To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: ESPE: Pilot Study Of The Use Of Orlistat (Xenical) In Obese Children URL: http://www.pslgroup.com/dg/20039A.htm Doctor's Guide July 9, 2001
By Cameron Johnston Special to DG News
MONTREAL, QC -- July 9, 2001 -- A study involving a group of severely obese young people treated with orlistat (Xenical, Roche) was able to achieve a mean weight loss of 2.9 kg and a mean reduction in BMI of 1.44.
Although orlistat (Xenical, Roche) has been on the market for the better part of three years and in that time has established itself as a useful tool in helping obese adults manage their weight more effectively, to date, no such studies have been conducted with children and adolescents using the drug.
The new study was presented at the 6th joint meeting of the Lawson Wilkins Pediatric Endocrine Society and the European Society for Paediatric Endocrinology (ESPE) in collaboration with the Australasian Paediatric Endocrine Group, the Japanese Society for Pediatric Endocrinology, and the Latin American Society for Paediatric Endocrinology being held in Montreal, Quebec, Canada this week.
The study was conducted at the Karim Calis Unit on Growth and Obesity at the National Institute of Child Health and Development in Maryland, United States. It involved 20 adolescents (mean age 14.7 years) who had significant co-morbidities in addition to their obesity.
Subjects received 129 mg of orlistat three times daily, plus a multivitamin. They were also given appropriate counselling and were put on a 12-week weight-loss program.
At the end of 12 weeks of follow-up, during which time 85 percent of the subjects completed the regimen and reported taking 83 percent of the drug, a mean weight-loss of 2.9 kg was reported, and a mean reduction in BMI of 1.44 was observed. The subjects' mean reduction in body fat was 4.6 percent.
Total and low-density lipoprotein (LDL) cholesterol were also lower, by 30.9 and 20.3 mg/dL, respectively. Insulin sensitivity and acute insulin response to glucose also improved.
"We conclude that overweight adolescents with obesity-related co-morbidities tolerate orlistat treatment over a three-month period, and that in conjunction with a osycho-educational program, orlistat treated overweight adolescents lost weight and exhibited improvements in plasma lipids and insulin sensitivity," according to lead investigator, Dr. Jack Yanovsky, of the NICHD.
He added, however, that the true benefit of orlistat versus conventional therapy remains to be seen, since this was a small trial, and larger placebo-controlled studies are needed.
The study was funded by Roche Pharmaceuticals, which makes orlistat.
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