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Produced in association with McNeil Products Limited the makers of nicorette How we can get the most out of NRT: a review and update on nicotine replacement therapy Date of preparation: May 2011. Prescribing Information can be found at the end of this presentation nicotine Dr Hayden McRobbie MB ChB PhD hayden.mcrobbie@inspiringlimited.com Date of preparation: May 2011 Prescribing Information can be found at the end of the presentation 06993 Slide 2 The risks of smoking are LARGE Smoking kills 1 in 2 smokers will die as a direct consequence of smoking 1 Helping people stop smoking is a life-saving intervention NRT is effective in helping people stop smoking 2 1 Doll, R., et al., British Medical Journal 2007; 328: 1519 2 Stead, L.F., et al., Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev, 2008(1): p. CD000146 Slide 3 NRT Is tried and tested 3 Chewing gum Skin patches Nasal spray Inhalator Microtab (sublingual tablet) Lozenges Mouthspray Slide 4 Widely used Is the most widely used medicine for smoking cessation e.g. 64% of NHS-SSS patients using NRT last year on prescription 1 Typically started when a person stops smoking and a standard dose is used for 8-12 weeks and then stopped 1. The Health and Social Care Information Centre. Statistics on NHS Stop Smoking Services: England, April 2009 - March 2010: NHS, 2009 Slide 5 NRT is effective Stead LF, Perera R, Bullen C, Mant D, Lancaster T. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev 2008(1) Slide 6 but is not a magic cure Despite NRTs significant effectiveness Versus a placebo, quitting figures are not as high as they could be. This may in part be due to Incorrect use Insufficient use Slide 7 Reasons for NRT failure Unrealistic expectations Incorrect use Not used for long enough Nicotine is often seen as the dangerous element in cigarette smoke Safety concerns can be a barrier to use Encouraging compliance is important Slide 8 Under-dosing? Depending on patch strength NRT patch may provide less than half the nicotine a smoker receives from their tobacco 1 Even with combination NRT treatment many smokers do not obtain blood nicotine levels comparable with their baseline smoking levels In a trial of combined nicotine 15mg patch and inhalator, blood nicotine levels were only 60% of that achieved during ad lib smoking at week 6 2 1.Johnstone E, Brown K, Saunders C, Roberts K, Drury M, Walton R, et al. Level of nicotine replacement during a quit- smoking attempt. Nicotine Tob Res 2004;6(2):377-9 2.Bohadana A, Nilsson F, Rasmussen T, Martinet Y. Nicotine inhaler and nicotine patch as a combination therapy for smoking cessation: a randomized, double-blind, placebo-controlled trial. Arch Intern Med 2000;160(20):3128-34 Slide 9 Nicotine delivery Rates Short half life of nicotine requires smokers to regularly smoke to maintain levels 1 Situations linked to smoking such as at home, watching TV, driving the car and socialising may make it difficult to quit 2 Smokers become accustomed to the regular hand to mouth activity 1.Royal College of Physicians, Nicotine Addiction in Britain, 2000 2.Van Gucht D, et. al. J Behav Ther & Exp Psychiat 2010; 41: 172-177 Adapted from Royal College of Physicians, 2000 1 Nasal Slide 10 Standard treatment regimens For many smokers the standard dosing is sufficient In others different (higher) doses may be needed It is also possible that using NRT only from the quit day is not an optimal treatment strategy Benowitz et al (1998) J Pharmacology & Experimental Therapeutics, 287: 958-962 Slide 11 Individualised treatment There has traditionally been a one size fits all approach with dosing of NRT This is at odds with the disease where people exhibit varying degrees of tobacco dependence There is very little individualisation of treatment for tobacco dependence as there is in the management of other chronic diseases. Slide 12 Optimizing treatment Encouraging compliance with use Higher NRT dosing Aiding reduction prior to quitting Continuing NRT after lapse Combining NRT with other medicines Slide 13 A quick refresher on NRT Slide 14 Patches 16hr and 24hr The Cochrane review has failed to detect a difference in efficacy 1 Sleep disturbance is a recognized symptom of nicotine withdrawal 2 16hr patch does not add to the insomnia that occurs as a result of nicotine withdrawal 3 Different strengths Medium and low strengths are for lighter smokers and weaning 4 Skin redness and itchiness is common Place a new patch on a different site each day 4 1.Stead LF, Perera R, Bullen C, Mant D, Lancaster T. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev 2008(1) 2.Nicotine addiction in Britain: A report of the Tobacco Advisory Group of the Royal College of Physicians. London: Royal college of physicians, 2001. 3.Tonnesen P et al. Eur Resp J 1999; 13:238-246. 4.Invisipatch SPC Slide 15 Oral products Gum, microtabs, inhalator, lozenges Different strengths of gum and lozenges Higher dose product for more dependent smokers Nicotine from the inhalator is absorbed from the buccal mucosa (not inhaled) Best to use these as and when cravings occur Prepare smokers for the fact that they dont taste very pleasant (at least initially) Slide 16 Nasal spray Fast acting Good for highly dependent smokers When first used format can be rejected due to usage experience Instruct how to use correctly and reassure people that they will get to like it Slide 17 Nicotine Nasal Spray Sutherland et al (1992) Lancet 340: 324-329 RR=2.61 (95%CI: 1.52-4.47) Slide 18 Fast Acting NRT Nicotine replacement treatments (NRT) deliver nicotine slowly when compared to nicotine delivered via smoking a cigarette Faster delivery systems may improve withdrawal relief and abstinence rates Slide 19 Fast acting formats: Nicotine mouth spray In an effort to create an effective NRT product to be taken at the moment craving emerges, a nicotine spray for use in the mouth has been developed. This spray allows a rapid transmucosal uptake of nicotine. Slide 20 Rapid absorption of nicotine Kraiczi H, et al. Single-Dose Pharmacokinetics of nicotine with a novel mouth spray form of nicoitine replacement therapy. Poster POS3-50 presented at SRNT, Feb 16-19 th, 2011, Toronto, Canada. Slide 21 Short and long term efficacy with nicotine mouth spray 1.Tonnesen P, et al. efficacy and safety of a novel nicotine mouth spray in smoking cessation. A randomised, placebo controlled, double blind, multi-centre study with a 52 week follow-up. Poster POS2-38 presented at SRNT, Feb 16-19 th, 2011, Toronto, Canada. 2. Data on file - 001 Slide 22 Safety and tolerability Most adverse events were mild to moderate 2 and similar in type to other oral NRTs 1 The majority of hiccups were reported as mild 1 No serious drug related adverse events reported 2 1 Data on file - 003 2 Tonnesen P, et al. efficacy and safety of a novel nicotine mouth spray in smoking cessation. A randomised, placebo controlled, double blind, multi-centre study with a 52 week follow-up. Poster POS2-38 presented at SRNT, Feb 16-19 th, 2011, Toronto, Canada. Slide 23 Nicotine mouth spray acts fast on cravings 1. Hansson A et al. Craving relief with a novel nicotine mouthspray form of nicotine replacement therapy. Poster POS3-45 presented at SRNT, Feb 16-19 th 2011, Toronto, Canada. Slide 24 Using enough NRT 1030 smokers who quit for at least 2 weeks in a trial of nicotine lozenges 28-day continuous abstinence at 6-week follow- up was positively correlated with increased NRT use Each one additional active lozenge used increased the odds of quitting by 10% (P