A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Varenicline for Smoking Cessation in Patients With Schizophrenia or Schizoaffective Disorder

Williams, Jill M.; Anthenelli, Robert M.; Morris, Chad; Treadow, Joan; Thompson, John R.; Yunis, Carla; George, Tony P.

doi:10.4088/jcp.11m07522

Cited by 150 publications

(133 citation statements)

References 30 publications

Supporting

Mentioning

119

Contrasting

Unclassified

Order By: Relevance

“…After the removal of duplicates and screening of titles and abstracts, 68 trials underwent full‐text review. In total, 38 RCTs met all eligibility criteria and were included in our meta‐analysis 10, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49…”

Section: Resultsmentioning

confidence: 99%

Varenicline and Adverse Cardiovascular Events: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials

Sterling

Windle

Filion

et al. 2016

JAHA

View full text Add to dashboard Cite

BackgroundVarenicline is an efficacious smoking‐cessation drug. However, previous meta‐analyses provide conflicting results regarding its cardiovascular safety. The publication of several new randomized controlled trials (RCTs) provides an opportunity to reassess this potential adverse drug reaction.Methods and ResultsWe searched MEDLINE, EMBASE, and the Cochrane Library for RCTs that compare varenicline with placebo for smoking cessation. RCTs reporting cardiovascular serious adverse events and/or all‐cause mortality during the treatment period or within 30 days of treatment discontinuation were eligible for inclusion. Relative risks (RRs) with 95% CIs were generated by using DerSimonian–Laird random‐effects models. Thirty‐eight RCTs met our inclusion criteria (N=12 706). Events were rare in both varenicline (57/7213) and placebo (43/5493) arms. No difference was observed for cardiovascular serious adverse events when comparing varenicline with placebo (RR 1.03, 95% CI 0.72–1.49). Similar findings were obtained when examining cardiovascular (RR 1.04, 95% CI 0.57–1.89) and noncardiovascular patients (RR 1.03, 95% CI 0.64–1.64). Deaths were rare in both varenicline (11/7213) and placebo (9/5493) arms. Although 95% CIs were wide, pooling of all‐cause mortality found no difference between groups (RR 0.88, 95% CI 0.50–1.52), including when stratified by participants with (RR 1.24, 95% CI 0.40–3.83) and without (RR 0.77, 95% CI 0.40–1.48) cardiovascular disease.ConclusionsWe found no evidence that varenicline increases the rate of cardiovascular serious adverse events. Results were similar among those with and without cardiovascular disease. Given varenicline's efficacy as a smoking cessation drug and the long‐term cardiovascular benefits of cessation, it should continue to be prescribed for smoking cessation.

show abstract

Section: Resultsmentioning

confidence: 99%

Varenicline and Adverse Cardiovascular Events: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials

Sterling

Windle

Filion

et al. 2016

JAHA

View full text Add to dashboard Cite

show abstract

“…In one trial [40], 60% of those who quit after 12 weeks on varenicline had relapsed by the end of six months, compared to 33% of those in the control group. The other study [46] reported a relapse rate of 38% in the varenicline group and a 50% relapse rate in the placebo group at six-month follow-up. This demonstrates that people with SMI who try to quit smoking relapse easily and more research is needed into relapse prevention interventions for smoking cessation in people with SMI.…”

Section: Discussionmentioning

confidence: 87%

“…Full-text assessments of the remaining 11 potentially relevant articles excluded a further three studies [37][38][39]. A total of eight studies (398 participants) met the selection criteria and were included in the analysis [40][41][42][43][44][45][46][47]. The included studies were published between 2011 and 2014.…”

Section: Included Studiesmentioning

confidence: 99%

“…Four trials, with a total of 240 participants, reported smoking abstinence rates after 12 weeks of treatment with varenicline [40,42,45,46]. The pooled results ( Figure 2) show that participants using varenicline were more than four times more likely to abstain from smoking at the end of the treatment than the placebo groups (RR 4.33, 95% CI 1.96 to 9.56, I² = 0%, p=0.910).…”

Section: Effectiveness Of the Interventionsmentioning

confidence: 99%

See 1 more Smart Citation

Varenicline for smoking cessation and reduction in people with severe mental illnesses: systematic review and meta-analysis

Gilbody

Peckham

et al. 2016

Addiction

View full text Add to dashboard Cite

ReuseItems deposited in White Rose Research Online are protected by copyright, with all rights reserved unless indicated otherwise. They may be downloaded and/or printed for private study, or other acts as permitted by national copyright laws. The publisher or other rights holders may allow further reproduction and re-use of the full text version. This is indicated by the licence information on the White Rose Research Online record for the item. TakedownIf you consider content in White Rose Research Online to be in breach of UK law, please notify us by emailing eprints@whiterose.ac.uk including the URL of the record and the reason for the withdrawal request.This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/add.13415 This article is protected by copyright. All rights reserved. COMPETING INTERESTS None. 2This article is protected by copyright. All rights reserved. ABSTRACT AimsTo determine the effectiveness and safety of varenicline in treating tobacco dependence in patients with severe mental illness.Design A systematic review and meta-analysis of randomised controlled trials that compared varenicline with a placebo or an alternative intervention for smoking cessation or reduction.Setting Both in-patient and out-patient settings in any country.Participants Adult patients aged 18 and over with any type of severe mental illness. The systematic review included eight studies comprising 398 participants.Measures Primary outcome measures were (1) smoking cessation (2) smoking reduction measured by changes in the number of cigarettes smoked per day and (3) number of psychiatric adverse events, which were collected at the end of treatment. FindingsThe random-effect pooled estimates from the five studies that reported smoking related outcomes found that varenicline is statistically superior to placebo in smoking cessation (risk ratios 4.33; 95% CI: 1.96-9.56), and smoking reduction was higher in varenicline groups (mean reduced daily cigarettes was 6.39; 95% CI: 2.22-10.56). There is no significant difference regarding neuropsychiatric and other adverse events.Conclusions Varenicline appears to be significantly more effective than placebo in assisting with smoking cessation and reduction in people with severe mental illness. There appears to be no clear evidence that varenicline was associated with an increased risk of neuropsychiatric or other adverse events compared with placebo. 3This article is

show abstract

“…The study reported in Cahill et al 15 as Pfizer 2011 40 was identified in the updated search as now being a published paper. 41 There were no differences in reported data in the published paper. Data for efficacy and adverse events were extracted from all newly included studies.…”

Section: Updated Searchmentioning

confidence: 86%

What is the clinical effectiveness and cost-effectiveness of cytisine compared with varenicline for smoking cessation? A systematic review and economic evaluation

Leaviss

Sullivan

Ren

et al. 2014

Health Technology Assessment

View full text Add to dashboard Cite

A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Varenicline for Smoking Cessation in Patients With Schizophrenia or Schizoaffective Disorder

Abstract: ClinicalTrials.gov identifier: NCT00644969.

Cited by 150 publications

References 30 publications

Varenicline and Adverse Cardiovascular Events: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials

Varenicline and Adverse Cardiovascular Events: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials

Varenicline for smoking cessation and reduction in people with severe mental illnesses: systematic review and meta-analysis

What is the clinical effectiveness and cost-effectiveness of cytisine compared with varenicline for smoking cessation? A systematic review and economic evaluation

Contact Info

Product

Resources

About