Source: Helicobacter  |  Posted 9 years ago

Treatment with the lipase inhibitor orlistat in addition to a low calorie diet significantly reduces weight of overweight patients with type 2 diabetes.

Glycaemic control and cardiovascular risk factor profile are also improved, report researchers in Dresden, Germany. Their multi-centre, double-blind study assessed the long-term effects of orlistat in overweight type 2 diabetics.

After a four-week lead-in period with placebo plus low calorie diet, the researchers randomised 369 overweight or obese adults with clinical type 2 diabetes to orlistat 120 mg. three times daily or placebo, in conjunction with a low-calorie diet, for 48-weeks.

Study participants had body mass index of at least 28 kg/m? and HbA1c of 6.5-11%. The patients were generally drug-na?ve although a few did receive sulphonylurea therapy for at least two months before the study.

After one year, the 189 patients who had received orlistat lost 5.4% of their weight, significantly more than the 180 patients on placebo (3.6%). In addition, more than half of the patients (51.3%) lost 5% or more weight. Fewer than a third (31.6%) of those given placebo did so.

Orlistat patients also had significantly greater improvements in HbA1c, fasting glucose and postprandial glucose. Orlistat had the further benefit of reducing low density lipoprotein cholesterol significantly more than placebo.

The drug's safety profile was similar to placebo except for a higher incidence of gastrointestinal side-effects known to be associated with its mode of action. These side-effects were mostly mild and transient.