Study design and participants
diabetes, hyperuricemia, gouty arthritis, gouty tophus
HYPERURICEMIA, GOUTY ARTHRITIS, DIABETES
This was a post-hoc analysis of the PRIZE (program of vascular evaluation under uric acid control by xanthine oxidase inhibitor, febuxostat: multicenter, randomized controlled) study, a prospective, open-label, blinded-endpoint clinical trial (University Hospital Medical Information Network Clinical Trial Registry; UMIN000012911 and UMIN000041322). The detailed study protocol and design are available in previous publicationsIndividuals were eligible for the PRIZE study when their SUA level was > 7.0 mg/dl and the maximum IMT of the common carotid artery (CCA) was ≥ 1.1 mm at screening. Patients who received SUA-lowering agents within the 8-week period prior to assessment of eligibility and had gouty tophus or symptoms of gouty arthritis within one year were excluded. Patents with hyperuricemia and not receiving SUA-lowering agents or showing significant carotid plaques were randomly allocated in a 1:1 ratio to receive febuxostat, a xanthine oxidase inhibitor, and appropriate lifestyle modification for hyperuricemia (febuxostat group) or lifestyle modification alone (control group). Randomization was stratified according to age (< 65 or ≥ 65 years), sex, diabetes, SUA level (< 8.0 or ≥ 8.0 mg/dl), and maximum CCA-IMT (< 1.3 or ≥ 1.3 mm). Participants allocated to receive febuxostat were treated with an initial dose of 10 mg daily, followed by an increase to 20 mg daily at one month and an increase to 40 mg daily at two months, if tolerated. Although a dose of 40 mg daily was targeted as the maintenance dose, it could be increased up to 60 mg daily at three months or later. Major exclusion criteria for the present sub-analysis were lack of carotid IMT measurement at baseline and/or 24 months and missing baseline data (Fig. Study flow. 