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FDA Advisory Committee Unanimously Recommends Xenical For Weight LossBETHESDA, Md., May l4, 1997.The Food and Drug Administration's (FDA) Endocrinology and Metabolic Drugs Advisory Committee today unanimously recommended the approval of Xenical(R) (orlistat) to help people lose weight and decrease other health risks. Xenical was discovered and developed by Hoffmann-La Roche. Xenical (pronounced: zen-i-cal) represents the first of a new class of non-systemic, anti-obesity drugs called lipase inhibitors, or fat blockers, which act in the gastrointestinal tract to prevent the absorption of fat by about 30 percent. Drugs in this class do not achieve their effect through brain chemistry. According to the data presented, almost three times as many patients on Xenical with a moderately reduced calorie diet lost 10 percent or more of body weight compared to placebo with diet. Nearly twice as many patients on Xenical lost at least 5 percent of body weight compared to placebo with diet. The average patient in the one-year clinical trials weighed 220 pounds and lost 20 pounds, or about 10 percent of body weight, after taking Xenical and being on a moderately reduced calorie diet. Many patients who continued into the second year of the studies were able to keep off the lost weight. In addition, Xenical-treated patients had statistically significant reductions in total and LDL cholesterol and systolic and diastolic blood pressure, as well as improvements in blood concentrations of glucose and insulin after one year over placebo with diet. Efficacy From Comprehensive Clinical Program The Advisory Committee's recommendation was based on double-blind, placebo-controlled and randomized studies involving more than 4,000 patients conducted in the U.S. and Europe. In the clinical trials, people took Xenical orally in 120 mg capsules three times daily in conjunction with a moderately reduced calorie diet containing 30 percent fat. Because low vitamin levels are an existing problem among the overweight and obese population, people following a moderately reduced calorie diet, including those using Xenical, should be sure they have adequate vitamin intake through supplementation. Data Support Tolerability and Quality of Life Improvement The clinical trials showed that Xenical was well-tolerated. The most common side effects reported were non-systemic and were primarily gastrointestinal. These effects generally occurred early in treatment and were self-limited and of short duration in most cases. Roche supports the Advisory Committee recommendation to continue studying the long-term effects of Xenical. Data provided to the Advisory Committee found statistically significant improvements in patient quality of life measurements, including overweight distress and satisfaction with treatment. Headquartered in Nutley, New Jersey, Hoffmann-La Roche Inc. is an affiliate of the multinational group of companies headed by Roche Holding Ltd. of Basel, Switzerland. One of the world's leading research-intensive companies, Roche has discovered, developed and introduced numerous innovative prescription pharmaceuticals designed to fulfill unmet medical needs. |
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