– Low-dose orlistat not only produces significant weight loss over 2 years but also provides persistent reductions in low-density lipoprotein (LDL) cholesterol
A 60-mg formulation of orlistat, expected to be made available for over-the-counter use in weight loss, has been evaluated in two large double-blind studies of 2 years’ duration.Pooling of the 60-mg data from these studies, which randomised patients to receive 60 or 120 mg of the drug or placebo three times per day, resulted in the finding that during year 1, 44.7% of those in the low-dose group achieved a 5% weight loss and were considered weight responders, compared with 29.3% in the placebo group.Taken together, the studies included 576 patients receiving the 60-mg dose or placebo. Their mean age was 45 years, mean baseline body mass index (kgm2) was 36.5, and mean baseline weight was approximately 100 kg.All patients were instructed to follow a hypocaloric diet during year 1, with fat consisting of approximately 30% of daily calories, and to follow a eucaloric weight-maintenance diet during year 2.Among the weight responders, there was a 6.65% reduction in LDL cholesterol. The corresponding decrease among responders receiving placebo was 1.84%, according to Dr. Bansal of GlaxoSmithKline Inc.The effect of 60-mg orlistat on changes in LDL cholesterol persisted even after correcting for weight loss from baseline, which was consistent with studies at the 120-mg dose, he explained.Among the weight nonresponders, there also was a reduction in LDL cholesterol in the orlistat-treated patients after the first year of treatment, whereas nonresponders receiving placebo showed increases in their LDL cholesterol.The most striking treatment difference, according to Dr. Bansal, was the high percentage of weight nonresponders whose LDL cholesterol was elevated at baseline but normalised at the end of 1 year, falling below 3.36 mmolL (129.7 mgdL), he wrote. This suggested an independent effect of orlistat on LDL cholesterol. (See box.)Orlistat is the only approved drug for weight loss that acts nonsystemically, inhibiting fat absorption in the gut. It is approved in more than 145 countries worldwide at the 120-mg three times daily dosage, Dr. Bansal noted. He anticipates that the over-the-counter formulation will be available in early 2007.
Fonte: Nancy Walsh