Randomized Placebo‐Controlled Clinical Trial of Lorcaserin for Weight Loss in Type 2 Diabetes Mellitus: The BLOOM‐DM Study

Abstract

Mellitus) study evaluated efficacy and safety of lorcaserin for weight loss in patients with type 2 diabetes. Secondary objectives included evaluations of glycemic control, lipids, blood pressure, and quality of life. This 1-year, randomized, placebo-controlled trial enrolled 604 patients 1:1:1 to placebo, lorcaserin 10 mg once daily (QD) or lorcaserin 10 mg twice daily (BID). Patients were treated with metformin, a sulfonylurea (SFU) or both; had glycated hemoglobin (HbA 1c ) 7-10%; were 18-65 years old; and had BMI 27-45 kg/m 2 . Patients received diet and exercise counseling. Safety monitoring included serial echocardiograms. Mean (± SD) age was 52.7 ± 8.7; 54.2% were women; 60.5% were white, 20.9% were African American, and 13.8% were Hispanic. Mean (± SD) weight was 103.6 ± 17.8 kg; BMI was 36.0 ± 4.5 kg/m 2 . Most patients (91.7%) took metformin; 50.2% took a SFU. More patients lost ≥5% body weight with lorcaserin BID (37.5%; P < 0.001) or lorcaserin QD (44.7%; P < 0.001) vs. placebo (16.1%; modified intent to treat (MITT)/last observation carried forward (LOCF)). Least square mean (± SEM) weight change was −4.5 ± 0.35% with lorcaserin BID and −5.0 ± 0.5% with lorcaserin QD vs. −1.5 ± 0.36% with placebo (P < 0.001 for each). HbA 1c decreased 0.9 ± 0.06 with lorcaserin BID, 1.0 ± 0.09 with lorcaserin QD, and 0.4 ± 0.06 with placebo (P < 0.001 for each); fasting glucose decreased 27.4 ± 2.5 mg/dl, −28.4 ± 3.8 mg/dl, and 11.9 ± 2.5 mg/dl, respectively (P < 0.001 for each). Symptomatic hypoglycemia occurred in 7.4% of patients on lorcaserin BID, 10.5% on lorcaserin QD, and 6.3% on placebo. Common adverse events were headache, back pain, nasopharyngitis, and nausea. Lorcaserin was associated with significant weight loss and improvement in glycemic control in patients with type 2 diabetes.Obesity ( articles intervention and PreventionThe BLOOM-DM (Behavioral Modification and Lorcaserin for Obesity and Overweight Management in Diabetes Mellitus) study had as its main objective the evaluation of the efficacy and safety of lorcaserin for weight loss in adults with type 2 diabetes treated with metformin and/or a sulfonylurea (SFU). Secondarily, the impact of lorcaserin on glycemic control was evaluated. Methods and Procedures study designThe study was conducted at 58 academic and private research sites in the United States between 27 December 2007 and 9 August 2010 under the guidelines of the Declaration of Helsinki. Institutional review boards reviewed and approved the protocol for each research site. All patients provided written informed consent before participation in the trial.The overall objective of the 1-year, randomized, double-blind, placebo-controlled trial was to evaluate the safety and efficacy of lorcaserin for weight loss in patients with type 2 diabetes when administered in conjunction with a lifestyle modification program. The prespecified coprimary endpoints were: (i) the proportion of patients achieving ≥5% reduction in baseline body weight at the end of 1 year, (ii) change in weight, and (iii) t...

Weight Management in Type 2 Diabetes: Current and Emerging Approaches to Treatment

“…In overweight or obese patients without diabetes, lorcaserin treatment provided a 25.81% reduction from baseline body weight after 1 year versus 22.16% with placebo (P , 0.001) (79). Lorcaserin is a selective small-molecule agonist of the 5-hydroxytryptamine 2C serotonin receptor (5HT2C), which regulates mechanisms related to satiety, ingestive behavior, glucose tolerance, and hepatic insulin sensitivity (71). Unlike previously available antiobesity agents, lorcaserin has a low affinity for the 5HT2B receptor subtype, whose activation has been linked to the development of valvular heart disease (78).…”

“…Unlike previously available antiobesity agents, lorcaserin has a low affinity for the 5HT2B receptor subtype, whose activation has been linked to the development of valvular heart disease (78). In a phase 3 study of subjects with type 2 diabetes treated with metformin or a sulfonylurea, lorcaserin treatment resulted in mean weight changes of 24.5% (twice daily) and 25.0% (once daily) compared with 21.5% with placebo at week 52 (71). Participants also showed a significant improvement in glycemic control: HbA 1c decreased 20.9% and 21.0% from baseline with lorcaserin twice daily and once daily, respectively, versus 20.4% with placebo (P , 0.001 for each lorcaserin dose).…”

Weight maintenance: challenges, tools and strategies for primary care physicians

“…These effects help patients sustain weight loss and help them comply with calorie‐reduced diets. Clinical trials have shown that the addition of pharmacotherapy to lifestyle interventions promotes greater weight loss and sustains weight loss for a longer period of time than lifestyle interventions alone 13, 96, 97, 99, 100, 116. The available data, while only encompassing ≤2 years of follow‐up, demonstrate that these pharmacotherapies sustain weight loss while patients randomized to lifestyle interventions plus placebo are regaining weight (Table 1) 13, 96, 97, 99, 100, 116.…”

Modern Obesity Pharmacotherapy: Weighing Cardiovascular Risk and Benefit

“…34 Among patients with DM in the BLOOM-DM trial, lorcaserin improved HbA 1c more than placebo (−0.8 vs −0.3). 33 Bupropion Plus Naltrexone Bupropion plus naltrexone, which has not been approved by the FDA at the time of this writing, has demonstrated weight-loss efficacy in 4 phase III clinical trials (Table 1). This combination pill has been tested in 2 dosages, 360 mg of bupropion together with either 16 mg or 32 mg of naltrexone.…”