ADVERTISING FEATURE
New evidence to set patients free from the confines of smoking
The burden of tobacco on morbidity and mortality is preventable and significant – yet tobacco consumption remains the single largest avoidable health risk in the UK.1 lives every year,1
and costs Scottish public
healthcare an estimated £400 million annually to treat tobacco-related diseases.2
Many smokers looking to quit become trapped in a cycle of failure as their methods do not address the physical and psychological challenges associated with successfully quitting smoking.3 to quit alone4
They often try – not seeking help from a healthcare
professional, such as a pharmacist, who is best placed to provide support and advice.4
Quitting smoking is the single biggest thing smokers can do to improve their health.5
It has been shown
that smokers are up to four times more likely to quit with the help of a healthcare professional than with willpower alone.6
Research shows that, to
be successful, smokers need behavioural support and evidence-based advice from their healthcare professional.6, 7, 8
Combining this valuable support with
a proven cessation aid can increase the chances of quitting. Pharmacists are often the first point of call for smokers looking to quit and consequently best placed to offer such advice and support.
New study. New data. New perspectives?
Smoking cessation medicines, such as Champix® (varenicline), have been shown to be one of the most effective methods to stop smoking, when combined with support from a healthcare professional.9
New
data, such as EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study), supports this claim. EAGLES was a randomised, double-blind, triple- dummy, placebo and active controlled trial to compare the relative neuropsychiatric (NPS) profile and efficacy of varenicline and bupropion with nicotine patch and placebo in over 8,000 smokers with or without a diagnosis of psychiatric disorders. The primary endpoint was the incidence of a composite measure of 16 moderate and severe NPS adverse events, with the main efficacy endpoint being carbon monoxide confirmed continuous abstinence rate for weeks 9-12.9
Data from EAGLES showed that varenicline was not associated with a significantly increased risk of NPS
adverse events vs placebo in smokers with or without a history of psychiatric disorders.9 It also showed
superior continuous abstinence rates for varenicline vs bupropion (odds ratio [OR] 1.75; 95% confidence interval [CI] 1.52–2.01), NiQuitinTM
patch 21mg per day
with taper (OR 1.68; 95% CI 1.46–1.93) and placebo (OR 3.61; 95% CI 3.07–4.24) at the end of treatment (week 9–12; p<0.0001). Continuous abstinence rates for varenicline were also superior to bupropion, NiQuitinTM
In April 2016 a positive CHMP opinion was received in the EU to update the Champix®
safety and efficacy data from the EAGLES.10
an informed decision and can draw on data such as EAGLES. In a time when smoking is still so prevalent in the UK, it is imperative that patients are offered the best evidence-based support and care available from a healthcare professional, coupled with effective smoking cessation aids. These data allow pharmacists to have confidence to recommend that smokers looking to quit speak to their GP or local NHS stop smoking service about varenicline.
patch 21mg per day with taper and placebo at follow-up (weeks 9–24; p<0.0001).9
labelling to include As part of
the update, the black triangle symbol, which indicated that additional safety monitoring for Champix® EU was required, has been removed.11 were implemented on 23rd May 2016.11
in the SPC changes
The safety and efficacy of varenicline has been studied across 39 clinical trials with more than 11,000 patients receiving varenicline.12
Varenicline can help to shield
smokers from cravings and withdrawal symptoms13 while breaking down the positive reinforcement of smoking.13
How EAGLES impacts the pharmacy setting
These data, from the largest randomised, placebo- controlled smoking cessation clinical trial published to date,9
highlight the benefits of varenicline for patients looking to quit smoking. Pharmacists in the community or hospital setting are in an ideal positon to offer evidence-based advice to help smokers make
REFERENCES 1 Action on Smoking and Health. Smoking Statistics: Illness and Death. Available at http://ash.
org.uk/files/documents/ASH_107.pdf. Last accessed December 2016 2
Scottish Government, Publication of Scottish Government Tobacco Control Strategy. Available at:
http://www.gov.scot/Topics/Health/Services/Smoking. Last accessed January 2017. 3
Smokefree. Quitting is Hard. Available at
https://smokefree.gov/why-quitting-is-hard Last accessed November 2016. 4
Smith, AL, Carter SM, Chapman S et al. Why do smokers try to quit without medication or counselling? A qualitative study with ex-smokers, BMJ Open, 2015, 5:e007301 doi:10.1136/ bmjopen-2014-007301 5
NHS, ‘One You: smoking’. Available at:
https://www.nhs.uk/oneyou/ smoking#0ztlDpho8V3ePteT.97. Last accessed January 2017. 6
West R, Stop smoking services: increased chances of quitting. NCSCT Briefing #8. London; National Centre for Smoking Cessation and Training, 2012. Available at
http://www.ncsct.co.uk/ usr/pub/Briefing%208.pdf Last accessed November 2016. 7
Cochrane.org. Does a combination of stop smoking medication and behavioural support help smokers to stop? Available at:
http://www.cochrane.org/CD008286/TOBACCO_does- combination-stop-smoking-medication-and-behavioural-support-help-smokers-stop Last accessed November 2016 8
Walsh RA and Sanson-Fisher RW, Encouraging people to stop smoking, World Health
Organisation, Geneva, 2001: p1-55. 9
Anthenelli RM, Benowitz NL,West R et al. 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; 387:2507-2520 10
EMA, Champix: procedural steps taken and scientific information after the authorisation,
Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Procedural_ steps_taken_and_scientific_information_after_authorisation/human/000699/WC500025256.pdf. Last accessed January 2017. 11
Champix® (varenicline): EU Summary of Product Characteristics. Pfizer; June 2016.
Cahill K, Lindson-Hawley N, Thomas KH et al. Nicotine receptor partial agonists for smoking cessation (Review). Cochrane Database of systematic reviews. 2016, issue 5 CD006103 13
12
West R, Baker CL, Cappelleri JC et al. Effect of varenicline and bupropion SR on craving, nicotine withdrawal symptoms and rewarding effects of smoking during a quit attempt. Psychopharmacology 2007;197(3):371-377
CHAMPIX vs. placebo Bupropion vs. placebo
NRT Patch vs. placebo -1.53 -3 -2 -1 It claims 96,000 -2.40 -1.28 -0.15 -1.37 -1.54 -0.08 -0·21 -0.42 -0.24 0.37 1.21 1.12 1.59
NRT Patch vs. placebo 3.59
1.78 2.26 0 1 2 3 Risk Difference with 95% CI 4 3.81
CHAMPIX vs. placebo Bupropion vs. placebo
40 35 30 25 20 15 10 5 0
Weeks 9–12 Overall (N=8,144)
CHAMPIX (N=2,037) Bupropion (N=2,034) NRT Patch (N=2,038) Placebo (N=2,035)
Weeks 9–24
CHAMPIX® Film-Coated Tablets (varenicline tartrate) ABBREVIATED PRESCRIBING INFORMATION – UK
(See Champix Summary of Product Characteristics for full Prescribing Information)
Please refer to the SmPC before prescribing Champix 0.5 mg and 1 mg. Presentation: White, capsular-shaped, biconvex tablets debossed with “Pfizer” on one side and “CHX 0.5” on the other side and light blue, capsular-shaped, biconvex tablets debossed with “Pfizer” on one side and “CHX 1.0” on the other side. Indications: Champix is indicated for smoking cessation in adults. Dosage: The recommended dose is 1 mg varenicline twice daily following a 1-week titration as follows: Days 1-3: 0.5 mg once daily, Days 4-7: 0.5 mg twice daily and Day 8 – End of treatment: 1 mg twice daily. The patient should set a date to stop smoking. Dosing should usually start 1-2 weeks before this date. Patients who are not willing or able to set the target quit date within 1-2 weeks, could be offered to start treatment and then choose their own quit date within 5 weeks. Patients should be treated with Champix for 12 weeks. For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks treatment at 1 mg twice daily may be considered for the maintenance of abstinence. A gradual approach to quitting smoking with Champix should be considered for patients who are not able or willing to quit abruptly. Patients should reduce smoking during the first 12 weeks of treatment and quit by the end of that treatment period. Patients should then continue taking Champix for an additional 12 weeks for a total of 24 weeks of treatment. Patients who are motivated to quit and who did not succeed in stopping smoking during prior Champix therapy, or who relapsed after treatment, may benefit from another quit attempt with Champix. Patients who cannot tolerate adverse effects may have the dose lowered temporarily or permanently to 0.5 mg twice daily. Following the end of treatment, dose tapering may be considered in patients with a high risk of relapse. Renal impairment; Mild to moderate renal impairment: No dosage adjustment is necessary. Patients with moderate renal impairment who experience intolerable adverse events: Dosing may be reduced to 1 mg once daily. Severe renal impairment: 1 mg once daily is recommended. Dosing should begin at 0.5 mg once daily for the first 3 days then increased to 1 mg once daily. End stage renal disease: Treatment is not recommended. Hepatic impairment and elderly patients; No dosage adjustment is necessary. Paediatric patients; Not recommended in patients below the age of 18 years. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Warnings and precautions: Effect of smoking cessation; Stopping smoking may alter the pharmacokinetics or pharmacodynamics of some medicinal products, for which dosage adjustment may be necessary (examples include theophylline, warfarin and insulin). Changes in behaviour or thinking, anxiety, psychosis, mood swings, aggressive behaviour, depression, suicidal ideation and behaviour and suicide attempts have been reported in patients attempting to quit smoking with Champix in the post-marketing experience. A large randomised, double-blind, active and placebo-controlled study was conducted to compare the risk of serious neuropsychiatric events in patients with and without a history of psychiatric disorder
Date of preparation: January 2017 Job code: PP-CHM-GBR-0611
treated for smoking cessation with varenicline, bupropion, nicotine replacement therapy patch (NRT) or placebo. The primary safety endpoint was a composite of neuropsychiatric adverse events that have been reported in post-marketing experience. The use of varenicline in patients with or without a history of psychiatric disorder was not associated with an increased risk of serious neuropsychiatric adverse events in the composite primary endpoint compared with placebo. Depressed mood, rarely including suicidal ideation and suicide attempt, may be a symptom of nicotine withdrawal. Clinicians should be aware of the possible emergence of serious neuropsychiatric symptoms in patients attempting to quit smoking with or without treatment. If serious neuropsychiatric symptoms occur whilst on varenicline treatment, patients should discontinue varenicline immediately and contact a healthcare professional for re-evaluation of treatment. Smoking cessation, with or without pharmacotherapy, has been associated with exacerbation of underlying psychiatric illness (e.g. depression). Champix smoking cessation studies have provided data in patients with a history of psychiatric disorders. In a smoking cessation clinical trial, neuropsychiatric adverse events were reported more frequently in patients with a history of psychiatric disorders compared to those without a history of psychiatric disorders, regardless of treatment. Care should be taken with patients with a history of psychiatric illness and patients should be advised accordingly. Patients taking Champix should be instructed to notify their doctor of new or worsening cardiovascular symptoms and to seek immediate medical attention if they experience signs and symptoms of myocardial infarction or stroke. In clinical trials and post-marketing experience there have been reports of seizures in patients with or without a history of seizures, treated with Champix. Champix should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold. At the end of treatment, discontinuation of Champix was associated with an increase in irritability, urge to smoke, depression, and/or insomnia in up to 3% of patients, therefore dose tapering may be considered. There have been post-marketing reports of hypersensitivity reactions including angioedema and reports of rare but severe cutaneous reactions, including Stevens-Johnson Syndrome and Erythema Multiforme in patients using varenicline. Patients experiencing these symptoms should discontinue treatment with varenicline and contact a health care provider immediately. Fertility, pregnancy and lactation: Champix should not be used during pregnancy. Women of child bearing potential should avoid becoming pregnant during treatment with Champix. It is unknown whether varenicline is excreted in human breast milk. Champix should only be prescribed to breast feeding mothers when the benefit outweighs the risk. There are no clinical data on the effects of varenicline on fertility. Non-clinical data revealed no hazard for humans based on standard male and female fertility studies in the rat. Driving and operating machinery: Champix may have minor or moderate influence on the ability to drive and use machines. Champix may cause dizziness and somnolence and therefore may influence the ability to drive and use machines. Patients are advised not to drive, operate complex machinery or engage in other potentially hazardous activities until it is known whether this medicinal product affects their ability to perform these activities. Side-Effects: Very commonly reported side effects were nasopharyngitis, abnormal dreams, insomnia, headache
and nausea. Commonly reported side-effects were bronchitis, sinusitis, weight increased, decreased appetite, increased appetite, somnolence, dizziness, dysgeusia, dyspnoea, cough, gastrooesophageal reflux disease, vomiting, constipation, diarrhoea, abdominal distension, abdominal pain, toothache, , dyspepsia, flatulence, dry mouth, rash, pruritis, arthralgia, myalgia, back pain, chest pain, fatigue and abnormal liver function tests. Other side effects were, diabetes mellitus, suicidal ideation, seizures, cerebrovascular accident, angina pectoris, atrial fibrillation, electrocardiogram ST segment depression, myocardial infarction, haematemesis, haematochezia, Stevens Johnson Syndrome, angioedema and decreased platelet count. For full list of side effects see SmPC. Overdose: Standard supportive measures to be adopted as required. Varenicline has been shown to be dialyzed in patients with end stage renal disease, however, there is no experience in dialysis following overdose. Legal category: POM.
Basic NHS cost: Pack of 25 Pack of 28 Pack of 56 Pack of 56 Pack of 53
11 x 0.5 mg and 14 x 1mg tablets Card 1mg tablets Card
0.5 mg tablets HDPE Bottle 1mg tablets Card
Not all pack sizes may be marketed / marketed at launch Marketing Authorisation Holder: Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom.
Further information on request: Pfizer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey KT20 7NS Last revised: 06/2016
Ref: CI 20_0
Adverse events should be reported. Reporting forms and information can be found at
www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Pfizer Medical Information on 01304 616161
11 x 0.5 mg and 42 x 1mg tablets Card
(EU/1/06/360/014) £27.30 (EU/1/06/360/015) £27.30 (EU/1/06/360/001) £54.60 (EU/1/06/360/016) £54.60 (EU/1/06/360/023) £54.60
SCOTTISH PHARMACIST - 27
Psychiatric cohort
Non-
psychiatric cohort
Continuous Abstinence Rate (%)
33.5
22.6 23.4
12.5 21.8
16.2 15.7
9.4
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