Reduction of body weight and co-morbidities by orlistat: The XXL - Primary Health Care Trial

Aim: The aim of this postmarketing surveillance (PMS) study was to investigate the effect of an orlistat therapy under the everyday conditions of our health care system. Methods: 11 131 women and 4418 men from Germany [mean age 48 years, mean body mass index (BMI) 34.7 kg/m(2) and mean duration of obesity 13.7 years] were included. The patients were predominantly cared for by general practitioners. Four fifths of the patients reported having obesity-associated co-morbidities. All patients were advised to take orlistat 120 mg three times daily. Results: After a mean treatment duration of 7.1 months, both women and men lost 10.7% of their baseline weight (87% lost > 5% weight and 51% lost > 10% weight). All cardiovascular risk factors improved markedly, and the intake of concomitant medications was either reduced or discontinued. Compared with baseline, 65% of the patients assessed their general state of health to have improved. For more than 90% of their patients, physicians described the success of the treatment as satisfactory, and most patients (62%) were willing to continue with the treatment. Conclusions: The results obtained in this naturalistic PMS study were comparable with the results of randomised and placebo-controlled studies, which were performed predominantly in special care centres. Therefore, without any risk of adversely affecting the quality of treatment provided, the treatment of obese patients with orlistat may be transferred to general practitioners.