MedStar Authors catalog › Details for: Randomized placebo-controlled clinical trial of lorcaserin for weight loss in type 2 diabetes mellitus: the BLOOM-DM study.
Randomized placebo-controlled clinical trial of lorcaserin for weight loss in type 2 diabetes mellitus: the BLOOM-DM study. Journal: Obesity (Silver Spring, Md.) .ISSN: 1930-7381.UI/PMID: 22421927.Subject(s): Adult | Aged | Anti-Obesity Agents/tu [Therapeutic Use] | Benzazepines/pd [Pharmacology] | *Benzazepines/tu [Therapeutic Use] | Blood Glucose/de [Drug Effects] | Blood Glucose/me [Metabolism] | Body Mass Index | Counseling | Diabetes Mellitus, Type 2/bl [Blood] | *Diabetes Mellitus, Type 2/dt [Drug Therapy] | Double-Blind Method | Echocardiography | Female | Hemoglobin A, Glycosylated/de [Drug Effects] | *Hemoglobin A, Glycosylated/me [Metabolism] | Humans | Hypoglycemic Agents/pd [Pharmacology] | *Hypoglycemic Agents/tu [Therapeutic Use] | Male | Middle Aged | Obesity/bl [Blood] | *Obesity/dt [Drug Therapy] | Quality of Life | *Receptor, Serotonin, 5-HT2C/de [Drug Effects] | Risk Reduction Behavior | *Weight Loss/de [Drug Effects]Institution(s): MedStar Heart & Vascular InstituteActivity type: Journal Article.Medline article type(s): Journal Article | Randomized Controlled TrialOnline resources: Click here to access online Digital Object Identifier: http://dx.doi.org/10.1038/oby.2012.66 (Click here) Abbreviated citation: Obesity (Silver Spring). 20(7):1426-36, 2012 Jul.Local Holdings: Available online from MWHC library: 2000 - after 1 year).Abstract: The BLOOM-DM (Behavioral Modification and Lorcaserin for Obesity and Overweight Management in Diabetes 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.