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Nicotine receptor partial agonists for smoking cessation 2008 Department of Primary Health Care, University of Oxford, Rosemary Rue Building, Old Road Campus, Oxford, UK, OX3 7LF. kate.cahill@dphpc.ox.ac.uk
Source Type
Print(0)
Ref Type
Journal Article
Periodical, Full
The Cochrane database of systematic reviews
Periodical, Abbrev.
Cochrane Database Syst.Rev.
Pub Date Free Form
16-Jul
Volume
(3):CD006103. doi
Issue
3
Start Page
CD006103
Other Pages
Notes
LR: 20151119; JID: 100909747; 0 (Alkaloids); 0 (Azocines); 0 (Benzazepines); 0 (Nicotinic Agonists); 0 (Quinolizines); 0 (Quinoxalines); 01ZG3TPX31 (Bupropion); 53S5U404NU (cytisine); 6M3C89ZY6R (Nicotine); W6HS99O8ZO (Varenicline); UIN: Cochrane Database
Place of Publication
England
ISSN/ISBN
1469-493X; 1361-6137
Accession Number
PMID: 18646137
Language
eng
SubFile
Journal Article; Meta-Analysis; Review; IM
DOI
10.1002/14651858.CD006103.pub3 [doi]
Output Language
Unknown(0)
PMID
18646137
Abstract
BACKGROUND: Nicotine receptor partial agonists may help people to stop smoking by a combination of maintaining moderate levels of dopamine to counteract withdrawal symptoms (acting as an agonist) and reducing smoking satisfaction (acting as an antagonist). Varenicline was developed as a nicotine receptor partial agonist from cytisine, a drug widely used in central and eastern Europe for smoking cessation. The first trial reports of varenicline were released in 2006, and further trials have now been published or are currently are underway. OBJECTIVES: The primary objective of this review is to assess the efficacy and tolerability of nicotine receptor partial agonists, including varenicline and cytisine, for smoking cessation. SEARCH STRATEGY: We searched the Cochrane Tobacco Addiction Group's specialised register for trials, using the terms ('varenicline' or 'cytisine' or 'Tabex' or 'nicotine receptor partial agonist') and 'smoking' in the title or abstract, or as keywords. We also searched MEDLINE, EMBASE, PsycINFO and CINAHL using MeSH terms and free text, and we contacted authors of trial reports for additional information where necessary. The latest search was in March 2008. SELECTION CRITERIA: We included randomized controlled trials which compared the treatment drug with placebo. We also included comparisons with bupropion and nicotine patches where available. We excluded trials which did not report a minimum follow-up period of six months from start of treatment. DATA COLLECTION AND ANALYSIS: We extracted data in duplicate on the type of participants, the dose and duration of treatment, the outcome measures, the randomization procedure, concealment of allocation, and completeness of follow up. The main outcome measured was abstinence from smoking after at least six months from the beginning of treatment. We used the most rigorous definition of abstinence, and preferred biochemically validated rates where they were reported. Where appropriate we performed meta-analysis to produce a risk ratio, using the Mantel-Haenszel fixed-effect model. MAIN RESULTS: We found seven trials of varenicline compared with placebo for smoking cessation; three of these also included a bupropion experimental arm. We found one relapse prevention trial, comparing varenicline with placebo. We also found one open-label trial comparing varenicline with nicotine replacement therapy. The nine trials covered 7267 participants, 4744 of whom used varenicline. We identified one trial of cytisine (Tabex) for inclusion. The pooled risk ratio (RR) for continuous abstinence at six months or longer for varenicline versus placebo was 2.33 (95% confidence interval [CI] 1.95 to 2.80). The pooled RR for varenicline versus bupropion at one year was 1.52 (95% CI 1.22 to 1.88). The RR for varenicline versus NRT at one year was 1.31 (95% CI 1.01 to 1.71). The two trials which tested the use of varenicline beyond the 12-week standard regimen found the drug to be well-tolerated during long-term use. The main adverse effect of varenicline was nausea, which was mostly at mild to moderate levels and usually subsided over time. Post-marketing safety data suggest that varenicline may be associated with depressed mood, agitation, and suicidal behaviour or ideation. The labelling of varenicline has been amended, and the FDA is conducting a safety review. The one cytisine trial included in this review found that more participants taking cytisine stopped smoking compared with placebo at two-year follow up, with an RR of 1.61 (95% CI 1.24 to 2.08). AUTHORS' CONCLUSIONS: Varenicline increased the chances of successful long-term smoking cessation between two- and threefold compared with pharmacologically unassisted quit attempts. More participants quit successfully with varenicline than with bupropion. One open-label trial of varenicline versus nicotine replacement therapy demonstrated a modest benefit of varenicline. The effectivenes
Descriptors
Alkaloids/therapeutic use, Azocines/therapeutic use, Benzazepines/adverse effects/therapeutic use, Bupropion/therapeutic use, Humans, Nicotine/antagonists & inhibitors, Nicotinic Agonists/adverse effects/therapeutic use, Quinolizines/therapeutic use, Quinoxalines/adverse effects/therapeutic use, Randomized Controlled Trials as Topic, Smoking/drug therapy, Smoking Cessation/methods, Varenicline
Links
Book Title
Database
Publisher
Data Source
Authors
Cahill,K., Stead,L. F., Lancaster,T.
Original/Translated Title
URL
Date of Electronic
20080716
PMCID
Editors
Nicotine receptor partial agonists for smoking cessation 2007 Department of Primary Health Care, Old Road Campus, University of Oxford, Oxford, UK, OX3 7LF. kate.cahill@dphpc.ox.ac.uk
Source Type
Print(0)
Ref Type
Journal Article
Periodical, Full
The Cochrane database of systematic reviews
Periodical, Abbrev.
Cochrane Database Syst.Rev.
Pub Date Free Form
24-Jan
Volume
-1
Issue
1
Start Page
CD006103
Other Pages
Notes
LR: 20151119; JID: 100909747; 0 (Alkaloids); 0 (Azocines); 0 (Benzazepines); 0 (Nicotinic Agonists); 0 (Quinolizines); 0 (Quinoxalines); 53S5U404NU (cytisine); 6M3C89ZY6R (Nicotine); W6HS99O8ZO (Varenicline); UIN: Cochrane Database Syst Rev. 2008;(3):CD00
Place of Publication
England
ISSN/ISBN
1469-493X; 1361-6137
Accession Number
PMID: 17253581
Language
eng
SubFile
Journal Article; Meta-Analysis; Review; IM
DOI
10.1002/14651858.CD006103.pub2 [doi]
Output Language
Unknown(0)
PMID
17253581
Abstract
BACKGROUND: Nicotine receptor partial agonists may help smokers to quit by a combination of maintaining moderate levels of dopamine to counteract withdrawal symptoms (acting as an agonist) and reducing smoking satisfaction (acting as an antagonist). Varenicline was developed as a nicotine receptor partial agonist from cytisine, a drug widely used in central and eastern Europe for smoking cessation. The first trial reports of varenicline were released in 2006, and further trials are underway. OBJECTIVES: The primary objective of this review is to assess the efficacy and tolerability of nicotine receptor partial agonists, including varenicline and cytisine, for smoking cessation. SEARCH STRATEGY: We searched the Cochrane Tobacco Addiction Group's specialised register for trials, using the terms ('varenicline' or 'cytisine' or 'Tabex' or 'nicotine receptor partial agonist') and 'smoking' in the title or abstract, or as keywords. We also searched MEDLINE, EMBASE, PsycINFO and CINAHL using MeSH terms and free text, and we contacted authors of trial reports for additional information where necessary. The last search was in October 2006. SELECTION CRITERIA: We included randomized controlled trials which compared the treatment drug with placebo. We also included comparisons with bupropion where available. We excluded trials which did not report a minimum follow-up period of six months from start of treatment. DATA COLLECTION AND ANALYSIS: We extracted data in duplicate on the type of participants, the dose and duration of treatment, the outcome measures, the randomization procedure, concealment of allocation, and completeness of follow up. The main outcome measured was abstinence from smoking after at least six months from the beginning of treatment. We used the most rigorous definition of abstinence, and preferred biochemically validated rates where they were reported. Where appropriate we performed meta-analysis using the Mantel-Haenszel fixed-effect model. MAIN RESULTS: We found five trials of varenicline compared with placebo for smoking cessation; three of these also included a bupropion experimental arm. We also found one relapse prevention trial, comparing varenicline with placebo. The six trials covered 4924 participants, 2451 of whom used varenicline. We identified one trial of cytisine (Tabex) for inclusion. The pooled odds ratio (OR) for continuous abstinence at 12 months for varenicline versus placebo was 3.22 (95% confidence interval [CI] 2.43 to 4.27). The pooled OR for varenicline versus bupropion was 1.66 (95% CI 1.28 to 2.16). The main adverse effect of varenicline was nausea, which was mostly at mild to moderate levels and usually subsided over time. The two trials which tested the use of varenicline beyond the 12-week standard regimen found the drug to be well-tolerated and effective during long-term use. The one cytisine trial included in this review found that more participants taking cytisine stopped smoking compared with placebo at two-year follow up, with an OR of 1.77 (95% CI 1.30 to 2.40). AUTHORS' CONCLUSIONS: Varenicline increased the odds of successful long-term smoking cessation approximately threefold compared with pharmacologically unassisted quit attempts. In trials reported so far, more participants quit successfully with varenicline than with bupropion. The effectiveness of varenicline as an aid to relapse prevention has not been clearly established. The main adverse effect of varenciline is nausea, but this is mostly at mild to moderate levels and tends to reduce with habituation. There is a need for independent trials of varenicline versus placebo, to test the early findings. There is also a need for direct comparisons with nicotine replacement therapy, and for further trials with bupropion, to establish the relative efficacy of the treatments.Cytisine may also increase the chances of quitting, but the evidence at present is inconclusive.
Descriptors
Alkaloids/therapeutic use, Azocines/therapeutic use, Benzazepines/therapeutic use, Humans, Nicotine/antagonists & inhibitors, Nicotinic Agonists/therapeutic use, Quinolizines/therapeutic use, Quinoxalines/therapeutic use, Randomized Controlled Trials as Topic, Smoking Cessation/methods, Varenicline
Links
Book Title
Database
Publisher
Data Source
Authors
Cahill,K., Stead,L. F., Lancaster,T.
Original/Translated Title
URL
Date of Electronic
20070124
PMCID
Editors
Nicotine receptor partial agonists for smoking cessation 2011 Department of Primary Health Care, University of Oxford, Rosemary Rue Building, Old Road Campus, Oxford, UK, OX3 7LF.
Source Type
Print(0)
Ref Type
Journal Article
Periodical, Full
The Cochrane database of systematic reviews
Periodical, Abbrev.
Cochrane Database Syst.Rev.
Pub Date Free Form
16-Feb
Volume
(2):CD006103. doi
Issue
2
Start Page
CD006103
Other Pages
Notes
LR: 20151119; JID: 100909747; 0 (Alkaloids); 0 (Azocines); 0 (Benzazepines); 0 (Nicotinic Agonists); 0 (Quinolizines); 0 (Quinoxalines); 01ZG3TPX31 (Bupropion); 53S5U404NU (cytisine); 6M3C89ZY6R (Nicotine); W6HS99O8ZO (Varenicline); CIN: Ann Intern Med. 2
Place of Publication
England
ISSN/ISBN
1469-493X; 1361-6137
Accession Number
PMID: 21328282
Language
eng
SubFile
Journal Article; Meta-Analysis; Review; IM
DOI
10.1002/14651858.CD006103.pub5 [doi]
Output Language
Unknown(0)
PMID
21328282
Abstract
BACKGROUND: Nicotine receptor partial agonists may help people to stop smoking by a combination of maintaining moderate levels of dopamine to counteract withdrawal symptoms (acting as an agonist) and reducing smoking satisfaction (acting as an antagonist). Varenicline was developed as a nicotine receptor partial agonist from cytisine, a drug widely used in central and eastern Europe for smoking cessation. The first trial reports of varenicline were released in 2006, and further trials have now been published or are currently underway. OBJECTIVES: The primary objective of this review is to assess the efficacy and tolerability of nicotine receptor partial agonists, including varenicline and cytisine, for smoking cessation. SEARCH STRATEGY: We searched the Cochrane Tobacco Addiction Group's specialised register for trials, using the terms ('varenicline' or 'cytisine' or 'Tabex' or 'nicotine receptor partial agonist') and 'smoking' in the title or abstract, or as keywords. We also searched MEDLINE, EMBASE, PsycINFO and CINAHL using MeSH terms and free text, and we contacted authors of trial reports for additional information where necessary. The latest search was in September 2010. SELECTION CRITERIA: We included randomized controlled trials which compared the treatment drug with placebo. We also included comparisons with bupropion and nicotine patches where available. We excluded trials which did not report a minimum follow-up period of six months from start of treatment. DATA COLLECTION AND ANALYSIS: We extracted data on the type of participants, the dose and duration of treatment, the outcome measures, the randomization procedure, concealment of allocation, and completeness of follow up.The main outcome measured was abstinence from smoking after at least six months from the beginning of treatment. We used the most rigorous definition of abstinence, and preferred biochemically validated rates where they were reported. Where appropriate we performed meta-analysis to produce a risk ratio, using the Mantel-Haenszel fixed-effect model. MAIN RESULTS: We found 11 trials of varenicline compared with placebo for smoking cessation; three of these included a bupropion experimental arm. We also found one relapse prevention trial, comparing varenicline with placebo, and two open-label trials comparing varenicline with nicotine replacement therapy (NRT). We also include one trial in which all the participants were given varenicline, but received behavioural support either online or by phone calls, or by both methods. This trial is not included in the analyses, but contributes to the data on safety and tolerability. The included studies covered >10,300 participants, 6892 of whom used varenicline. We identified one trial of cytisine (Tabex) for inclusion.The pooled risk ratio (RR) (10 trials, 4443 people, excluding one trial evaluating long term safety) for continuous abstinence at six months or longer for varenicline at standard dosage versus placebo was 2.31 (95% confidence interval [CI] 2.01 to 2.66). Varenicline at lower or variable doses was also shown to be effective, with an RR of 2.09 (95% CI 1.56 to 2.78; 4 trials, 1272 people). The pooled RR for varenicline versus bupropion at one year was 1.52 (95% CI 1.22 to 1.88; 3 trials, 1622 people). The RR for varenicline versus NRT for point prevalence abstinence at 24 weeks was 1.13 (95% CI 0.94 to 1.35; 2 trials, 778 people). The two trials which tested the use of varenicline beyond the 12-week standard regimen found the drug to be well-tolerated during long-term use. The main adverse effect of varenicline was nausea, which was mostly at mild to moderate levels and usually subsided over time. Post-marketing safety data raised questions about a possible association between varenicline and depressed mood, agitation, and suicidal behaviour or ideation. The labelling of varenicline was amended in 2008, and the manufacturers produced a Medication Guide. Thus far, surveillance reports and seconda
Descriptors
Links
Book Title
Database
Publisher
Data Source
Authors
Cahill,K., Stead,L.F., Lancaster,T.
Original/Translated Title
URL
Date of Electronic
20110216
PMCID
Editors
Nicotine receptor partial agonists for smoking cessation 2012 Department of Primary Care Health Sciences, University of Oxford, Oxford, UK. kate.cahill@phc.ox.ac.uk.
Source Type
Print(0)
Ref Type
Journal Article
Periodical, Full
The Cochrane database of systematic reviews
Periodical, Abbrev.
Cochrane Database Syst.Rev.
Pub Date Free Form
18-Apr
Volume
(4):CD006103. doi
Issue
4
Start Page
CD006103
Other Pages
Notes
LR: 20160608; GR: Department of Health/United Kingdom; JID: 100909747; 0 (Alkaloids); 0 (Azepines); 0 (Azocines); 0 (Benzazepines); 0 (Heterocyclic Compounds with 4 or More Rings); 0 (Nicotinic Agonists); 0 (Quinolizines); 0 (Quinoxalines); 01ZG3TPX31 (Bu
Place of Publication
England
ISSN/ISBN
1469-493X; 1361-6137
Accession Number
PMID: 22513936
Language
eng
SubFile
Journal Article; Meta-Analysis; Research Support, Non-U.S. Gov't; Review; IM
DOI
10.1002/14651858.CD006103.pub6 [doi]
Output Language
Unknown(0)
PMID
22513936
Abstract
BACKGROUND: Nicotine receptor partial agonists may help people to stop smoking by a combination of maintaining moderate levels of dopamine to counteract withdrawal symptoms (acting as an agonist) and reducing smoking satisfaction (acting as an antagonist). OBJECTIVES: The primary objective of this review is to assess the efficacy and tolerability of nicotine receptor partial agonists, including cytisine, dianicline and varenicline for smoking cessation. SEARCH METHODS: We searched the Cochrane Tobacco Addiction Group's specialised register for trials, using the terms ('cytisine' or 'Tabex' or 'dianicline' or 'varenicline' or 'nicotine receptor partial agonist') in the title or abstract, or as keywords. The register is compiled from searches of MEDLINE, EMBASE, PsycINFO and Web of Science using MeSH terms and free text to identify controlled trials of interventions for smoking cessation and prevention. We contacted authors of trial reports for additional information where necessary. The latest update of the specialised register was in December 2011. We also searched online clinical trials registers. SELECTION CRITERIA: We included randomized controlled trials which compared the treatment drug with placebo. We also included comparisons with bupropion and nicotine patches where available. We excluded trials which did not report a minimum follow-up period of six months from start of treatment. DATA COLLECTION AND ANALYSIS: We extracted data on the type of participants, the dose and duration of treatment, the outcome measures, the randomization procedure, concealment of allocation, and completeness of follow-up.The main outcome measured was abstinence from smoking at longest follow-up. We used the most rigorous definition of abstinence, and preferred biochemically validated rates where they were reported. Where appropriate we pooled risk ratios (RRs), using the Mantel-Haenszel fixed-effect model. MAIN RESULTS: Two recent cytisine trials (937 people) found that more participants taking cytisine stopped smoking compared with placebo at longest follow-up, with a pooled RR of 3.98 (95% confidence interval (CI) 2.01 to 7.87). One trial of dianicline (602 people) failed to find evidence that it was effective (RR 1.20, 95% CI 0.82 to 1.75). Fifteen trials compared varenicline with placebo for smoking cessation; three of these also included a bupropion treatment arm. We also found one open-label trial comparing varenicline plus counselling with counselling alone. We found one relapse prevention trial, comparing varenicline with placebo, and two open-label trials comparing varenicline with nicotine replacement therapy (NRT). We also include one trial in which all the participants were given varenicline, but received behavioural support either online or by phone calls, or by both methods. This trial is not included in the analyses, but contributes to the data on safety and tolerability. The included studies covered 12,223 participants, 8100 of whom used varenicline.The pooled RR for continuous or sustained abstinence at six months or longer for varenicline at standard dosage versus placebo was 2.27 (95% CI 2.02 to 2.55; 14 trials, 6166 people, excluding one trial evaluating long term safety). Varenicline at lower or variable doses was also shown to be effective, with an RR of 2.09 (95% CI 1.56 to 2.78; 4 trials, 1272 people). The pooled RR for varenicline versus bupropion at one year was 1.52 (95% CI 1.22 to 1.88; 3 trials, 1622 people). The RR for varenicline versus NRT for point prevalence abstinence at 24 weeks was 1.13 (95% CI 0.94 to 1.35; 2 trials, 778 people). The two trials which tested the use of varenicline beyond the 12-week standard regimen found the drug to be well-tolerated during long-term use. The main adverse effect of varenicline was nausea, which was mostly at mild to moderate levels and usually subsided over time. A meta-analysis of reported serious adverse events occurring during or after active treatment and not necessa
Descriptors
Links
Book Title
Database
Publisher
Data Source
Authors
Cahill,K., Stead,L.F., Lancaster,T.
Original/Translated Title
URL
Date of Electronic
20120418
PMCID
Editors
Nicotine receptor partial agonists for smoking cessation 2016 Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, UK, OX2 6GG.
Source Type
Print(0)
Ref Type
Journal Article
Periodical, Full
The Cochrane database of systematic reviews
Periodical, Abbrev.
Cochrane Database Syst.Rev.
Pub Date Free Form
9-May
Volume
(5):CD006103. doi
Issue
5
Start Page
CD006103
Other Pages
Notes
JID: 100909747; 0 (Alkaloids); 0 (Azepines); 0 (Azocines); 0 (Benzazepines); 0 (Heterocyclic Compounds with 4 or More Rings); 0 (Nicotinic Agonists); 0 (Quinolizines); 01ZG3TPX31 (Bupropion); 53S5U404NU (cytisine); 6M3C89ZY6R (Nicotine); W6HS99O8ZO (Varen
Place of Publication
England
ISSN/ISBN
1469-493X; 1361-6137
Accession Number
PMID: 27158893
Language
eng
SubFile
Journal Article; Meta-Analysis; Research Support, Non-U.S. Gov't; Review; IM
DOI
10.1002/14651858.CD006103.pub7 [doi]
Output Language
Unknown(0)
PMID
27158893
Abstract
BACKGROUND: Nicotine receptor partial agonists may help people to stop smoking by a combination of maintaining moderate levels of dopamine to counteract withdrawal symptoms (acting as an agonist) and reducing smoking satisfaction (acting as an antagonist). OBJECTIVES: To review the efficacy of nicotine receptor partial agonists, including varenicline and cytisine, for smoking cessation. SEARCH METHODS: We searched the Cochrane Tobacco Addiction Group's specialised register for trials, using the terms ('cytisine' or 'Tabex' or 'dianicline' or 'varenicline' or 'nicotine receptor partial agonist') in the title or abstract, or as keywords. The register is compiled from searches of MEDLINE, EMBASE, and PsycINFO using MeSH terms and free text to identify controlled trials of interventions for smoking cessation and prevention. We contacted authors of trial reports for additional information where necessary. The latest update of the specialised register was in May 2015, although we have included a few key trials published after this date. We also searched online clinical trials registers. SELECTION CRITERIA: We included randomised controlled trials which compared the treatment drug with placebo. We also included comparisons with bupropion and nicotine patches where available. We excluded trials which did not report a minimum follow-up period of six months from start of treatment. DATA COLLECTION AND ANALYSIS: We extracted data on the type of participants, the dose and duration of treatment, the outcome measures, the randomisation procedure, concealment of allocation, and completeness of follow-up.The main outcome measured was abstinence from smoking at longest follow-up. We used the most rigorous definition of abstinence, and preferred biochemically validated rates where they were reported. Where appropriate we pooled risk ratios (RRs), using the Mantel-Haenszel fixed-effect model. MAIN RESULTS: Two trials of cytisine (937 people) found that more participants taking cytisine stopped smoking compared with placebo at longest follow-up, with a pooled risk ratio (RR) of 3.98 (95% confidence interval (CI) 2.01 to 7.87; low-quality evidence). One recent trial comparing cytisine with NRT in 1310 people found a benefit for cytisine at six months (RR 1.43, 95% CI 1.13 to 1.80).One trial of dianicline (602 people) failed to find evidence that it was effective (RR 1.20, 95% CI 0.82 to 1.75). This drug is no longer in development.We identified 39 trials that tested varenicline, 27 of which contributed to the primary analysis (varenicline versus placebo). Five of these trials also included a bupropion treatment arm. Eight trials compared varenicline with nicotine replacement therapy (NRT). Nine studies tested variations in varenicline dosage, and 13 tested usage in disease-specific subgroups of patients. The included studies covered 25,290 participants, 11,801 of whom used varenicline.The pooled RR for continuous or sustained abstinence at six months or longer for varenicline at standard dosage versus placebo was 2.24 (95% CI 2.06 to 2.43; 27 trials, 12,625 people; high-quality evidence). Varenicline at lower or variable doses was also shown to be effective, with an RR of 2.08 (95% CI 1.56 to 2.78; 4 trials, 1266 people). The pooled RR for varenicline versus bupropion at six months was 1.39 (95% CI 1.25 to 1.54; 5 trials, 5877 people; high-quality evidence). The RR for varenicline versus NRT for abstinence at 24 weeks was 1.25 (95% CI 1.14 to 1.37; 8 trials, 6264 people; moderate-quality evidence). Four trials which tested the use of varenicline beyond the 12-week standard regimen found the drug to be well-tolerated during long-term use. The number needed to treat with varenicline for an additional beneficial outcome, based on the weighted mean control rate, is 11 (95% CI 9 to 13). The most commonly reported adverse effect of varenicline was nausea, which was mostly at mild to moderate levels and usually subsided over time. Our analysis of reporte
Descriptors
Links
Book Title
Database
Publisher
Data Source
Authors
Cahill,K., Lindson-Hawley,N., Thomas,K.H., Fanshawe,T.R., Lancaster,T.
Original/Translated Title
URL
Date of Electronic
20160509
PMCID
Editors
Nicotine replacement therapy for smoking cessation 2000 Monash Institute of Public Health and Health Service Research, Monash Medical Centre, Locked Bag 29, Clayton, Victoria, Australia, 3168. chris.silagy@med.monash.edu.au
Source Type
Print(0)
Ref Type
Journal Article
Periodical, Full
The Cochrane database of systematic reviews
Periodical, Abbrev.
Cochrane Database Syst.Rev.
Pub Date Free Form
Volume
-3
Issue
3
Start Page
CD000146
Other Pages
Notes
LR: 20151119; JID: 100909747; 6M3C89ZY6R (Nicotine); UIN: Cochrane Database Syst Rev. 2001;(3):CD000146. PMID: 11686953; RF: 131; ppublish
Place of Publication
ENGLAND
ISSN/ISBN
1469-493X; 1361-6137
Accession Number
PMID: 10908462
Language
eng
SubFile
Journal Article; Review; IM
DOI
CD000146 [pii]
Output Language
Unknown(0)
PMID
10908462
Abstract
BACKGROUND: The aim of nicotine replacement therapy (NRT) is to replace nicotine from cigarettes. This reduces withdrawal symptoms associated with smoking cessation thus helping resist the urge to smoke cigarettes. OBJECTIVES: The aims of this review were to determine the effectiveness of the different forms of nicotine replacement therapy (chewing gum, transdermal patches, nasal spray, inhalers and tablets) in achieving abstinence from cigarettes; to determine whether the effect is influenced by the clinical setting in which the smoker is recruited and treated, the dosage and form of the NRT used, or the intensity of additional advice and support offered to the smoker; to determine whether combinations of NRT are more effective than one type alone; and to determine its effectiveness compared to other pharmacotherapies. SEARCH STRATEGY: We searched the Cochrane Tobacco Addiction Group trials register in April 2000. SELECTION CRITERIA: Randomized trials in which NRT was compared to placebo or no treatment, or where different doses of NRT were compared. We excluded trials which did not report cessation rates, and those with follow-up of less than six months. DATA COLLECTION AND ANALYSIS: We extracted data in duplicate on the type of subjects, the dose and duration and form of nicotine therapy, the outcome measures, method of randomisation, and completeness of follow-up. The main outcome measure was abstinence from smoking after at least six months of follow-up. We used the most rigorous definition of abstinence for each trial, and biochemically validated rates if available. Where appropriate, we performed meta-analysis using a fixed effects model. MAIN RESULTS: We identified one hundred trials; of the 88 with a non NRT control group, 48 trials were of nicotine gum, 30 of transdermal nicotine patch, four of intranasal nicotine spray, four of inhaled nicotine and two of nicotine sublingual tablet. Four trials compared combinations of two forms of nicotine therapy with one form alone. The odds ratio for abstinence with NRT compared to control was 1.71 (95% confidence interval 1.60 to 1.82), The odds ratios for the different forms of NRT were 1.63 for gum, 1.73 for patches, 2.27 for nasal spray, 2.08 for inhaled nicotine and 1.73 for nicotine sublingual tablet. These odds were largely independent of the intensity of additional support provided or the setting in which the NRT was offered. Eight weeks of patch therapy was as effective as longer courses and there was no evidence that tapered therapy was better than abrupt withdrawal. Wearing the patch only during waking hours (16 hours/day) was as effective as wearing it for 24 hours/day. The odds ratio for abstinence in the trials which directly compared 4 mg versus 2 mg gum in highly dependent smokers found a significant benefit in favour of 4 mg gum (odds ratio 2.67, 95% confidence interval 1.69 to 4.22). There is no strong evidence that combinations of forms of NRT are more effective. Only one study directly compared NRT to an antidepressant (bupropion). In this study, bupropion was significantly more effective than nicotine patch or placebo. The combination of bupropion and nicotine patch was significantly more effective than nicotine patch alone. There was also a suggestion of greater of efficacy for bupropion and nicotine patch compared to bupropion alone, but the difference was not statistically significant. REVIEWER'S CONCLUSIONS: All of the commercially available forms of NRT (nicotine gum, transdermal patch, the nicotine nasal spray, nicotine inhaler and nicotine sublingual tablets) are effective as part of a strategy to promote smoking cessation. They increase quit rates approximately 1.5 to 2 fold regardless of setting. The effectiveness of NRT appears to be largely independent of the intensity of additional support provided to the smoker. Since all the trials of NRT reported so far have included at least some form of brief advice to the smoker, this represents the min
Descriptors
Administration, Cutaneous, Humans, Nicotine/administration & dosage/therapeutic use, Randomized Controlled Trials as Topic, Smoking/prevention & control, Smoking Cessation/methods
Links
Book Title
Database
Publisher
Data Source
Authors
Silagy,C., Mant,D., Fowler,G., Lancaster,T.
Original/Translated Title
URL
Date of Electronic
PMCID
Editors
Nicotine replacement therapy for smoking cessation 2008 University of Oxford, Department of Primary Health Care, Old Road Campus, Headington, Oxford, UK OX3 7LF. lindsay.stead@dphpc.ox.ac.uk
Source Type
Print(0)
Ref Type
Journal Article
Periodical, Full
The Cochrane database of systematic reviews
Periodical, Abbrev.
Cochrane Database Syst.Rev.
Pub Date Free Form
23-Jan
Volume
(1):CD000146. doi
Issue
1
Start Page
CD000146
Other Pages
Notes
LR: 20151119; JID: 100909747; 0 (Chewing Gum); 0 (Nicotinic Agonists); 0 (Tablets); 6M3C89ZY6R (Nicotine); UIN: Cochrane Database Syst Rev. 2012;11:CD000146. PMID: 23152200; RF: 277; epublish
Place of Publication
England
ISSN/ISBN
1469-493X; 1361-6137
Accession Number
PMID: 18253970
Language
eng
SubFile
Journal Article; Meta-Analysis; Review; IM
DOI
10.1002/14651858.CD000146.pub3 [doi]
Output Language
Unknown(0)
PMID
18253970
Abstract
BACKGROUND: The aim of nicotine replacement therapy (NRT) is temporarily to replace much of the nicotine from cigarettes to reduce motivation to smoke and nicotine withdrawal symptoms, thus easing the transition from cigarette smoking to complete abstinence. OBJECTIVES: The aims of this review were:To determine the effect of NRT compared to placebo in aiding smoking cessation, and to consider whether there is a difference in effect for the different forms of NRT (chewing gum, transdermal patches, nasal spray, inhalers and tablets/lozenges) in achieving abstinence from cigarettes. To determine whether the effect is influenced by the dosage, form and timing of use of NRT; the intensity of additional advice and support offered to the smoker; or the clinical setting in which the smoker is recruited and treated. To determine whether combinations of NRT are more likely to lead to successful quitting than one type alone. To determine whether NRT is more or less likely to lead to successful quitting compared to other pharmacotherapies. SEARCH STRATEGY: We searched the Cochrane Tobacco Addiction Group trials register for papers with 'nicotine' or 'NRT' in the title, abstract or keywords. Date of most recent search July 2007. SELECTION CRITERIA: Randomized trials in which NRT was compared to placebo or to no treatment, or where different doses of NRT were compared. We excluded trials which did not report cessation rates, and those with follow up of less than six months. DATA COLLECTION AND ANALYSIS: We extracted data in duplicate on the type of participants, the dose, duration and form of nicotine therapy, the outcome measures, method of randomization, and completeness of follow up. The main outcome measure was abstinence from smoking after at least six months of follow up. We used the most rigorous definition of abstinence for each trial, and biochemically validated rates if available. We calculated the risk ratio (RR) for each study. Where appropriate, we performed meta-analysis using a Mantel-Haenszel fixed-effect model. MAIN RESULTS: We identified 132 trials; 111 with over 40,000 participants contributed to the primary comparison between any type of NRT and a placebo or non-NRT control group. The RR of abstinence for any form of NRT relative to control was 1.58 (95% confidence interval [CI]: 1.50 to 1.66). The pooled RR for each type were 1.43 (95% CI: 1.33 to 1.53, 53 trials) for nicotine gum; 1.66 (95% CI: 1.53 to 1.81, 41 trials) for nicotine patch; 1.90 (95% CI: 1.36 to 2.67, 4 trials) for nicotine inhaler; 2.00 (95% CI: 1.63 to 2.45, 6 trials) for oral tablets/lozenges; and 2.02 (95% CI: 1.49 to 3.73, 4 trials) for nicotine nasal spray. The effects were largely independent of the duration of therapy, the intensity of additional support provided or the setting in which the NRT was offered. The effect was similar in a small group of studies that aimed to assess use of NRT obtained without a prescription. In highly dependent smokers there was a significant benefit of 4 mg gum compared with 2 mg gum, but weaker evidence of a benefit from higher doses of patch. There was evidence that combining a nicotine patch with a rapid delivery form of NRT was more effective than a single type of NRT. Only one study directly compared NRT to another pharmacotherapy. In this study quit rates with nicotine patch were lower than with the antidepressant bupropion. AUTHORS' CONCLUSIONS: All of the commercially available forms of NRT (gum, transdermal patch, nasal spray, inhaler and sublingual tablets/lozenges) can help people who make a quit attempt to increase their chances of successfully stopping smoking. NRTs increase the rate of quitting by 50-70%, regardless of setting. The effectiveness of NRT appears to be largely independent of the intensity of additional support provided to the individual. Provision of more intense levels of support, although beneficial in facilitating the likelihood of quitting, is not essential to the
Descriptors
Administration, Cutaneous, Administration, Inhalation, Chewing Gum, Humans, Nicotine/administration & dosage, Nicotinic Agonists/administration & dosage, Randomized Controlled Trials as Topic, Smoking/prevention & control, Smoking Cessation/methods, Tablets
Links
Book Title
Database
Publisher
Data Source
Authors
Stead,L. F., Perera,R., Bullen,C., Mant,D., Lancaster,T.
Original/Translated Title
URL
Date of Electronic
20080123
PMCID
Editors
Nicotine replacement therapy for smoking cessation 2012 Department of Primary Care Health Sciences, University of Oxford,Oxford,UK. lindsay.stead@phc.ox.ac.uk.
Source Type
Print(0)
Ref Type
Journal Article
Periodical, Full
The Cochrane database of systematic reviews
Periodical, Abbrev.
Cochrane Database Syst.Rev.
Pub Date Free Form
14-Nov
Volume
11
Issue
Start Page
CD000146
Other Pages
Notes
LR: 20151119; JID: 100909747; 0 (Chewing Gum); 0 (Nicotinic Agonists); 0 (Tablets); 6M3C89ZY6R (Nicotine); epublish
Place of Publication
England
ISSN/ISBN
1469-493X; 1361-6137
Accession Number
PMID: 23152200
Language
eng
SubFile
Journal Article; Meta-Analysis; Research Support, Non-U.S. Gov't; Review; IM
DOI
10.1002/14651858.CD000146.pub4 [doi]
Output Language
Unknown(0)
PMID
23152200
Abstract
BACKGROUND: The aim of nicotine replacement therapy (NRT) is to temporarily replace much of the nicotine from cigarettes to reduce motivation to smoke and nicotine withdrawal symptoms, thus easing the transition from cigarette smoking to complete abstinence. OBJECTIVES: The aims of this review were: To determine the effect of NRT compared to placebo in aiding smoking cessation, and to consider whether there is a difference in effect for the different forms of NRT (chewing gum, transdermal patches, oral and nasal sprays, inhalers and tablets/lozenges) in achieving abstinence from cigarettes. To determine whether the effect is influenced by the dosage, form and timing of use of NRT; the intensity of additional advice and support offered to the smoker; or the clinical setting in which the smoker is recruited and treated. To determine whether combinations of NRT are more likely to lead to successful quitting than one type alone. To determine whether NRT is more or less likely to lead to successful quitting compared to other pharmacotherapies. SEARCH METHODS: We searched the Cochrane Tobacco Addiction Group trials register for papers mentioning 'NRT' or any type of nicotine replacement therapy in the title, abstract or keywords. Date of most recent search July 2012. SELECTION CRITERIA: Randomized trials in which NRT was compared to placebo or to no treatment, or where different doses of NRT were compared. We excluded trials which did not report cessation rates, and those with follow-up of less than six months. DATA COLLECTION AND ANALYSIS: We extracted data in duplicate on the type of participants, the dose, duration and form of nicotine therapy, the outcome measures, method of randomization, and completeness of follow-up. The main outcome measure was abstinence from smoking after at least six months of follow-up. We used the most rigorous definition of abstinence for each trial, and biochemically validated rates if available. We calculated the risk ratio (RR) for each study. Where appropriate, we performed meta-analysis using a Mantel-Haenszel fixed-effect model. MAIN RESULTS: We identified 150 trials; 117 with over 50,000 participants contributed to the primary comparison between any type of NRT and a placebo or non-NRT control group. The risk ratio (RR) of abstinence for any form of NRT relative to control was 1.60 (95% confidence interval [CI] 1.53 to 1.68). The pooled RRs for each type were 1.49 (95% CI 1.40 to 1.60, 55 trials) for nicotine gum; 1.64 (95% CI 1.52 to 1.78, 43 trials) for nicotine patch; 1.95 (95% CI 1.61 to 2.36, 6 trials) for oral tablets/lozenges; 1.90 (95% CI 1.36 to 2.67, 4 trials) for nicotine inhaler; and 2.02 (95% CI 1.49 to 2.73, 4 trials) for nicotine nasal spray. One trial of oral spray had an RR of 2.48 (95% CI 1.24 to 4.94). The effects were largely independent of the duration of therapy, the intensity of additional support provided or the setting in which the NRT was offered. The effect was similar in a small group of studies that aimed to assess use of NRT obtained without a prescription. In highly dependent smokers there was a significant benefit of 4 mg gum compared with 2 mg gum, but weaker evidence of a benefit from higher doses of patch. There was evidence that combining a nicotine patch with a rapid delivery form of NRT was more effective than a single type of NRT (RR 1.34, 95% CI 1.18 to 1.51, 9 trials). The RR for NRT used for a short period prior to the quit date was 1.18 (95% CI 0.98 to 1.40, 8 trials), just missing statistical significance, though the efficacy increased when we pooled only patch trials and when we removed one trial in which confounding was likely. Five studies directly compared NRT to a non-nicotine pharmacotherapy, bupropion; there was no evidence of a difference in efficacy (RR 1.01; 95% CI 0.87 to 1.18). A combination of NRT and bupropion was more effective than bupropion alone (RR 1.24; 95% CI 1.06 to 1.45, 4 trials). Adverse effects from using NRT are related to th
Descriptors
Links
Book Title
Database
Publisher
Data Source
Authors
Stead,L.F., Perera,R., Bullen,C., Mant,D., Hartmann-Boyce,J., Cahill,K., Lancaster,T.
Original/Translated Title
URL
Date of Electronic
20121114
PMCID
Editors
Nicotine vaccines for smoking cessation 2012 Department of Primary Care Health Sciences, University ofOxford, Oxford, UK. jamie.hartmann-boyce@phc.ox.ac.uk.
Source Type
Print(0)
Ref Type
Journal Article
Periodical, Full
The Cochrane database of systematic reviews
Periodical, Abbrev.
Cochrane Database Syst.Rev.
Pub Date Free Form
15-Aug
Volume
(8):CD007072. doi
Issue
8
Start Page
CD007072
Other Pages
Notes
LR: 20160602; JID: 100909747; 0 (NicVAX); 0 (Vaccines); 0 (nicotine Qbeta vaccine); epublish
Place of Publication
England
ISSN/ISBN
1469-493X; 1361-6137
Accession Number
PMID: 22895958
Language
eng
SubFile
Journal Article; Meta-Analysis; Review; IM
DOI
10.1002/14651858.CD007072.pub2 [doi]
Output Language
Unknown(0)
PMID
22895958
Abstract
BACKGROUND: By reducing the amount of nicotine that reaches the brain when a person smokes a cigarette, nicotine vaccines may help people to stop smoking or to prevent recent quitters from relapsing. OBJECTIVES: The aims of this review are to assess the efficacy of nicotine vaccines for smoking cessation and for relapse prevention, and to assess the frequency and type of adverse events associated with the use of nicotine vaccines. SEARCH METHODS: We searched the Cochrane Tobacco Addiction Review Group specialised register for trials, using the term 'vaccine' in the title or abstract, or in a keyword (date of most recent search April 2012). To identify any other material including reviews and papers potentially relevant to the background or discussion sections, we also searched MEDLINE, EMBASE, and PsycINFO, combining terms for nicotine vaccines with terms for smoking and tobacco use, without design limits or limits for human subjects. We searched the Annual Meeting abstracts of the Society for Research on Nicotine and Tobacco up to 2012, using the search string 'vaccin'. We searched Google Scholar for 'nicotine vaccine'. We also searched company websites and Google for information related to specific vaccines. We searched clinicaltrials.gov in March 2012 for 'nicotine vaccine' and for the trade names of known vaccine candidates. SELECTION CRITERIA: We included randomized controlled trials of nicotine vaccines, at Phase II and Phase III trial stage and beyond, in adult smokers or recent ex-smokers. We included studies of nicotine vaccines used as part of smoking cessation or relapse prevention interventions. DATA COLLECTION AND ANALYSIS: We extracted data on the type of participants, the dose and duration of treatment, the outcome measures, the randomization procedure, concealment of allocation, blinding of participants and personnel, reporting of outcomes, and completeness of follow-up.Our primary outcome measure was a minimum of six months abstinence from smoking. We used the most rigorous definition of abstinence, and preferred cessation rates at 12 months and biochemically validated rates where available. We have used the risk ratio (RR) to summarize individual trial outcomes. We have not pooled the current group of included studies as they cover different vaccines and variable regimens. MAIN RESULTS: There are no nicotine vaccines currently licensed for public use, but there are a number in development. We found four trials which met our inclusion criteria, three comparing NicVAX to placebo and one comparing NIC002 (formerly NicQbeta) to placebo. All were smoking cessation trials conducted by pharmaceutical companies as part of the drug development process, and all trials were judged to be at high or unclear risk of bias in at least one domain. Overall, 2642 smokers participated in the included studies in this review. None of the four included studies detected a statistically significant difference in long-term cessation between participants receiving vaccine and those receiving placebo. The RR for 12 month cessation in active and placebo groups was 1.35 (95% Confidence Interval (CI) 0.82 to 2.22) in the trial of NIC002 and 1.74 (95% CI 0.73 to 4.18) in one NicVAX trial. Two Phase III NicVAX trials, for which full results were not available, reported similar quit rates of approximately 11% in both groups. In the two studies with full results available, post hoc analyses detected higher cessation rates in participants with higher levels of nicotine antibodies, but these findings are not readily generalisable. The two studies with full results showed nicotine vaccines to be well tolerated, with the majority of adverse events classified as mild or moderate. In the study of NIC002, participants receiving the vaccine were more likely to report mild to moderate adverse events, most commonly flu-like symptoms, whereas in the study of NicVAX there was no significant difference between the two arms. Information on adverse events wa
Descriptors
Links
Book Title
Database
Publisher
Data Source
Authors
Hartmann-Boyce,J., Cahill,K., Hatsukami,D., Cornuz,J.
Original/Translated Title
URL
Date of Electronic
20120815
PMCID
Editors
Nicotine-dependence symptoms are associated with smoking frequency in adolescents 2003 Department of Epidemiology and Biostatistics, McGill University, Montreal, Quebec, Canada. jennifer.oloughlin@mcgill.ca
Source Type
Print(0)
Ref Type
Journal Article
Periodical, Full
American Journal of Preventive Medicine
Periodical, Abbrev.
Am.J.Prev.Med.
Pub Date Free Form
Oct
Volume
25
Issue
3
Start Page
219
Other Pages
225
Notes
LR: 20061115; JID: 8704773; ppublish
Place of Publication
Netherlands
ISSN/ISBN
0749-3797; 0749-3797
Accession Number
PMID: 14507528
Language
eng
SubFile
Journal Article; Research Support, Non-U.S. Gov't; IM
DOI
S0749379703001983 [pii]
Output Language
Unknown(0)
PMID
14507528
Abstract
BACKGROUND: Although many sociodemographic and psychosocial factors have been identified as related to adolescent smoking, few studies have examined the role of nicotine-dependence (ND) symptoms. The objective was to study the association between ND symptoms and smoking status among adolescents in the early stages of the smoking onset process. METHODS: The McGill University Study on the Natural History of Nicotine Dependence is an ongoing 6-year prospective investigation of the natural history of ND among 1267 grade 7 students in ten Montreal high schools. The baseline response was 55.4%. Subjects for this cross-sectional analysis of baseline data, collected in 1999, included 241 past 3-month smokers (mean age [SD]=13.0+/-0.7 years at baseline). ND symptoms were measured in five indicators, including a measure based on the criteria for tobacco dependence in the International Classification of Diseases-10th Revision (ICD-10), the Hooked on Nicotine Checklist, and three symptom clusters (withdrawal, self-medication, and ND/cravings symptoms). The association between ND symptom indicators and each of sporadic, monthly, weekly, and daily smoking relative to less frequent smoking was investigated in multiple logistic regression analysis. RESULTS: Despite low cigarette exposure, 16.6% (95% confidence interval [CI], 11.9%-21.3%) of past 3-month smokers were tobacco dependent. The proportion increased from 0%, 3.1% (95% CI, 0.0%-9.2%), and 4.6% (95% CI, 0.2%-9.0%) among triers, sporadic smokers, and monthly smokers, respectively, to 19.4% (95% CI, 5.5%-33.3%) and 65.9% (95% CI, 51.9%-79.9%) among weekly and daily smokers, respectively. ND/cravings consistently distinguished each smoking category from less frequent smokers; the odds ratios (95% CI) for ND/cravings symptoms were 1.16 (0.99-1.35) in sporadic smokers; 1.17 (1.06-1.29) in monthly smokers; 1.34 (1.19-1.50) in weekly smokers; and 1.39 (1.22-1.59) in daily smokers. CONCLUSIONS: These data challenge current smoking onset models, which suggest that ND develops only after several years of heavy or daily smoking. ND symptoms are associated, at least cross-sectionally, with increased smoking in adolescents. To increase the likelihood of being effective, tobacco-control programs for children and adolescents will need to take early ND symptoms into account.
Descriptors
Adolescent, Behavior, Addictive, Female, Humans, Logistic Models, Male, Odds Ratio, Smoking/epidemiology/psychology, Tobacco Use Disorder/epidemiology/psychology
Links
Book Title
Database
Publisher
Data Source
Authors
O'Loughlin,J., DiFranza,J., Tyndale,R. F., Meshefedjian,G., McMillan-Davey,E., Clarke,P. B., Hanley,J., Paradis,G.
Original/Translated Title
URL
Date of Electronic
PMCID
Editors