Studies on Xenical

Numerous studies on Xenical efficacy has been conducted in the past. All of the Xenical studies shows that the medication delivers exceptional results. The studies on Xenical implies that the medication works as an appetite suppressant to help loose weight fast.

Here we have provided with clinical studies on Xenical for the patients information.

Clinical Studies on Xenical

Results from two new clinical trials indicate that patients with type 2 diabetes who took the prescription weight-loss treatment Xenical (orlistat) in addition to their diabetes medication not only lost weight, but were also able to reduce the daily dose of their diabetes medications. Additionally, these patients improved their blood sugar and blood cholesterol levels. The studies, presented here today at the 17th International Diabetes Federation Congress, examined the effect of Xenical and a reduced-calorie diet in type 2 diabetic patients who were also being treated with the diabetes medications metformin or insulin.

"These studies on Xenical may be a new therapeutic option for patients with type 2 diabetes, by helping them effectively manage their weight while improving their diabetic condition," said John M. Miles, MD, Professor of Medicine, University of Missouri, Kansas City, School of Medicine, and lead investigator of the Xenical with metformin study. "In both studies, patients taking Xenical lost weight while some also were able to reduce or discontinue their diabetes medication."

Weight is the most important modifiable risk factor for the development of type 2 diabetes. However, of the estimated 15 million people with type 2 diabetes in the United States, 67 percent are either overweight or obese. Some diabetes medications, such as sulfonylureas and insulin, can cause unfavorable weight gain in patients with type 2 diabetes. Effective weight management is an essential component of the long-term treatment of the disease. Weight loss --even as little as 5 to 10 percent-- improves control of blood sugar levels and other cardiovascular risk factors commonly seen in patients with this condition.

"The relationship between obesity and type 2 diabetes is well established, yet reducing weight has proven to be one of the most difficult challenges for these patients," said David Kelley, MD of the University of Pittsburgh School of Medicine, Pittsburgh, Pa., lead investigator of the Xenical with insulin study. "We are hopeful that more patients with diabetes will be able not only to reduce their weight, but also to more effectively manage their diabetes by using Xenical in conjunction with a reduced-calorie diet and their current diabetes medication."

Studies on Xenical
Studies on Xenical in overweight patients with type 2 diabetes receiving metformin. This one-year multicenter, randomized, placebo-controlled trial was performed in 503 patients with type 2 diabetes treated with metformin at the onset of the study. These patients were given Xenical (120 mg three times daily) plus diet or placebo plus diet. All patients were prescribed a mildly reduced-calorie diet and received regular dietary counseling.

One year later, Xenical plus diet treated patients lost more weight than patients in the diet plus placebo group (4.5 percent vs. 1.4 percent). Furthermore, treatment with Xenical plus diet was also associated with a significantly greater improvement in control of blood sugar levels. The average reduction in fasting plasma glucose was significantly greater (-36.07 mg/dL vs. -12.32 mg/dL) with Xenical plus diet than with placebo plus diet, and more patients in the Xenical plus diet group had reductions in HbA1c of ³ -0.5 percent (61 percent of patients vs. 43 percent) or ³ -1.0 percent (46 percent of patients vs. 29 percent). In addition, more Xenical plus diet treated patients had their diabetes medications reduced or discontinued (16 percent vs. 8 percent); while, conversely, fewer required an increase in diabetes medication (12 percent vs. 21 percent).

Effect of Xenical in overweight patients with type 2 diabetes receiving insulin
This one-year, multicenter, randomized, placebo-controlled study involved 535 overweight or obese patients with type 2 diabetes who were receiving insulin when the study was begun. They were then given either Xenical (120 mg three times daily) plus diet or placebo plus diet. All patients were prescribed a mildly reduced-calorie diet and received regular dietary counseling.
After one year, mean weight loss was significantly greater with Xenical plus diet than placebo plus diet (3.9 percent vs. 1.3 percent). Treatment with Xenical plus diet also resulted in significantly greater mean reductions in both HbA1c (-0.62 percent vs. -0.27 percent) and fasting plasma glucose (-29.11 mg/dL vs. -19.29 mg/dL) compared with placebo plus diet. In addition, significantly more patients in the Xenical plus diet group were able to reduce or discontinue their insulin or other diabetes medication while fewer needed increased or additional diabetes medication (p<0.001).

About Xenical
Xenical (orlistat) is the only non-systemically acting prescription lipase inhibitor 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. In clinical trials involving more than 4,000 patients, weight loss with Xenical also resulted in improvements in many obesity-related cardiovascular risk factors such as high blood pressure, high cholesterol, and diabetes. The long-term effects of Xenical on weight-related illnesses and life expectancy have not been studied.

Since Xenical blocks about one-third of the fat in the food consumed from being digested, 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.

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 doctor before taking Xenical. Xenical reduces the absorption of some vitamins, therefore, a daily multivitamin is recommended.

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. prescription drug unit of the Roche Group, a leading research-based health care enterprise that ranks among the world’s leaders in pharmaceuticals, diagnostics and vitamins. Roche discovers, develops, manufactures and markets numerous important prescription drugs that enhance people's health, well-being and quality of life. Among the company’s areas of therapeutic interest are: virology, including HIV/AIDS and hepatitis C; infectious diseases, including influenza; cardiology; neurology; oncology; transplantation; dermatology; and metabolic diseases, including obesity and diabetes.

Many clinical trials and studies on Xenical have been co. The FDA reports that over 4,000 obese participants were studied over 7 clinical trials prior to Xenical FDA approval. The research suggests that Xenical can help to promote weight loss
when used in conjunction with increased physical activity and low fat diet. All participants used Xenical in conjunction with a low fat, reduced calorie diet and regular physical exercise.

In the study participants who completed one year of treatment:

• 57% of those taking Xenical lost at least 5% of their original body weight
• 31% of those taking a placebo lost at least 5% of their original body weight
  In one of the seven studies:
• Those taking Xenical lost an average of 22.7 pounds
• Those taking a placebo lost an average of 13.4 pounds
  The results of these clinical trials led to the following recommendations by the FDA:
• Xenical only be prescribed to individuals with a BMI of 30 or higher
• The exception to the above rule are for individuals with a BMI of 27 or higher who have high cholesterol, high blood pressure or diabetes

Research on Xenical has also demonstrated that Xenical can not only promote successful weight loss when combined with diet and exercise, but may also have a small, but positive, effect in decreasing total cholesterol, LDL cholesterol, insulin levels and blood pressure.

It is important to note that those study participants who participated in a 1 year weight maintenance program after completing the 1 year weight loss program regained some of the weight initially lost. This was true of the participants who
continued taking Xenical as well as those taking a placebo.

There are important observations to be made about the clinical studies of Xenical. Firstly, they indicate that Xenical can successfully promote weight loss in obese individuals. Secondly, weight loss can be successfully obtained without taking Xenical. Thirdly, the results underline the importance of low fat, reduced calorie diets and increased physical activity in the long term maintenance

Other Short-term Studies: In several studies of up to 6-weeks duration, the effects of therapeutic doses of XENICAL on gastrointestinal and systemic physiological processes were assessed in normal-weight and obese subjects. Postprandial cholecystokinin plasma concentrations were lowered after multiple doses of XENICAL in two studies but not significantly different from placebo in two other experiments. There were no clinically significant changes observed in gallbladder motility, bile composition or lithogenicity, or colonic cell proliferation rate, and no clinically significant reduction of gastric emptying time or gastric acidity. In addition, no effects on plasma triglyceride levels or systemic lipases were observed with the administration of XENICAL in these studies. In a 3-week study of 28 healthy male volunteers, XENICAL (120 mg three times a day) did not significantly affect the balance of calcium, magnesium, phosphorus, zinc, copper, and iron.

Observational epidemiologic studies have established a relationship between obesity and visceral fat and the risks for cardiovascular disease, type 2 diabetes, certain forms of cancer, gallstones, certain respiratory disorders, and an increase in overall mortality. These studies suggest that weight loss, if maintained, may produce health benefits for obese patients who have or are at risk of developing weight-related comorbidities. The long-term effects of orlistat on morbidity and mortality associated with obesity have not been established.

The effects of XENICAL on weight loss, weight maintenance, and weight regain and on a number of comorbidities (eg, type 2 diabetes, lipids, blood pressure) were assessed in seven long-term (1- to 2-years duration) multicenter, double-blind, placebo-controlled clinical trials. During the first year of therapy, weight loss and weight maintenance were assessed. During the second year of therapy, some studies assessed continued weight loss and weight maintenance and others assessed the effect of orlistat on weight regain. These studies included over 2800 patients treated with XENICAL and 1400 patients treated with placebo. The majority of these patients had obesity-related risk factors and comorbidities. In these 7 studies, treatment with XENICAL and placebo designates treatment with XENICAL plus diet and placebo plus diet, respectively.

During the weight loss and weight maintenance period, a well-balanced, reduced-calorie diet that was intended to result in an approximate 20% decrease in caloric intake and provide 30% of calories from fat was recommended to all patients. In addition, all patients were offered nutritional counseling.

One-year Results: Weight Loss, Weight Maintenance, and Risk Factors: Weight loss was observed within 2 weeks of initiation of therapy and continued for 6 to 12 months.

Pooled data from five clinical trials indicated that the overall mean weight loss from randomization to the end of 6 months and 1 year of treatment in the intent-to-treat population were 12.4 lbs and 13.4 lbs in the patients treated with XENICAL and 6.2 lbs and 5.8 lbs in the placebo-treated patients, respectively.

During the 4-week placebo lead-in period of the studies, an additional 5 to 6 lb weight loss was also observed in the same patients. Of the patients who completed 1 year of treatment, 57% of the patients treated with XENICAL (120 mg three times a day) and 31% of the placebo-treated patients lost at least 5% of their baseline body weight.

The percentages of patients achieving ³5% and ³10% weight loss after 1 year in five large multicenter studies for the intent-to-treat populations are presented in Table 1.