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NEW STUDY SUGGESTS THAT XENICAL (orlistat) ENHANCES WEIGHT LOSS AND IMPROVES GLYCEMIC CONTROL IN TYPE 2 DIABETES PATIENTS TREATED WITH METFORMINImprovements were also seen in many cardiovascular risk factors associated with type 2 diabetes, including cholesterol and blood pressure.A study in the July issue of the journal Diabetes Care finds that adding the prescription weight-loss medication Xenical® (orlistat) to the diabetes drug metformin can have significant benefits for overweight or obese people with type 2 diabetes. Researchers at St. Luke’s Hospital in Kansas City who conducted the study found treatment benefits in body weight, HbA1c levels (a measure of blood sugar) and fasting blood glucose. In addition, improvements were seen in cardiovascular risk factors including total cholesterol, LDL-cholesterol (bad cholesterol) and LDL/HDL ratio (the ratio of bad to good cholesterol). Metformin is the most commonly used oral diabetes treatment. This is the first study to evaluate the additional benefits of Xenical plus diet in a large number of metformin-treated type 2 diabetes patients. "The results of this study show that the addition of orlistat plus a reduced calorie diet to existing metformin therapy can benefit patients by helping lower body weight and serum glucose levels," said John M. Miles, M.D., an endocrinologist now at the Mayo Clinic in Rochester, Minn., and lead investigator in the study. "This study also found the combination of Xenical and metformin had a positive impact on many cardiovascular risk factors, which are among the most common and potentially serious risks associated with type 2 diabetes. Patients in this study treated with orlistat plus diet also had a reduced need for one or more diabetes medications." About the Study A total of 516 patients at 34 centers in the United States and six centers in Canada were enrolled in this study. Patients receiving metformin at 1,000 – 2,550 mg/day for at least six weeks were eligible for study participation and those receiving a stable dose of sulfonylureas for 12 weeks prior to study entry in addition to their metformin therapy were also enrolled. Once enrolled, patients were randomized to receive either Xenical 120 mg three times daily (n=255) or placebo (n=261) in addition to a reduced-calorie diet. Of the original study group, 311 patients completed one year of treatment. Similar numbers of patients in the control and Xenical groups were receiving metformin monotherapy (39% and 44% respectively) or metformin in combination with sulfonylureas (60% and 55% respectively) at the onset of the trial. Study Results After one year of treatment, patients in the Xenical-treated group experienced greater weight loss than patients in the control group. Twice as many Xenical-treated patients lost 5% of baseline body weight compared to the control group (39.0% versus 15.7%). Additionally, significantly more patients in the Xenical-treated group lost 10% of their baseline body weight compared with the control group (14.1% vs. 3.9%). Changes in treatment with diabetes medications during the course of the study were significantly different between the Xenical and control groups. Twice as many patients in the Xenical-treated group compared to the control group either reduced or discontinued one or more diabetes medications (17.1% vs. 8.2%). More patients in the control group required either additional or increased dosages of diabetes medications compared with Xenical-treated patients (21.7% vs. 12.2%). Xenical therapy was also associated with reduction in serum HbA1c levels. Significantly more patients treated with Xenical experienced a mean reduction in HbA1c of 0.5% or 1.0% compared to those in the control group. Compared to control, weight loss with Xenical was associated with greater improvements in total cholesterol (-4.1% for Xenical-treated patients vs. +2.6% for the control group), LDL-cholesterol (-2.8% vs. +3.9%) and LDL/HDL cholesterol (-0.60 vs. -0.46). And after 52 weeks, patients treated with Xenical experienced a greater decrease in systolic blood pressure compared to control. Adverse event profiles were similar in the two groups, with the exception of a higher incidence of gastrointestinal (GI) side effects associated with Xenical treatment. However, more than 75% of patients who had GI events reported only a single episode, and the majority of GI events were mild, transient and occurred during the early phase of treatment. Although GI events were more frequent in the Xenical treatment group, it did not lead to a greater dropout rate. In fact, the overall rate of withdrawal was actually higher in the control group than in the Xenical-treated group. This indicates that GI events are generally not a cause for discontinuation of Xenical therapy. About Xenical Approved in April 1999 for weight loss, maintenance of lost weight, and the reduction of risk of weight regain after prior weight loss when used with a reduced-calorie diet, Xenical is the only non-systemically acting gastrointestinal lipase inhibitor. Its mechanism of action is to prevent one-third of dietary fat from being absorbed. Weight loss with Xenical also has resulted in improvements in many cardiovascular risk factors such as high blood pressure, high cholesterol, and diabetes, compared with diet alone. Xenical has an established safety profile and is the most extensively studied weight management treatment to date. Xenical has been used in two million patients worldwide. The long-term effects of Xenical on morbidity and mortality associated with obesity have not been established. Because Xenical prevents about one-third of the fat in the food consumed from being absorbed, patients may experience gas with oily discharge, increased bowel movements, an urgent need to have them and an inability to control them, particularly after meals containing more fat than recommended. In clinical trials, these effects appear to occur less often among Xenical patients with type 2 diabetes than in patients treated for obesity. Xenical should not be taken if patients are pregnant, nursing, have food absorption problems or reduced bile flow. If taking cyclosporine, patients should speak to their doctors before taking Xenical. Xenical reduces the absorption of some vitamins. Therefore, a daily multivitamin is recommended. |
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