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
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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European Guidelines for Obesity Management in Adults
Yumuk, V., Tsigos, C., Fried, M., Schindler, K., Busetto, L., Micic, D., & Toplak, H. (2015) · Obesity Facts · doi:10.1159/000442721 · Cited by 3,432
Pathophysiology of human visceral obesity: an update
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Garvey, W. T., Mechanick, J. I., Brett, E. M., Garber, A. J., Hurley, D. L., Jastreboff, A. M., Nadolsky, K., Pessah-Pollack, R., & Plodkowski, R. (2016) · Endocrine Practice · doi:10.4158/ep161365.gl · Cited by 1,914
Pharmacological Management of Obesity: An Endocrine Society Clinical Practice Guideline
Apovian, C. M., Aronne, L. J., Bessesen, D. H., McDonnell, M. E., Murad, M. H., Pagotto, U., Ryan, D. H., & Still, C. D. (2015) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2014-3415 · Cited by 1,347
Leon, B. M. (2015) · World Journal of Diabetes · doi:10.4239/wjd.v6.i13.1246 · Cited by 1,215
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
- OpenAlex
- W2001562531
- Cited by
- 530
- References
- 33
- FWCI
- 45.01
- Type
- journal article
- Language
- en
- Open access
- closed
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- 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. (2012). Randomized Placebo‐Controlled Clinical Trial of Lorcaserin for Weight Loss in Type 2 Diabetes Mellitus: The BLOOM‐DM Study. Obesity. https://doi.org/10.1038/oby.2012.66
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