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        Superior Weight Loss with Sibutramine Not Associated with Improved Health-Related Quality of Life

        A DGReview of :"Health-related quality of life in a randomised placebo-controlled trial of sibutramine in obese patients with type II diabetes"
        International Journal of Obesity and Related Metabolic Disorders

        02/24/2004
        By Mary Beth Nierengarten


        Obese patients with type 2 diabetes who are treated with sibutramine for weight loss do not experience improvement in health-related quality of life (HRQL) compared to placebo, reports a study from Finland. However, patients who experienced even modest weight loss had an increased ability to perform daily tasks and an improved perception of their heath.

        Decreased HRQL, particularly physical functioning, associated with both obesity and diabetes has led to weight loss treatments to help improve measures of HRQL as well as glycaemic control.

        Based on studies that show sustained weight loss in obese patients treated with sibutramine, Jarmo Kaukua, MD, and colleagues, Helsinki University Central Hospital, conducted a 12-month randomised trial to assess the effect of sibutramine on HRQL among obese patients with type 2 diabetes. After a 2-week single-blind run in period with a hypocaloric diet (700 kcl daily deficit), 114 patients were given sibutramine (15 mg, once daily) and 122 patients were given placebo. All patients in the study had type 2 diabetes and were obese.

        Body weight and HRQL were the main outcomes measured. Measurement of HRQL was based on RAND-36, a health survey that covers a number of physical, mental, and social functioning scales including physical role functioning, bodily pain, general health, emotional role functioning, vitality, and mental health. Patients were administered RAND-36 at baseline and every 3 months up to 12 months.

        Patients treated with sibutramine had significantly greater weight loss than placebo (mean -7.1 kg vs. -2.6 kg; P < .001). No significant difference in HRQL or glycaemic control was seen between the two groups. For patients in both groups who lost weight, physical functioning and health change improved at the end of 12 months from baseline. This improvement was noted with a weight loss of 5% or more, whereas improvements in vitality and general health were noted only when weight loss increased to 15% or more.

        Factors predicting weight loss at 12 months were high baseline scores on emotional role and social functioning, low scores on vitality, and increasing scores on physical functioning and vitality during the first 3 months of the study.

        Although weight loss in the sibutramine-treated patients was superior to that achieved in the placebo group, no difference in HRQL was observed between the 2 groups. However, all patients who lost weight improved in some measurements of HRQL. The authors conclude that "obese type II diabetes patients achieved HRQL improvements with intentional weight loss."

        Int J Obes Relat Metab Disord 2004 Feb 10;[Epub ahead of print]. "Health-related quality of life in a randomised placebo-controlled trial of sibutramine in obese patients with type II diabetes"

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