Efficacy and Safety of Orlistat in Patients With Overweight/Obese and Hyperuricemia: Results of a Randomized, Double-Blind, Placebo-Controlled Trial

Abstract

Abstract Background Obesity is associated with elevated serum uric acid (SUA) and frequent gout flares. Losing weight can lower SUA and reduce gout flares. The effect of orlistat on SUA and gout flares in patients with overweight/obese and hyperuricemia (HUA) has not been extensively studied. In this study, we investigated the effects of orlistat on SUA and gout flares compared to placebo in overweight or obese patients with HUA. Methods A total of 72 Chinese patients with overweight/obese and HUA were randomly divided into placebo group and orlistat group for 12 weeks. The primary endpoints were relative changes in body weight and SUA, as well as gout flares. Results 72 patients with overweight/obesity and HUA were randomly assigned to placebo group (35, 48.61%) and orlistat group (37, 51.39%). Orlistat was associated with a lower proportion of patients with gout flares (log-rank p = 0.023, hazard rate = 0.31, 95% CI 0.11–0.85). There was no significant difference in SUA level between the two groups. The average weight loss of orlistat group was 2.85kg, which was significantly better than that of control group (P < 0.05). Conclusions This study is the first to demonstrate that orlistat has no direct effect on SUA levels in patients with overweight/obese and HUA. The value of orlistat as an adjunct therapy to prevent gout flares during weight loss in patients with HUA was emphasized. Trial registration: Clinicaltrials.gov NCT05496075