Clinical Efficacy of Orlistat Therapy in Overweight and Obese Patients With Insulin-Treated Type 2 Diabetes
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OBJECTIVE—Weight loss improves glycemic control, lipid profiles, and blood pressure in patients with type 2 diabetes. However, successful long-term weight loss is difficult for these patients, particularly those treated with insulin. The aim of this study was to assess the effect of orlistat, a gastrointestinal lipase inhibitor, on weight loss, glycemic control, and cardiovascular risk factors in overweight or obese insulin-treated type 2 diabetic patients. RESEARCH DESIGN AND METHODS—This study was a 1-year multicenter, randomized, double-blind, placebo-controlled trial of orlistat (120 mg three times a day) or placebo combined with a reduced-calorie diet in overweight or obese adults (BMI 28–40 kg/m2) with type 2 diabetes treated with insulin alone or combined with oral agents, but with suboptimal metabolic control (HbA1c 7.5–12.0%). Outcome measurements included changes in body weight, glycemic control, blood pressure, and serum lipids. RESULTS—After 1 year, the orlistat group lost significantly more weight (−3.89 ± 0.3% of baseline body weight, means ± SE) than the placebo group (−1.27 ± 0.3%, P < 0.001). Orlistat treatment, compared with placebo, produced greater decreases in HbA1c (−0.62 ± 0.08 vs. −0.27 ± 0.08%, P = 0.002), fasting serum glucose (−1.63 ± 0.3 vs. −1.08 ± 0.3 mmol/l, P = 0.02), and the required doses of insulin and other diabetic medications. Orlistat also produced greater improvements than placebo in serum total cholesterol (P = 0.0002) and LDL cholesterol concentrations (P = 0.001) and LDL/HDL ratio (P = 0.01). CONCLUSIONS—Orlistat therapy produces clinically significant weight loss, with improvements in glycemic control and cardiovascular disease risk factors, in overweight or obese patients with type 2 diabetes who have suboptimal metabolic control with insulin therapy.
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Less weight loss in people with type 2 diabetes than in those without has also been seen with other anti-obesity drugs-orlistat, naltrexone-bupropion, and liraglutide 3.0 mg-and with some behavioral programs.
“Similar attenuation in weight loss in patients with vs without type 2 diabetes has been observed with other AOM, including orlistat,(44) naltrexone-bupropion,(45) and liraglutide 3.0 mg,(46) as well as with some behavioral interventions.(47, 48)”
From Semaglutide for the treatment of obesity (2023) · cites this paper as [44]
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- Authors
- Kelley, D. E., Bray, G. A., Pi-Sunyer, F. X., Klein, S., Hill, J., Miles, J., & Hollander, P.
- Affiliations
- University of Pittsburgh (US)
- Pennington Research Center, Baton Rouge, Louisiana
- Columbia University, New York, New York
- Washington University in St. Louis (US)
- University of Colorado Denver (US)
- University of Missouri–Kansas City (US)
- Baylor College of Medicine (US)
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2002-06-01
- Volume
- 25
- Issue
- 6
- Pages
- 1033-1041
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- OpenAlex
- W2060268563
- Cited by
- 314
- References
- 35
- Citations by year
- 2026: 5 · 2025: 10 · 2024: 8 · 2023: 8 · 2022: 8 · 2021: 9 · 2020: 7 · 2019: 4 · 2018: 4 · 2017: 12 · 2016: 11 · 2015: 8 · 2014: 10 · 2013: 13 · 2012: 6
- FWCI
- 15.73
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Diabetes Care (publishedVersion)
- PubMed (publishedVersion)
- Funders
- F. Hoffmann-La Roche
- University of Missouri
- University of Pittsburgh
- University of Missouri-Kansas City
- Regeneron Pharmaceuticals
- Topics
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
- Keywords
- orlistat, type 2 diabetes, obesity, overweight, insulin therapy, weight loss, glycemic control, lipase inhibitors, hypocaloric diet, cardiovascular risk factors, serum lipids, LDL cholesterol, HbA1c
- MeSH terms
- Orlistat, Blood Glucose, Body Weight, Diabetes Mellitus, Diabetes Mellitus, Type 2, Double-Blind Method, Fasting, Female, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Insulin, Lactones, Male, Middle Aged, Obesity, Patient Dropouts, Placebos, Time Factors, Weight Loss, Body Mass Index, Anti-Obesity Agents, Racial Groups
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