Objective: To compare the clinical efficacy and safety of domestic orlistat and imported orlistat in Chinese overweight and obese patients.
Methods: In a randomized, double-blinded and positive-controlled study, 228 adults (BMI 24- < 40 kg/m(2)) evaluated at seven research centers were randomized to receive domestic orlistat or imported orlistat 120 mg 3 times a day with an energy-controlled diet for 24 weeks.
Results: After 24 weeks, domestic orlistat treated patients got significant weight-loss (5.0 +/- 3.7) kg, which was comparable with that of imported orlistat treated patients (4.5 +/- 3.5) kg (P = 0.3922). Compared with the findings before treatment, there was significant decrease of systolic blood pressure (4.4 +/- 11.5) mm Hg (1 mm Hg = 0.133 kPa) and serum levels of TC (0.54 +/- 0.79) mmol/L and LDL-C (0.32 +/- 0.64) mmol/L in the domestic orlistat treated group (compared with levels of baseline, P < 0.0001). There was no significant difference between the two groups in the changes of blood pressure and lipid levels. Both groups had similar adverse event profiles, most of which were mild and transient gastrointestinal events. There were no serious adverse events in both groups.
Conclusions: Domestic orlistat combined with a light low-energy diet promoted significant weight loss, which was comparable with that of imported orlistat after 24 weeks of treatment. There was also improvement in blood pressure and serum levels of TC and LDL-C. Domestic orlistat was as effective and safe as imported orlistat in the treatment of obesity.