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1.
J Mal Vasc ; 28(5): 293-300, 2003 Dec.
Article in French | MEDLINE | ID: mdl-14978435

ABSTRACT

Tobacco use causes enormous morbidity and mortality because of the high risk of smoking-related diseases and the high prevalence of cigarette smoking. Existing smoking cessation methods only help motivated smokers who are ready to quit, but the vast majority of smokers are pre-contemplators who are neither ready nor willing to attempt to quit. This means that a high proportion of smokers are not adequately served by current strategies for treating tobacco dependence. As cigarettes prematurely kill 50% of long-term users, any additional measure that may reduce death or illness should be given serious consideration. Many addicted smokers are now forced to live and work much of their life in environments in which smoking is prohibited. Most smokers are dependent on nicotine and abstinence from smoking results in tobacco withdrawal and craving, which manifest as clinical symptoms within a few hours of smoking the last cigarette. Craving and withdrawal symptoms can be controlled by supplying nicotine from sources other than cigarettes, such as Nicotine Replacement Therapy (NRT). Clinical studies of short-term abstinence show that all NRT formulations relieve tobacco withdrawal symptoms and craving. Most unaided attempts to decrease health risks by reducing smoking fail because smokers revert to their 'usual' nicotine intake. However, using NRT to reduce smoking allows smokers to reduce their cigarette consumption (and intake of toxic substances in smoke) while maintaining their nicotine dose. Data suggest that smokers who use NRT can significantly reduce the withdrawal symptoms and craving caused by abstaining from cigarettes, and thereby reduce the number of cigarettes/day and maintain these reductions for up to 2 years. The data also indicate that, despite some compensatory smoking behaviour, reduced smoking with NRT results in decreased toxin exposure. In smoking reduction studies, this translated into an improvement in variables that impact on health: cardiovascular risk factors and haemorheology parameters moved towards more healthy (i.e. non-smoker) levels, and pulmonary function improved. The improvements in established cardiovascular risk factors provide objective proof that exposure reduction translates into clinically meaningful health benefits. Furthermore, the known reversibility of many smoking-induced diseases, the mainly linear dose-effect curve and the absence of any indication of threshold effects suggest that additional health benefits may result from smoking reduction. Even more importantly, smoking reduction may move smokers along the behavioural model towards the ultimate goal--stopping smoking. In all three large smoking reduction studies, a number of subjects who were unwilling or unable to stop smoking at baseline were abstinent at 4 months and 1 and 2 years, which clearly supports the concept of smoking reduction as a step towards abstinence. Rather than undermining cessation, smoking reduction appears to increase motivation to quit. The importance of allowing smokers to gradually take control of their smoking was reflected by the increasing point prevalence abstinence rates seen in the long-term studies. When encouraging smoking reduction, it should clearly be emphasised that complete cessation remains the ultimate goal, but smokers in the precontemplation stage need to progress along the behavioural model before becoming receptive to messages about quitting. In conclusion, the evidence presented in this review supports reduced smoking as a legitimate treatment approach that could be pursued by those smokers who are currently unable or unwilling to quit. Sustained smoking reduction can be achieved and maintained with NRT. The corresponding reduction in exposure is associated with tangible health benefits, measured using surrogate markers. Smoking reduction also promotes abstinence in smokers who are unable or unwilling to quit smoking abruptly. NRT is well tolerated for smoking reduction, and nicotine intake does not increase during concomitant use of NRT and smoking.


Subject(s)
Smoking Cessation/methods , Smoking/therapy , Humans , Motivation , Smoking/psychology , Time Factors , Tobacco Smoke Pollution/prevention & control
2.
Monaldi Arch Chest Dis ; 56(1): 5-10, 2001 Feb.
Article in English | MEDLINE | ID: mdl-11407211

ABSTRACT

The aim of this retrospective analysis was to assess the extent of smoking reduction in smokers who were compliant to a smoking cessation trial with nicotine patch, and failed to completely quit smoking. Out of 297 smokers in total, 237 participants received active treatment (60 received placebo). Eighty treated subjects attended all the scheduled visits and were classified as either abstainers (nonsmokers), regular smokers or occasional smokers. Compared to the remaining 157 participants, these 80 subjects had significantly lower mean baseline daily cigarette consumption (24 versus 30; p < 0.001), expired carbon monoxide levels (25 versus 33 ppm; p < 0.001), plasma nicotine and cotinine levels, and Fagerström Tolerance Questionnaire score (5.7 versus 7.0; p < 0.001). All subjects received active treatment for up to 18 weeks (full dose for 12 weeks plus tapering dose for 6 weeks), with follow-up visits scheduled up to 1 yr. A statistically significant reduction in cigarette consumption (versus baseline) was observed among both the occasional (-99%) and regular (-77%) smokers between week 1 and week 52 (p < 0.001). Concomitant smoking and patch use was well tolerated since adverse events were infrequent, mild and transient. Thus, in addition to those subjects who successfully quit smoking, a further group of subjects who attended all the follow-up visits during the smoking cessation trial significantly reduced their mean daily cigarette consumption.


Subject(s)
Nicotine/therapeutic use , Patient Compliance , Smoking Cessation , Smoking/drug therapy , Administration, Cutaneous , Adult , Carbon Dioxide/analysis , Cotinine/blood , Female , Humans , Male , Middle Aged , Nicotine/administration & dosage , Nicotine/blood , Retrospective Studies , Treatment Outcome
3.
BMJ ; 321(7257): 329-33, 2000 Aug 05.
Article in English | MEDLINE | ID: mdl-10926587

ABSTRACT

OBJECTIVES: To determine whether use of an oral nicotine inhaler can result in long term reduction in smoking and whether concomitant use of nicotine replacement and smoking is safe. DESIGN: Double blind, randomised, placebo controlled trial. Four month trial with a two year follow up. SETTING: Two university hospital pulmonary clinics in Switzerland. PARTICIPANTS: 400 healthy volunteers, recruited through newspaper advertisements, willing to reduce their smoking but unable or unwilling to stop smoking immediately. INTERVENTION: Active or placebo inhaler as needed for up to 18 months, with participants encouraged to limit their smoking as much as possible. MAIN OUTCOME MEASURES: Number of cigarettes smoked per day from week six to end point. Decrease verified by a measurement of exhaled carbon monoxide at each time point compared with measurement at baseline. RESULTS: At four months sustained reduction of smoking was achieved in 52 (26%) participants in the active group and 18 (9%) in the placebo group (P<0.001; Fisher's test). Corresponding figures after two years were 19 (9.5%) and 6 (3.0%) (P=0.012). CONCLUSION: Nicotine inhalers effectively and safely achieved sustained reduction in smoking over 24 months. Reduction with or without nicotine substitution may be a feasible first step towards smoking cessation in people not able or not willing to stop abruptly.


Subject(s)
Nicotine/administration & dosage , Smoking Prevention , Administration, Inhalation , Administration, Oral , Adolescent , Adult , Aged , Double-Blind Method , Follow-Up Studies , Humans , Middle Aged , Nicotine/adverse effects , Patient Compliance , Smoking Cessation/methods , Treatment Outcome
4.
J Intern Med ; 246(1): 61-6, 1999 Jul.
Article in English | MEDLINE | ID: mdl-10447226

ABSTRACT

OBJECTIVES: To investigate changes in cardiovascular risk factor parameters when stopping smoking and to identify any impact of nicotine nasal spray on these factors. DESIGN AND SUBJECTS: In a placebo-controlled, double-blind 3-month prospective study, nicotine nasal spray (NNS) or a placebo was given to 157 subjects attending a smoking cessation programme. Blood samples from 46 subjects who remained abstinent for 3 months were analysed. Nasal spray use was given on an ad libitum basis. RESULTS: The haemoglobin (Hb) decreased from 149.0 to 143.2 g L(-1) (P<0.001). The haematocrit (Hct) decreased from 44.6 to 42.4% (P<0.001). The mean corpuscular volume (MCV) decreased from 93.4 to 92.3 fl (P<0.001). The mean corpuscular haemoglobin concentration (MCHC) increased from 333.9 to 338.1 g L(-1) (P = 0.029). The white blood cell count (WBC) decreased from 8.4 to 6.6x10(9) L(-1) (P<0.001). The total cholesterol decreased from 5.92 to 5.65 mmol L(-1) (P = 0.015). The high-density lipoprotein cholesterol (HDL) increased from 1.29 to 1.44 mmol L(-1) (P = 0.48) and low-density lipoprotein cholesterol (LDL) decreased from 4.00 to 3.54 mmol L(-1) (P = 0.004). The HDL/LDL ratio increased from 0.36 to 0.46 (P = 0.011). CONCLUSION: Stopping smoking resulted in positive effects on cardiovascular risk factors. Nicotine treatment for as long as 3 months did not have any significant effect on these 'stopping smoking changes'. In smoking cessation, nicotine substitution up to 3 months seems to be safe.


Subject(s)
Arteriosclerosis/etiology , Nicotine/pharmacology , Nicotinic Agonists/pharmacology , Smoking Cessation , Thrombosis/etiology , Administration, Inhalation , Administration, Intranasal , Adult , Aged , Cardiovascular Diseases/etiology , Cholesterol/blood , Double-Blind Method , Erythrocyte Indices , Female , Fibrinogen/metabolism , Hematocrit , Hemoglobins/metabolism , Humans , Leukocyte Count , Male , Middle Aged , Platelet Count , Prospective Studies , Risk Factors
5.
Eur Respir J ; 13(2): 238-46, 1999 Feb.
Article in English | MEDLINE | ID: mdl-10065662

ABSTRACT

The Collaborative European Anti-Smoking Evaluation (CEASE) was a European multicentre, randomized, double-blind placebo controlled smoking cessation study. The objectives were to determine whether higher dosage and longer duration of nicotine patch therapy would increase the success rate. Thirty-six chest clinics enrolled a total of 3,575 smokers. Subjects were allocated to one of five treatment arms: placebo and either standard or higher dose nicotine patches (15 mg and 25 mg daily) each given for 8 or 22 weeks with adjunctive moderately intensive support. The 12 month sustained success rates were: 25 mg patch for 22 weeks (L-25), 15.4%; 25 mg patch for 8 weeks (S-25), 15.9%; 15 mg patch for 22 weeks (L-15), 13.7%; 15 mg patch for 8 weeks (S-15), 11.7%; and placebo (P-0) 9.9% (placebo versus 15 mg, p<0.05; 25 mg versus 15 mg, p<0.03; 25 mg versus placebo, p<0.001, Chi-squared test). There was no significant difference in success rate between the two active treatment durations. Of the first week abstainers (n=1,698), 25.1% achieved success at 12 months as opposed to first week smokers, 2.7% of 1,877 subjects (p< 0.001). In summary, a higher than standard dose of nicotine patch was associated with an increase in the long-term success in smoking cessation but continuation of treatment beyond 8-12 weeks did not increase the success rates.


Subject(s)
Nicotine/administration & dosage , Smoking Cessation/methods , Administration, Cutaneous , Adult , Aged , Body Weight , Double-Blind Method , Female , Humans , Male , Middle Aged , Nicotine/adverse effects , Patient Compliance , Treatment Outcome
6.
Rhinology ; 36(3): 98-100, 1998 Sep.
Article in English | MEDLINE | ID: mdl-9830671

ABSTRACT

Thirty-three subjects with chronic rhinitis used nicotine nasal spray in an open study as an aid in smoking cessation. Thirty-eight percent of them were completely abstinent at 12 weeks, whereas 35% were completely abstinent at 20 weeks. The nasal spray was associated with irritant nasal side effects, which occurred most often in the early stages of treatment. Clinical nasal examinations could not observe any significant impairment in nasal conditions following spray use. In conclusion, this study confirms the short-term safety of the nicotine nasal spray as an aid in smoking cessation.


Subject(s)
Nicotine/adverse effects , Nicotinic Agonists/adverse effects , Rhinitis/physiopathology , Smoking Cessation/methods , Administration, Intranasal , Adult , Aerosols , Aged , Cell Nucleus/ultrastructure , Chronic Disease , Cilia/ultrastructure , Cytoplasm/ultrastructure , Epithelial Cells/pathology , Evaluation Studies as Topic , Female , Follow-Up Studies , Goblet Cells/pathology , Humans , Irritants/adverse effects , Male , Middle Aged , Nasal Mucosa/drug effects , Nasal Mucosa/pathology , Nicotine/administration & dosage , Nicotinic Agonists/administration & dosage , Nose/pathology , Nose/physiopathology , Peak Expiratory Flow Rate/physiology , Safety , Smell/physiology , Smoking/pathology , Smoking/physiopathology , Smoking Prevention
7.
Int J Cancer ; 70(2): 145-9, 1997 Jan 17.
Article in English | MEDLINE | ID: mdl-9009151

ABSTRACT

Among biomarkers of tobacco smoke (TS)-induced genotoxic damage, benzo[a]pyrene diolepoxide-DNA adducts (BPDE-DNA) are extensively studied. Adducted DNA becomes antigenic and antibodies anti-BPDE-DNA (BPDE-DNA-Abs) may be found in serum of exposed subjects. Little is known about the persistence of BPDE-DNA, and no study has been performed to evaluate the persistence of BPDE-DNA-Abs after cessation of exposure. Fifty heavy smokers, enrolled in a smoking cessation program with nicotine patch substitution therapy, were evaluated for the presence of BPDE-DNA-Abs before (w0) and 1, 3, 6 and 12 weeks (w1-12) after the start of the program. Nicotine or placebo patches were randomly assigned to the subjects. BPDE-DNA-Abs were determined in serum by non-competitive ELISA. After the start of the cessation program, 28 subjects quit smoking (group Q) and the other 22 reduced by about 75% the number of cigarettes smoked per day (group R). At the start of the program (w0) 8% of subjects were positive. At w1 the prevalence of positivity had increased both in subjects who quit smoking (Q: 21%) and in subjects who had reduced the number of cigarettes per day (R: 27%). Positivity remained stable up to w12 (21%) for group Q, whereas it increased to 41% in group R. Serum BPDE-DNA-Abs can be detected in smokers, and their persistence for months after smoking cessation suggests their usefulness for relatively long-term surveys. The low percentage of positivity in actual heavy smokers and the increase in antibody positivity with smoking cessation or reduction must be taken into account when interpreting serum BPDE-DNA-Ab measurement in exposed individuals.


Subject(s)
7,8-Dihydro-7,8-dihydroxybenzo(a)pyrene 9,10-oxide , Antibodies, Antinuclear/immunology , DNA Adducts/immunology , Smoking Cessation , Smoking/immunology , Biomarkers , DNA Damage , Humans , Nicotine/administration & dosage , Nicotine/therapeutic use , Single-Blind Method , Smoking/genetics , Smoking/metabolism
8.
Eur Respir J ; 9(4): 643-51, 1996 Apr.
Article in English | MEDLINE | ID: mdl-8726925

ABSTRACT

Nicotine replacement by transdermal patches is more effective than placebo in smoking cessation, but has a low success rate after one year (9-18%). We tested whether this was attributed to insufficient nicotine replacement. We conducted a randomized trial to investigate the effect on outcome of different doses of transdermal nicotine replacement after stratification according to baseline plasma cotinine values. Two hundred and ninety seven adult smokers were enrolled. Those with baseline cotinine < or = 250 ng.ml-1 (low cotinine) were randomly assigned to placebo (LC-P) or to 15 mg 16 h nicotine patches (LC-15), and those with baseline cotinine > 250 ng.mL-1 (high cotinine) were randomly assigned to 15 mg (HC-15) or 25 mg (HC-25) 16 h nicotine patches. Plasma nicotine and cotinine values, expired carbon monoxide and withdrawal symptoms were measured at scheduled intervals during treatment. Smokers in the LC-15 group had a significantly higher success rate than placebo (28 vs 9%). Smokers with high baseline cotinine had lower success rates, and a high dose of nicotine did not increase success rate (HC-25 9% vs HC-15 11%). Subjects in the HC-15 group had the lowest percentage of nicotine replacement and a higher prevalence of withdrawal symptoms than the HC-25 group. Replacement was similar in groups LC-15 and HC-25, but the success rate was significantly lower in HC-25 group, despite similar levels of withdrawal symptoms. We conclude that a higher success rate was obtained after one year in smokers with low baseline plasma cotinine values. Determination of plasma cotinine values may be, thus, helpful in identifying smokers who could benefit from transdermal nicotine replacement.


Subject(s)
Cotinine/analysis , Cotinine/blood , Nicotine/therapeutic use , Nicotinic Agonists/therapeutic use , Smoking Cessation , Tobacco Use Disorder/drug therapy , Tobacco Use Disorder/metabolism , Adult , Double-Blind Method , Female , Humans , Male , Middle Aged
9.
J R Coll Physicians Lond ; 29(5): 392-6, 1995.
Article in English | MEDLINE | ID: mdl-8847680

ABSTRACT

We had the unique opportunity to study the effects of transdermal nicotine on markers of haemostasis and serum lipids in patients with ulcerative colitis; all were non-smokers and were given transdermal nicotine to assess its value in maintenance therapy for colitis. In a controlled double-blind trial, 45 patients with ulcerative colitis in remission on 5-aminosalicylic acid, were randomly allocated to receive transdermal nicotine (20) or placebo (25) patches. Markers of haemostasis, including platelet activation (platelet volume and surface expression of P selectin), endothelial damage (plasma von Willebrand factor antigen) and plasma fibrinogen were measured at the beginning and after 12 weeks of treatment. The white cell count and serum lipids were also measured. Nicotine significantly lowered plasma fibrinogen but did not affect markers of platelet activation, endothelial damage, white cell count and serum lipids. The possibility that transdermal nicotine may beneficially influence cardiovascular risk factors warrants further exploration.


Subject(s)
Cardiovascular System/drug effects , Nicotine/administration & dosage , Nicotine/adverse effects , Administration, Cutaneous , Adult , Colitis, Ulcerative/drug therapy , Double-Blind Method , Female , Fibrinogen/analysis , Hemoglobins/analysis , Hemostasis/drug effects , Humans , Leukocyte Count , Lipids/blood , Male , Middle Aged , P-Selectin/analysis , Platelet Activation/drug effects , Platelet Count , von Willebrand Factor/analysis
10.
Addiction ; 90(1): 31-42, 1995 Jan.
Article in English | MEDLINE | ID: mdl-7888977

ABSTRACT

The transdermal nicotine patch has proved an effective aid to smoking cessation. The ease of securing good compliance gives it a potential advantage over nicotine gum as an adjunct to brief advice and support in primary care settings where the major public health impact is obtained. In a preliminary report of half the sample of a randomized placebo controlled trial, we showed the patch to be effective in a general practice setting. We report here the definitive results of the full sample, including dose effects, predictors of outcome and other issues of theoretical and practical interest. A total of 1200 heavy smokers (> or = 15 per day), attending 30 general practices in 15 English counties received brief GP advice, a booklet and 16 hours per day patch treatment for 18 weeks. Dose increase and abrupt vs. gradual reduction of patch dosage were also randomized and follow-ups conducted at 1, 3, 6, 12, 26 and 52 weeks. Outcome was measured by self-reported complete abstinence from week 3 to 52 with biochemical validation at all follow-up points. Nicotine patch treatment doubled the rate of continuous abstinence up to 1 year (nicotine 9.6%, placebo 4.8%, p < 0.01); it most likely worked by reducing withdrawal symptoms. It enhanced cessation during the first week and reduced relapse during the second week. The dose increase after week 1 produced no sustained increase in cessation. Gradual reduction was no better at preventing relapse than abrupt withdrawal of patches after week 12. Whether relapse would have increased by ending treatment at some point between weeks 3 and 12 was not tested. Although pre-treatment dependence on cigarettes was prognostic of failure, the patches were equally helpful to both highly and less dependent smokers. Patches were particularly helpful to smokers with pre-treatment subclinical dysthymic symptoms. All but one of the 96 subjects eventually achieving long-term abstinence in the study quit during the first week of cessation.


Subject(s)
Nicotine/administration & dosage , Smoking Cessation/methods , Administration, Cutaneous , Adult , Affect/drug effects , Dose-Response Relationship, Drug , Double-Blind Method , Drug Administration Schedule , Family Practice , Female , Follow-Up Studies , Humans , Male , Middle Aged , Nicotine/adverse effects , Smoking Cessation/psychology , Treatment Outcome
11.
Arch Phys Med Rehabil ; 75(5): 551-4, 1994 May.
Article in English | MEDLINE | ID: mdl-8185448

ABSTRACT

This study evaluated long-term effects of 12 weeks of supervised training, of at least 45 minutes duration with two sessions per week, on physical performance and psychological well-being after myocardial infarction (MI). Sixty-nine patients were randomized to either an exercise or a nonexercise group. Maximum exercise capacity 6 weeks post-MI was inversely related to the acute peak aspartate aminotransferase values in serum, as an index of infarct size. One year post-MI, the increase in level of fitness (10%) in the training group did not significantly exceed (p = .10) that of the controls (2%). No intergroup differences were registered in self-rated psychological well-being and physical scores or in the return to work rate. In the training group, but not in the controls, the change in perceived dyspnoea at leisure-time activities was positively related to the objectively measured peak exercise capacity. We conclude that after MI only marginal improvements in physical performance are achieved 6 months after training is finished, with no long-term psychological benefits apparent versus a usual care program. The adaptive implications of supervised conventional exercise programs post-MI are therefore questioned.


Subject(s)
Exercise Therapy , Myocardial Infarction/rehabilitation , Physical Fitness , Adult , Aged , Aspartate Aminotransferases/blood , Female , Humans , Male , Middle Aged , Myocardial Infarction/enzymology , Myocardial Infarction/psychology , Quality of Life , Work
12.
Arch Intern Med ; 153(16): 1881-90, 1993 Aug 23.
Article in English | MEDLINE | ID: mdl-8110249

ABSTRACT

BACKGROUND: To determine the effectiveness of a 16-hour transdermal nicotine patch in assisting smokers to stop smoking, when used in a primary medical practice model. METHODS: A single-site, randomized, double-blind, out-patient, parallel-group, placebo-controlled trial consisting of 220 regular, otherwise healthy cigarette smokers. Patients participated in a 12-week patch treatment phase plus a 6-week tapering phase. A standard medical office model of physician intervention, such as could easily be employed by any primary care physician, without need for any special psychological services, training, or skills, was the behavioral intervention. RESULTS: Sustained abstinence, determined at each visit by absolutely no cigarette use, carbon monoxide level of 9 ppm or less, and serum cotinine level of 15 ng/mL or less (after week 18), was significantly greater for those patients receiving the active nicotine patch than for those receiving the placebo patch: the percent of patients not smoking at 6, 12, 18, 26, and 52 weeks was 61% vs 35%, 45% vs 26%, 41% vs 16%, 34% vs 12%, and 25% vs 9%, respectively (P < .001). This 16-hour nicotine patch produced no systemic side effects and minimal skin irritation. CONCLUSIONS: Nicotine replacement therapy via a 16-hour transdermal nicotine patch provided safe and effective treatment for tobacco-dependent patients. One-year sustained nonsmoking rates were nearly three times higher in the active than in the placebo condition, when the patch was used in an easily applicable standard medical practice setting, without the need for psychological interventions. This outcome was as good as or better than results achieved by nicotine patches using behavior modification or group counseling.


Subject(s)
Nicotine/administration & dosage , Smoking/drug therapy , Administration, Cutaneous , Adult , Aged , Body Weight , Cotinine/blood , Delayed-Action Preparations , Double-Blind Method , Family Practice , Female , Humans , Male , Middle Aged , Nicotine/adverse effects , Nicotine/therapeutic use , Patient Compliance , Psychotherapy, Group , Smoking/blood , Smoking/physiopathology , Substance Withdrawal Syndrome/physiopathology , Substance Withdrawal Syndrome/prevention & control , Time Factors , Treatment Outcome
13.
BMJ ; 306(6888): 1308-12, 1993 May 15.
Article in English | MEDLINE | ID: mdl-8518572

ABSTRACT

OBJECTIVES: (a) To evaluate the efficacy of transdermal nicotine patches as an aid to stopping smoking when used as an adjunct to brief advice and support in a general practice setting; (b) to see whether an increase in nicotine patch dosage enhances the rate of initial cessation. DESIGN: Randomised double blind placebo controlled parallel group study with one year of follow up. SETTING: 30 general practices in 15 English counties. SUBJECTS: 600 dependent heavy smokers (> or = 15 cigarettes daily) who were well motivated to give up. INTERVENTIONS: Brief general practitioner advice, booklet, and 16 hours per day patch treatment for 18 weeks with brief support and follow up at one, three, six, 12, 26, and 52 weeks. MAIN OUTCOME MEASURES: Self reported complete abstinence for up to one year with biochemical validation at all follow up points. RESULTS: Nicotine patches reduced the severity of craving and adverse mood changes in the first weeks of withdrawal and doubled the rate of initial cessation at week 3 (nicotine group 36% of patients (144/400), placebo group 16.5% of patients (33/200)) and of continuous abstinence throughout one year (nicotine group 9.3% (37), placebo group 5.0% (10)). A dose increase at week 1 among patients experiencing difficulty in quitting increased the proportion who achieved abstinence at week 3. There were no adverse systemic effects attributable to nicotine, but the incidence of moderate or severe local irritation or itching at the patch site was 16.4% (63 patients), compared with 3.8% (seven) with placebo. CONCLUSION: Transdermal nicotine patches used as an adjunct to brief advice and support in a general practice setting are an effective aid to long term cessation of smoking in highly dependent smokers.


Subject(s)
Nicotine/administration & dosage , Smoking Cessation , Administration, Cutaneous , Adult , Dose-Response Relationship, Drug , Double-Blind Method , Family Practice , Female , Health Education , Humans , Male , Middle Aged , Patient Compliance , Smoking Cessation/methods , Smoking Cessation/psychology , Social Support , Substance Withdrawal Syndrome/rehabilitation , Treatment Outcome
14.
Addiction ; 88(4): 533-9, 1993 Apr.
Article in English | MEDLINE | ID: mdl-8485431

ABSTRACT

The aim was to evaluate if recycling of failures from a smoking cessation study may be of value. The study comprised 126 smokers (50%) of 252 failures, from a double-blind smoking cessation trial with nicotine patch, who accepted recycling after 1 year. Subjects were allocated nicotine patches delivering 15, 20 or 25 mg of nicotine (over 16 hours) according to their base-line saliva cotinine concentrations in an open trial. The treatment period was 12 weeks followed by tapering over 6 weeks. The percentage of quitters after 3, 12, 26, and 52 weeks was 44, 20, 7 and 6%, respectively. After 26 weeks, all subjects had relapsed in the group previously treated with active nicotine patch compared with 12% abstainers in the previous placebo subjects. The sustained abstinence rate without slips after one year was 2%. Recycling does not seem to be of long-term clinical relevance in our set-up for subjects initially treated with nicotine, but of some value in subjects quitting without nicotine therapy initially.


Subject(s)
Nicotine/administration & dosage , Smoking Cessation , Administration, Cutaneous , Adult , Aged , Cotinine/pharmacokinetics , Dose-Response Relationship, Drug , Female , Follow-Up Studies , Humans , Male , Middle Aged , Nicotine/adverse effects , Recurrence , Saliva/metabolism , Substance Withdrawal Syndrome/etiology
15.
Br J Addict ; 87(8): 1189-94, 1992 Aug.
Article in English | MEDLINE | ID: mdl-1511231

ABSTRACT

Reports of smoking cessation studies often claim that many relapsed subjects reduce their smoking. We investigated the smoking habits of relapsers 1 year after quitting in a smoking cessation trial using nicotine or placebo patches. All 289 participants in that study were summoned to a 1-year follow-up visit--148 (57%) of 259 relapsers attended, as did all 30 sustained abstainers. Fewer than 1% of the subjects had quit spontaneously after the primary relapse. Daily cigarette consumption, standard nicotine yield per cigarette, saliva cotinine concentration, expired carbon monoxide level and two nicotine dependency scales were assessed at entry and at the 1-year follow-up. In five of these six smoking-related characteristics, there was a small but significant mean reduction of 7%-27%. A significant weight gain of 0.5 +/- 2.9 kg (mean +/- SD) was recorded in the relapsers compared with 4.8 +/- 4.2 kg for abstainers (p less than 0.001). It is concluded that smoking habits in relapsers are relatively unchanged, and thus the most important outcome measure in smoking cessation trials is abstinent subjects.


Subject(s)
Carbon Monoxide/pharmacokinetics , Cotinine/pharmacokinetics , Patient Compliance/psychology , Smoking Cessation/psychology , Smoking/physiopathology , Administration, Cutaneous , Adult , Body Weight/drug effects , Female , Follow-Up Studies , Humans , Male , Nicotine/administration & dosage , Recurrence , Smoking/psychology
17.
Eur J Clin Pharmacol ; 43(1): 57-60, 1992.
Article in English | MEDLINE | ID: mdl-1505610

ABSTRACT

The purpose of the study was to examine long-term nicotine substitution and its variability during use of a nicotine patch. In two smoking cessation studies a 16-h nicotine patch, releasing 15 mg nicotine, was applied daily for 16 h over 12 weeks, to 167 smokers. Salivary cotinine was highly correlated with plasma cotinine (r = 0.93), and the concentration of cotinine in a single sample in the afternoon was well correlated with the AUCcontinine over 24 h (r = 0.94). The salivary cotinine concentration after 1 week in 60 abstainers was 183 ng.ml-1. After 3,6 and 12 weeks the cotinine concentrations were 86%, 79% and 59% of the 1-week value. The degree of nicotine compensation attained by the patch after 1 week was 52% (SD 24%) in subjects who succeeded in stopping smoking for at least 3 weeks. A quarter of the subjects achieved a compensation of less than 35% of their usual nicotine intake. Nicotine substitution with this 16-h nicotine patch was stable and the risk of overcompensation was small in this group of smokers.


Subject(s)
Nicotine/administration & dosage , Smoking Cessation , Administration, Cutaneous , Adult , Aged , Cotinine/analysis , Cotinine/blood , Double-Blind Method , Female , Humans , Male , Middle Aged , Nicotine/blood , Nicotine/metabolism , Saliva/chemistry
18.
Ugeskr Laeger ; 154(5): 251-4, 1992 Jan 27.
Article in Danish | MEDLINE | ID: mdl-1736456

ABSTRACT

The use of nicotine chewing gum combined with psychological support improves the success rate in stopping smoking. We studied the safety and efficacy of a transdermal nicotine patch in stopping smoking. We conducted a double-blind randomized study comparing the effect of a 16-hour nicotine patch (15 +/- 3.5 mg of nicotine in 16 hours) with those of a placebo patch. Of the 289 smokers (207 women and 82 men) enrolled in the study, 145 were treated with nicotine patches and 144 with placebo patches for 16 weeks. The rates of sustained abstinence were significantly better with active treatment than with the placebo: 53, 41, 24 and 17% of those in the nicotine-patch group were abstinent after 6, 12, 26, and 52 weeks, respectively, as compared with 17, 10, 5 and 4% of those in the placebo-patch group (p less than 0.0001). Only two subjects with the nicotine patch and one with the placebo patch withdrew from the study because of side effects. The nicotine skin patch proved to be safe and effective, as demonstrated by a higher rate of abstinence than with the placebo.


Subject(s)
Nicotine/administration & dosage , Smoking Cessation/methods , Administration, Cutaneous , Adult , Aged , Double-Blind Method , Female , Humans , Male , Middle Aged
19.
N Engl J Med ; 325(5): 311-5, 1991 Aug 01.
Article in English | MEDLINE | ID: mdl-2057036

ABSTRACT

BACKGROUND: The use of nicotine chewing gum combined with psychological support improves the success rate in quitting smoking. We studied the safety and efficacy of a transdermal nicotine patch in smoking cessation. METHODS: We conducted a double-blind randomized study comparing the effects of a 16-hour nicotine patch (15 +/- 3.5 mg of nicotine in 16 hours) with those of a placebo patch. Of the 289 smokers (207 women and 82 men) enrolled in the study, 145 were treated with nicotine patches and 144 with placebo patches for 16 weeks. RESULTS: Rates of sustained abstinence were significantly better with active treatment than with placebo: 53, 41, 24, and 17 percent of those in the nicotine-patch group were abstinent after 6, 12, 26, and 52 weeks, respectively, as compared with 17, 10, 5, and 4 percent of those in the placebo-patch group (P less than 0.0001). Only two subjects with the nicotine patch and one with the placebo patch had to withdraw from the study because of side effects. CONCLUSIONS: The nicotine skin patch proved to be safe and effective, as demonstrated by a higher rate of abstinence than with placebo. However, the absolute rate of abstinence after one year was only 17 percent, which is lower than the rate in studies that have combined the use of nicotine chewing gum with behavioral therapy.


Subject(s)
Nicotine/administration & dosage , Smoking Prevention , Administration, Cutaneous , Adult , Aged , Behavior Therapy , Body Weight , Chewing Gum , Double-Blind Method , Female , Humans , Male , Middle Aged , Nicotine/adverse effects , Patient Compliance , Substance Withdrawal Syndrome
20.
Thromb Res ; 49(1): 103-10, 1988 Jan 01.
Article in English | MEDLINE | ID: mdl-3347924

ABSTRACT

Serum lipoprotein concentrations were related to hemostatic parameters in a group of 31 men before and during three different hormone treatment regimens for prostate cancer in an attempt to analyse to what extent the changes in these two systems correlate. In a correlation matrix the number of significant relationships at the 5% and 1% level corresponded to what could be expected by chance. The study thus failed to demonstrate any consistent relationship between any lipoprotein lipid concentration and the hemostatic parameters in men treated for prostate cancer. Most significant relationships were found for HDL-TG versus plasminogen, but the clinical significance of this observation is not clear.


Subject(s)
Hemostasis , Lipoproteins/blood , Prostatic Neoplasms/blood , Estradiol Congeners/therapeutic use , Humans , Lipoproteins, HDL/blood , Male , Orchiectomy , Plasminogen/metabolism , Prostatic Neoplasms/drug therapy , Prostatic Neoplasms/surgery , Time Factors , Triglycerides/blood , Urokinase-Type Plasminogen Activator/antagonists & inhibitors
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