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Cited by 530

The DOI matches its Crossref record; 33 of the 33 references it cites were found in a registry or an index.

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

O'Neil, Patrick M., Smith, Steven R., Weissman, Neil J., Fidler, Meredith C., Sanchez, Matilde, Zhang, Jinkun, Raether, Brian, Anderson, Christen M., Shanahan, William R.·2012·Obesity
DOI 10.1038/oby.2012.66
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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.

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Metadata

Authors
O'Neil, P. M., Smith, S. R., Weissman, N. J., Fidler, M. C., Sanchez, M., Zhang, J., Raether, B., Anderson, C. M., & Shanahan, W. R.
Venue
Obesity
Publisher
Wiley
Published
2012-07
Volume
20
Issue
7
Pages
1426-1436
ISSN
  • 1930-7381 (ISSN-L)
  • 1930-739X
DOI
10.1038/oby.2012.66
OpenAlex
W2001562531
Cited by
530
References
33
FWCI
45.01
Type
journal article
Language
en
Open access
closed

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