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Varenicline was efficacious at weeks 12, 24, and 52 of the trial compared with placebo in a smoking cessation program.
The inclusion of twice-daily 1 mg varenicline in smoking cessation programs for patients with type 2 diabetes (T2D) may result in prolonged abstinence without serious adverse events, according to new findings published in JAMA Network Open.
The findings suggest the agent was efficacious at weeks 12, 24, and 52 of the randomized clinical trial, in comparison to placebo.
“The findings suggest that substantial changes in smoking habits may occur among patients with type 2 diabetes who intend to stop smoking, leading to prolonged abstinence from smoking,” wrote study author Riccardo Polosa, MD, PhD, Centro per la Prevenzione e Cura del Tabagismo, Azienda Ospedaliero Universitaria Policlinico-V. Emanuele dell’Università di Catania.
Prior observations have noted that stopping smoking has been associated with reduced mortality risk in patients with T2D, so providing counseling on quitting smoking should be a component of routine diabetes care. Varenicline has been shown to be efficacious in smokers with cardiovascular disease (CVD), chronic obstructive pulmonary disease (COPD), or depressive disorders, but it has not been studied in smokers with diabetes.
The multicenter, double-blind, placebo-controlled RCT included patients from 6 outpatient clinics in 5 hospitals in Italy. Investigators screened eligibility of patients with T2D who were receiving treatment in an outpatient diabetic clinic, smoking ≥10 cigarettes a day, and intending to quit smoking.
It consisted of a 12-week treatment phase followed by a 40-week follow-up, non-treatment phase, with intention-to-treat analysis was performed from December 2020 - April 2021. The primary efficacy endpoint was the continuous abstinence rate (CAR) at weeks 9 to 24.
A total of 300 patients were randomized to either varenicline (n = 150) or placebo (n = 150) treatment, with a mean age of 57.4 years. There were 117 men [78.0%] in the varenicline group and 119 men [79.3%] in the placebo group. Investigators noted the baseline characteristics were comparable between groups and treatment discontinuation was frequent (approximately 30%).
Data show the CAR at weeks 9 to 24 were significantly higher for the varenicline group versus the placebo group (24.0% vs 6.0%; odds ratio [OR], 4.95; 95% CI, 2.29 - 10.70; P <.001).
Moreover, the CARs at weeks 9 to 12 (31.3% vs 7.3%; OR, 5.77; 95% CI, 2.85 - 11.66; P <.001) and weeks 9 to 52 (18.7% vs 5.3%; OR, 4.07; 95% CI, 1.79 - 9.27; P <.001) were also significantly higher for varenclinice, as were the 7-day point prevalence of abstinence at weeks 12, 24, and 52.
Few adverse events were reported (n = 380) and only a few withdrawals from the study occurred as a result (n = 11), according to the investigators. The most frequent adverse events occurring in the varenicline group compared with the placebo group were nausea (41 [27.3%] vs 17 [11.4%], insomnia (29 [19.4%] vs 19 [12.7%], abnormal dreams (19 [12.7%] vs 5 [3.4%]), anxiety (17 [11.4%] vs 11 [7.3%]), and irritability (14 [9.4%] vs 8 [5.4%]).
“These findings support the notion that patients with type 2 diabetes who smoke have greater difficulty quitting when provided with only cessation counseling,” Polosa concluded.
The study, “Efficacy and Safety for Varenicline for Smoking Cessation in Patients with Type 2 Diabetes: A Randomized Clinical Trials,” was published in JAMA Network Open.