July 17, 1998. Press Release The Lancet Issue July 18, 1998.
Embargoed July 17, 1998

DRUG TREATMENT FOR OBESITY (pp 160-61, 167-72)

Obesity is becoming increasingly common and is now recognised as a major public-health issue worldwide. In the UK, the overweight and obese population increased by almost 15% between 1980 and 1992, by which time 54% of men and 45% of women were affected. Similar increases have been recorded in other countries.

Obesity is now regarded as a disease that has reached epidemic proportions. Until now, the general complaint about medical treatments for obesity was that they simply have not worked. In this weekÕs Lancet, however Professor Lars Sjšstršm and colleagues from Gšteburg, Sweden, report the findings of their 2-year trial of the drug orlistat for weight loss and prevention of weight regain in obese patients.

Orlistat induces weight loss by blocking pancreatic lipase, and thereby reducing the amount of dietary fat available to be metabolised. 743 obese patients were recruited at 15 European centres and began a low-calorie (hypocaloric) diet lasting 4 weeks. 688 patients who completed the diet were given orlistat (120 mg three times daily) or placebo for 1 year in combination with the hypocaloric diet. In the second year, together with a weight-maintenance/(eucaloric diet), the allocation of orlistat or placebo was swapped.

From the start of the 4-week diet to the end of year 1, the orlistat group lost, on average, more bodyweight than the placeby group (10.3 vs 6.1 kg). During year 2 patients who continued on orlistat regained, on average, half as much weight as those who were switched to placebo. Patients switched from placebo to orlistat lost an additional 0.9 kg during year 2, compared with a mean weight regain of 2.5 kg in those continued on placebo. However, adverse gastrointestinal effects were more common in the orlistat group, and the long-term consequences of taking orlistat are unknown. In his Commentary (pp160-61), George Bray from Louisiana State University, USA, says that the Ņtime bomb of obesity is tickingÓ, and stresses the importance of finding treatments for obesity and its related diseases (such as diabetes) in the future.

 /ENDS

Professor Lars Sjšstršm, Medical Deoartment, Sahlgrenskia University Hospital, Gšteburg, Sweden tel +46 31 603-053/602-485, fax +46 31 418-527; and George Bray, Pennington Biomedical Research Centre, Louisiana State University, Baton Rouge, LA USA, tel = 1 504 763 2500, fax +1 504 763 0935

Please mention The Lancet as the source of this material

EDS Š Reuters report: WESTPORT, May 14 - Roche Holdings, based in Basel, Switzerland, said on Tuesday that the Food and Drug administration issued a letter of approvability to the company for its orlistat (Xenical) weight management drug to treat obesity. The drug, which is a lipase inhibitor that blocks absorption of fat by 30%, was recently recommended for approval by European Union advisory panel.