Combining varenicline and nicotine patches: a randomized controlled trial study in smoking cessation
Some smokers may benefit from a therapy that combines different nicotine replacement therapies (NRT) or drugs with different mechanisms of action.The aim of this study was to determine the efficacy of the combined therapy of varenicline and nicotine patches versus varenicline monotherapy. Three hund...
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| Veröffentlicht in: | BMC medicine 2014-10, Vol.12 (1), p.172, Article 172 |
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| description | Some smokers may benefit from a therapy that combines different nicotine replacement therapies (NRT) or drugs with different mechanisms of action.The aim of this study was to determine the efficacy of the combined therapy of varenicline and nicotine patches versus varenicline monotherapy.
Three hundred forty-one smokers who smoked 20 or more cigarettes per day were recruited from a smoking cessation clinic between February 2012 and June 2013. The participants were randomized to receive a varenicline plus nicotine patch of 21 mg every 24 hours (170) or varenicline plus a placebo patch (171). All of the smokers received a standard 12-week course of varenicline and an 11-week course of either the placebo patch or the active patch after the target quit day. Both groups received behavioral support. The primary outcome was continuous abstinence for weeks 2 through 12 confirmed by exhaled levels of carbon monoxide. Post hoc subgroup analyses were performed to evaluate the treatment effects for a specific endpoint in subgroups of smokers.
The combination of the nicotine patch with varenicline was not associated with higher rates of continuous abstinence at 12 weeks (39.1% versus 31.8%; odds ratio (OR) 1.24; 95% confidence interval (CI) 0.8 to 2.6) and 24 weeks (32.8% versus 28.2%; OR 1.17; 95% CI 0.4 to 1.9). When participants were analyzed by subgroups according to cigarette consumption, the abstinence rates among smokers who smoked more than 29 cigarettes per day at 12 weeks (OR 1.39; 95% CI 1.2 to 2.5) and 24 weeks (OR 1.46; 95% CI 1.2 to 2.8) were significantly higher in the combination group. Other post hoc analyses based on level of dependence and previous quit attempts did not show subgroup differences. No differences between the groups for the reported adverse events were observed (χ2 value 0.07; P 0.79).
The combination of varenicline with the nicotine patch does not improve abstinence rates at 12 and 24 weeks compared with varenicline used as monotherapy when all smokers were analyzed as a whole, independent of consumption level.
This study is registered at clinicaltrial.gov (NCT01538394). |
| doi_str_mv | 10.1186/s12916-014-0172-8 |
| format | Article |
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Three hundred forty-one smokers who smoked 20 or more cigarettes per day were recruited from a smoking cessation clinic between February 2012 and June 2013. The participants were randomized to receive a varenicline plus nicotine patch of 21 mg every 24 hours (170) or varenicline plus a placebo patch (171). All of the smokers received a standard 12-week course of varenicline and an 11-week course of either the placebo patch or the active patch after the target quit day. Both groups received behavioral support. The primary outcome was continuous abstinence for weeks 2 through 12 confirmed by exhaled levels of carbon monoxide. Post hoc subgroup analyses were performed to evaluate the treatment effects for a specific endpoint in subgroups of smokers.
The combination of the nicotine patch with varenicline was not associated with higher rates of continuous abstinence at 12 weeks (39.1% versus 31.8%; odds ratio (OR) 1.24; 95% confidence interval (CI) 0.8 to 2.6) and 24 weeks (32.8% versus 28.2%; OR 1.17; 95% CI 0.4 to 1.9). When participants were analyzed by subgroups according to cigarette consumption, the abstinence rates among smokers who smoked more than 29 cigarettes per day at 12 weeks (OR 1.39; 95% CI 1.2 to 2.5) and 24 weeks (OR 1.46; 95% CI 1.2 to 2.8) were significantly higher in the combination group. Other post hoc analyses based on level of dependence and previous quit attempts did not show subgroup differences. No differences between the groups for the reported adverse events were observed (χ2 value 0.07; P 0.79).
The combination of varenicline with the nicotine patch does not improve abstinence rates at 12 and 24 weeks compared with varenicline used as monotherapy when all smokers were analyzed as a whole, independent of consumption level.
This study is registered at clinicaltrial.gov (NCT01538394).</description><identifier>ISSN: 1741-7015</identifier><identifier>EISSN: 1741-7015</identifier><identifier>DOI: 10.1186/s12916-014-0172-8</identifier><identifier>PMID: 25296623</identifier><language>eng</language><publisher>England: BioMed Central Ltd</publisher><subject>Administration, Cutaneous ; Adolescent ; Adult ; Analysis ; Benzazepines - administration & dosage ; Bias ; Biomedical research ; Cigarette smokers ; Clinical trials ; Confidence intervals ; Consent ; Drug Therapy, Combination ; Female ; Fumadors ; Health aspects ; Hospitals ; Humans ; Hàbit de fumar ; Inventory ; Male ; Middle Aged ; Nicotina ; Nicotine ; Nicotine - administration & dosage ; Nicotinic Agonists - administration & dosage ; Preventive medicine ; Quinoxalines - administration & dosage ; School dropout programs ; School dropouts ; Smoking Cessation ; Studies ; Suicides & suicide attempts ; Tabac ; Therapy ; Tobacco ; Tobacco Use Cessation Products ; Tobacco Use Disorder - drug therapy ; Tobbacco habit ; Transdermal medication ; Treatment Outcome ; Varenicline</subject><ispartof>BMC medicine, 2014-10, Vol.12 (1), p.172, Article 172</ispartof><rights>COPYRIGHT 2014 BioMed Central Ltd.</rights><rights>2014 Ramon et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.</rights><rights>cc-by (c) BioMed Central, 2014 info:eu-repo/semantics/openAccess <a href="http://creativecommons.org/licenses/by/3.0/es">http://creativecommons.org/licenses/by/3.0/es</a></rights><rights>Ramon et al.; licensee BioMed Central Ltd. 2014</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c567t-217ef94a5ecbad8af27824b1f213e4f137651bfcba8f3a0c711a6f0eeb3538df3</citedby><cites>FETCH-LOGICAL-c567t-217ef94a5ecbad8af27824b1f213e4f137651bfcba8f3a0c711a6f0eeb3538df3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4198796/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4198796/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,26953,27903,27904,53770,53772</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25296623$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ramon, Josep M</creatorcontrib><creatorcontrib>Morchon, Sergio</creatorcontrib><creatorcontrib>Baena, Antoni</creatorcontrib><creatorcontrib>Masuet-Aumatell, Cristina</creatorcontrib><title>Combining varenicline and nicotine patches: a randomized controlled trial study in smoking cessation</title><title>BMC medicine</title><addtitle>BMC Med</addtitle><description>Some smokers may benefit from a therapy that combines different nicotine replacement therapies (NRT) or drugs with different mechanisms of action.The aim of this study was to determine the efficacy of the combined therapy of varenicline and nicotine patches versus varenicline monotherapy.
Three hundred forty-one smokers who smoked 20 or more cigarettes per day were recruited from a smoking cessation clinic between February 2012 and June 2013. The participants were randomized to receive a varenicline plus nicotine patch of 21 mg every 24 hours (170) or varenicline plus a placebo patch (171). All of the smokers received a standard 12-week course of varenicline and an 11-week course of either the placebo patch or the active patch after the target quit day. Both groups received behavioral support. The primary outcome was continuous abstinence for weeks 2 through 12 confirmed by exhaled levels of carbon monoxide. Post hoc subgroup analyses were performed to evaluate the treatment effects for a specific endpoint in subgroups of smokers.
The combination of the nicotine patch with varenicline was not associated with higher rates of continuous abstinence at 12 weeks (39.1% versus 31.8%; odds ratio (OR) 1.24; 95% confidence interval (CI) 0.8 to 2.6) and 24 weeks (32.8% versus 28.2%; OR 1.17; 95% CI 0.4 to 1.9). When participants were analyzed by subgroups according to cigarette consumption, the abstinence rates among smokers who smoked more than 29 cigarettes per day at 12 weeks (OR 1.39; 95% CI 1.2 to 2.5) and 24 weeks (OR 1.46; 95% CI 1.2 to 2.8) were significantly higher in the combination group. Other post hoc analyses based on level of dependence and previous quit attempts did not show subgroup differences. No differences between the groups for the reported adverse events were observed (χ2 value 0.07; P 0.79).
The combination of varenicline with the nicotine patch does not improve abstinence rates at 12 and 24 weeks compared with varenicline used as monotherapy when all smokers were analyzed as a whole, independent of consumption level.
This study is registered at clinicaltrial.gov (NCT01538394).</description><subject>Administration, Cutaneous</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Analysis</subject><subject>Benzazepines - administration & dosage</subject><subject>Bias</subject><subject>Biomedical research</subject><subject>Cigarette smokers</subject><subject>Clinical trials</subject><subject>Confidence intervals</subject><subject>Consent</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>Fumadors</subject><subject>Health aspects</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Hàbit de fumar</subject><subject>Inventory</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Nicotina</subject><subject>Nicotine</subject><subject>Nicotine - administration & dosage</subject><subject>Nicotinic Agonists - administration & dosage</subject><subject>Preventive medicine</subject><subject>Quinoxalines - administration & dosage</subject><subject>School dropout programs</subject><subject>School dropouts</subject><subject>Smoking Cessation</subject><subject>Studies</subject><subject>Suicides & suicide attempts</subject><subject>Tabac</subject><subject>Therapy</subject><subject>Tobacco</subject><subject>Tobacco Use Cessation Products</subject><subject>Tobacco Use Disorder - drug therapy</subject><subject>Tobbacco habit</subject><subject>Transdermal medication</subject><subject>Treatment Outcome</subject><subject>Varenicline</subject><issn>1741-7015</issn><issn>1741-7015</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>XX2</sourceid><recordid>eNptUt-L1DAQLqJ4P_QP8EUKgm89M0mbtD4Ix6KncOCLPoc0nezmbJM1SQ_u_nrT271lFyQMmcnM9yUz-YriHZArgJZ_ikA74BWBOpugVfuiOAdRQyUINC-P_LPiIsY7QmgjRP26OKMN7Tin7LwYVn7qrbNuXd6rgM7q0ToslRvK7Pu0BFuV9Abj51KVISf8ZB9xKLV3KfhxzG4KVo1lTPPwUFpXxsn_WQg1xqiS9e5N8cqoMeLb_X5Z_P729dfqe3X78-bH6vq20g0XqaIg0HS1alD3amiVoaKldQ-GAsPaABO8gd7kZGuYIloAKG4IYs8a1g6GXRZfdrzbuZ9w0JhfqEa5DXZS4UF6ZeVpxtmNXPt7WUPXio5nAtgR6DhrGVBj0Co9AQ_BYpQIKhnhtGsz5sP-0uD_zhiTvPNzcLlPCRwop9A-Me-r1mpEaZ3x-QF6slHL64Z1nNSsbnLV1X-q8hpwyr_h0Nh8fgL4eATYoBrTJvpxXqYeTwufOws-xoDmMBUgchGT3IlJZjHJRUxy6ez98TgPiGf1sH-du8WT</recordid><startdate>20141008</startdate><enddate>20141008</enddate><creator>Ramon, Josep M</creator><creator>Morchon, Sergio</creator><creator>Baena, Antoni</creator><creator>Masuet-Aumatell, Cristina</creator><general>BioMed Central Ltd</general><general>BioMed Central</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QL</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>XX2</scope><scope>5PM</scope></search><sort><creationdate>20141008</creationdate><title>Combining varenicline and nicotine patches: a randomized controlled trial study in smoking cessation</title><author>Ramon, Josep M ; Morchon, Sergio ; Baena, Antoni ; Masuet-Aumatell, Cristina</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c567t-217ef94a5ecbad8af27824b1f213e4f137651bfcba8f3a0c711a6f0eeb3538df3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Administration, Cutaneous</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Analysis</topic><topic>Benzazepines - administration & dosage</topic><topic>Bias</topic><topic>Biomedical research</topic><topic>Cigarette smokers</topic><topic>Clinical trials</topic><topic>Confidence intervals</topic><topic>Consent</topic><topic>Drug Therapy, Combination</topic><topic>Female</topic><topic>Fumadors</topic><topic>Health aspects</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Hàbit de fumar</topic><topic>Inventory</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Nicotina</topic><topic>Nicotine</topic><topic>Nicotine - administration & dosage</topic><topic>Nicotinic Agonists - administration & dosage</topic><topic>Preventive medicine</topic><topic>Quinoxalines - administration & dosage</topic><topic>School dropout programs</topic><topic>School dropouts</topic><topic>Smoking Cessation</topic><topic>Studies</topic><topic>Suicides & suicide attempts</topic><topic>Tabac</topic><topic>Therapy</topic><topic>Tobacco</topic><topic>Tobacco Use Cessation Products</topic><topic>Tobacco Use Disorder - drug therapy</topic><topic>Tobbacco habit</topic><topic>Transdermal medication</topic><topic>Treatment Outcome</topic><topic>Varenicline</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ramon, Josep M</creatorcontrib><creatorcontrib>Morchon, Sergio</creatorcontrib><creatorcontrib>Baena, Antoni</creatorcontrib><creatorcontrib>Masuet-Aumatell, Cristina</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Recercat</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BMC medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ramon, Josep M</au><au>Morchon, Sergio</au><au>Baena, Antoni</au><au>Masuet-Aumatell, Cristina</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Combining varenicline and nicotine patches: a randomized controlled trial study in smoking cessation</atitle><jtitle>BMC medicine</jtitle><addtitle>BMC Med</addtitle><date>2014-10-08</date><risdate>2014</risdate><volume>12</volume><issue>1</issue><spage>172</spage><pages>172-</pages><artnum>172</artnum><issn>1741-7015</issn><eissn>1741-7015</eissn><abstract>Some smokers may benefit from a therapy that combines different nicotine replacement therapies (NRT) or drugs with different mechanisms of action.The aim of this study was to determine the efficacy of the combined therapy of varenicline and nicotine patches versus varenicline monotherapy.
Three hundred forty-one smokers who smoked 20 or more cigarettes per day were recruited from a smoking cessation clinic between February 2012 and June 2013. The participants were randomized to receive a varenicline plus nicotine patch of 21 mg every 24 hours (170) or varenicline plus a placebo patch (171). All of the smokers received a standard 12-week course of varenicline and an 11-week course of either the placebo patch or the active patch after the target quit day. Both groups received behavioral support. The primary outcome was continuous abstinence for weeks 2 through 12 confirmed by exhaled levels of carbon monoxide. Post hoc subgroup analyses were performed to evaluate the treatment effects for a specific endpoint in subgroups of smokers.
The combination of the nicotine patch with varenicline was not associated with higher rates of continuous abstinence at 12 weeks (39.1% versus 31.8%; odds ratio (OR) 1.24; 95% confidence interval (CI) 0.8 to 2.6) and 24 weeks (32.8% versus 28.2%; OR 1.17; 95% CI 0.4 to 1.9). When participants were analyzed by subgroups according to cigarette consumption, the abstinence rates among smokers who smoked more than 29 cigarettes per day at 12 weeks (OR 1.39; 95% CI 1.2 to 2.5) and 24 weeks (OR 1.46; 95% CI 1.2 to 2.8) were significantly higher in the combination group. Other post hoc analyses based on level of dependence and previous quit attempts did not show subgroup differences. No differences between the groups for the reported adverse events were observed (χ2 value 0.07; P 0.79).
The combination of varenicline with the nicotine patch does not improve abstinence rates at 12 and 24 weeks compared with varenicline used as monotherapy when all smokers were analyzed as a whole, independent of consumption level.
This study is registered at clinicaltrial.gov (NCT01538394).</abstract><cop>England</cop><pub>BioMed Central Ltd</pub><pmid>25296623</pmid><doi>10.1186/s12916-014-0172-8</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | BMC medicine, 2014-10, Vol.12 (1), p.172, Article 172 |
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| source | MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central Open Access; Springer Nature OA Free Journals; Springer Nature - Complete Springer Journals; Recercat; PubMed Central |
| subjects | Administration, Cutaneous Adolescent Adult Analysis Benzazepines - administration & dosage Bias Biomedical research Cigarette smokers Clinical trials Confidence intervals Consent Drug Therapy, Combination Female Fumadors Health aspects Hospitals Humans Hàbit de fumar Inventory Male Middle Aged Nicotina Nicotine Nicotine - administration & dosage Nicotinic Agonists - administration & dosage Preventive medicine Quinoxalines - administration & dosage School dropout programs School dropouts Smoking Cessation Studies Suicides & suicide attempts Tabac Therapy Tobacco Tobacco Use Cessation Products Tobacco Use Disorder - drug therapy Tobbacco habit Transdermal medication Treatment Outcome Varenicline |
| title | Combining varenicline and nicotine patches: a randomized controlled trial study in smoking cessation |
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