P. Reddy et Mss. Chow, FOCUS ON ORLISTAT - A NONSYSTEMIC INHIBITOR OF GASTROINTESTINAL LIPASE FOR WEIGHT-REDUCTION IN THE MANAGEMENT OF OBESITY, Formulary (Cleveland, Ohio), 33(10), 1998, pp. 943
Orlistat, a gastric and pancreatic lipase inhibitor, is currently unde
rgoing FDA review for the indication of weight reduction, In clinical
trials, a significant weight loss of 5% to 10% has been demonstrated w
ith orlistat dosages of 120 mg three times a day, for as long as 104 w
eeks. Furthermore, modest reductions in cholesterol and LDL were obser
ved. The drug was well tolerated, in trials, despite a high frequency
of gastrointestinal side effects. Levels of vitamin A and F declined i
n the short term, requiring vitamin supplementation in some patients.
In preliminary data, a statistically significant increase in the risk
of breast cancer has been observed; FDA approval is pending a review o
f this safety information. In summary, orlistat is a well-tolerated ag
ent with efficacy in the management of obesity, producing a significan
t and sustained weight loss of up to 2 years.