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Orlistat Keeps The Weight Off Over Three Years In Metabolic Syndrome Patients: Presented at ECO

By Mark Pownall

HELSINKI, FINLAND -- June 3, 2003 -- The obesity drug orlistat (Xenical) together with a lifestyle programme produced more weight loss and maintained such losses better than the lifestyle programme given on its own in a group of high risk obese patients.

Results from the Scandinavian Study or Orlistat in the Metabolic syndrome (SMOMS) showed that patients with the metabolic syndrome who were taking orlistat lost a mean of 9 kg compared to 7.3 kg for those on the identical lifestyle programme who were taking placebo, a significant difference (P<0.05).

The study was presented here May 30^th at the 12^th European Congress on Obesity.

In the study, 309 patients were randomly assigned to receive either orlistat or placebo after 8 weeks on a very low calorie diet. Both groups then received lifestyle advice, chiefly about diet, but were also encouraged to be more physically active. They were prescribed a mildly calorie reduced diet, with an energy deficit of 600 kcal a day. Two thirds of the patients in each arm of the study completed it.

Patients were 18 to 65 years of age and half were male. They were obese, but not severely so, with waist measurements of more than 92 cm in women and 102 cm in men (an indication of abdominal obesity). Half of patients had type 2 diabetes or impaired fasting glucose tolerance.

Twenty-seven percent of patients taking orlistat continued to lose weight after the initial weight loss. This was more than double the 13% who continued to lose weight in the placebo arm.

Ten percent of those taking orlistat gained weight after the initial very low calorie diet period, while 17% did in the placebo arm.

The proportion of those who had a significant long-term weight loss (>15% over 3 years) was 18% of orlistat patients and 9% of placebo patients.

Professor Aila Rissanen, of the Obesity Research Unit at Helsinki University Central Hospital, in Helsinki, Finland, and one of the study authors said, 'This kind of weight loss is remarkable, when you consider the success criteria was patients losing more than 5% of their initial weight at 1 year'.

According to the 5% criterion, 85% of orlistat patients and 75% of controls had successfully lost weight at the end of Year 1 of the study. By the end of Year 3, 65% of orlistat patients compared to 50% of placebo patients had lost more than 5% of their body weight.

The incidence of new cases of type 2 diabetes in this high-risk population was 5.2% in those taking orlistat and 10.9% among controls. Similarly there was a 10.5% incidence of cardiovascular disease among those on orlistat, and a 17.3% incidence among those on placebo.

'There was a sustained and significant decrease in cardiovascular risk factors, and the incidence of new cases of type 2 diabetes and cardiovascular disease was significantly [greater] among those on placebo than in those on orlistat," Professor Rissanen said.

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