Document Detail


Randomized Placebo-Controlled Clinical Trial of Lorcaserin for Weight Loss in Type 2 Diabetes Mellitus: the BLOOM-DM Study.
MedLine Citation:
PMID:  22421927     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
The BLOOM-DM 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 or both; had HbA1c 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 Caucasian, 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 sulfonylurea. 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/last observation carried forward). LSmean (±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). HbA1c 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.
Authors:
Patrick O'Neil; Steven R Smith; Neil J Weissman; Meredith Fidler; Matilde Sanchez; Jinkun Zhang; Brian Raether; Christen M Anderson; William R Shanahan
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-3-16
Journal Detail:
Title:  Obesity (Silver Spring, Md.)     Volume:  -     ISSN:  1930-7381     ISO Abbreviation:  -     Publication Date:  2012 Mar 
Date Detail:
Created Date:  2012-3-16     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101264860     Medline TA:  Obesity (Silver Spring)     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Weight Management Center, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.
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