Rationale, design, and baseline characteristics of a study to evaluate the effect of febuxostat in preventing cerebral, cardiovascular, and renal events in patients with hyperuricemia

Abstract

This study is a prospective randomized open-label blinded endpoint study. Patient enrolment was started in November 2013 and was completed in October 2014. The patients will be followed for at least 3 years. The primary endpoint is a composite of cerebral, cardiovascular, and renal events, and all deaths including death due to cerebral, cardiovascular, and renal disease, new or recurring cerebrovascular disease, new or recurring non-fatal coronary artery disease, cardiac failure requiring hospitalization, arteriosclerotic disease requiring treatment, renal impairment, new atrial fibrillation, and all deaths other than cerebral or cardiovascular or renal disease. These events will be independently evaluated by the Event Assessment Committee under blinded information regarding the treatment group. The study was registered at ClinicalTrials.gov with the identifier NCT01984749.

New Perspectives in Rheumatology: Implications of the Cardiovascular Safety of Febuxostat and Allopurinol in Patients With Gout and Cardiovascular Morbidities Trial and the Associated Food and Drug Administration Public Safety Alert

“…This RCT is ongoing in the UK and Denmark (15). An ongoing RCT in Japan is distinct, in large part, by studying patients with asymptomatic hyperuricemia (FREED: febuxostat for cerebral and cardio-renovascular events prevention study)(16)(Table 1). …”

Gout – An update of aetiology, genetics, co-morbidities and management

“…As an example, in the APEX trial there were 11 cardiovascular events in the 670 febuxostat patients, 1 in the 268 allopurinol patients and 1 in the 134 placebo patients (76). Mandated safety trials were completed, and the US based trial has been published (CARES) with the European trial still pending (FAST, febuxostat versus allopurinol streamlined trial) and an additional Japanese trial in asymptomatic hyperuricaemia also ongoing ((FREED: febuxostat for cerebral and cardiorenovascular events prevention study) (64,77,78). The CARES study randomized 6,190 patients to allopurinol or febuxostat for a median of 32 months (79).…”

Some opportunities of using xanthine oxidase inhibitors

“…Сможет ли ингибирование КСО снижать риск сердечно-сосудистых событий у пациентов с высоким или даже нормальным уровнем МК, покажут дальнейшие исследования, часть из которых уже начата [31][32].…”