Varenicline and Lorcaserin for Smoking Cessation and Weight Gain Prevention: A Randomized Clinical Trial
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 I...
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| Format: | Article |
| Language: | English |
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Elsevier
2022-10-01
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| Series: | Mayo Clinic Proceedings: Innovations, Quality & Outcomes |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2542454822000042 |
| _version_ | 1817969267684933632 |
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| author | Ryan T. Hurt, MD, PhD Ivana T. Croghan, PhD Darrell R. Schroeder, MS Doo-Sup Choi, PhD Karen Fischer, MA Shawn Fokken, CCRP Jon O. Ebbert, MD |
| author_facet | Ryan T. Hurt, MD, PhD Ivana T. Croghan, PhD Darrell R. Schroeder, MS Doo-Sup Choi, PhD Karen Fischer, MA Shawn Fokken, CCRP Jon O. Ebbert, MD |
| author_sort | Ryan T. Hurt, MD, PhD |
| collection | DOAJ |
| description | 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 |
| first_indexed | 2024-04-13T20:19:07Z |
| format | Article |
| id | doaj.art-7368643706dc49e6b5d71b7cd8c29ce4 |
| institution | Directory Open Access Journal |
| issn | 2542-4548 |
| language | English |
| last_indexed | 2024-04-13T20:19:07Z |
| publishDate | 2022-10-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Mayo Clinic Proceedings: Innovations, Quality & Outcomes |
| spelling | doaj.art-7368643706dc49e6b5d71b7cd8c29ce42022-12-22T02:31:36ZengElsevierMayo Clinic Proceedings: Innovations, Quality & Outcomes2542-45482022-10-0165465474Varenicline and Lorcaserin for Smoking Cessation and Weight Gain Prevention: A Randomized Clinical TrialRyan T. Hurt, MD, PhD0Ivana T. Croghan, PhD1Darrell R. Schroeder, MS2Doo-Sup Choi, PhD3Karen Fischer, MA4Shawn Fokken, CCRP5Jon O. Ebbert, MD6Division of General Internal Medicine, Department of Medicine, Mayo Clinic, Rochester, MN; Nicotine Dependence Research Program, Mayo Clinic, Rochester, MN; Correspondence: Address to Ryan T. Hurt, MD, PhD, Division of General Internal Medicine, Department of Medicine, Mayo Clinic, 200 First St SW, Rochester, MN.Division of General Internal Medicine, Department of Medicine, Mayo Clinic, Rochester, MN; Division of Community Internal Medicine, Department of Medicine, Mayo Clinic, Rochester, MN; Division of Clinical Trials and Biostatistics, Department of Qualitative Health Sciences, Mayo Clinic, Rochester, MN; Division of Epidemiology, Department of Qualitative Health Sciences, Mayo Clinic, Rochester, MN; Clinical Research Office, Department of Medicine, Mayo Clinic, Rochester, MNDivision of Clinical Trials and Biostatistics, Department of Qualitative Health Sciences, Mayo Clinic, Rochester, MN; Nicotine Dependence Research Program, Mayo Clinic, Rochester, MN; Clinical Research Office, Department of Medicine, Mayo Clinic, Rochester, MNDepartment of Molecular Pharmacology and Experimental Therapeutics, Mayo Clinic, Rochester, MNDivision of Clinical Trials and Biostatistics, Department of Qualitative Health Sciences, Mayo Clinic, Rochester, MN; Clinical Research Office, Department of Medicine, Mayo Clinic, Rochester, MNDivision of General Internal Medicine, Department of Medicine, Mayo Clinic, Rochester, MN; Clinical Research Office, Department of Medicine, Mayo Clinic, Rochester, MNDivision of Community Internal Medicine, Department of Medicine, Mayo Clinic, Rochester, MN; Nicotine Dependence Research Program, Mayo Clinic, Rochester, MNObjective: 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: NCT02412631http://www.sciencedirect.com/science/article/pii/S2542454822000042 |
| spellingShingle | Ryan T. Hurt, MD, PhD Ivana T. Croghan, PhD Darrell R. Schroeder, MS Doo-Sup Choi, PhD Karen Fischer, MA Shawn Fokken, CCRP Jon O. Ebbert, MD Varenicline and Lorcaserin for Smoking Cessation and Weight Gain Prevention: A Randomized Clinical Trial Mayo Clinic Proceedings: Innovations, Quality & Outcomes |
| title | Varenicline and Lorcaserin for Smoking Cessation and Weight Gain Prevention: A Randomized Clinical Trial |
| title_full | Varenicline and Lorcaserin for Smoking Cessation and Weight Gain Prevention: A Randomized Clinical Trial |
| title_fullStr | Varenicline and Lorcaserin for Smoking Cessation and Weight Gain Prevention: A Randomized Clinical Trial |
| title_full_unstemmed | Varenicline and Lorcaserin for Smoking Cessation and Weight Gain Prevention: A Randomized Clinical Trial |
| title_short | Varenicline and Lorcaserin for Smoking Cessation and Weight Gain Prevention: A Randomized Clinical Trial |
| title_sort | varenicline and lorcaserin for smoking cessation and weight gain prevention a randomized clinical trial |
| url | http://www.sciencedirect.com/science/article/pii/S2542454822000042 |
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