Investigational OTC Version of Orlistat also Lowers LDL-C

From NAASO, The Obesity Society

BOSTON?An investigational, low-dose, over-the-counter (OTC) version of the popular prescription weight-loss drug orlistat (Xenical) not only helps patients lose weight, it also appears to significantly reduce low-density lipoprotein cholesterol (LDL-C), researchers reported at NAASO, The Obesity Society annual meeting.

IMWR

"The data demonstrate that the effect of low-dose orlistat on change in LDL cholesterol persisted even after correcting for weight loss, meaning the lowering of cholesterol was independent of weight loss," lead investigator Vidhu Bansal, PharmD, director of medical affairs, GlaxoSmithKline Consumer Healthcare, told . "In addition, more patients with elevated LDL cholesterol levels at the beginning of the study normalized those levels after treatment with low-dose orlistat for 1 year when compared with those on placebo plus diet alone." Orlistat works by preventing the absorption of about 25% of ingested fat.

Data were pooled from two, 24-month, double-blind, randomized, placebo-controlled trials involving 576 patients; 318 received orlistat 60 mg, and 258 received placebo. All patients followed a reduced-calorie diet.

Weight and LDL-C data were collected at 12 and 24 months. A total of 44.7% of patients taking orlistat achieved at least a 5% weight loss from baseline compared with 29.3% of the placebo-taking patients at 24 months.

"The mean reduction in LDL cholesterol was significantly greater in the orli-stat 60 mg plus diet compared with the placebo plus diet group throughout the study period," the investigators reported.

In addition, the LDL-C reduction among those receiving orlistat persisted after correcting for weight loss, indicating that the drug had an independent effect on LDL-C.

"The clinical implications of the study are that, in taking low-dose orlistat with a reduced-calorie diet, there will be not only an amelioration of body weight, but an independent effect on LDL cholesterol, which may lessen risk of cardiovascular disease," Caroline M. Apovian, MD, of Boston University School of Medicine, told IMWR.

Orlistat is currently available as a 120-mg formulation by prescription only. The company has already received an approvable letter for the OTC 60-mg formulation.

Dr Apovian noted, "Orlistat, 60-mg dose, will be the only FDA-approved OTC weight-loss medication on the market. Not only does it have the potential to help millions of Americans lose weight, but based on recent data, it also has the potential to help millions of Americans reduce their LDL cholesterol at the same time. The public health ramifications are tremendous, provided that Americans take the drug as directed?and with a low-fat diet."

The OTC formulation of orlistat will be marketed under the trade name "Alli."