Effects of Sibutramine in Obese Female Subjects With Type 2 Diabetes and Poor Blood Glucose Control

Gökçel, Adnan; Karakose, Hatice; Ertorer, Melek Eda; Tanaci, Nedret; Tütüncü, Neslihan Başçıl; Güvener, Nilgün

doi:10.2337/diacare.24.11.1957

Cited by 94 publications

(54 citation statements)

References 21 publications

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“…Modest weight loss leads to improvements in LDL-C, blood pressure, insulin resistance and left-ventricular mass. [201][202][203][204][205][206] (1++)…”

Section: Benefits Of Weight Loss Interventionmentioning

confidence: 99%

Absolute risk of cardiovascular disease events, and blood pressure‐ and lipid‐lowering therapy in Australia

Banks

Crouch

Korda

et al. 2016

Medical Journal of Australia

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Objective: To quantify absolute cardiovascular disease (CVD) risk and treatment in Australian adults. Design, participants: Cross‐sectional representative study of 9564 people aged 18 years or more who had participated in the 2011–12 Australian National Health Measures Survey (response rate for those aged 45–74 years: 46.5%). Main outcome measures: Prior CVD was ascertained and 5‐year absolute risk of a primary CVD event calculated (using the Australian National Vascular Disease Prevention Alliance algorithm; categories: low [< 10%], moderate [10–15%], and high [> 15%] risk) on the basis of data on medical history, risk factors and medications, derived from interviews, physical measurements, and blood and urine samples. Results: Absolute CVD risk increased with age and was higher among men than women. Overall, 19.9% (95% CI, 18.5–21.3%) of Australians aged 45–74 years had a high absolute risk of a future CVD event (an estimated 1 445 000 people): 8.7% (95% CI, 7.8–9.6%) had prior CVD (estimated 634 000 people) and 11.2% (95% CI, 10.2–12.2%) had high primary CVD risk (estimated 811 000 people). A further 8.6% (95% CI, 7.4–9.8%, estimated 625 000) were at moderate primary CVD risk. Among those with prior CVD, 44.2% (95% CI, 36.8–51.6%) were receiving blood pressure‐ and lipid‐lowering medications, 35.4% (95% CI, 27.8–43.0%) were receiving only one of these, and 20.4% (95% CI, 13.9–26.9%) were receiving neither. Corresponding figures for high primary CVD risk were 24.3% (95% CI, 18.3–30.3%); 28.7% (95% CI, 22.7–34.7%); and 47.1% (95% CI, 39.9–54.3%). Conclusions: About one‐fifth of the Australian population aged 45–74 years (about 1.4 million individuals) were estimated to have a high absolute risk of a future CVD event. Most (estimated 970 000) were not receiving currently recommended combination blood pressure‐ and lipid‐lowering therapy, indicating substantial potential for health gains by increasing routine assessment and treatment according to absolute CVD risk.

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“…Modest weight loss leads to improvements in LDL-C, blood pressure, insulin resistance and left-ventricular mass. [201][202][203][204][205][206] (1++)…”

Section: Benefits Of Weight Loss Interventionmentioning

confidence: 99%

Absolute risk of cardiovascular disease events, and blood pressure‐ and lipid‐lowering therapy in Australia

Banks

Crouch

Korda

et al. 2016

Medical Journal of Australia

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“…At least four short-term trials have evaluated the effect of sibutramine alone in obese people with type 2 diabetes (10,20 -22). All four trials found sibutramine produced greater weight loss than placebo; however, in only one trial was there a significant improvement in HbA 1c (21).…”

Section: Adverse Effectsmentioning

confidence: 99%

One-Year Outcome of a Combination of Weight Loss Therapies for Subjects With Type 2 Diabetes

et al. 2003

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OBJECTIVE -The purpose of this study was to evaluate the effects of a combination weight loss program using intermittent low-calorie diets, energy-controlled meal replacement products, and sibutramine on weight loss, diabetes control, and cardiovascular risk factors in overweight or obese subjects with type 2 diabetes.RESEARCH DESIGN AND METHODS -Overweight or obese individuals with type 2 diabetes treated with diet or oral medication were randomly assigned to either a standard therapy or combination therapy group. Both groups received a standardized program to facilitate weight loss. The combination therapy group also received 10 -15 mg sibutramine daily, low-calorie diets using meal replacement products for 1 week every 2 months, and between low-calorie diet weeks, once daily use of meal replacement product and snack bars to replace one usual meal and snack. Primary outcome measures were changes in body weight, glycemic control, plasma lipids, blood pressure, pulse, and body composition at 1 year.RESULTS -At 1 year, combination therapy, compared with standard therapy, resulted in significantly more weight loss (Ϫ7.3 Ϯ 1.3 kg vs. Ϫ0.8 Ϯ 0.9 kg, P Ͻ 0.001) and reduction in HbA 1c (Ϫ0.6 Ϯ 0.3 vs. 0.0 Ϯ 0.2%, P ϭ 0.05). Combination therapy resulted in reduced requirement for diabetes medications and decreased fat mass and lean body mass. A 5-kg decrease in weight at 1 year was associated with a decrease of 0.4% in HbA 1c (P ϭ 0.006). Changes in fasting glucose, lipids, pulse, and blood pressure did not differ between groups.CONCLUSIONS -This combination weight loss program resulted in greater weight loss and improved diabetes control compared with a standard weight loss program in overweight or obese subjects with type 2 diabetes.

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“…17 Sibutramine, a norepinephrine and serotonin reuptake inhibitor enhances satiety 18,19 and results in sustained weight loss in obese patients. [20][21][22][23][24][25][26][27] The aim of this randomised 12-month trial was to examine the effects of sibutramine 15 mg vs placebo on HRQL among obese patients with type II diabetes treated with hypocaloric diet for 12 months.…”

Section: Introductionmentioning

confidence: 99%

Health-related quality of life in a randomised placebo-controlled trial of sibutramine in obese patients with type II diabetes

2004

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OBJECTIVE:We evaluated the effects of 12-month treatment with sibutramine 15 mg daily compared with placebo on healthrelated quality of life (HRQL) in obese type II diabetes patients. We examined the associations between the changes in HRQL and in weight, glycaemic control, and haemodynamic variables. We also explored the predictive value of HRQL and its changes early during treatment. DESIGN: A randomised clinical trial. The subjects were enrolled in a 2-week single-blind run-in period with a modestly hypocaloric diet (700 kcal daily deficit) and then randomised to receive either sibutramine 15 mg (n ¼ 114, 60% female) or placebo (n ¼ 122, 58% female) once daily with the hypocaloric diet for 12 months. SUBJECTS: Obese (mean BMI 36 kg/m 2 and age 54 y) type II diabetes patients untreated with antidiabetic medications. MEASUREMENTS: The main outcome measures included body weight and HRQL (the RAND 36-Item Health Survey 1.0). RESULTS: The mean weight loss was greater in the sibutramine group (À7.1 kg) than in the placebo group (À2.6 kg, Po0.001). The baseline HRQL was relatively high. There were no significant differences between the treatment groups in glycaemic control or in any of the RAND-36 scales during the study. The scores on physical functioning (PF) and health change (HC) since last year improved in both groups and this improvement was related to weight loss. When HRQL changes were examined in categories of weight loss, the scores on PF and HC increased with Z5% weight loss, but the scores on vitality (V) and general health (GH) increased only after Z15% weight loss. Decrease in HbA1c was associated with increases in the scores of PF, GH, V, mental health, and HC. In the sibutramine group, the increase in diastolic blood pressure was associated with the decrease in the scores of PF, physical role functioning, emotional role functioning (ERF), social functioning (SF), and bodily pain. High baseline scores on ERF and SF, and low scores on V predicted weight loss at 12 months. Also, increasing scores on PF and V during the first 3 months predicted weight loss at 12 months. The sum of four dichotomised HRQL variables (baseline ERF Z75 ¼ 1 and o75 ¼ 0; baseline SFZ80 ¼ 1 and o80 ¼ 0; 3-month change in PF40 ¼ 1 and r0 ¼ 0; 3-month change in V40 ¼ 1 and r0 ¼ 0) predicted weight loss: In the group with sum 0, the mean(s.d.) weight change at 12 months was 0.0(2.6)% and with sum 4 it was -9.0(8.1)% of baseline weight. CONCLUSION: Despite the superior weight loss, sibutramine 15 mg daily did not produce HRQL benefits over placebo when measured with the generic RAND-36 in obese type II diabetes patients. PF and HC since last year improved with Z5% weight loss, but Z15% weight loss was needed to achieve a cluster of HRQL improvements. The decrease in HbA1c was associated with many HRQL benefits. Poor baseline HRQL and the improvement observed in the first months of treatment may prove to be useful in predicting success in long-term weight loss.

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Effects of Sibutramine in Obese Female Subjects With Type 2 Diabetes and Poor Blood Glucose Control

Cited by 94 publications

References 21 publications

Absolute risk of cardiovascular disease events, and blood pressure‐ and lipid‐lowering therapy in Australia

Absolute risk of cardiovascular disease events, and blood pressure‐ and lipid‐lowering therapy in Australia

One-Year Outcome of a Combination of Weight Loss Therapies for Subjects With Type 2 Diabetes

Health-related quality of life in a randomised placebo-controlled trial of sibutramine in obese patients with type II diabetes

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