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Jessica Schwartz, Opeyemi Fadahunsi, Rittu Hingorani, Naba Raj Mainali, Adetokunbo Oluwasanjo, Madan Raj Aryal, Anthony Donato, Use of Varenicline in Smokeless Tobacco Cessation: A Systematic Review and Meta-Analysis, Nicotine & Tobacco Research, Volume 18, Issue 1, January 2016, Pages 10–16, https://doi.org/10.1093/ntr/ntv010
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Abstract
Conduct a systematic review and meta-analysis on the effectiveness and safety of varenicline in smokeless tobacco (SLT) cessation.
PubMed, EMBASE, clinicaltrials.gov , and the Cochrane Registry were searched up to February 1, 2014, for randomized clinical trials (RCTs) comparing varenicline to placebo. Random effects Mantel–Haenszel summary relative risks (RRs), risk difference (RD), and 95% CIs were used for analysis and reporting of outcomes. Primary and secondary outcomes were the 7-day point prevalence of SLT abstinence at the end of 12 and 26 weeks, respectively. Adverse events reported include nausea, sleep disturbance, and mood disorders.
Three published RCTs involving 744 SLT users with a mean age of 39.7 years, of which greater than 88% were males, were randomized to varenicline ( n = 370) and placebo ( n = 374). Subjects in the varenicline arm had a significantly higher 7-day point prevalence of SLT abstinence at 12 weeks (48% vs. 33%; RR = 1.45, 95% CI = 1.22–1.72, p < .0001, I2 = 0%; RD = 13%, 95% CI = 4%–23%, p = .008) but not at 26 weeks (49% vs. 39%; RR = 1.38, 95% CI = 0.93–2.03, p = .11, I2 = 51%). There were no statistically significant differences in the incidences of adverse events between the 2 arms but interpretation is limited by high heterogeneity.
This pooled analysis suggests that varenicline is effective in achieving a 7-day point prevalence of SLT abstinence at 12 weeks but showed that this effect was not sustained at 26 weeks.
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