Richard Nesto1, Randi Fain2, Yuhan Li3, William Shanahan4. 1. a Department of Cardiovascular Medicine , Lahey Hospital & Medical Center , Burlington , MA , USA. 2. b Medical & Scientific Affairs , Eisai Inc ., Woodcliff Lake , NJ , USA. 3. c Formerly of Eisai Inc ., Woodcliff Lake , NJ , USA. 4. d Preclinical and Clinical Drug Development, Arena Pharmaceuticals, Inc ., San Diego , CA , USA.
Abstract
OBJECTIVES:Lorcaserin is a selective 5-HT2C (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).
RCT Entities:
OBJECTIVES:Lorcaserin is a selective 5-HT2C (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).
Entities:
Keywords:
Obesity; anti-obesity agents; anti-obesity drugs; diabetes mellitus, type 2; prediabetic state
Authors: Maria Lazo-Porras; Antonio Bernabe-Ortiz; Andrea Ruiz-Alejos; Liam Smeeth; Robert H Gilman; William Checkley; German Málaga; J Jaime Miranda Journal: Diabetes Res Clin Pract Date: 2019-08-26 Impact factor: 5.602
Authors: Luke K Burke; Emmanuel Ogunnowo-Bada; Teodora Georgescu; Claudia Cristiano; Pablo B Martinez de Morentin; Lourdes Valencia Torres; Giuseppe D'Agostino; Christine Riches; Nicholas Heeley; Yue Ruan; Marcelo Rubinstein; Malcolm J Low; Martin G Myers; Justin J Rochford; Mark L Evans; Lora K Heisler Journal: Mol Metab Date: 2017-07-21 Impact factor: 7.422