Evidence of effective smoking cessation interventions in patients with diabetes is limited. The unique behavioral and metabolic characteristics of smokers with type 2 diabetes to justify the recent trial of the smoking cessation drug varenicline.
A randomized clinical trial in JAMA Network involving 300 patients with type 2 diabetes who smoked, found that varenicline was efficacious at weeks 12, 24, and 52 of the trial compared with placebo. Nausea, insomnia, abnormal dreams, anxiety, and irritability were reported at higher frequency among patients in the varenicline vs placebo group. No treatment-related serious adverse events were noted.
The multicenter, double-blind, placebo-controlled randomized clinical trial recruited patients from 6 outpatient clinics in 5 hospitals in Catania, Italy. Patients with type 2 diabetes, who were smoking at least 10 cigarettes a day, and who intended to quit smoking were screened for eligibility. Eligible patients were randomized to either varenicline or placebo treatment. The trial consisted of a 12-week treatment phase followed by a 40-week follow-up, nontreatment phase. The primary efficacy end point of the study was the continuous abstinence rate (CAR) at weeks 9 to 24.
The CAR at weeks 9 to 24 was significantly higher for the varenicline than placebo group (24.0% vs 6.0%; 4.95). The CARs at weeks 9 to 12 (31.3% vs 7.3%) and weeks 9 to 52 (18.7% vs 5.3%) as well as the 7-day point prevalence of abstinence at weeks 12, 24, and 52 were also significantly higher for the varenicline vs placebo group.
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%]). Serious adverse events were infrequent in both groups and not treatment-related.
Results of this trial showed that inclusion of varenicline in a smoking cessation program is efficacious in achieving long-term abstinence without serious adverse event Varenicline should be routinely used in diabetes education programs to help patients with type 2 diabetes stop smoking.
Reference:
Russo C, Walicka M, Caponnetto P, et al. Efficacy and Safety of Varenicline for Smoking Cessation in Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2022;5(6):e2217709. doi:10.1001/jamanetworkopen.2022.17709.
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