Varenicline efficacy and safety among methadone maintained smokers: a randomized placebo-controlled trial

Nahvi, Shadi; Ning, Yuming; Segal, Kate S.; Richter, Kimber P.; Arnsten, Julia H.

doi:10.1111/add.12631

Cited by 41 publications

(36 citation statements)

References 43 publications

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“…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

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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.

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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

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“…Study methods of the parent trial have been previously described. 13 Briefly, participants were recruited at three urban methadone maintenance clinics in Bronx, NY. Participants were eligible if they were: (a) stable in methadone maintenance treatment; (b) at least 18 years old; (c) currently smoking 5 or more cigarettes per day; (d) interested in quitting tobacco use; (e) without varenicline use in the past 30 days; and (f) proficient in English.…”

Section: Setting and Participantsmentioning

confidence: 99%

Barriers to Telephone Quitline Use Among Methadone-Maintained Smokers

Griffin

Segal

Nahvi

2015

NICTOB

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Introduction: Drug users have high rates of tobacco use and tobacco-related disease. Telephone quitlines promote smoking cessation, but their reach among drug users is unknown. We thus aimed to assess utilization of and barriers to telephone quitlines among methadone-maintained smokers. Methods: Subjects were opioid-dependent smokers in Bronx, New York, methadone treatment programs who were enrolled in a clinical trial of varenicline. All subjects were offered referral to a free, proactive quitline. We examined quitline records, surveyed barriers to quitline use, and queried reasons for declining referral. Results: Of the 112 subjects enrolled, 47% were male, 54% were Hispanic, and 28% were Black. All subjects were offered referral, and 25 (22% of study participants) utilized the quitline. Quitline utilizers (vs. nonutilizers) were significantly more likely to have landline phone service (72 vs. 42%, p = .01), interest in quitline participation (92 vs. 62%, p < .01), and willingness to receive calls (96 vs. 76%, p = .02). Nonutilizers were significantly more likely to report cell phone service lapse (38 vs. 14%, p = .04), and difficulty charging cell phones (19 vs. 0%, p = .02). Reasons for quitline refusal included: (a) skepticism of quitline efficacy; (b) aversion to telephone communication; (c) competing life demands (e.g., drug treatment, shelter); and (d) problems with cell phone service or minutes. Conclusions: Despite several limitations to quitline access among methadone-maintained smokers, routine quitline referral was associated with 22% utilization. To expand provision of smoking cessation treatment to opioid-dependent smokers, interventions to promote routine quitline referral in substance abuse treatment programs warrant investigation.

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“…Varenicline, a partial a4b2 nAChR agonist and full a7 nAChR agonist, increases the chances of successful smoking cessation between two-and threefold compared with pharmacologically unassisted quit attempts [135]. However, in methadone-maintained patients, varenicline induces only a moderate reduction in smoking rates, and the long-term abstinence rates are low [136,137]. Varenicline also reduces alcohol craving, seeking and consumption [138][139][140].…”

Section: Implications For Future Drug Discoverymentioning

confidence: 99%