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Weight loss with sibutramine improves glycaemic control and other metabolic parameters in obese patients with type 2 diabetes mellitus

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Fujioka, K., Seaton, T. B., Rowe, E., Jelinek, C. A., Raskin, P., Lebovitz, H. E., Weinstein, S. P., Group, The Sibutramine/Diabetes Clinical Study·2000·Diabetes, Obesity and Metabolism
DOI 10.1046/j.1463-1326.2000.00081.x
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Abstract

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 orlistat and sibutramine have both been associated with weight loss, improvements in serum lipids, and insulin sensitivity.

    “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]

  • Orlistat treatment usually reduces blood pressure, while sibutramine is commonly associated with increased heart rate and blood pressure.

    “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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2 of the 42 references couldn’t be matched to a known paper.

Research works printed but not linked: 6

  1. Albu J, Konnarides C, Pi-Sunyer FX. Weight control: metabolic and cardiovascular effects. Diabetes Rev 1995; 3: 335±347.
  2. Olkin I, Hoeffding W, Ghurye SG, Madow WG, Mann HB, eds. Contributions to Probability and Statistics: Essays in Honor of Harold Hotelling. Stanford, CA: Stanford University Press, 1960.
  3. McNeely W, Goa KL. Sibutramine: a review of its contribution to the management of obesity. Drugs 1998; 56: 1093±1124.
  4. Wynne RD, Braybrooke RM, Brown T, Jones S, Stott DA, Thornton GM. A single-dose, placebo-controlled, com- parative evaluation of the cardiovascular effects of sibutramine and amitriptyline in normal volunteers. Int J Pharmaceut Med 1997; 11: 65±70.
  5. Goldstein DJ, Rampey AH Jr, Potvin JH, Fludzinski LA. Fluoxetine in obese patients with noninsulin-dependent diabetes mellitus [abstract]. Clin Res 1992; 40: 240A.
  6. Yip I, Gratton L, Ashley J et al. Sibutramine reduces visceral fat, leptin, and estradiol level in obese women. FASEB 1998; 12: A353.

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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
DOI
10.1046/j.1463-1326.2000.00081.x
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
Licence
onlinelibrary.wiley.com/termsAndConditions#vor (vor, 603 d)
Locations
  • Diabetes Obesity and Metabolism (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Pharmacology › 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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