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Varenicline in smokers with diabetes: A pooled analysis of 15 randomized, placebo-controlled studies of varenicline.

ABSTRACT: AIMS/INTRODUCTION:Stopping smoking deserves high priority in preventing complications of diabetes; however, only sparse data are available regarding the efficacy of pharmacotherapy in smokers with diabetes. We assessed the efficacy and safety of varenicline in smokers with diabetes who participated in 15 double-blind, randomized, placebo-controlled studies. MATERIALS AND METHODS:This retrospective pooled analysis included data from smokers of ?10 cigarettes per day with diabetes. Participants received varenicline 1 mg b.i.d. or placebo for 12 weeks. We examined carbon monoxide-confirmed continuous abstinence rates (CARs) for weeks 9-12, 9-24 and 9-52, and compared safety in participants with and without diabetes. RESULTS:Of 6,771 participants, 323 had diabetes (varenicline n = 162; placebo n = 161). Week 9-12 CAR was higher with varenicline than placebo (43.8% vs 24.8%; odds ratio 2.36, 95% CI 1.47-3.79), as was week 9-24 CAR (27.5% vs 14.4%; odds ratio 2.25, 95% CI 1.27-4.00). Week 9-52 CAR was 18.4% for varenicline and 10.1% for placebo (odds ratio 2.00, 95% CI 0.90-4.49). The most commonly-reported adverse events in participants with diabetes for varenicline vs placebo were: nausea (27.2% vs 8.1%); headache (9.3% vs 9.9%); and insomnia (8.6% vs 5.6%), incidences that were similar in participants without diabetes (29.6% vs 9.7%; 13.4% vs 10.9%; and 11.4% vs 7.1%, respectively). Weight gain in quitters with diabetes (1.7 kg) was similar to that of those without diabetes (2.1 kg). CONCLUSIONS:Varenicline was an effective and well-tolerated aid for smoking cessation in individuals with diabetes. Safety was comparable with participants without diabetes.

SUBMITTER: Tonstad S

PROVIDER: S-EPMC5217903 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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Varenicline in smokers with diabetes: A pooled analysis of 15 randomized, placebo-controlled studies of varenicline.

Tonstad Serena S Lawrence David D

Journal of diabetes investigation 20160714 1

<h4>Aims/introduction</h4>Stopping smoking deserves high priority in preventing complications of diabetes; however, only sparse data are available regarding the efficacy of pharmacotherapy in smokers with diabetes. We assessed the efficacy and safety of varenicline in smokers with diabetes who participated in 15 double-blind, randomized, placebo-controlled studies.<h4>Materials and methods</h4>This retrospective pooled analysis included data from smokers of ≥10 cigarettes per day with diabetes. ...[more]

PMID: 27223809

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Project description:Background and aimsLevel of adherence to tobacco cessation medication regimens is believed to be causally related to medication effectiveness. This study aimed to evaluate the efficacy of varenicline directly observed therapy (DOT) on varenicline adherence and smoking cessation rates among smokers with opioid use disorder (OUD) receiving methadone treatment.DesignMulticenter, parallel-group two-arm randomized controlled trial.SettingUrban opioid treatment program (OTP) in the Bronx, New York, USA.ParticipantsDaily smokers of ≥ 5 cigarettes/day, interested in quitting (ladder of change score 6-8), in methadone treatment for ≥ 3 months, attending OTP ≥ 3 days/week. Participants' mean age was 49 years, 56% were male, 44% Latino, 30% Black, and they smoked a median of 10 cigarettes/day.InterventionsIndividual, block, random assignment to 12 weeks of varenicline, either directly observed with methadone (DOT, n = 50) or via unsupervised self-administered treatment (SAT, n = 50).MeasurementsThe primary outcome was adherence measured by pill count. The secondary outcome was 7-day point prevalence tobacco abstinence verified by expired carbon monoxide (CO) < 8 parts per million.FindingsRetention at 24 weeks was 92%. Mean adherence was 78.5% [95% confidence interval (CI) = 71.8-85.2%] in the DOT group versus 61.8% in the SAT group (95% CI = 55.0-68.6%); differences were driven by DOT effects in the first 6 weeks. CO-verified abstinence did not differ between groups during the intervention (P = 0.26), but was higher in the DOT than the SAT group at intervention end (DOT = 18% versus SAT = 10%, difference = 8%, 95% CI = -13, 28); this difference was not significant (P = 0.39) and was not sustained at 24-week follow-up.ConclusionsAmong daily smokers attending opioid treatment programs, opioid treatment program-based varenicline directly observed therapy was associated with early increases in varenicline adherence compared with self-administered treatment, but findings were inconclusive as to whether directly observed therapy was associated with a difference in tobacco abstinence.

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Varenicline in smokers with diabetes: A pooled analysis of 15 randomized, placebo-controlled studies of varenicline.

Publications

Varenicline in smokers with diabetes: A pooled analysis of 15 randomized, placebo-controlled studies of varenicline.

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