CPD
COMMON ADVERSE EFFECTS The most common side effects of varenicline, which patients should be made aware of are nausea, gastrointestinal disturbances, appetite changes, headache, sleep disturbances and dizziness. These effects are usually self limiting, but in severe cases treatment may have to be stopped, although in most cases the dose can be reduced to 0.5 mg twice daily, given after food or taken with a large glass of water. This should help reduce the nausea and gastrointestinal disturbances (GI). The second dose, if taken a few hours before bed, or after an evening meal, should reduce the sleep disturbances that can manifest as vivid abnormal dreams. In general, these adverse reactions occur in the first week of therapy.
Smoking cessation is often associated with nicotine withdrawal symptoms:
PHYSICAL
• GI – nausea, abdominal cramps, constipation diarrhoea
• Headache • Cough or nasal drip • Mouth ulcers • Chest discomfort • Hunger + weight gain • Sleepiness
PSYCHOLOGICAL
• Irritability • Fatigue, drowsiness, insomnia
• Dizziness • Poor concentration • Anxiety • Depression • Suicidal thoughts
- some of which can be mistaken as side effects of varenicline. It is therefore important to take this into consideration when a patient presents with them. Patients should exercise caution before driving or using machinery until they are reasonably certain that varenicline does not adversely affect their performance.
REFERRAL CRITERIA Pharmacists should refer patients to their GP when a patient is considered eligible for varenicline but supply through pharmacy is not recommended due to the exclusion criteria. Patients on theophylline, clozapine and warfarin should be referred as close monitoring of these patients is required.
Caution should be applied to diabetic patients they may be supplied with varenicline, however patients should be advised to monitor their blood glucose level closely.
GUIDANCE
The suitability for this treatment in patients is governed by your local patient group direction (PGD),
CONSULTATIONS
A Risk Assessment form must be completed for each patient.
If the patient answers ‘YES’ to any of the questions, the patient is either declined varenicline or may need to be referred to their GP. (Figure 6)
The new public health service (PHS) specification also includes changes to the follow-up reporting process. Patients should be followed up at four weeks and twelve weeks post-quit date, with a carbon monoxide breath test, taken at each week and the
results electronically recorded in the smoking cessation support tool in the patient care record (PCR). Payment will be linked to the submission of electronic data. (Figures 6 and 7)
NEW STUDIES AND CLINICAL DATA
The EAGLES Study Design The study was the largest comparative randomised controlled trial of pharmacotherapy for smoking cessation conducted to date.
Main Objectives: Safety: Characterise the neuropsychiatric safety (NPS) profiles of varenicline and bupropion vs. placebo in subjects with and without a diagnosis of psychiatric disorder.
Efficacy: Compare smoking abstinence rates of varenicline and bupropion relative to placebo in subjects with and without a diagnosis of psychiatric disorder.
Design: Randomised, double-blind, 24-week, and NRT Patch active comparator and placebo-controlled.
Four Treatment Arms: varenicline, bupropion, NRT Patch*, placebo.
Primary comparisons: varenicline vs. placebo and bupropion vs. placebo.
NRT Patch was used as an active control.
Figure 3: TREATMENT PLAN Consultations Treatment plan
1st week- Assessment week
Patient should set a quit date between the next 8-14 days. Supply 14 day starter pack (11 x 500 mcg tabs with 14 X 1mg tablets)
*Make arrangement to see patient again before tablets run out i.e. between days 10- 14
3rd week
Patient should have set a quit date. Monitor carbon monoxide level. If patient is still smoking, he/she should be informed that treatment with varenicline would have to be stopped if he continued to smoke.
Supply 14 x 1mg varenicline tablets Make arrangement to see patient the following week
4th- 12th week Monitor carbon monoxide level and check if patient has stopped smoking.
If patient is still smoking, treatment with varenicline should be stopped.
If patient has quit smoking supply varenicline tablets.
If side effects are tolerable then continue supplying one week’s supply at a time (14 x 1mg tablets). If patient is troubled by side effects assess whether they are tolerable or whether supply should be stopped.
Triple dummy design: all three active study drugs were blinded.
Twelve weeks of active treatment followed by twelve weeks of non- treatment follow-up.
All participants received counselling of up to ten minutes at each clinic visit.
Targeted Sample Size: 8000 total randomised subjects.
2000 per treatment arm, including 1000 with and 1000 without psychiatric disorder.
UPDATES TO THE VARENICLINE SUMMARY OF PRODUCT CHARACTERISTICS As a result of the EAGLES study, the varenicline SPC has been updated effective as of May 23rd 2016. The black triangle and associated warning have been removed.
• 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 varenicline 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 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
Figure 4: VARENICLINE CLINICAL RISK ASSESSMENT FORM
Is patient under 18 years of age Is patient pregnant or breastfeeding? Does patient suffer from renal impairment or has end stage renal disease? Does patient have a history of psychiatric illness ? Does patient suffer from epilepsy? Is patient currently on another smoking cessation therapy? Is patient on any other medication? Is patient hypersensitive to varenicline or any of its excipients?
Only make a supply if you are certain that to the best of your knowledge, it is appropriate to do so
SCOTTISH PHARMACIST - 33
CPD
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