Orlistat: a second look. At best, a minor adjunct to dietary measures.

(1) Treatments for obesity are disappointing, and none has yet shown an effect on morbidity or mortality. Non drug treatments have not been assessed adequately. Long-term maintenance of weight loss requires long-term patient management. (2) Orlistat, a gastrointestinal lipase inhibitor, is licensed in Europe for the treatment of obesity, in combination with a low-calorie diet. (3) The risk-benefit ratio of orlistat could not be estimated from the initial assessment file in 1999. There were fears over a possible increase in the risk of breast cancer. (4) Few new efficacy data have been obtained since. Medium-term trials (12-24 months) show that orlistat (120 mg three times a day), combined with dietary intervention, has a minor supplementary effect on weight loss (-3.5 kg on average). (5) A meta-analysis of three of the four available comparative trials lasting two years failed to conclude that orlistat prevents the onset of type 2 diabetes. Likewise, there is no firm evidence that orlistat lowers cardiovascular morbidity or mortality. (6) Orlistat frequently has gastrointestinal adverse effects, and case reports of hypertension have been published. Orlistat probably interacts with a number of other drugs. (7) Follow-up of nearly 8,000 women for only a few years showed no increase in the incidence of breast cancer on orlistat. (8) In practice, dietary intervention and risk factor management remain the cornerstones in the management of obesity. Orlistat is only a minor, optional and temporary aid, although it appears so far to have no serious adverse effects.