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Arena Pharmaceuticals, Inc. Message Board

  • sauve9 sauve9 Apr 3, 2012 12:41 AM Flag

    BLOOM-DM manuscript before print 3/16/12

    Original Article

    obesity, a research journal

    advance online publication before print
    This is an unedited manuscript that has been accepted for publication. NPG are providing this early version of the manuscript as a service to our customers. The manuscript will undergo copyediting, typesetting and a proof review before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers apply.

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

    Patrick O'Neil1, Steven R. Smith3, Neil J. Weissman4, Meredith Fidler2, Matilde Sanchez2, Jinkun Zhang2, Brian Raether2, Christen M. Anderson2 and William R. Shanahan2

    1Weight Management Center, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC
    2Arena Pharmaceuticals, San Diego, CA
    3Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Medical Research Institute
    4MedStar Health Research Institute at Washington Hospital Center and Georgetown University, Washington, DC

    Correspondence: Christen M. Anderson, M.D., Ph.D. Arena Pharmaceuticals, Inc. 6166 Nancy Ridge Drive, San Diego, CA 92121, PH: 858-453-7200, ext. 1434, FAX: 858-812-3223, E-mail: canderson@arenapharm.com

    Received 19 September 2011; Revised 25 January 2012; Accepted 6 March 2012
    Accepted article preview online 16 March 2012
    Top of page
    Abstract

    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/m2. 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/m2. 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.

    http://www.nature.com/oby/journal/vaop/naam/abs/oby201266a.html

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