Evaluation of lorcaserin on progression of prediabetes to type 2 diabetes and reversion to euglycemia

ABSTRACT

Objectives: Lorcaserin is a selective 5-HT_2C (5-hydroxytryptamine 2C) receptor agonist indicated for weight management. Here, we assess the impact of lorcaserin on progression from prediabetes to type 2 diabetes (T2D) and on reversion from prediabetes to euglycemia.

Methods: This is a post hoc analysis of pooled data from two Phase 3 studies, BLOOM and BLOSSOM (N = 6136), evaluating the impact of lorcaserin on weight and glycemic parameters over 52 weeks in the subpopulation of obese/overweight subjects with prediabetes, alternately defined by fasting plasma glucose (FPG) 100–125 mg/dl or glycated hemoglobin (HbA1c) 5.7–6.4% at baseline.

Results: At Week 52, in the subpopulation with prediabetes, nearly twice as many lorcaserin-treated subjects achieved ≥5% weight loss versus placebo (HbA1c: 55.6% vs. 27.5%, p < 0.001; FPG: 52.8% vs. 28.8%, p < 0.001), and a significantly lower percentage of lorcaserin-treated subjects progressed to T2D versus placebo based on HbA1c (lorcaserin 3.2%, placebo 5.0%, p = 0.032) but not FPG (lorcaserin 1.6%, placebo 2.6%, p = 0.227). A significantly greater proportion of lorcaserin-treated subjects versus placebo also reverted to euglycemia based on both HbA1c (lorcaserin 40%, placebo 29.5%, p < 0.001) and FPG (lorcaserin 52.4%, placebo 46.5%, p = 0.047).

Conclusion: In subjects with prediabetes, lorcaserin may contribute to weight loss and improve glycemic parameters, and thus may help with preventing progression to T2D and promoting reversion to euglycemia.

Clinical trial registration: www.clinicaltrials.gov identifiers are NCT00395135 (BLOOM) and NCT00603902 (BLOSSOM)

KEYWORDS:

• Obesity
• anti-obesity drugs
• prediabetic state
• diabetes mellitus, type 2
• anti-obesity agents

Acknowledgments

We gratefully acknowledge the scientific guidance of William Soliman. Some of these data were previously presented at the American Diabetes Association 74th Scientific Sessions, San Francisco, California; June 13-17, 2014.

Financial and competing interests disclosure

Editorial support was provided by Imprint Publication Science, New York, NY, USA, and was funded by Eisai Inc. These studies were funded by Arena Pharmaceuticals, Inc., and this post hoc analysis was funded by Eisai Inc. R Fain is an employee of Eisai Inc. Y Li is a former employee of Eisai Inc. W Shanahan is an 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.