Role of sibutramine in the treatment of obese Type 2 diabetic patients receiving sulphonylurea therapy

Authors

  • M. Serrano-Rios,

    Corresponding author
    1. Servicio de Medicina Interna II, Hospital Clínico de San Carlos, Madrid, Spain, on behalf of the Spanish investigators, *Dipartimento di Medicina Interna e Gastroenterologia, Az. Ospedaliera S. Orsola-Malpighi, Bologna, Italy, on behalf of the Belgian and Italian investigators, and †Departamento Médico, Laboratorios Knoll, Madrid, Spain
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  • N. Melchionda,

    1. Servicio de Medicina Interna II, Hospital Clínico de San Carlos, Madrid, Spain, on behalf of the Spanish investigators, *Dipartimento di Medicina Interna e Gastroenterologia, Az. Ospedaliera S. Orsola-Malpighi, Bologna, Italy, on behalf of the Belgian and Italian investigators, and †Departamento Médico, Laboratorios Knoll, Madrid, Spain
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  • and * E. Moreno-Carretero

    1. Servicio de Medicina Interna II, Hospital Clínico de San Carlos, Madrid, Spain, on behalf of the Spanish investigators, *Dipartimento di Medicina Interna e Gastroenterologia, Az. Ospedaliera S. Orsola-Malpighi, Bologna, Italy, on behalf of the Belgian and Italian investigators, and †Departamento Médico, Laboratorios Knoll, Madrid, Spain
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M. Serrano Rios, Servicio de Medicina Interna II, Hospital Clinico de San Carlos, (Ala norte, 6a planta), C/Martin Lagos s/n, 28040 Madrid, Spain. E-mail: mserrano@hcsc.insalud.es

Abstract

Aims 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 ± 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 HbA1c 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 ≥ 10% of their baseline body weight.

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