ABSTRACT
Objectives: Treatment guidelines for type 2 diabetes mellitus (T2DM) suggest weight loss as a means to maintain glycemic control. Lorcaserin has been approved for chronic weight management in the United States as an adjunct to a reduced-calorie diet and exercise, and the previous phase 3 Behavioral Modification and Lorcaserin for Obesity and Overweight Management in Diabetes Mellitus (BLOOM-DM) study has shown that, in addition to weight loss, lorcaserin is associated with improvements in glycemic parameters. In this post hoc analysis of the BLOOM-DM trial, the relationship between responder status (patients achieving ≥5% weight loss at Week 52) and glycemic and cardiometabolic parameters is evaluated.
Methods: Data are presented for patients receiving lorcaserin 10 mg twice daily or placebo for 52 weeks.
Results: More than twice as many patients receiving lorcaserin plus diet and exercise counseling were classified as Week 52 responders compared to those receiving diet and exercise counseling alone (37.5% vs. 16.1%, respectively; p < 0.001), and lorcaserin Week 52 responders had greater improvements vs. placebo Week 52 responders in FPG (−38.1 mg/dL vs. −26.0 mg/dL) and HbA1c (−1.3% vs. −1.0%). Furthermore, more lorcaserin-treated Week 52 responders decreased the number of concomitant oral antidiabetic medications (OADs) used, and fewer increased the number of OADs used, compared to placebo. Unexpectedly, lorcaserin Week 52 nonresponders also had substantial reductions in glycemic levels, despite very modest weight loss.
Conclusions: These data support lorcaserin use in overweight and obese patients with T2DM to promote weight loss and facilitate glycemic control.
Clinical trial registration: www.clinicaltrials.gov identifier is NCT00603291
Acknowledgments
We gratefully acknowledge the scientific guidance of William Soliman and Yuhan Li.
Declaration of interest
The BLOOM-DM study was funded by Arena Pharmaceuticals, Inc., and this post hoc analysis was funded by Eisai Inc. Editorial support was provided by Medicus International New York and Imprint Publication Science, New York, NY, USA, with funding from Eisai Inc. X Pi-Sunyer is on Scientific Advisory Committees for Lilly, Novo Nordisk, Vivus, Eisai, and Zafgen. WT Garvey has served on advisory boards for Eisai Inc., Novo Nordisk, Daiichi-Sankyo, Liposcience, Vivus, Takeda, Janssen, Boehringer Ingelheim, and AstraZeneca; and has conducted research for Eisai Inc., Merck, Sanofi, AstraZeneca, Weight Watchers, Pfizer, Lexicon, Elcelyx Therapeutics, and Novo Nordisk. T Ma and R Fain are former employees of Eisai Inc. W Shanahan is a former employee of Arena Pharmaceuticals, Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.