Pharmacokinetic drug evaluation of extended release lorcaserin for the treatment of obesity

References

• Ogden CL, Carroll MD, Fryar CD, et al. Prevalence of obesity among adults and youth: United States, 2011-2014. NCHS Data Brief. 2015;219:1–8.
   Google Scholar
• Garvey WT, Mechanick JI, Brett EM, et al. American Association of Clinical Endocrinologists and American College of Endocrinology comprehensive clinical practice guidelines for medical care of patients with obesity. Endocr Pract. 2016;22(Suppl 3):1–203.
   PubMed Web of Science ®Google Scholar
• Cawley J, Meyerhoefer C. The medical care costs of obesity: an instrumental variables approach. J Health Econ. 2012;31:219–230.
   PubMed Web of Science ®Google Scholar
• Jensen MD, Ryan DH, Apovian CM, et al. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 2014;129:S102–138.
   PubMed Web of Science ®Google Scholar
• Mechanick JI, Youdim A, Jones DB, et al. Clinical practice guidelines for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient–2013 update: cosponsored by American Association of Clinical Endocrinologists, the Obesity Society, and American Society for Metabolic & Bariatric Surgery. Endocr Pract. 2013;19:337–372.
   PubMed Web of Science ®Google Scholar
• Apovian CM, Aronne LJ, Bessesen DH, et al. Pharmacological management of obesity: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2015;100:342–362.
   PubMed Web of Science ®Google Scholar
• Khera R, Murad MH, Chandar AK, et al. Association of pharmacological treatments for obesity with weight loss and adverse events: a systematic review and meta-analysis. JAMA. 2016;315:2424–2434.
   PubMed Web of Science ®Google Scholar
• Martinussen C, Bojsen-Moller KN, Svane MS, et al. Emerging drugs for the treatment of obesity. Expert Opin Emerg Drugs. 2016;22:87–99.
   PubMed Web of Science ®Google Scholar
• Saini SD, Schoenfeld P, Kaulback K, et al. Effect of medication dosing frequency on adherence in chronic diseases. Am J Manag Care. 2009;15:e22–e33.
   PubMed Web of Science ®Google Scholar
• Smith J. Summary review for regulatory action: belviq XR (lorcaserin hydrochloride). Silver Springs, MD: U. S. Food and Drug Administration. 2016 [cited 2017 Jan 23]. Available from. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208524Orig1s000SumR.pdf
   Google Scholar
• Morton GJ, Cummings DE, Baskin DG, et al. Central nervous system control of food intake and body weight. Nature. 2006;443:289–295.
   PubMed Web of Science ®Google Scholar
• Vickers SP, Dourish CT, Kennett GA. Evidence that hypophagia induced by d-fenfluramine and d-norfenfluramine in the rat is mediated by 5-HT2C receptors. Neuropharmacology. 2001;41:200–209.
   PubMed Web of Science ®Google Scholar
• Rothman RB, Baumann MH, Savage JE, et al. Evidence for possible involvement of 5-HT(2B) receptors in the cardiac valvulopathy associated with fenfluramine and other serotonergic medications. Circulation. 2000;102:2836–2841.
   PubMed Web of Science ®Google Scholar
• Nichols DE. Hallucinogens. Pharmacol Ther. 2004;101:131–181.
   PubMed Web of Science ®Google Scholar
• FDA briefing document, NDA 22529, lorcaserin hydrochloride tablets, 10mg. Silver Spring, MD: U.S. Food and Drug Administration; 2012. [cited 2017 Jan 3]. Available from: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM303198.pdf
   Google Scholar
• Shram MJ, Schoedel KA, Bartlett C, et al. Evaluation of the abuse potential of lorcaserin, a serotonin 2C (5-HT2C) receptor agonist, in recreational polydrug users. Clin Pharmacol Ther. 2011;89:683–692.
   PubMed Web of Science ®Google Scholar
• Lam DD, Przydzial MJ, Ridley SH, et al. Serotonin 5-HT2C receptor agonist promotes hypophagia via downstream activation of melanocortin 4 receptors. Endocrinology. 2008;149:1323–1328.
   PubMed Web of Science ®Google Scholar
• Heisler LK, Jobst EE, Sutton GM, et al. Serotonin reciprocally regulates melanocortin neurons to modulate food intake. Neuron. 2006;51:239–249.
   PubMed Web of Science ®Google Scholar
• Martin CK, Redman LM, Zhang J, et al. Lorcaserin, a 5-HT(2C) receptor agonist, reduces body weight by decreasing energy intake without influencing energy expenditure. J Clin Endocrinol Metab. 2011;96:837–845.
   PubMed Web of Science ®Google Scholar
• Farr OM, Upadhyay J, Gavrieli A, et al. Lorcaserin administration decreases activation of brain centers in response to food cues and these emotion- and salience-related changes correlate with weight loss effects: a 4-week-long randomized, placebo-controlled, double-blind clinical trial. Diabetes. 2016;65:2943–2953.
   PubMed Web of Science ®Google Scholar
• Christopher R, Morgan M, Ferry J, et al. Single- and multiple-dose pharmacokinetics of a lorcaserin extended-release tablet. Clin Ther. 2016;38:2227–2238 e4.
   PubMed Web of Science ®Google Scholar
• Guidance for industry: bioequivalence studies with pharmacokinetic endpoints for drugs submitted under an ANDA [Internet]. Silver Springs, MD: Food and Drug Administration; 2013. [cited 2017 Feb 24]. Available from: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM377465.pdf
   Google Scholar
• Belviq XR (Package Insert). Woodcliff Lake, NJ: Eisai Inc.; 2016 .
   Google Scholar
• Solas M, Milagro FI, Martinez-Urbistondo D, et al. Precision obesity treatments including pharmacogenetic and nutrigenetic approaches. Trends Pharmacol Sci. 2016;37:575–593.
   PubMed Web of Science ®Google Scholar
• de Luca V, Mueller DJ, de Bartolomeis A, et al. Association of the HTR2C gene and antipsychotic induced weight gain: a meta-analysis. Int J Neuropsychopharmacol. 2007;10:697–704.
   PubMed Web of Science ®Google Scholar
• Smith SR, Weissman NJ, Anderson CM, et al. Multicenter, placebo-controlled trial of lorcaserin for weight management. N Engl J Med. 2010;363:245–256.
   PubMed Web of Science ®Google Scholar
• Fidler MC, Sanchez M, Raether B, et al. A one-year randomized trial of lorcaserin for weight loss in obese and overweight adults: the BLOSSOM trial. J Clin Endocrinol Metab. 2011;96:3067–3077.
   PubMed Web of Science ®Google Scholar
• O’Neil PM, Smith SR, Weissman NJ, et al. Randomized placebo-controlled clinical trial of lorcaserin for weight loss in type 2 diabetes mellitus: the BLOOM-DM study. Obesity (Silver Spring). 2012;20:1426–1436.
   PubMed Web of Science ®Google Scholar
• Berlie HD, Hurren KM. Evaluation of lorcaserin for the treatment of obesity. Expert Opin Drug Metab Toxicol. 2013;9:1053–1059.
   PubMed Web of Science ®Google Scholar
• Croghan IT, Ebbert JO, Schroeder DR, et al. A randomized, open-label pilot of the combination of low-level laser therapy and lorcaserin for weight loss. BMC Obes. 2016;3:42.
   PubMedGoogle Scholar
• Shanahan WR, Rose JE, Glicklich A, et al. Lorcaserin for smoking cessation and associated weight gain: a randomized 12-week clinical trial. Nicotine Tob Res. 2016 [cited 2017 Feb 3];8. DOI:10.1093/ntr/ntw301
   Web of Science ®Google Scholar
• Weissman NJ, Sanchez M, Koch GG, et al. Echocardiographic assessment of cardiac valvular regurgitation with lorcaserin from analysis of 3 phase 3 clinical trials. Circ Cardiovasc Imaging. 2013;6:560–567.
   PubMed Web of Science ®Google Scholar
• Weissman NJ, Smith SR, Fain R, et al. Effects of lorcaserin on pre-existing valvulopathy: a pooled analysis of phase 3 trials. Obesity (Silver Spring). 2017;25:39–44.
   PubMed Web of Science ®Google Scholar
• Nguyen CT, Zhou S, Shanahan W, et al. Lorcaserin in obese and overweight patients taking prohibited serotonergic agents: a retrospective analysis. Clin Ther. 2016;38:1498–1509.
   PubMed Web of Science ®Google Scholar
• Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016;375:311–322.
   PubMed Web of Science ®Google Scholar