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NEW STUDY SUGGESTS THAT WEIGHT LOSS WITH XENICAL (orlistat) IMPROVES GLYCEMIC CONTROL IN TYPE 2 DIABETES PATIENTS TAKING MAXIMAL DOSES OF ANTI-DIABETIC MEDICATIONSSecond study at American Diabetes Association Meeting shows a beneficial effect on post-prandial glucose levels in type 2 diabetes patients.Treatment with the prescription weight-loss medication Xenical (orlistat) provides additional glycemic control benefits in patients with type 2 diabetes taking maximal or near-maximal doses of anti-diabetes medications, according to new data being presented Monday at the 62nd annual meeting of the American Diabetes Association. Results were consistent regardless of the type of oral anti-diabetes treatment patients were receiving. Typically, if a patient’s blood sugar cannot be controlled by maximum-tolerated doses of oral anti-diabetes medications, insulin therapy is the next step. "These results are important for patients who are struggling to control their glucose levels without resorting to daily insulin injections," said Stephan Jacob, M.D., medical director of the Albert Schweitzer Klinic in Konigsfeld, Germany. "The findings suggest that weight loss with Xenical plus diet may provide physicians with another tool to control blood sugar in overweight or obese patients with type 2 diabetes, and prolong the utility of oral anti-diabetes medications." Researchers analyzed pooled data from seven double-blind, placebo-controlled trials of Xenical in overweight or obese patients with type 2 diabetes who were being treated with oral anti-diabetes medications. Study subjects were randomized to receive either Xenical 120 mg three times per day with meals or placebo. In addition, all participants were placed on a mildly reduced calorie diet (500-600 calorie deficit per day). A sub-group of patients receiving maximal or near maximal doses of either metformin (³ 2000 mg) or sulfonylureas (³ 80% of standardized dose) was identified. This group was analyzed to determine treatment effects on HbA1c levels and fasting plasma glucose (FPG) – both measures of glycemic control. In the metformin group, researchers found that, compared to the placebo plus diet group, Xenical plus diet had a significantly greater impact on both HbA1c (-0.81% Xenical vs. -0.38% placebo) and FPG levels (-1.74 mmol/L Xenical vs. -0.38 mmol/L placebo). In patients treated with sulfonylureas, Xenical plus diet reduced HbA1c levels by -0.66% compared to -0.09% with placebo plus diet. Fasting plasma glucose was reduced -1.24 mmol/L by Xenical, versus an increase of +0.16 mmol/L for placebo. Second Study Shows Benefits on Post-Prandial Glucose On Saturday, researchers also presented new data that suggest treatment with Xenical for weight control also has a statistically significant effect on post-prandial glucose (PPG) levels in overweight or obese patients with type 2 diabetes. Post-prandial glucose is a measure of blood sugar taken two hours after a meal and is an important measure of glycemic control. The study was a retrospective analysis of pooled data from three multicenter, double-blind trials. Patients receiving metformin and/or sulfonylureas were randomized to treatment with Xenical 120 mg three times per day with meals or placebo. All patients were placed on a mildly reduced calorie diet. At 24 weeks, Xenical-treated patients had significantly greater decreases in PPG levels compared to placebo recipients (-1.61 mmol/L vs. -0.10 mmol/L.). At 52 weeks, PPG levels for Xenical-treated patients, on average, were -1.13 mmol/L. However, PPG levels actually increased for placebo-treated recipients (+0.36 mmol/L) at the 52-week point. "These results demonstrate that Xenical, in combination with anti-diabetic agents and a mildly reduced-calorie diet, can have a significant impact on PPG levels," said Markolf Hanefeld, M.D., professor of internal medicine, Center of Clinical Studies, Technical University, Dresden, Germany. "This is important because PPG levels are a strong indicator of how well a patient’s blood sugar is being controlled." |
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