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Weight loss with sibutramine improves glycaemic control and other metabolic parameters in obese patients with type 2 diabetes mellitus
Open accessAbstract
Summary: Aim : To determine the efficacy and tolerability of sibutramine hydrochloride in obese patients whose type 2 diabetes was poorly controlled on diet alone or with an oral antidiabetic agent Methods : This study was a 24‐week, double‐blind, multicentre trial following a 5‐week placebo run‐in period. One hundred and seventy‐five obese (body mass index (b.m.i.) ≥27 kg/m 2 ) patients with poorly controlled type 2 diabetes mellitus were randomized either to sibutramine (n = 89; mean age 53.5 years; mean weight 99.3 kg) or placebo (n = 86; mean age 55 years; mean weight 98.2 kg) at 16 participating centres. To achieve moderate calorie restriction (deficit ≥ 250–500 kcal/day), individual dietary counselling was accompanied by either placebo or sibutramine (initial dosage of 5 mg/day titrated up by 5 mg biweekly through week 6, and maintained at 20 mg through week 24). The main outcome measures included changes in weight, b.m.i., waist and hip circumference, glycaemic control, lipid profile, and quality of life, and evaluation of reported adverse events. Results : Sixty‐seven per cent of sibutramine patients and 71% of placebo patients completed the study. At week 24 when comparing those who completed the course, sibutramine compared with placebo patients showed significantly greater (p < 0.001) absolute (−4.3 vs. −0.4 kg) and percentage (−4.5% vs. −0.5%) weight loss. Weight loss ≥5% or 10% was achieved by 33% and 8% of sibutramine patients, respectively, but no placebo patients (p < 0.03 or better). Improvement in glycaemic control was correlated with weight loss (p < 0.001). In 5% and 10% weight‐loss responders, mean treatment differences were −0.53% and −1.65% (p ≤ 0.05), respectively, for HbA 1c , and −1.4 mmol/l (p ≤0.05) and −3.8 (p ≤0.05) mmol/l for fasting plasma glucose. Sibutramine patients also showed improvements in fasting insulin, triglycerides, HDL cholesterol, and quality‐of‐life assessments. Overall, sibutramine was well tolerated compared with the placebo. Sibutramine treatment was associated with small mean increases in blood pressure (BP) and pulse, although an increase in BP was not seen in sibutramine‐treated patients who lost ≥ 5% of their weight. Conclusions : Sibutramine produced statistically and clinically significant weight loss when used in combination with recommendations for moderate caloric restriction. This weight loss was associated with improvements in metabolic control and quality of life, and sibutramine was generally well tolerated in obese patients with type 2 diabetes.
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“Pharmacotherapy with the two currently approved drugs for obesity treatment, orlistat (a gastrointestinal lipase inhibitor) and sibutramine (a monoamine reuptake inhibitor), have both been associated with weight loss, improvements in serum lipids, and insulin sensitivity (76, 109, 270).”
From Cardiac remodeling in obesity (2008) · cites this paper as [109]
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“Orlistat treatment usually reduces blood pressure, while sibutramine is commonly associated with increased heart rate and blood pressure (109, 393).”
From Cardiac remodeling in obesity (2008) · cites this paper as [109]
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“Orlistat treatment usually reduces blood pressure, while sibutramine is commonly associated with increased heart rate and blood pressure (109, 393).”
Background
Metadata
- Authors
- Fujioka, K., Seaton, T. B., Rowe, E., Jelinek, C. A., Raskin, P., Lebovitz, H. E., Weinstein, S. P., & Group, T. S. C. S.
- Affiliations
- Scripps Health (US)
- The University of Texas Southwestern Medical Center (US)
- State University of New York (US)
- Corresponding author
- Fujioka, K.
- ORCID
- Fujioka, K.
- Venue
- Diabetes, Obesity and Metabolism
- Publisher
- Wiley
- Published
- 2000-05
- Volume
- 2
- Issue
- 3
- Pages
- 175-187
- ISSN
- 1462-8902 (ISSN-L)
- 1463-1326
- OpenAlex
- W2032907323
- Cited by
- 244
- References
- 42
- Citations by year
- 2025: 1 · 2024: 1 · 2023: 2 · 2022: 5 · 2021: 4 · 2020: 4 · 2019: 5 · 2018: 3 · 2017: 7 · 2016: 7 · 2015: 4 · 2014: 8 · 2013: 7 · 2012: 3
- FWCI
- 11.65
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Diabetes Obesity and Metabolism (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pharmacology (medical) › Pharmacology and Obesity Treatment
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- sibutramine, type 2 diabetes, obesity, weight loss, glycemic control, HbA1c, fasting blood glucose, lipid profile, quality of life, adverse events, appetite suppressants, nutrition counseling, caloric restriction, drug efficacy and tolerability, body mass index, waist and hip circumference
- MeSH terms
- Adolescent, Adult, Aged, Appetite Depressants, Blood Pressure, Cyclobutanes, Diabetes Mellitus, Diabetes Mellitus, Type 2, Diet, Reducing, Double-Blind Method, Female, Humans, Hyperglycemia, Lipids, Male, Middle Aged, Obesity, Quality of Life, Weight Loss, Body Mass Index, Treatment Outcome
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