Pharmacokinetics, safety and efficacy from randomized controlled trials of 1 and 2 mg nicotine bitartrate lozenges (Nicotinell®)

BMC Clinical Pharmacology

Volumn 7, Issue , 2007, Pages

  Dautzenberg, Bertrand ^a   Nides, Mitchell ^b   Kienzler, Jean Luc ^c   Callens, Anne ^d  

^a PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

^b Los Angeles Clinical Trials   (United States)

^c Novartis Consumer Health SA   (Switzerland)

^d Novartis Santé Familiale   (France)

Author keywords

[No Author keywords available]

Indexed keywords

NICOTINE; NICOTINE GUM; PLACEBO;

ABNORMAL LABORATORY RESULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CARDIOVASCULAR PARAMETERS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DISEASE SEVERITY; DOSE TIME EFFECT RELATION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSAGE FORM; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG DOSE SEQUENCE; DRUG EFFICACY; DRUG EXCRETION; DRUG FORMULATION; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FLATULENCE; FOLLOW UP; FRANCE; GASTROINTESTINAL TOXICITY; GUM; HEADACHE; HICCUP; HUMAN; LOZENGE; MAXIMUM PLASMA CONCENTRATION; MULTIPLE DRUG DOSE; NAUSEA; NICOTINE REPLACEMENT THERAPY; RANDOMIZED CONTROLLED TRIAL; SALIVATION; SIDE EFFECT; SINGLE DRUG DOSE; SMOKING CESSATION; THROAT IRRITATION; TIME TO MAXIMUM PLASMA CONCENTRATION; TOBACCO DEPENDENCE; UNITED STATES; VOMITING; BIOAVAILABILITY; CROSSOVER PROCEDURE; DOSE RESPONSE; REVIEW; SAFETY; SMOKING;

BIOLOGICAL AVAILABILITY; CROSS-OVER STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; HUMANS; NICOTINE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SAFETY; SMOKING;

EID: 38149010465     PISSN: None     EISSN: 14726904     Source Type: Journal    
DOI: 10.1186/1472-6904-7-11     Document Type: Article

References (37)

1. Hecht SS Tobacco smoke carcinogens and lung cancer J Natl Cancer Inst 1999, 91(14):1194-1210. 10.1093/jnci/91.14.1194 10413421
2. Chen Z Boreham J Smoking and cardiovascular disease Semin Vasc Med 2002, 2(3):243-252. 10.1055/s-2002-35392 16222617
3. Kamholz SL Pulmonary and cardiovascular consequences of smoking Med Clin North Am 2004, 88(6):1415-1430. ix-x 10.1016/j.mcna.2004.07.008 15464105
4. West R DiMarino ME Gitchell J McNeill A Impact of UK policy initiatives on use of medicines to aid smoking cessation Tob Control 2005, 14(3):166-171. 10.1136/tc.2004.008649 15923466
5. Shiffman S Gitchell J Pinney JM Burton SL Kemper KE Lara EA Public health benefit of over-the-counter nicotine medications Tob Control 1997, 6(4):306-310. 9583628
6. Law MR Hackshaw AK Environmental tobacco smoke Br Med Bull 1996, 52(1):22-34. 8746294
7. Schroeder SA What to do with a patient who smokes JAMA 2005, 294(4):482-487. 10.1001/jama.294.4.482 16046655
8. Henningfield JE Fant RV Buchhalter AR Stitzer ML Pharmacotherapy for nicotine dependence CA Cancer J Clin 2005, 55(5):281-299. 16166074
9. Silagy C Lancaster T Stead L Mant D Fowler G Nicotine replacement therapy for smoking cessation Cochrane Database Syst Rev 2004, 3: CD000146. 15266423
10. McNeill A Foulds J Bates C Regulation of nicotine replacement therapies (NRT): A critique of current practice Addiction 2001, 96(12):1757-1768. 10.1046/j.1360-0443.2001.961217575.x 11784468
11. WHO Europe McNeill A Hendrie A Regulation of nicotine replacement therapies: An expert consensus Copenhagen 2001 http://www.euro.who.int/ document/e74522.pdf.
12. Fiore MC Bailey WC Cohen SJ Dorfman SF Goldstein MG Gritz ER Heyman RB Jaen CR Kottke TE Lando HA A clinical practice guideline for treating tobacco use and dependence: A US Public Health Service report JAMA 2000, 283(24):3244-3254. 10.1001/jama.283.24.3244 10866874
13. Shiffman S Fant RV Buchhalter AR Gitchell JG Henningfield JE Nicotine delivery systems Expert Opin Drug Deliv 2005, 2(3):563-577. 10.1517/ 17425247.2.3.563 16296775
14. Le Houezec J Role of nicotine pharmacokinetics in nicotine addiction and nicotine replacement therapy: A review Int J Tuberc Lung Dis 2003, 7(9):811-819. 12971663
15. Burton SL Gitchell JG Shiffman S Use of FDA-approved pharmacological treatments for tobacco dependence - United States, 1984-1998 MMWR Morb Mortal Wkly Rep 2000, 49(29):665-668. 10943254
16. Shiffman S Dresler CM Hajek P Gilburt SJ Targett DA Strahs KR Efficacy of a nicotine lozenge for smoking cessation Arch Intern Med 2002, 162(11):1267-1276. 10.1001/archinte.162.11.1267 12038945
17. Dautzenberg B Ruff F Vaucher M Maillon P Jacob N Kienzler JL Rentsch D Callens A First demonstration of the good efficacy/safety ratio of Nicotinell(R) 1 mg lozenge (NL 1 mg), a new form of nicotine substitution, by randomised clinical trial [abstract] Eur Respir J 2001, (Suppl 33):s12.
18. Dautzenberg B Vaucher M Maillon P Peiffer G Toulouse F Lagrue G Jacob N Kienzler JL Rentsch D Callens A [Efficacy and tolerance of a 1 mg nicotine lozenge in smoking cessation. Randomized double-blind trial] Le courrier des addictions 2005, 7(1):7-12.
19. Shiffman S Di Marino ME Pillitteri JL The effectiveness of nicotine patch and nicotine lozenge in very heavy smokers J Subst Abuse Treat 2005, 28(1):49-55. 10.1016/j.jsat.2004.10.006 15723732
20. Shiffman S Nicotine lozenge efficacy in light smokers Drug Alcohol Depend 2005, 77(3):311-314. 10.1016/j.drugalcdep.2004.08.026 15734231
21. Shiffman S Dresler CM Rohay JM Successful treatment with a nicotine lozenge of smokers with prior failure in pharmacological therapy Addiction 2004, 99(1):83-92. 10.1111/j.1360-0443.2004.00576.x 14678066
22. Demazieres A Luthringer R Coppel E Gilles C Fleury C Roegel JC Delarue A Laur C Lagrue G Ability of a new oral nicotine substitute to reduce smoking urge in moderate smokers Addict Behav 2005, 31(3):537-543. 10.1016/j.addbeh.2005.05.017 15964703
23. Choi JH Dresler CM Norton MR Strahs KR Pharmacokinetics of a nicotine polacrilex lozenge Nicotine Tob Res 2003, 5(5):635-644. 10.1080/ 1462220031000158690 14577980
24. Heatherton TF Kozlowski LT Frecker RC Fagerstrom KO The Fagerstrom Test for Nicotine Dependence: A revision of the Fagerstrom Tolerance Questionnaire Br J Addict 1991, 86(9):1119-1127. 10.1111/ j.1360-0443.1991.tb01879.x 1932883
25. Benowitz N Porchet H Jacob P Pharmacokinetics, metabolism and pharmacodynamics of nicotine Nicotine psychopharmacology: Molecular, cellular and behavioral aspects Oxford: Oxford University Press Wonnacott S, Russell MA, Stolerman IP 1990:112-157.
26. Benowitz NL Jacob P 3rd Savanapridi C Determinants of nicotine intake while chewing nicotine polacrilex gum Clin Pharmacol Ther 1987, 41(4):467-473. 3829583
27. Benowitz NL Pharmacology of nicotine: Addiction and therapeutics Annu Rev Pharmacol Toxicol 1996, 36:597-613. 10.1146/ annurev.pa.36.040196.003121 8725403
28. Lunell E Molander L Andersson M Relative bioavailability of nicotine from a nasal spray in infectious rhinitis and after use of a topical decongestant Eur J Clin Pharmacol 1995, 48(1):71-75. 10.1007/BF00202176 7542589
29. Fagerstrom KO Efficacy of nicotine chewing gum: A review Prog Clin Biol Res 1988, 261:109-128. 3289000
30. Henningfield JE Stapleton JM Benowitz NL Grayson RF London ED Higher levels of nicotine in arterial than in venous blood after cigarette smoking Drug Alcohol Depend 1993, 33(1):23-29 10.1016/ 0376-8716(93)90030-T 8370337
31. George TP O'Malley SS Current pharmacological treatments for nicotine dependence Trends Pharmacol Sci 2004, 25(1):42-48. 10.1016/ j.tips.2003.11.003 14723978
32. Cohen LM Collins FL Jr Britt DM The effect of chewing gum on tobacco withdrawal Addict Behav 1997, 22(6):769-773. 10.1016/ S0306-4603(96)00072-X 9426794
33. Murray RP Bailey WC Daniels K Bjornson WM Kurnow K Connett JE Nides MA Kiley JP Safety of nicotine polacrilex gum used by 3,094 participants in the Lung Health Study Chest 1996, 109(2):438-445. 8620719
34. Hu T Sung HY Keeler TE Marciniak M Cigarette consumption and sales of nicotine replacement products Tob Control 2000, 9(Suppl 2): II60-63. 10841593
35. Tonnesen P Fryd V Hansen M Helsted J Gunnersen AB Forchammer H Stockner M Two and four mg nicotine chewing gum and group counselling in smoking cessation: An open, randomized, controlled trial with a 22 month follow-up Addict Behav 1988, 13(1):17-27. 10.1016/0306-4603(88)90021-4 3284283
36. Marsh HS Dresler CM Choi JH Targett DA Gamble ML Strahs KR Safety profile of a nicotine lozenge compared with that of nicotine gum in adult smokers with underlying medical conditions: A 12-week, randomized, open-label study Clin Ther 2005, 27(10):1571-1587. 10.1016/ j.clinthera.2005.10.008 16330293
37. Shiffman S Hughes JR Di Marino ME Sweeney CT Patterns of over-the-counter nicotine gum use: Persistent use and concurrent smoking Addiction 2003, 98(12):1747-1753. 10.1111/j.1360-0443.2003.00575.x 14651507