Combining varenicline with nicotine patch therapy was not associated with greater tobacco smoking cessation than varencline monotherapy at up to 52 weeks in adults who smoked 5 or more cigarettes per day, according to research findings published in JAMA.
The double-blind study included 1251 adults (mean age, 49.1 years; 54.0% women) who smoked 5 or more cigarettes per day during the last 6 months of enrollment. Participants underwent cessation counseling and were randomly assigned to receive either varenicline monotherapy for a total of 12 weeks (n=315), a 12-week course of combination therapy comprising varenicline plus nicotine patch (n=314), varenicline monotherapy for 24 weeks (n=311), or the same combination regimen of varenicline plus nicotine patch for 24 weeks (n=311).
Researchers evaluated the primary outcome of carbon monoxide-confirmed self-reported 7-day point prevalence abstinence at 52 weeks. The investigators found no significant interaction between medication type and medication duration (odds ratio [OR], 1.03; 95% CI, 0.91-1.17; P =.66).
No significant difference was found between the patients randomized to the 24-week vs 12-week treatment durations in terms of the primary outcome (24.8% vs 24.3%, respectively; risk difference, −0.4%; 95% CI, −5.2% to 4.3%; OR, 1.01; 95% CI, 0.89-1.15).
In addition, there was no difference for the primary outcome between patients randomly assigned to varenicline combination therapy vs varenicline alone (24.3% vs 24.8%, respectively; risk difference, 0.4%; 95% CI, −4.3% to 5.2%; OR, 0.99; 95% CI, 0.87-1.12).
Regarding adverse events, the researchers reported that nausea occurred between 24.0% and 30.9% of patients. The incidences of insomnia ranged between 24.4% to 30.5% across the 4 treatment groups.
The investigators noted that up to 23% of patients in the study were lost to the long-term follow-up, while 9% of patients discontinued the study. According to the researchers, the loss of such data may “have reduced the accuracy of the effect sizes obtained and perhaps contributed to the failure to detect predicted group differences.”
The researchers concluded that their “findings do not support the use of combined therapy or of extended treatment duration.”
Baker TB, Piper ME, Smith SS, Bolt DM, Stein JH, Fiore MC. Effects of combined varenicline with nicotine patch and of extended treatment duration on smoking cessation: A randomized clinical trial. JAMA. 2021;326(15):1485-1493. doi:10.1001/jama.2021.15333