- The Washington Times - Tuesday, June 14, 2005

A prescription drug approved to treat obesity helps fat teens lose weight without causing serious side effects, according to a study released today.

Obese teenagers who took orlistat, a drug that blocks fat absorption in the body, with a reduced-calorie diet and regular exercise had a better rate of losing weight and keeping it off than teens who made the same lifestyle changes but took a placebo, said the study in the current Journal of the American Medical Association (JAMA).

The majority of the patients on orlistat experienced moderate gastrointestinal problems, such as nausea and uncontrollable bowel movements, but they did not show any major safety concerns, the study said.

“We are at the beginning of understanding the issue of adolescent obesity from a clinical point of view,” said Dr. Jean-Pierre Chanoine, co-author of the study.

Orlistat, a lipase inhibitor, is sold in the United States as Xenical by Hoffman-La Roche Inc., the Nutley, N.J., subsidiary of global pharmaceutical company Roche Group.

The drug, which was approved by the Food and Drug Administration in 1999, reduces fat absorption by 30 percent.

The FDA in December 2003 approved the drug to be used in younger patients, from ages 12 to 16, for up to one year of treatment.

The federal agency based its approval on preliminary results that were previously released from the JAMA study, which did not determine how effective or tolerable orlistat would be in teens beyond one year of treatment.

“It takes a lot of processing time to get a study like this published,” said Dr. Chanoine, head of the endocrinology and diabetes unit at the British Columbia Children’s Hospital.

The JAMA study tracked 539 obese teens, with an average weight of 210 pounds, for 54 weeks. About 357 patients took 120 milligrams of orlistat three times daily, while 182 patients received a placebo.

Both groups lost weight during the first 12 weeks of treatment. But patients taking orlistat lost additional weight and ultimately lowered their average body mass index (BMI), a height and weight measurement, by nearly one unit at the end of the study.

Teens on the placebo increased their average BMI by nearly half a BMI unit at the end, the study said.

“It’s a modest positive” for Hoffman-La Roche, said Viren Mehta, a pharmaceutical analyst and principal of New York investment bank Mehta Partners LLC.

Mr. Mehta said he doubted Xenical sales would jump, citing the gastrointestinal side effects that many adults and younger patients cannot handle.

Hoffman-La Roche spokesman Terence Hurley would not give sales data for Xenical, saying Roche has seen a “modest” increase in sales since the drug was approved for teen use.

The company has had no plans to broadly market Xenical to teens, he said.

The report comes as 16 percent of American youths, ages 6 to 19, are overweight, with an additional 15 percent of them at risk for becoming overweight, according to the latest data from the Centers for Disease Control and Prevention.

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