FDA Advisory Committee Unanimously Recommends XENICAL(R) (Orlistat) for Weight Loss

BETHESDA, Md., May l4 /PRNewswire/ -- 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.

"We are very pleased that the members of the Advisory Committee recognize that XENICAL will be an important tool in reducing obesity and its consequences," said Patrick J. Zenner, Roche's President and Chief Executive Officer. "While this milestone represents one of the final steps in the development of XENICAL, it also marks the beginning of Roche's long-term commitment to educating the medical community and the public on obesity prevention and treatment. We will stress diet modification, with good nutrition, exercise, and appropriate use of drugs when medically necessary."

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.

The company's commitment to metabolic research and development stems from its recognition of obesity as a chronic disease needing long-term therapy. In addition to XENICAL, Roche is pursuing investigation of genetic therapy research through its collaboration with the biotechnology company, Millennium.

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SOURCE Hoffmann-La Roche Inc.

ＧＨＢの後遺症で頭がボケてたんで、どこか間違ってるかもしれませんが・・・一応いいかげんに訳しときました。あ、あと余計なところは訳してません。

体重増加による健康被害に対するリスクを少なくするため、全身性ではない新しいタイプの抗肥満薬がＦＤＡに承認された。このクスリは脳には作用せず、全身作用を示さない。

二重盲検比較試験では、プラセボと比較して約３倍の肥満患者が適度にカロリー制限をした食事で１０％からそれ以上の体重減少が見られた。それ以外にも、プラセボと比べて約２倍の肥満患者が少なくとも５％の体重減少が見られた。（１年間の投与）

２年目も実験を続けた患者は、その体重をキープし続けた。

そして、糖尿病患者に対しても、インスリンやグルコースの血中濃度の改善を示した。総コレステロールとＬＤＬコレステロールの減少作用や、収縮期血圧と拡張期血圧（最低血圧と最高血圧のこと）を下げる作用もあった。

そして、投与時には脂溶性ビタミンの吸収も減るために、脂溶性ビタミンをサプリメントで摂るべきだ。

副作用に関しては、全身性の副作用はほとんどなく、一番多い副作用としては胃腸に対する副作用が上げられる。しかし、この副作用はクスリの本質的な作用であり、投与初期に現れ、短期間で終わる。

また、ゼニカルの長期投与に関するデータはまだない。