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4000
3500
per capita consumption
# cigs/person/yr
3000
2500
2000
1500
1000
500
0
00
30
40
60
70
00
10
20
50
80
90
04
19
19
19
19
19
19
19
19
19
19
20
20
Year
STATE-SPECIFIC
PREVALENCE of SMOKING
among ADULTS, 2002
Illinoi
Californi s
Kentuck
a 22.9
y
16.4% %
32.6%
Nevada
26.0% New York
22.4%
Utah
12.7% Florida
Texas 22.1 %
22.9%
Centers for Disease Control and Prevention. MMWR 2004;52:1277–1280.
TRENDS in ADULT SMOKING, by
SEX—U.S., 1955–2002
Trends in cigarette current smoking among persons aged 18 or older, by sex
60
22.5% of
50 Male adults are
40 current
30
smokers
Percent
25.2%
20
Female
20.0%
10
0
1955 1959 1963 1967 1971 1975 1979 1983 1987 1991 1995 1999
Year
35
30
Native Amer/
Alaska Native
25
White Non-Hisp
% Smokers
20
Black Non-Hisp
15
Hispanic
10
Asian/ Pacific Isl
Ethnicity
Prevalence of Adult Smoking by Education1
50
45
40
35
% smoker
30
25
20
15
10
60
50
40
30
%
Male
Female
20
10
0
1965 1970 1975 1980 1985 1990 1995 2000 2003
Smoking Mortality
Smoking remains the leading preventable
cause of death in the US
1 out of 5 deaths
438,000 deaths annually
Projected death toll – end of 21st century
Expected to reach 1 billion total
100 million mark reached at the end of 1900’s
Economic Impact of Smoking
Medical expenditures
$75.5 billion
Productivity
$ 82 billion
Total cost (annual)
$ 157.5 billion
Health Risks
Cardiovascular disease
Lung disease (COPD)
Cancer
Sexual dysfunction
Osteoporosis
Delayed post-surgical healing
Periodontal disease
Health Risks of 2 -Hand Smoke
nd
SIDS
Asthma
Growth retardation (children)
Cancer
Cardiovascular disease
Otitis media (↑ incidence in children)
Health Benefits of Quitting
20 minutes - BP↓, HR↓
8 hours – Carbon monoxide ↓, O2 ↑ to
normal levels
24 hours – Risk of heart attack ↓
48 hours – Nerve endings regenerate,
sense of taste and smell return to normal
QUITTING: HEALTH
BENEFITS2
Time Since Quit Date
Circulation improves, Lung cilia regain normal
walking becomes easier 2 weeks
to function
3 months
Lung function increases Ability to clear lungs of mucus
1 to 9
up to 30% months increases
Excess risk of CHD Coughing, fatigue, shortness of
1
decreases to half that of a year breath decrease
continuing smoker
5
Risk of stroke is reduced to that
Lung cancer death rate years of people who have never
drops to half that of a smoked
continuing smoker 10
years
Risk of cancer of mouth,
throat, esophagus, after Risk of CHD is similar to that of
bladder, kidney, pancreas 15 years people who have never smoked
decrease
BENEFICIAL EFFECTS of
QUITTING: PULMONARY
EFFECTS
AT ANY AGE, there are benefits of
quitting Never smoked
or not susceptible
100 to smoke
FEV1 (% of value at age 25)
75
Stopped smoking
Smoked
at 45 (mild COPD)
regularly and
50
susceptible to
effects of smoke
Disability
25
Stopped smoking
Death at 65 (severe
COPD)
0
25 50 75
Age (years)
COPD = chronic obstructive pulmonary disease
Heatherton TF, Kozlozwski LT, Frecker RC, Fagerstrom KO. The Fagerstrom
Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance
Questionnaire. Br J Addict 1991;86:1119-1127.
IS A PATIENT READY TO
QUIT?
Does the patient use tobacco?
Yes No
Fiore et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline.
Rockville, MD: USDHHS, PHS, 2000.
Assist
Not ready to quit
Motivational intervention
Repeat offers at future visits
Ready to quit
Enroll in smoking cessation program
Recently quit
Continued support
Assisting Patients With Quitting
Discuss key issues
Motivation to quit
Confidence in abiltiy to quit
Triggers
Routines associated with smoking
Stress-related smoking
Social support (family, friends)
Weight gain
Withdrawal
Assisting Patients With Quitting
Facilitate
Tobacco use log
Identifies smoking patterns and triggers
When and why
Pros & cons of different cessation methods
Coping strategies
Environmental control
Behavior modification
Assisting With Weight Gain
Average ↑ = 10 lbs.
Good eating habits
Discourage dieting while trying to quit
Recommend healthy snacks, sugarless gum
Increase physical activity
Non-food rewards
Assisting With Withdrawal
Educate patient to recognize
Anger, irritability
Anxiety
Cravings
Restlessness
Impatience
Sleep disturbances
Nervousness
Arrange
Follow-up care
In person or by phone
Verify phone #, cell, HIPPA
Increased # of visits = higher success rate
First appointment – 1 week after quit date
Second appointment – 30 days or less
Depends on progress, pt needs
Quit Rate : Visit Ratio 2
0-1 12.4
2-3 16.3
4-8 20.9
>8 24.7
Methods For Quitting
Non-Pharmacologic
“Cold turkey”
Unassisted tapering
Lighter brand
↓ allotment per day
Special filters or holders
Assisted tapering
LifeSign® - computerized schedule with telephone
support
Methods For Quitting
Self-help programs
Massage therapy
Acupuncture
Hypnosis
Pharmacologic Methods For
Quitting
Nicotine Replacement Therapy (NRT)
Gum, lozenge, patch, nasal spray, inhaler
Psychotropics
Bupropion SR
Partial nicotine agonist
Varenicline (Chantix®)
Other
Clonidine, nortriptyline, etc.
Nicotine Replacement Therapy
Reduces intensity of physical withdrawal
symptoms from nicotine
Allows patient to focus on behavioral and
psychological aspects of smoking
cessation
Beware: Nicotine replacement therapy
can also be addicting!
Nicotine Replacement Therapy
Advantages
No carcinogens or toxic agents
Slower, lower, less variable nicotine levels
Antagonizes the reinforcing action of repeated
smoking
Delays weight gain
Nicotine Replacement Therapy
Disadvantages
Cardiovascular
CI in post-MI (< 2 weeks), arrhythmias, unstable
angina
TMJ
Gum only
Pregnancy and lactation
Category D
Nicotine Replacement Products
Nicotine Gum (Nicorettte®, generics) OTC
Nicotine polacrilex resin complex
Sugar-free
Buffered to ↑ buccal absorption
Flavored (regular, mint, orange)
Strengths – 2 mg, 4 mg
Dose
> 25 cigs/day – 4 mg
< 25 cigs/day – 2 mg
Nicotine Gum
Peak effect – 30 min (cigs = 10 min)
Fixed dosing schedule
Weeks 1-6 – 1 pc. Q 1-2 hrs (9 pc./d, max 24)
Weeks 7-9 – 1 pc. Q 2-4 hrs
Weeks 10-12 – 1 pc. Q 4-8 hrs
RCT’s – 50% higher success rate than
placebo , 4 mg > 2 mg in heavy smokers
Nicotine Gum
Patient Information
Place 1 piece of gum at a time in mouth
Chew slowly
Stop chewing at first sign of taste
Park between cheek and gum
Repeat prn (fades in ~ 30 min.)
Do not eat or drink for 15 min. before or
while chewing gum. Coffee, cola, acidic
juices, wine decrease absorption
Nicotine Gum
ADR’s
Lightheadedness
Belching
Hiccups
Headache
GI upset
Jaw muscle ache
Nicotine Lozenge
Commit OTC
Nicotine polacrilex
25% more nicotine absorption than gum
Sugar-free
Mint flavored
Buffered
Strengths – 2 mg, 4 mg
Nicotine Lozenge
Dose – based on “Time to First Cigarette”
(TTFC) after waking
TTFC < 30 min – 4 mg
TTFC > 30 min – 2 mg
Max = 9pc./day
Based in fixed schedule like gum
RCT’s – 50% higher success rate than
placebo
Nicotine Lozenge
Patient Information
Place one lozenge at a time in mouth and allow
to dissolve slowly
Will experience warm, tingling sensation
Switch lozenge from side to side
Do not chew or swallow
Effect will last 20-30 minutes
Do not eat or drink for 15 min. before or while
using. Coffee, cola, acidic juices, wine decrease
absorption
Nicotine Patch
Nicoderm CQ, Nicotrol®, generics OTC
General composition
Top layer - impermeable surface layer
Middle layer – nicotine reservoir
Bottom layer (closest to skin) – adhesive layer
Nicotine absorption via skin avoids 1st
pass metabolism
TRANSDERMAL NICOTINE
PATCH:
COMPARISON2
Product Nicotrol Nicoderm Generics
CQ
Nicotine
delivery 16 hours 24 hours 24 hours
Strength 5 mg patch 7 mg patch 7 mg patch
10 mg 14 mg patch 14 mg patch
patch 21 mg patch 21 mg patch
15 mg
patch
NICOTINE PATCH: DOSING2
Product Light Smoker Heavy Smoker
Nicotrol ≤10 cigarettes/day >10 cigarettes/day
Not indicated Step 1 (15 mg x 6 weeks)
Step 2 (10 mg x 2 weeks)
Step 3 (5 mg x 2 weeks)
Nicoderm CQ ≤10 cigarettes/day >10 cigarettes/day
Step 2 (14 mg x 6 weeks) Step 1 (21 mg x 6 weeks)
Step 3 (7 mg x 2 weeks) Step 2 (14 mg x 2 weeks)
Step 3 (7 mg x 2 weeks)
Generic ≤10 cigarettes/day >10 cigarettes/day
(formerly Habitrol) Step 2 (14 mg x 6 weeks) Step 1 (21 mg x 4 weeks)
Step 3 (7 mg x 2 weeks) Step 2 (14 mg x 2 weeks)
Step 3 (7 mg x 2 weeks)
Generic ≤15 cigarettes/day >15 cigarettes/day
(formerly ProStep) 11 mg x 6 weeks 22 mg x 6 weeks
Nicotine Patch Facts
Plasma levels 50% less than cigarettes
Slow delivery system
Alleviates withdrawal (not so with gum,
lozenge, spray, inhaler)
RCT’s – 50% higher abstinence rate vs.
placebo
Highest compliance rate among NRT’s
Nicotine Patch
Patient Information
Choose area on upper body or arm
Choose hairless area (do not shave)
Avoid inflamed or irritated areas
Rotate sites daily
Do not use same area for at least a week
Do not cut patches
Wash hands after application, avoid eyes
OK to swim, bathe, shower
Do not smoke while on the patch
Nicotine Patch
ADR’s
Mild redness (24 hrs) after removal
Itching, burning, tingling – 50%
OK to try OTC topical steroid or H1 antagonist
Headache
Vivid dreams (remove HS)
Nicotine Nasal Spray
Nicotrol NS® Rx
Aqueous nicotine solution
Metered dose delivers 0.5 mg
nicotine/spray
Rapid mucosal absorpton
Fastest onset of all NRT’s (11-13 min.)
Dose = 2 sprays (1mg)
One bottle = 160 sprays
Nicotine Nasal Spray
Dosing schedule
Initial = 1-2 sprays q nostril/hr prn
Max 10 sprays/hr
Titrate up prn
Usual dose = 16 sprays/day x 6-8 weeks,
taper down over subsequent 4-6 weeks
Precautions – nasal disorders, asthma
High abuse potential d/t fast nicotine
release
Nicotine Nasal Spray
Patient Information
Remove cap (safety cap)
Prime pump before first use or if > 24 hrs since
last use
Blow nose if necessary
Tilt head back, insert tip and spray into nostril
Do not sniff in or inhale while spraying
Wait at least 3 min before blowing nose again
Do not smoke while using the spray
Wait 5 min before driving or operating machinery
Nicotine Nasal Spray
ADR’s
Hot, peppery sensation in nose and back
of throat – 94%
Cough
Watery eyes
Runny nose
Most sx diminish in 3 weeks
81% report continued sx at lower intensity
Nicotine Inhaler
Nicotrol Inhaler® Rx
Nicotine oral inhaler system
Re-usable mouthpiece and porous cartridge (10 mg)
Delivers 4 mg nicotine vapor + menthol to decrease
irritation
Buccal absorption
Active puffing x 20 min = ~ 4 mg nicotine (2 mg
absorbed)
Satisfies hand-to-mouth behavior
Nicotine Inhaler
Dosing
6 cartridges/day
Increase prn to max 16 cartridges/day
12 weeks duration
Taper over subsequent 6-12 weeks
Peak
30 min
50-70% lower plasma levels than cigarettes
Nicotine Inhaler
Patient Information
Take small puffs as if lighting a pipe
Actively puff for 20 minutes (not necessarily all
at once)
Avoid deep inhalation (↑lung absorption,↑SE)
Discard cartridge after 24 hrs
Wash mouthpiece regularly
Do not smoke while using the inhaler
Do not eat or drink for 15 min. before or while
using inhaler. Coffee, cola, acidic juices, wine
decrease absorption
Nicotine Inhaler
ADR’s
Mild mouth and throat irritation
Unpleasant taste
Cough
Dyspepsia
Hiccups
Headache
Rhinitis
Bupropion SR
Zyban®, generics Rx
Oral tablet formulation
Antidepressant
NE and dopamine
Cravings – dopamine reward pathway
Withdrawal - NE
Bupropion SR
Kinetics
5-20% bioavailable
CYP2B6 metabolism (tegretol↓, ritonavir↑)
MAOI interaction
87% renal elimination
t1/2 = 21 hrs (parent drug)
20-27 hrs (metabolite)
Steady state 5-8 days
Bupropion Dosing
Day 1-3 – 150mg qd
Thereafter 150mg bid x 7-12 weeks
Studies > 12 weeks show lower relapse rate
Begin treatment 1 week prior to quitting
Bupropion Contraindications
Seizure disorder
Anorexia
Bulemia nervosa
Abrupt d/c of alcohol or benzodiazepines
Bupropion ADR’s
Insomnia (30-40%)
Take second dose 8 hrs later
Dry mouth (11%)
Tremor (3%)
Skin rash (2%)
Bupropion
Advantages
No adverse effects of nicotine
Can be used in combination with NRT
Disadvantages
Seizure risk
Drug interactions
If ineffective after 7 weeks then d/c
Other Pharmacologic Therapies
Clonidine
Nortriptyline
SSRI’s
Mecamylamine
Benzodiazepines
Rimonabant (Acomplia®)
Nicotine vaccine (NicVax®)
Combination Therapies
Long-acting + short-acting
Patch + (gum, lozenge, inhaler, spray)
Use only in patients unable to quit on
monotherapy
Risk of toxicity
No long term studies
Bupropion + patch
↑ 5.2% in RCT over either agent alone
Not statistically significant
Varenicline
Chantix® Rx
May 2006
Oral dosage form
Alpha-4-beta-2 nicotinic acetylcholine receptor
agonist - ↓ cravings
Concomitantly blocks nicotine-receptor binding -
↓ satisfaction from smoking
Stimulates receptor at lower intensity than
nicotine - ↓ withdrawal
Chantix® Dosing
Days 1-3 0.5 mg qd
Days 4-7 0.5 mg bid
Days 8 – end of tx 1 mg bid
Recommended tx duration = 12 weeks
subsequent 12 weeks tx = ↑ abstinence rate
Renal dosing
CrCl < 30 ml/min = 0.5mg bid
CrCl < 10 ml/min = 0.5mg qd
Chantix® ADR’s
Nausea (30%)
Full glass water, after meals
Insomnia (18%)
Headache (15%)
Abnormal dreams (13%)
Other GI (5-8%)
Chantix® Information
No drug interactions to date
Pregnancy category C
Not recommended in combination with NRT
GET QUIT - Patient support program
1-877-CHANTIX or www.chantix.com
2 studies vs. bupropion3,4
12 weeks
+40 week follow-up
Conclusion – at least “as effective as” bupropion
Superior at 24 week point
LONG-TERM (>5 month) QUIT
RATES for AVAILABLE
CESSATION MEDICATIONS
35
Active drug 30.5 30.5
30
Placebo
25 23.7 23.9
22.8
Percent quit
20
17.1 17.7 17.3
15 13.9
12.3
10.0 10.5
10
0
Nicotine gum Nicotine patch Nicotine Nicotine nasal Nicotine Bupropion
lozenge spray inhaler
Data adapted from Fiore et al. Treating Tobacco Use and Dependence. Clinical Practice
Guideline. USDHHS, PHS, 2000 and Shiffman et al. Arch Int Med 2002;162:1267-
COMBINATION THERAPY:
PATCH PLUS BUPROPION
Percentage of patients quit at 12 months after
Nicotine patch
cessation
plus bupropion 35.5%
Bupropion
30.3%
Nicotine patch
16.4%
Placebo
15.6%
0 1 2 3 4 5 6 7