Varenicline and Lorcaserin for Smoking Cessation and Weight Gain Prevention: A Randomized Clinical Trial

Ryan T Hurt, Ivana T Croghan, Darrell R Schroeder, Doo-Sup Choi, Karen Fischer, Shawn Fokken, Jon O Ebbert, Ryan T Hurt, Ivana T Croghan, Darrell R Schroeder, Doo-Sup Choi, Karen Fischer, Shawn Fokken, Jon O Ebbert

Abstract

Objective: To evaluate the safety and effectiveness of combination varenicline with lorcaserin in preventing post-cessation weight gain.

Participants and methods: We conducted a randomized (varenicline for 12 weeks + lorcaserin for 24 weeks vs varenicline for 12 weeks + placebo for 24 weeks) phase II clinical study to obtain preliminary data on the safety and effectiveness of combination varenicline and lorcaserin in preventing post-cessation weight gain in overweight and obese smokers. Eighty-four overweight and obese (body mass index [BMI], 27-40 kg/m2) cigarette smokers were randomized before study termination (lorcaserin: n=40; placebo: n=44). The primary outcomes were weight and waist circumference (WC) changes at 12 and 24 weeks in smokers meeting criteria for prolonged smoking abstinence.

Results: Thirty-nine participants met criteria for prolonged smoking abstinence at 12 weeks (46%) and 21 at 24 weeks (25%). No significant treatment effect was observed at 12 weeks with lorcaserin compared with placebo (weight difference, -0.7 kg; 90% CI, -2.6 to 1.1 kg; P=.51; WC difference, -1.9 cm; 90% CI, -4.2 to 0.5 cm; P=.18; or BMI difference, -0.4 kg/m2; 90% CI, -1.1 to 0.3 kg/m2; P=.33). No significant treatment effect was observed between lorcaserin at 24 weeks compared with placebo (weight, 1.4 kg; 90% CI, -3.8 to 6.7 kg; P=.65; WC, -0.9 cm; 90% CI, -5.8 to 4.0 cm; P=.75; or BMI 0.29 kg/m2; 90% CI, -1.5 to 2.12 kg/m2; P=.79).

Conclusion: Weight gain and WC increases after prolonged smoking abstinence were not reduced using combination varenicline and lorcaserin. The results do not support further research in the obese and weight-concerned smoking population using lorcaserin or similar drugs.

Trial registration: clinicaltrials.gov Identifier: NCT02412631.

Keywords: BMI, body mass index; CAMELLIA-TIMI 61 trial, Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients – Thrombolysis in Myocardial Infarction 61, trial; DM, diabetes mellitus; FDA, Food and Drug Administration; GLP-1 RA, glucagon like peptide-1 receptor agonist; NRT, nicotine replacement therapy; OR, odds ratio; PCWG, post-cessation weight gain; WC, waist circumference.

© 2022 Published by Elsevier Inc on behalf of Mayo Foundation for Medical Education and Research.

Figures

Figure
Figure
Participant flow in the study. CPD, cigarette per day; FDA, Food and Drug Administration.

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Source: PubMed

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