The efficacy of a high strength patch: The Cease Study
The aim of NRT is to help wean smokers off the habit of smoking by providing them with some of the nicotine they are used to getting from cigarettes.
What is the aim of Nicotine Replacement Therapy?
The aim of NRT is to help wean smokers off the habit of smoking by providing them with some of the nicotine they are used to getting from cigarettes. Yet despite its good efficacy, it has been demonstrated that the nicotine substitution it provides is still sub-optimal1. It is thought that increasing the level of nicotine substitution may increase efficacy further2,3
The CEASE study1
The Collaborative European Anti-Smoking Evaluation study was conducted on behalf of the European Respiratory Society (ERS) and funded by Pharmacia & Upjohn Consumer Healthcare. Its main objective was to determine whether higher dosage and longer duration of nicotine patch therapy increases success rate.
– Starting dose: 25mg versus 15mg
– Duration: 26 weeks versus 12 weeks
CEASE Study: Study Design
This was a multicentre, randomised, double-blind placebo-controlled study involving 3,575 subjects enrolled in 36 chest clinics in 17 countries. To be eligible for inclusion, subjects had to have smoked at least 15 cigarettes a day for at least 3 years, be between 20 and 70 years of age, be motivated to stop smoking and to have made at least one prior attempt to give up.
Subjects were randomized to one of five parallel treatment arms
• Study population
The 3575 subjects had a mean average age of 41 years, were heavy smokers (a mean of 27 cigarettes a day), had an average of three previous quit attempts and a third of them (34%) had previously used nicotine replacement therapy.
• 3 key Measurements
1. Smoking consumption
2. Carbon monoxide (CO) levels
3. Withdrawal symptoms, which included: Craving for cigarettes, irritability, anxiety, depression, drowsiness, difficulty in concentrating, restlessness, headache, hunger and sleep disturbances.
Smokers attended scheduled visits on quit day and at weeks 1, 2, 4, 8, 12, 22 and 26, and month 12
The primary definition for success was continuous self-reported abstinence from week 2 until month 12 (confirmed by CO measurement of less than 10 ppm)
Withdrawal Symptoms
The 25mg patch was found to significantly reduce adverse mood withdrawal symptoms at week 1 by 79% compared with placebo and by 47% compared with 15mg patch1
Success Rates at Week 14
• Significantly more smokers were abstinent during week 1 with the 25mg patch compared with our 15mg patch programme4
• Week 1 abstinence is an important predictor of long-term success1,5
CEASE Study: Efficacy
The 25mg patch is significantly more effective at helping smokers quit compared with our previous patch programme:
• 24% more effective at 4 weeks (P<0.001)1,6
• 44% more effective at 12 weeks (P<0.005)1,6
• 36% more effective at 52 weeks (P<0.05)1,6
CEASE Study: Conclusions
• Treatment with 25mg nicotine patch is more effective than 15mg patch: the 25mg patch is 44% more effective at helping smokers quit compared with our previous patch programme at 12 weeks (P<0.005)1,6
• Increasing treatment duration does not improve outcome1
• 25mg patches are generally well tolerated and have a good safety profile1
How to recommend the 25mg patch:
Nicorette Invisi Patch Product Information:
Presentation: Transdermal delivery system available in 3 sizes (22.5, 13.5 and 9cm2) releasing 25mg, 15mg and 10mg of nicotine respectively over 16 hours. Uses: Relief of nicotine withdrawal symptoms as an aid to smoking cessation. Dosage: Adults (over 18 years): Patients should stop smoking during treatment. The patch should be applied to the skin on the hip, upper arm or chest in the morning and removed at bedtime. Application should be limited to 16 hours per day. Most smokers are recommended to start on 25mg patch, applying one 25mg patch daily initially. In patients who successfully abstain in 8 weeks, dose should then be reduced to 15mg for 2 weeks and then 10mg for a further 2 weeks. Lighter smokers (smoking less than 10 cigarettes per day) are recommended to start at step 2 (15mg) for 8 weeks and then to decrease to 10mg for the final 4 weeks. Adults who use NRT beyond 9 months should seek advice from a healthcare professional. See SPC for further details. Adolescents (12 to 18 years): As per adults, but duration of therapy should not exceed 12 weeks without consulting a healthcare professional. Under 12 years: Not recommended. Contraindications: Hypersensitivity. Precautions: Unstable cardiovascular disease, diabetes mellitus, phaeochromocytoma or uncontrolled hyperthyroidism, renal or hepatic impairment, generalised dermatological disorders. Erythema may occur. If severe or persistent, discontinue treatment. Stopping smoking may alter the metabolism of certain drugs. Transferred dependence is rare and less harmful and easier to break than smoking dependence. May enhance the haemodynamic effects of, and pain response, to adenosine. Keep out of reach and sight of children and dispose of with care. Pregnancy and lactation: Only after consulting a healthcare professional. Side effects: Erythema, itching, urticaria, headache, nausea, vomiting, GI discomfort, dizziness, palpitations, reversible atrial fibrillation. See SPC for further details. RRP (ex-VAT): 25mg packs of 7: (£14.83); 15mg packs of 7: (£14.83); 10mg packs of 7: (£14.83). Legal category: GSL. PL holder: McNeil Products Ltd, Roxborough Way, Maidenhead, Berkshire, SL6 3UG. PL numbers: 15513/0161; 15513/0160; 15513/0159. Date of preparation: December 2008
References
1 Tønnesen P, et al. Eur Resp J 1999; 13:238-246.
2 Sachs DPL, et al. Eur Resp J 1996; 9:629-631
3 Paoletti P, et al. Eur Resp J 1996; 9:643-651
4 Data on file, CEASE 2
5 Stapleton, JA, et al. Dose effects and predictors of outcome in a randomised trial of transdermal nicotine patches in general practice. Addiction 1995: 90:31-42.
6 Data on file, CEASE 3
Published in partnership with the Royal College of Nursing's Practice Nurse Association
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