Evaluation of urate-lowering efficacy of isolated and combined use of febuxostat and empagliflozin in patients with gout and type 2 diabetes mellitus (OPORA Clinical Trial)

Abstract

Introduction. Given the increasing frequency of the association of gout and type 2 diabetes, it is necessary to study the impact of modern therapy on their course.Aim. To evaluate the influence of isolated and combined use of febuxostat and empagliflozin on metabolic parameters and inflammatory markers in patients with gout and type 2 diabetes.Materials and methods. The “OPORA” study included 120 men aged 40–65 years with the simultaneous presence of gout and type 2 diabetes. The subjects were randomized into 3 groups (n = 40): group 1 (F), receiving febuxostat 80 mg/day; group 2 (E) – empagliflozin 25 mg/day; group 3 (FE) – combination of drugs febuxostat 80 mg/day + empagliflozin 25 mg/day. The studied parameters were analyzed before the appointment of therapy and after 12 weeks of treatment.Results. The decrease in uric acid levels was most significant in group 1 (F) (Δ = 22.3%, p < 0.01). The most pronounced decrease in glucose levels was achieved in group 2 (E) (Δ = 32.2%, p < 0.01) and group 3 (FE) (Δ = 21.6%, p < 0.01). In group 3 (FE) a more significant decrease in insulin levels was revealed (Δ = 26.2%, p < 0.01) and HOMA-IR (Δ = 23.0%, p < 0.01) after 3 months. The most significant increase in the level of adiponectin and decrease in the level of leptin was noted in group 3 (FE), p < 0.01. The greatest effect in reducing indicators characterizing inflammation was observed in group 3 (PE) in the form of a significant decrease in the levels of ESR, CRP, TNF-a. After 12 weeks, a decrease in body weight of ~3 kg was noted in groups 2 (E) and 3 (FE).Conclusions. The combination of febuxostat and empagliflozin has an additive effect in positively influencing inflammatory markers and adiponectin levels, without mutual attenuation of urateand glucose-lowering effects.