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        Orlistat Helps Control Blood Sugar in Type 2 Diabetes: Presented at EASD

        By Emma Hitt
        Special to DG News

        BUDAPEST, HUNGARY -- September 2, 2002 -- Xenical (orlistat) may help improve blood sugar control in overweight and obese type 2 diabetic patients whose oral anti-diabetic medication is failing them, according to new research.

        Dr. Paul Valensi with L'Hôpital Jean Verdier, University Paris Nord, France, and colleagues presented the results of their study today (September 2) during the European Association for the Study of Diabetes (EASD), in Budapest, Hungary.

        Orlistat blocks the action of lipases, inhibiting the absorption of dietary fats. Thus, the drug may aid weight loss and improve the blood glucose profile of overweight and obese patients with type 2 diabetes.

        Dr. Valensi and colleagues recruited 193 overweight and obese (BMI 28-40kg/m²) patients with type 2 diabetes with an HbA1c level ranging from 7 to 9 percent.

        The patients, aged 18 to 65 years, had taken metformin, sulphonylureas, or both, for at least three months, but had not achieved blood glucose control.

        Of the participants, 97 were randomized to treatment with orlistat, 120 mg three times a day, and the remaining 96 received a placebo. All ate a mildly reduced-calorie diet for six months.

        After six months, weight loss was significantly greater among the patients receiving orlistat (-3.9 ± 3.4 percent) compared with those receiving placebo (-1.3 ± 2.6 percent), (p<0.0001). The improvement in HbA1c levels was also greater in the orlistat group (-0.54 ± 0.10 percent vs -0.18 ± 0.09 percent; p<0.002). Furthermore, 36 percent of the orlistat-treated patients achieved the target plasma HbA1c level of 6.5 percent.

        Of the orlistat-treated patients, about a third showed at least a 1 percent reduction in HbA1c compared to only 21 percent of the placebo-treated patients (p=0.023). Similarly, a reduction of 1.5 percent or more was achieved in 19 percent of orlistat- compared to only 4 percent of placebo-treated patients (p<0.001).

        Fasting blood sugar levels also improved significantly in the orlistat compared to the placebo group (-1.39 ± 0.22 mmol/L vs -0.50 ± 0.24 mmol/L, p<0.0001); and the dose reduction of oral anti-diabetic medication was possible in more patients treated with orlistat (10.3 percent) than with placebo (1.2 percent; p<0.002).

        About one quarter of the orlistat-treated patients lost more than 5 percent of their initial weight at three months, constituting a sub-group of "early responders." These patients lost more than 8 percent of their body weight and their mean HbA1c levels decreased by 1.27 percent.

        "These results demonstrate that the addition of orlistat to conventional but insufficiently active oral anti-diabetic therapy enables a further improvement in the blood sugar control of overweight and obese patients with type 2 diabetes," the researchers conclude.

        "We are not surprised by the results since control of type 2 diabetes depends strongly on weight and food intake," Dr. Valensi told Doctor's Guide. "We suspect the results are mostly due to weight loss, but complicated mechanisms involving fatty acid metabolism may also play a role in the response of these patients," he said.

        The study was funded by Roche Laboratories, Inc., the manufacturers of orlistat.



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