feel they need to use NRT products for longer time periods to prevent relapse http://www.fda.gov/forconsumers/consumerupdates/ucm345087.htm Vaping and e-Cigarettes Safety of Electronic Cigarettes  Battery-operated devices with nicotine & flavor filled cartridges  July 2009 FDA News Release  Electronic cigarettes contain carcinogens (nitrosamines) & toxic chemicals (diethylene glycol)  E-cigarettes have been regulated by the FDA since 2016 http://www.ash.org.uk/files/documents/ASH_715.pdf Circulation 2014;129:1972-1986. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm173222.htm  Public Health Concerns https://www.fda.gov/tobacco-products/youth-and-tobacco/2018-nyts-data-startling-rise-youth-e-cigarette-use Public Health Concerns www.nejm.org/v Clinician Resources  http://rxforchange.ucsf.edu/resources.php  http://www.treatobacco.net/  www.surgeongeneral.gov/tobacco  http://www.who.int/tobacco/publications/smokin g_cessation/en/  http://www.fip.org/projectsfip/pharmacistsagains ttobacco/ Patient Resources  http://smokefree.gov/  www.quitnet.com  http://www.lung.org/stop-smoking/  http://www.ffsonline.org/  1-800-QUI-TNOW  Smoking Cessation Case Scenarios (These cases will be worked through in class – this is not a pre-class assignment) Patient Case Scenario #1 Past medical history: Hypertension, diabetes, dyslipidemia, and peripheral arterial disease Past social history: Cigarette smoking: 1.5 packs per day for 20 years 2-5 servings of alcohol most nights of the week Employment status: Attorney (job-related stress) Past quit attempts: 1 (unsuccessful) - Quit “cold turkey” for 2 days - anxious & irritable Readiness to quit: Not willing to quit today or in the next 6 months On a scale of 1-10, desire to quit smoking is a 3 First morning cigarette smoked within 5 min of waking Notes: Patient Case Scenario #2 (same patient as Scenario #1, just 5 years later) Past medical history: COPD (recently diagnosed) heart attack (1 year ago), angina (recently diagnosed; has symptoms frequently) hypertension, diabetes, dyslipidemia, and peripheral arterial disease Past social history: Cigarette smoking: 1.5 packs per day for 25 years 1-2 servings of alcohol most nights of the week Employment status: Retired attorney Past quit attempts: 1 (unsuccessful) - Quit “cold turkey” for 2 days - anxious & irritable Readiness to quit: Ready to quit in the next few weeks On a scale of 1-10, desire to quit smoking is a 9 First morning cigarette will be hardest to give up Notes: Patient Case Scenario #3 (same patient as Scenario #1 & 2, just 4 months after Scenario #2) Past medical history: COPD heart attack (~1.5 years ago) angina (no symptoms in the last 5 months) hypertension, diabetes, dyslipidemia, and peripheral arterial disease Past social history: Cigarette smoking: quit completely for 4 months, but had occasional slips in the last few weeks 1-2 servings of alcohol most nights of the week Employment status: Retired attorney Past quit attempts: Attempt 1: Quit “cold turkey” for 2 days - anxious & irritable (unsuccessful) Attempt 2: o Ongoing (CO monitor (+) for last 24-48 hrs) o Has been taking varenicline exactly as prescribed with no adverse effects Notes: