A Discrete-Event Simulation of Smoking-Cessation Strategies Based on Varenicline Pivotal Trial Data
Background Smoking is the leading cause of preventable death in the US. While one in five individuals smoke, and 70% of these indicate a desire to quit,
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| Veröffentlicht in: | PharmacoEconomics 2011-06, Vol.29 (6), p.497-510 |
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| creator | Xenakis, James G. Kinter, Elizabeth T. Ishak, K. Jack Ward, Alexandra J. Marton, Jenő P. Willke, Richard J. Davies, Simon Caro, J. Jaime |
| description | Background
Smoking is the leading cause of preventable death in the US. While one in five individuals smoke, and 70% of these indicate a desire to quit, |
| doi_str_mv | 10.2165/11589230-000000000-00000 |
| format | Article |
| fullrecord | <record><control><sourceid>gale_proqu</sourceid><recordid>TN_cdi_proquest_journals_866418458</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A257128594</galeid><sourcerecordid>A257128594</sourcerecordid><originalsourceid>FETCH-LOGICAL-c605t-e6413758a8911fe936b4d41407254ef008b245094d7e058c1ad33e222a6940663</originalsourceid><addsrcrecordid>eNqFkVFv0zAQxyMEYmPwFVAE4jHDdmzHfizdGKBJIHXwarnOpfWWOJmdFu3b70raTkhIODr7dPn97-y7LMspOWdUio-UCqVZSQpyWJP3LDultNIFI6x6_scnRSU1OclepXSLgCwr9jI7YZQLpok6zdwsv_DJRRihuNxCGPOF7zatHX0f8r7JF11_58OqmENKU3AxRjvCykPKP9kEdY6xXzZC8K71AfIfftuPts1vosf9wo72dfaisW2CN_vzLPv5-fJm_qW4_n71dT67LpwkYixAclpWQlmlKW1Al3LJa045qZjg0BCilowLonldARHKUVuXJTDGrNScSFmeZe-mvEPs7zeQRnPbb2LAkkZJTK64UAi9n6CVbcH40PT4HtdhD8yMiYoyJTRH6vwfFH41dN71ARqP8b8EahK42KcUoTFD9J2ND4YSs5uZOczMHGc2eSj9NkkjDOCOut9362ENWMtsTWmZxu1h5xBK8fBoEm1A47oyAsusxw6Tvd33YLPsoD5mO0wcgQ97wCZn2yba4Hx64nhJK8Z3t9ITl_BXWEF8auZ_X_QIFxrEXQ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>866418458</pqid></control><display><type>article</type><title>A Discrete-Event Simulation of Smoking-Cessation Strategies Based on Varenicline Pivotal Trial Data</title><source>MEDLINE</source><source>RePEc</source><source>SpringerLink Journals - AutoHoldings</source><creator>Xenakis, James G. ; Kinter, Elizabeth T. ; Ishak, K. Jack ; Ward, Alexandra J. ; Marton, Jenő P. ; Willke, Richard J. ; Davies, Simon ; Caro, J. Jaime</creator><creatorcontrib>Xenakis, James G. ; Kinter, Elizabeth T. ; Ishak, K. Jack ; Ward, Alexandra J. ; Marton, Jenő P. ; Willke, Richard J. ; Davies, Simon ; Caro, J. Jaime</creatorcontrib><description>Background
Smoking is the leading cause of preventable death in the US. While one in five individuals smoke, and 70% of these indicate a desire to quit, <5% of unaided quit attempts succeed. Cessation aids can double or triple the odds of successfully quitting. Models of smoking-cessation behaviour can elucidate the implications of individual abstinence patterns to allow better tailoring of quit attempts to an individual’s characteristics.
Objective
The objectives of this study were to develop and validate a discrete-event simulation (DES) to evaluate the benefits of smoking abstinence using data from the pooled pivotal clinical trials of varenicline versus bupropion or placebo for smoking cessation and to provide a foundation for the development of a lifetime smoking-cessation model.
Methods
The DES model simulated the outcome of a single smoking-cessation attempt over 1 year, in accordance with the clinical trial timeframes. Pharmaceutical costs were assessed from the perspective of a healthcare payer. The model randomly sampled patient profiles from the pooled varenicline clinical trials. All patients were physically and mentally healthy adult smokers who were motivated to quit abruptly. The model allowed for comparisons of up to five distinct treatment approaches for smoking cessation. In the current analyses, three interventions corresponding to the clinical trials were evaluated, which included brief counselling plus varenicline 1.0 mg twice daily (bid) or bupropion SR 150mg bid versus placebo (i.e. brief counselling only). The treatment periods in the clinical trials were 12 weeks (target quit date: day 8), with a 40-week non-treatment follow-up, and counselling continuing over the entire 52-week period in all treatment groups. The main outcome modelled was the continuous abstinence rate (CAR; defined as complete abstinence from smoking and confirmed by exhaled carbon monoxide ≤10 ppm) at end of treatment (weeks 9–12) and long-term follow-up (weeks 9–52), and total time abstinent from smoking over the course of 52 weeks. The model also evaluated costs and cost-effectiveness outcomes.
Results
For the varenicline, bupropion and placebo cohorts, respectively, the model predicted CARs for weeks 9–12 of 44.3%, 30.4% and 18.6% compared with observed rates of 44.0%, 29.7% and 17.7%; over weeks 9–52, predicted CARs in the model compared with observed rates in the pooled clinical studies were 22.9%, 16.4% and 9.4% versus 22.4%, 15.4% and 9.3%, respectively. Total mean abstinence times accrued in the model varenicline, bupropion and placebo groups, respectively, were 3.6, 2.6 and 1.5 months and total pharmaceutical treatment costs were $US261, $US442 and $US0 (year 2008 values) over the 1-year model period. Using cost per abstinent-month achieved as a measure of cost effectiveness, varenicline dominated bupropion and yielded an incremental cost-effectiveness ratio of $US124 compared with placebo.
Conclusion
The model accurately replicated abstinence patterns observed in the clinical trial data using individualized predictions and indicated that varenicline was more effective and may be less costly than bupropion. This simulation incorporated individual predictions of abstinence and relapse, and provides a framework for lifetime modelling that considers multiple quit attempts over time in diverse patient populations using a variety of quit attempt strategies.</description><identifier>ISSN: 1170-7690</identifier><identifier>EISSN: 1179-2027</identifier><identifier>DOI: 10.2165/11589230-000000000-00000</identifier><identifier>PMID: 21452908</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Abstinence ; Adult ; Analysis ; Benzazepines - therapeutic use ; Biological and medical sciences ; Bupropion ; Cardiovascular disease ; Clinical trials ; Clinical Trials as Topic ; Combinatorics ; Computerized, statistical medical data processing and models in biomedicine ; Coronary heart disease ; Cost-effectiveness ; Costs ; Counseling ; Counselling ; Drug therapy ; Female ; General pharmacology ; Health Administration ; Health aspects ; Health Care Costs ; Health Economics ; Humans ; Intervention ; Male ; Medical care, Cost of ; Medical research ; Medical sciences ; Medicine ; Medicine & Public Health ; Miscellaneous ; Models and simulation ; Models, Statistical ; Nicotinic Agonists - therapeutic use ; Original Research Article ; Patients ; Pharmaceuticals ; Pharmacoeconomics and Health Outcomes ; Pharmacology. Drug treatments ; Public Health ; Public health. Hygiene ; Public health. Hygiene-occupational medicine ; Quality of Life Research ; Quinoxalines - therapeutic use ; Recurrence ; Risk factors ; Simulation ; Smoking ; Smoking cessation ; Smoking Cessation - methods ; Smoking cessation programs ; Smoking-cessation- therapies ; Studies ; therapeutic use ; Tobacco Use Disorder - drug therapy ; Tobacco Use Disorder - mortality ; Tobacco, tobacco smoking ; Toxicology ; Treatment Outcome ; Varenicline</subject><ispartof>PharmacoEconomics, 2011-06, Vol.29 (6), p.497-510</ispartof><rights>Adis Data Information BV 2011</rights><rights>2015 INIST-CNRS</rights><rights>COPYRIGHT 2011 Wolters Kluwer Health, Inc.</rights><rights>Copyright Wolters Kluwer Health Adis International Jun 2011</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c605t-e6413758a8911fe936b4d41407254ef008b245094d7e058c1ad33e222a6940663</citedby><cites>FETCH-LOGICAL-c605t-e6413758a8911fe936b4d41407254ef008b245094d7e058c1ad33e222a6940663</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.2165/11589230-000000000-00000$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.2165/11589230-000000000-00000$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,3993,27903,27904,41467,42536,51297</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=24317240$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21452908$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttp://econpapers.repec.org/article/wkhphecon/v_3a29_3ay_3a2011_3ai_3a6_3ap_3a497-510.htm$$DView record in RePEc$$Hfree_for_read</backlink></links><search><creatorcontrib>Xenakis, James G.</creatorcontrib><creatorcontrib>Kinter, Elizabeth T.</creatorcontrib><creatorcontrib>Ishak, K. Jack</creatorcontrib><creatorcontrib>Ward, Alexandra J.</creatorcontrib><creatorcontrib>Marton, Jenő P.</creatorcontrib><creatorcontrib>Willke, Richard J.</creatorcontrib><creatorcontrib>Davies, Simon</creatorcontrib><creatorcontrib>Caro, J. Jaime</creatorcontrib><title>A Discrete-Event Simulation of Smoking-Cessation Strategies Based on Varenicline Pivotal Trial Data</title><title>PharmacoEconomics</title><addtitle>Pharmacoeconomics</addtitle><addtitle>Pharmacoeconomics</addtitle><description>Background
Smoking is the leading cause of preventable death in the US. While one in five individuals smoke, and 70% of these indicate a desire to quit, <5% of unaided quit attempts succeed. Cessation aids can double or triple the odds of successfully quitting. Models of smoking-cessation behaviour can elucidate the implications of individual abstinence patterns to allow better tailoring of quit attempts to an individual’s characteristics.
Objective
The objectives of this study were to develop and validate a discrete-event simulation (DES) to evaluate the benefits of smoking abstinence using data from the pooled pivotal clinical trials of varenicline versus bupropion or placebo for smoking cessation and to provide a foundation for the development of a lifetime smoking-cessation model.
Methods
The DES model simulated the outcome of a single smoking-cessation attempt over 1 year, in accordance with the clinical trial timeframes. Pharmaceutical costs were assessed from the perspective of a healthcare payer. The model randomly sampled patient profiles from the pooled varenicline clinical trials. All patients were physically and mentally healthy adult smokers who were motivated to quit abruptly. The model allowed for comparisons of up to five distinct treatment approaches for smoking cessation. In the current analyses, three interventions corresponding to the clinical trials were evaluated, which included brief counselling plus varenicline 1.0 mg twice daily (bid) or bupropion SR 150mg bid versus placebo (i.e. brief counselling only). The treatment periods in the clinical trials were 12 weeks (target quit date: day 8), with a 40-week non-treatment follow-up, and counselling continuing over the entire 52-week period in all treatment groups. The main outcome modelled was the continuous abstinence rate (CAR; defined as complete abstinence from smoking and confirmed by exhaled carbon monoxide ≤10 ppm) at end of treatment (weeks 9–12) and long-term follow-up (weeks 9–52), and total time abstinent from smoking over the course of 52 weeks. The model also evaluated costs and cost-effectiveness outcomes.
Results
For the varenicline, bupropion and placebo cohorts, respectively, the model predicted CARs for weeks 9–12 of 44.3%, 30.4% and 18.6% compared with observed rates of 44.0%, 29.7% and 17.7%; over weeks 9–52, predicted CARs in the model compared with observed rates in the pooled clinical studies were 22.9%, 16.4% and 9.4% versus 22.4%, 15.4% and 9.3%, respectively. Total mean abstinence times accrued in the model varenicline, bupropion and placebo groups, respectively, were 3.6, 2.6 and 1.5 months and total pharmaceutical treatment costs were $US261, $US442 and $US0 (year 2008 values) over the 1-year model period. Using cost per abstinent-month achieved as a measure of cost effectiveness, varenicline dominated bupropion and yielded an incremental cost-effectiveness ratio of $US124 compared with placebo.
Conclusion
The model accurately replicated abstinence patterns observed in the clinical trial data using individualized predictions and indicated that varenicline was more effective and may be less costly than bupropion. This simulation incorporated individual predictions of abstinence and relapse, and provides a framework for lifetime modelling that considers multiple quit attempts over time in diverse patient populations using a variety of quit attempt strategies.</description><subject>Abstinence</subject><subject>Adult</subject><subject>Analysis</subject><subject>Benzazepines - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Bupropion</subject><subject>Cardiovascular disease</subject><subject>Clinical trials</subject><subject>Clinical Trials as Topic</subject><subject>Combinatorics</subject><subject>Computerized, statistical medical data processing and models in biomedicine</subject><subject>Coronary heart disease</subject><subject>Cost-effectiveness</subject><subject>Costs</subject><subject>Counseling</subject><subject>Counselling</subject><subject>Drug therapy</subject><subject>Female</subject><subject>General pharmacology</subject><subject>Health Administration</subject><subject>Health aspects</subject><subject>Health Care Costs</subject><subject>Health Economics</subject><subject>Humans</subject><subject>Intervention</subject><subject>Male</subject><subject>Medical care, Cost of</subject><subject>Medical research</subject><subject>Medical sciences</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Miscellaneous</subject><subject>Models and simulation</subject><subject>Models, Statistical</subject><subject>Nicotinic Agonists - therapeutic use</subject><subject>Original Research Article</subject><subject>Patients</subject><subject>Pharmaceuticals</subject><subject>Pharmacoeconomics and Health Outcomes</subject><subject>Pharmacology. Drug treatments</subject><subject>Public Health</subject><subject>Public health. Hygiene</subject><subject>Public health. Hygiene-occupational medicine</subject><subject>Quality of Life Research</subject><subject>Quinoxalines - therapeutic use</subject><subject>Recurrence</subject><subject>Risk factors</subject><subject>Simulation</subject><subject>Smoking</subject><subject>Smoking cessation</subject><subject>Smoking Cessation - methods</subject><subject>Smoking cessation programs</subject><subject>Smoking-cessation- therapies</subject><subject>Studies</subject><subject>therapeutic use</subject><subject>Tobacco Use Disorder - drug therapy</subject><subject>Tobacco Use Disorder - mortality</subject><subject>Tobacco, tobacco smoking</subject><subject>Toxicology</subject><subject>Treatment Outcome</subject><subject>Varenicline</subject><issn>1170-7690</issn><issn>1179-2027</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>X2L</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNqFkVFv0zAQxyMEYmPwFVAE4jHDdmzHfizdGKBJIHXwarnOpfWWOJmdFu3b70raTkhIODr7dPn97-y7LMspOWdUio-UCqVZSQpyWJP3LDultNIFI6x6_scnRSU1OclepXSLgCwr9jI7YZQLpok6zdwsv_DJRRihuNxCGPOF7zatHX0f8r7JF11_58OqmENKU3AxRjvCykPKP9kEdY6xXzZC8K71AfIfftuPts1vosf9wo72dfaisW2CN_vzLPv5-fJm_qW4_n71dT67LpwkYixAclpWQlmlKW1Al3LJa045qZjg0BCilowLonldARHKUVuXJTDGrNScSFmeZe-mvEPs7zeQRnPbb2LAkkZJTK64UAi9n6CVbcH40PT4HtdhD8yMiYoyJTRH6vwfFH41dN71ARqP8b8EahK42KcUoTFD9J2ND4YSs5uZOczMHGc2eSj9NkkjDOCOut9362ENWMtsTWmZxu1h5xBK8fBoEm1A47oyAsusxw6Tvd33YLPsoD5mO0wcgQ97wCZn2yba4Hx64nhJK8Z3t9ITl_BXWEF8auZ_X_QIFxrEXQ</recordid><startdate>201106</startdate><enddate>201106</enddate><creator>Xenakis, James G.</creator><creator>Kinter, Elizabeth T.</creator><creator>Ishak, K. Jack</creator><creator>Ward, Alexandra J.</creator><creator>Marton, Jenő P.</creator><creator>Willke, Richard J.</creator><creator>Davies, Simon</creator><creator>Caro, J. Jaime</creator><general>Springer International Publishing</general><general>Adis International</general><general>Springer Healthcare | Adis</general><general>Wolters Kluwer Health, Inc</general><general>Springer Nature B.V</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>DKI</scope><scope>X2L</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>0U~</scope><scope>1-H</scope><scope>3V.</scope><scope>4T-</scope><scope>7WY</scope><scope>7WZ</scope><scope>7X7</scope><scope>7XB</scope><scope>87Z</scope><scope>88C</scope><scope>88E</scope><scope>88G</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8FL</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>BEZIV</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FRNLG</scope><scope>FYUFA</scope><scope>F~G</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K60</scope><scope>K6~</scope><scope>K9.</scope><scope>L.-</scope><scope>L.0</scope><scope>M0C</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2M</scope><scope>PQBIZ</scope><scope>PQBZA</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PSYQQ</scope><scope>Q9U</scope></search><sort><creationdate>201106</creationdate><title>A Discrete-Event Simulation of Smoking-Cessation Strategies Based on Varenicline Pivotal Trial Data</title><author>Xenakis, James G. ; Kinter, Elizabeth T. ; Ishak, K. Jack ; Ward, Alexandra J. ; Marton, Jenő P. ; Willke, Richard J. ; Davies, Simon ; Caro, J. Jaime</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c605t-e6413758a8911fe936b4d41407254ef008b245094d7e058c1ad33e222a6940663</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Abstinence</topic><topic>Adult</topic><topic>Analysis</topic><topic>Benzazepines - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Bupropion</topic><topic>Cardiovascular disease</topic><topic>Clinical trials</topic><topic>Clinical Trials as Topic</topic><topic>Combinatorics</topic><topic>Computerized, statistical medical data processing and models in biomedicine</topic><topic>Coronary heart disease</topic><topic>Cost-effectiveness</topic><topic>Costs</topic><topic>Counseling</topic><topic>Counselling</topic><topic>Drug therapy</topic><topic>Female</topic><topic>General pharmacology</topic><topic>Health Administration</topic><topic>Health aspects</topic><topic>Health Care Costs</topic><topic>Health Economics</topic><topic>Humans</topic><topic>Intervention</topic><topic>Male</topic><topic>Medical care, Cost of</topic><topic>Medical research</topic><topic>Medical sciences</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Miscellaneous</topic><topic>Models and simulation</topic><topic>Models, Statistical</topic><topic>Nicotinic Agonists - therapeutic use</topic><topic>Original Research Article</topic><topic>Patients</topic><topic>Pharmaceuticals</topic><topic>Pharmacoeconomics and Health Outcomes</topic><topic>Pharmacology. Drug treatments</topic><topic>Public Health</topic><topic>Public health. Hygiene</topic><topic>Public health. Hygiene-occupational medicine</topic><topic>Quality of Life Research</topic><topic>Quinoxalines - therapeutic use</topic><topic>Recurrence</topic><topic>Risk factors</topic><topic>Simulation</topic><topic>Smoking</topic><topic>Smoking cessation</topic><topic>Smoking Cessation - methods</topic><topic>Smoking cessation programs</topic><topic>Smoking-cessation- therapies</topic><topic>Studies</topic><topic>therapeutic use</topic><topic>Tobacco Use Disorder - drug therapy</topic><topic>Tobacco Use Disorder - mortality</topic><topic>Tobacco, tobacco smoking</topic><topic>Toxicology</topic><topic>Treatment Outcome</topic><topic>Varenicline</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Xenakis, James G.</creatorcontrib><creatorcontrib>Kinter, Elizabeth T.</creatorcontrib><creatorcontrib>Ishak, K. Jack</creatorcontrib><creatorcontrib>Ward, Alexandra J.</creatorcontrib><creatorcontrib>Marton, Jenő P.</creatorcontrib><creatorcontrib>Willke, Richard J.</creatorcontrib><creatorcontrib>Davies, Simon</creatorcontrib><creatorcontrib>Caro, J. Jaime</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>RePEc IDEAS</collection><collection>RePEc</collection><collection>CrossRef</collection><collection>Global News & ABI/Inform Professional</collection><collection>Trade PRO</collection><collection>ProQuest Central (Corporate)</collection><collection>Docstoc</collection><collection>ABI/INFORM Collection</collection><collection>ABI/INFORM Global (PDF only)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>ABI/INFORM Global (Alumni Edition)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ABI/INFORM Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>Business Premium Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Business Premium Collection (Alumni)</collection><collection>Health Research Premium Collection</collection><collection>ABI/INFORM Global (Corporate)</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>ProQuest Business Collection (Alumni Edition)</collection><collection>ProQuest Business Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>ABI/INFORM Professional Advanced</collection><collection>ABI/INFORM Professional Standard</collection><collection>ABI/INFORM Global</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>ProQuest Psychology</collection><collection>ProQuest One Business</collection><collection>ProQuest One Business (Alumni)</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 One Psychology</collection><collection>ProQuest Central Basic</collection><jtitle>PharmacoEconomics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Xenakis, James G.</au><au>Kinter, Elizabeth T.</au><au>Ishak, K. Jack</au><au>Ward, Alexandra J.</au><au>Marton, Jenő P.</au><au>Willke, Richard J.</au><au>Davies, Simon</au><au>Caro, J. Jaime</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Discrete-Event Simulation of Smoking-Cessation Strategies Based on Varenicline Pivotal Trial Data</atitle><jtitle>PharmacoEconomics</jtitle><stitle>Pharmacoeconomics</stitle><addtitle>Pharmacoeconomics</addtitle><date>2011-06</date><risdate>2011</risdate><volume>29</volume><issue>6</issue><spage>497</spage><epage>510</epage><pages>497-510</pages><issn>1170-7690</issn><eissn>1179-2027</eissn><abstract>Background
Smoking is the leading cause of preventable death in the US. While one in five individuals smoke, and 70% of these indicate a desire to quit, <5% of unaided quit attempts succeed. Cessation aids can double or triple the odds of successfully quitting. Models of smoking-cessation behaviour can elucidate the implications of individual abstinence patterns to allow better tailoring of quit attempts to an individual’s characteristics.
Objective
The objectives of this study were to develop and validate a discrete-event simulation (DES) to evaluate the benefits of smoking abstinence using data from the pooled pivotal clinical trials of varenicline versus bupropion or placebo for smoking cessation and to provide a foundation for the development of a lifetime smoking-cessation model.
Methods
The DES model simulated the outcome of a single smoking-cessation attempt over 1 year, in accordance with the clinical trial timeframes. Pharmaceutical costs were assessed from the perspective of a healthcare payer. The model randomly sampled patient profiles from the pooled varenicline clinical trials. All patients were physically and mentally healthy adult smokers who were motivated to quit abruptly. The model allowed for comparisons of up to five distinct treatment approaches for smoking cessation. In the current analyses, three interventions corresponding to the clinical trials were evaluated, which included brief counselling plus varenicline 1.0 mg twice daily (bid) or bupropion SR 150mg bid versus placebo (i.e. brief counselling only). The treatment periods in the clinical trials were 12 weeks (target quit date: day 8), with a 40-week non-treatment follow-up, and counselling continuing over the entire 52-week period in all treatment groups. The main outcome modelled was the continuous abstinence rate (CAR; defined as complete abstinence from smoking and confirmed by exhaled carbon monoxide ≤10 ppm) at end of treatment (weeks 9–12) and long-term follow-up (weeks 9–52), and total time abstinent from smoking over the course of 52 weeks. The model also evaluated costs and cost-effectiveness outcomes.
Results
For the varenicline, bupropion and placebo cohorts, respectively, the model predicted CARs for weeks 9–12 of 44.3%, 30.4% and 18.6% compared with observed rates of 44.0%, 29.7% and 17.7%; over weeks 9–52, predicted CARs in the model compared with observed rates in the pooled clinical studies were 22.9%, 16.4% and 9.4% versus 22.4%, 15.4% and 9.3%, respectively. Total mean abstinence times accrued in the model varenicline, bupropion and placebo groups, respectively, were 3.6, 2.6 and 1.5 months and total pharmaceutical treatment costs were $US261, $US442 and $US0 (year 2008 values) over the 1-year model period. Using cost per abstinent-month achieved as a measure of cost effectiveness, varenicline dominated bupropion and yielded an incremental cost-effectiveness ratio of $US124 compared with placebo.
Conclusion
The model accurately replicated abstinence patterns observed in the clinical trial data using individualized predictions and indicated that varenicline was more effective and may be less costly than bupropion. This simulation incorporated individual predictions of abstinence and relapse, and provides a framework for lifetime modelling that considers multiple quit attempts over time in diverse patient populations using a variety of quit attempt strategies.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>21452908</pmid><doi>10.2165/11589230-000000000-00000</doi><tpages>14</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1170-7690 |
| ispartof | PharmacoEconomics, 2011-06, Vol.29 (6), p.497-510 |
| issn | 1170-7690 1179-2027 |
| language | eng |
| recordid | cdi_proquest_journals_866418458 |
| source | MEDLINE; RePEc; SpringerLink Journals - AutoHoldings |
| subjects | Abstinence Adult Analysis Benzazepines - therapeutic use Biological and medical sciences Bupropion Cardiovascular disease Clinical trials Clinical Trials as Topic Combinatorics Computerized, statistical medical data processing and models in biomedicine Coronary heart disease Cost-effectiveness Costs Counseling Counselling Drug therapy Female General pharmacology Health Administration Health aspects Health Care Costs Health Economics Humans Intervention Male Medical care, Cost of Medical research Medical sciences Medicine Medicine & Public Health Miscellaneous Models and simulation Models, Statistical Nicotinic Agonists - therapeutic use Original Research Article Patients Pharmaceuticals Pharmacoeconomics and Health Outcomes Pharmacology. Drug treatments Public Health Public health. Hygiene Public health. Hygiene-occupational medicine Quality of Life Research Quinoxalines - therapeutic use Recurrence Risk factors Simulation Smoking Smoking cessation Smoking Cessation - methods Smoking cessation programs Smoking-cessation- therapies Studies therapeutic use Tobacco Use Disorder - drug therapy Tobacco Use Disorder - mortality Tobacco, tobacco smoking Toxicology Treatment Outcome Varenicline |
| title | A Discrete-Event Simulation of Smoking-Cessation Strategies Based on Varenicline Pivotal Trial Data |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-26T05%3A03%3A54IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_proqu&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=A%20Discrete-Event%20Simulation%20of%20Smoking-Cessation%20Strategies%20Based%20on%20Varenicline%20Pivotal%20Trial%20Data&rft.jtitle=PharmacoEconomics&rft.au=Xenakis,%20James%20G.&rft.date=2011-06&rft.volume=29&rft.issue=6&rft.spage=497&rft.epage=510&rft.pages=497-510&rft.issn=1170-7690&rft.eissn=1179-2027&rft_id=info:doi/10.2165/11589230-000000000-00000&rft_dat=%3Cgale_proqu%3EA257128594%3C/gale_proqu%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=866418458&rft_id=info:pmid/21452908&rft_galeid=A257128594&rfr_iscdi=true |