Role of sibutramine in the treatment of obese Type 2 diabetic patients receiving sulphonylurea therapy.
OBJECTIVE
To investigate whether the satiety-inducing agent sibutramine affected body weight and associated anthropometry in overweight and obese (body mass index (BMI) > 27) Type 2 diabetic patients on sulphonylurea therapy.


METHODS
A randomized, placebo-controlled trial was undertaken in 134 patients with stable metabolic control on chronic sulphonylurea therapy. Patients were placed on moderate caloric restriction and received treatment with either sibutramine (15 mg/day) or placebo for 6 months.


RESULTS
Fifty-three of 69 sibutramine-treated and 57/65 placebo-treated patients completed the study. Both groups showed progressive weight loss. At the end of the trial weight loss was two times greater in the sibutramine group (mean +/- SEM; -4.5 +/- 0.5 kg) than placebo (-1.7 plus minus 0.5 kg, P < 0.001 vs. sibutramine). There was a trend for more patients to lose > 5% of initial body weight in the sibutramine group than placebo. BMI (P < 0.001) and waist circumference (P < 0.001) were also decreased to a greater extent by sibutramine. Mean reductions in HbA(1c) were commensurate with weight loss in both the sibutramine and placebo (- 0.78 +/- 0.17% and -0.73 +/- 0.23%; P = 0.84). Sibutramine was well tolerated with only two patients withdrawn due to potentially drug-related serious adverse events (palpitations).


CONCLUSIONS
Sibutramine, in conjunction with moderate caloric restriction, enhances weight loss and reduces waist circumference in overweight and obese Type 2 diabetic patients receiving sulphonylurea therapy. This is associated with additional improvements in glycaemic control in a limited number of patients losing > or = 10% of their baseline body weight.
Serrano-Rios
M
M
Servicio de Medicina Interna II, Hospital Clínico de San Carlos, Madrid, Spain. mserrano@hcsc.insalud.es
Melchionda
N
N
Moreno-Carretero
E
E
D001067:Appetite Depressants / Q000009:adverse effects / Q000627:therapeutic use*; D015992:Body Mass Index; D001835:Body Weight / Q000187:drug effects; D002784:Cholesterol / Q000097:blood; D003503:Cyclobutanes / Q000009:adverse effects / Q000627:therapeutic use*; D003920:Diabetes Mellitus / Q000188:drug therapy*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009765:Obesity; D010919:Placebos; D013453:Sulfonylurea Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D014280:Triglycerides / Q000097:blood; D015431:Weight Loss / Q000187:drug effects*
D001067:Appetite Depressants; D003503:Cyclobutanes; D007004:Hypoglycemic Agents; D010919:Placebos; D013453:Sulfonylurea Compounds; D014280:Triglycerides; D002784:Cholesterol; C058254:sibutramine