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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: email@example.com
Received 19 September 2011; Revised 25 January 2012; Accepted 6 March 2012
Accepted article preview online 16 March 2012
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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.
Thanks for the insight.... although it's published in more of a specialty journal, it's good to see these results are now published and documented in a credible, peer-reviewed, scientific journal.
I looked back at your other posts and can see that your not just trying to pick it apart. cheers
Brandon, in addition to your trial design comments, in a perfect world ARNA would have recruited enough patients in the DM trial to rule out valvulopathy-stat sig. They didn't and thus they want to pool the DM valve data with Bloom and Blossom. That is generally a reasonable assumption, except for the fact that the week 52 FDA defined valvulopathy results were (2.9% vs. .5%) loc. vs. placebo. These results, specifically for placebo, were considerably different than in the other studies. Might not be a major factor, but provides some doubt. I raise this only because 2 of the panel members at the last ADCOM said specifically they would like to see more than 600 diabetic patients in the study (and this was before the top line data was out for DM, and prior to submittal to the FDA) - Dr. Felner and Dr. Weide who both voted no last time.
I have a copy of the trial and briefly read the methods. One first glance, participants were stratified based on taking metformin or a sulfonylurea or metformin and sulfonylurea in the sulfonylurea group. They were then randomized in a 1:1:1 ratio into placebo, treated QD or BID. This is good and answers my original question. Investigators were also blinded to lorcaserin.