Smoking Still Kills! (Figs for England)

Smoking Cessation Gay Sutherland (Clinical Psychologist) Visiting Researcher - Tobacco Research Unit Inst. of Psychiatry, Psychology & Neuroscience King s College London

Smoking Still Kills! (Figs for England) Leading cause of preventable death Alcohol: 6,669 Traffic: 1,850 HIV: 504 Smoking: 79,100 Obesity: 34,100 Suicide: 5,377 Illegal drugs: 1,605 2 ASH, Smoking Statistics: Illness & Death 2014

For every death caused by smoking ~20 smokers are suffering from a smokingrelated disease (a) Smoking interventions save public purse more than 2 for every 1 spent (b) (a) U.S. Dept of Health & Human Services (2010): The Biology and Behavioral Basis for Smoking-Attributable Disease: Report of the Surgeon General. Atlanta, GA. (a) BMA News: What price public health? (June 2016)

Tobacco costs economy > 11 billion/yr 2.5 billion cost to NHS 474,000 smoking-related hospital admissions (2015-16) Smokers see GPs 35% more often than nonsmokers

Non-Life Threatening Diseases Linked to Smoking: Age-related hearing loss Cataracts Chronic back and neck pain Crohn s disease Dementia Diabetes (T2) Erectile dysfunction Gum/peridontal disease Macular degeneration Osteoarthritis Osteoporosis Rheumatoid arthritis Tissue damage (by cold exposure) Skin wrinkles Adapted from: Cigarettes: What the warning labels doesn t tell you. American Council on Science & Health (ACSH) 1997

Smokers Attending NHS Stop Smoking Services 2001-2017 900000 800000 700000 600000 500000 400000 300000 200000 100000 Set a Quit Day 4 Wk Self-Reported Quit CO Validated Quit 0 2001-02 2002-03 2003-04 2004-05 2005-06 2006-07 2007-08 2008-09 2009-10 2010-11 2011-12 2012-13 2013-14 2014-15 2015-16 2016-17 Statistics on NHS Stop Smoking Services in England: NHS Digital

Prevalence of Cigarette Smoking 2007-2017 www.smokinginengland.info/latest-statistics 23.3% 16.9% 11.7% A-C1: Professional to clerical occupation C2-E: Manual occupation

Mental Health and Smoking? 8

Mental Illness & Smoking: Scale of the Problem? >40% prevalence!! >40% of tobacco deaths are in those with mental illness or substance misuse Die 15-25 yrs earlier

Why do so many people with mental illness smoke? Embedded part of culture of mental health settings: Their only pleasure De-stressor Helps therapeutic relationship Boredom etc Genetics Self-Medication - Biological e.g. Improve cognitive deficits, reduce side effects of antipsychotic medications 10

Barriers to Intervening Mental health staff have higher smoking rates than general pop. and less likely to support cessation Believe mentally ill smokers do not want to quit Believe they can not quit Believe quitting would negatively affect mental health and make management difficult All Wrong 11

Motivation to Quit: Among Smokers: (Health Survey England) 66% of gen pop. want to quit 69% on psychotropic drugs want to quit 61% of those with long-standing mental health condition want to quit NHS Information Centre: Health Survey for England. www.ic.nhs.uk/statistics-and-data-collections/health-and-lifestyles-relatedsurveys/health-survey-for-england 12

Are mentally ill smokers able to quit? 13

Meta-Analytic Review: 14

Most studies found mentally ill smokers could quit or significantly reduce smoking Same interventions that work with other smokers also work with those with mental illness (Behavioural Support + Stop-Smoking Medications) Banham and Gilbody. Addiction 2010; 105(7): 1176-89 15

Is it safe for mentally ill smokers to quit? 16

Treating smokers with stable psychiatric conditions does not worsen their mental state Banham and Gilbody. Addiction 2010; 105(7): 1176-89 17

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Anxiety Solomon 2006 Dawkins 2009 McDermott 2011 Becona 2002 Total Solomon 2006 Berlin 2010 Blalock 2008 Dawkin 2009 Kahler 2011 Vazquez 1999 Busch 2011 Kahler 2002 Munafo 2008 Kinnunen 2006 Total Depression Taylor et al., BMJ 2014 Effect same as antidepressants Blalock 2008 Kahler 2009 Steinberg 2011 Mino 2000 Chassin 2002 Total Manning 2005 Hajek 2010 Chassin 2002 Total Mixed Anxiety & Depression Stress -1-0.5 0 0.5 1 Favours Quitters Favours Smokers Favours Quitters Favours Smokers 19

Psychological Quality of Life McFall 2006 Stewart 1995 Balduyck 2011 Croghan 2005 Longmoore 2007 Uist-Paulsen 2006 Mitra 2004 Sarna 2008 Total Positive Affect Blalock 2008 Croghan 2005 Mitra 2004 Total Taylor et al., BMJ 2014 Smoking cessation is associated with Reduced: Depression Anxiety Stress & Improved Mood Quality of Life vs Continuing to Smoke Favours Smokers -0.5 0 0.5 1 Favours Quitters 20

Montgomery-Asberg Depression Rating Scale (MADRS): Mean Change from Baseline (95% CI) Anthenelli RM et al. Ann Intern Med 2013; 159: 390-400 21

Hamilton Anxiety Rating (HAM-A): Mean Change from Baseline (95% CI) Anthenelli RM et al. Ann Intern Med 2013; 159: 390-400 22

Treatment Update

Medications Efficacy: Cochrane Reviews Stead et al 2008, Cahill et al 2012 Varenicline: N=6,166 Single NRT: N=51,265 Dual NRT: 4,664 95% CIs from meta-analyses 26

Pharmacotherapy Used (%) in Stop Smoking Services England 2016-17 (NHS Digital Data) % 80 70 60 50 40 30 20 23 34 25 Single NRT Combined NRT Varenicline Bupropion NRT + Var or Bup E-Cig + 1 or more Pharmaco. E-Cig None Unknown 10 0 0 2 3 Pharmacotherapy Used in Quit Attempt 1 7 4

E-cigarette use for quitting has plateaued N=12859 adults who smoke and tried to stop, or who stopped in the past year; method is coded as any (not exclusive) use www.smokinginengland.info/latest-statistics (Slide Designed by Robert West)

Shahab L, McEwan A, et al. Cost-effectiveness of pharmacotherapy for smoking cessation. 2012 www.ncsct. co.uk/usr/pub/b7_costeffectiveness_pharmacotherapy.pdf

What can you do in 30 seconds to promote quit attempts?

All NHS Staff Should be Trained to Offer Very Brief Advice (30 secs) Given opportunistically Evidence-Based, Effective & Fast! Satisfies QoF GP Training Module: BMJ Learning Website - Search VBA Or at www.ncsct.co.uk/vba

ASK About smoking status: Are you still smoking? How s the smoking? www.ncsct.co.uk/vba

ADVISE The best way to stop: The very best way to stop is with support and medication Both available on the NHS Make it much more likely you will stop and stay stopped www.ncsct.co.uk/vba

ACT: Offer Medication & Support: We ve got a fantastic specially trained nurse/hca etc running our stop smoking service Reception will make you an appointment www.ncsct.co.uk/vba

Note: Don t Advise them to stop! Don t Ask how much or what they smoke! Don t Even ask if they want to stop! www.ncsct.co.uk/vba

Motivation to Quit?

What can you do with 1-3 minutes? As above plus - Prescribe stop-smoking medication in those who want to stop on their own. Recommend online or phone support

Use of Champix in those with Psychiatric Illness?

Eagles Study Anthenelli RM, Benowitz NL, West R, St Aubin L, McRae T, Lawrence D, Ascher J, Russ C, Krishen A, Evins AE. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. Lancet 2016 Apr 22. doi: 10.1016/S0140-6736(16)30272-0 [Epub ahead of print]

Eagles Study: Large-scale, multi-site, randomized, double-blind, triple dummy, placebo controlled trial comparing efficacy of varenicline vs bupropion vs NRT patch and placebo in smokers with and without a diagnosis of psychiatric disorder Trial requested by FDA, who consulted on trial design, funded by GSK & Pfizer Anthenelli RM, Benowitz NL, West R, St Aubin L, McRae T, Lawrence D, Ascher J, Russ C, Krishen A, Evins AE. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. Lancet 2016 Apr 22. doi: 10.1016/S0140-6736(16)30272-0 [Epub ahead of print]

Eagles Study Details: 161 centers in 16 countries on 6 continents 8144 smokers (4028 non-psychiatric: 4116 psychiatric) 30 th Nov 2011 13 th Jan 2015 * 2037 2034 2038 2035 *NiQuitin CQ 21mg per 24 hour with taper Anthenelli RM, Benowitz NL, West R, St Aubin L, McRae T, Lawrence D, Ascher J, Russ C, Krishen A, Evins AE. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. Lancet 2016 Apr 22. doi: 10.1016/S0140-6736(16)30272-0 [Epub ahead of print]

Primary Outcome Measure: % of subjects reporting at least one of the following neuropsychiatric adverse events during treatment and up to 30 days after last dose: Agitation Panic Aggression Paranoia Delusions Psychosis Hallucinations Suicidal ideation Homicidal ideation Suicidal behavior Mania Completed suicide Classified as Moderate or Severe Anxiety Depression Feeling abnormal Hostility Classified as Severe Primary Efficacy Measure: CO-confirmed 4-week continuous abstinence rates (CAR) for Weeks 9-12 Anthenelli RM, Benowitz NL, West R, St Aubin L, McRae T, Lawrence D, Ascher J, Russ C, Krishen A, Evins AE. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. Lancet 2016 Apr 22. doi: 10.1016/S0140-6736(16)30272-0 [Epub ahead of print] 42

Neuropsychiatric Adverse Events: Results

Severe-Only NPS AEs in the Primary Endpoint Secondary Outcome Measure Varenicline Bupropion NRT Placebo Non-Psychiatric Cohort, N 990 989 1006 999 NPS AE Endpoint, n (%) 13 (1.3%) 22 (2.2%) 25 (2.5%) 24 (2.4%) Severe Only 1 (0.1%) 4 (0.4%) 3 (0.3%) 5 (0.5%) Psychiatric Cohort, N 1026 1017 1016 1015 NPS AE Endpoint, n (%) 67 (6.5%) 68 (6.7%) 53 (5.2%) 50 (4.9%) Severe only 14 (1.4%) 14 (1.4%) 14 (1.4%) 13 (1.3%) Anthenelli RM, Benowitz NL, West R, St Aubin L, McRae T, Lawrence D, Ascher J, Russ C, Krishen A, Evins AE. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. Lancet 2016 Apr 22. doi: 10.1016/S0140-6736(16)30272-0 [Epub ahead of print] 45

Severe-Only NPS AEs in the Primary Endpoint Secondary Outcome Measure Varenicline Bupropion NRT Placebo Psychiatric Cohort, N 1026 1017 1016 1015 NPS AE Endpoint, n (%) 67 (6.5%) 68 (6.7%) 53 (5.2%) 50 (4.9%) Severe Only 14 (1.4%) 14 (1.4%) 14 (1.4%) 13 (1.3%) Psychiatric Cohort, N 1026 1017 1016 1015 NPS AE Endpoint, n (%) 67 (6.5%) 68 (6.7%) 53 (5.2%) 50 (4.9%) Severe only 14 (1.4%) 14 (1.4%) 14 (1.4%) 13 (1.3%) Anthenelli RM, Benowitz NL, West R, St Aubin L, McRae T, Lawrence D, Ascher J, Russ C, Krishen A, Evins AE. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. Lancet 2016 Apr 22. doi: 10.1016/S0140-6736(16)30272-0 [Epub ahead of print] 46

Quit Rates: Results

Mood Scores: Pre - Post Treatment

Secondary Outcome Measure Depression & Anxiety: HADS Mean Total Score by Week and Cohort Treatment Varenicline 1.0 mg BID Bupropion 150 mg BID NRT patch QD Placebo https://clinicaltrials.gov/ct2/show/nct01456936 Data on file 51

Eagles Study Conclusions: No significant increase in rates of moderate or severe neuropsychiatric AEs in varenicline or bupropion compared with patch or placebo, in those with or without psychiatric disorders Varenicline had superior efficacy to patch, bupropion, and placebo in both cohorts Bupropion and patch more effective than placebo

E-Cigarettes or Vaporisers 54

National Centre for Smoking Cessation Training Feb 2016 www.ncsct.co.uk

National Centre for Smoking Cessation Training Stop smoking services should be open to e-cig use in people keen to try them to help then quit This is especially so in those who have tried and failed to quit using licensed stop smoking medicines

60 The Clock Keeps on Ticking Each year delaying quitting..? Each day delaying quitting..?

Take Home Message: Use very brief advice, to keep triggering repeated attempts to stop Offering treatment can spur quit attempts in smokers who might not have seemed motivated Champix + Behavioural Support currently most effective. Single NRT the least If you don t mention smoking, smokers think it s not important, OR that you don t think they can quit!