Varenicline and nicotine patch combo no better than varenicline alone for Smoking cessation: JAMA

Smoking cessation medications are popularly used in health care to help smokers adapt a better life. Research in the past suggests that combining varenicline with the nicotine patch, may increase cessation effectiveness.

Dr Timothy B. Baker, PhD and team have found in a randomized clinical trial that among adults smoking five cigarettes per day or more, there were no significant differences in seven-day abstinence at 52 weeks among those treated with combined varenicline plus nicotine patch therapy compared with varenicline alone or among those treated for 24 weeks compared with 12 weeks.

The findings of this randomized clinical trial don't support the use of combined therapy or of extended treatment duration.

These findings are published in JAMA Network.

The objective of the study was to compare combinations of varenicline plus the nicotine or placebo patch vs combinations used for either 12 weeks (standard duration) or 24 weeks (extended duration).

The study was a double-blinded, 2 × 2 factorial randomized clinical trial conducted from November 11, 2017, to July 9, 2020, at 1 research clinic in Madison, Wisconsin, and at 1 clinic in Milwaukee, Wisconsin. 5836 adults were asked to participate in the study, 1251 who smoked 5 cigarettes/d or more were randomized. All participants received cessation counseling and were randomized to 1 of 4 medication groups: varenicline monotherapy for 12 weeks (n = 315), varenicline plus nicotine patch for 12 weeks (n = 314), varenicline monotherapy for 24 weeks (n = 311), or varenicline plus nicotine patch for 24 weeks (n = 311). The primary outcome was carbon monoxide confirmed self-reported 7-day point prevalence abstinence at 52 weeks.

The results of the study were

• A total of 1251 patients were randomized (mean [SD] age, 49.1 [11.9] years; 675 [54.0%] women), 751 (60.0%) completed treatment and 881 (70.4%) provided final follow-up.

• the primary outcome, showed no significant interaction between the 2 treatment factors of medication type and medication duration (odds ratio [OR], 1.03 [95% CI, 0.91 to 1.17]; P = .66).

• For patients randomized to 24-week vs 12-week treatment duration, the primary outcome was seen in 24.8% (154/622) vs 24.3% (153/629), respectively (risk difference, −0.4% [95% CI, −5.2% to 4.3%]; OR, 1.01 [95% CI, 0.89 to 1.15]).

• In patients randomized to varenicline combination therapy vs varenicline monotherapy, the primary outcome was seen in 24.3% (152/625) vs 24.8% (155/626), respectively (risk difference, 0.4% [95% CI, −4.3% to 5.2%]; OR, 0.99 [95% CI, 0.87 to 1.12]).

• Nausea occurrence ranged from 24.0% to 30.9% and insomnia occurrence ranged from 24.4% to 30.5% across the 4 groups.

Dr Baker and team conveyed that the study suggested adults who smoked 5cigarretes/day or more showed no significant difference in 7-day point prevalence abstinence at 52 weeks among those treated with combined varenicline plus nicotine patch therapy vs varenicline monotherapy, or among those treated for 24 weeks vs 12 weeks. These findings did not support the use of combined therapy or of extended treatment duration.

Reference : 

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