Intensive Urate Lowering Therapy of Febuxostat Compared to Allopurinol on Cardiovascular Risk in Patients With Gout
Status:
Completed
Trial end date:
2017-05-10
Target enrollment:
Participant gender:
Summary
There is a mounting and clear association between hyperuricaemia, gout and the presence of
traditional cardiovascular (CV) risk factors and CV event-equivalent conditions such as
chronic kidney disease, metabolic syndrome, and diabetes. Gout is associated with increased
risk of CV events such as myocardial infarction and CV death. Furthermore hyperuricaemia is
clearly associated with an increased arterial stiffness, a marker of pre-clinical
atherosclerosis. Carotid-femoral pulse wave velocity (PWV) is the "gold standard" measurement
of arterial stiffness and it is considered, in this trial, as a valid surrogate endpoint with
clearly established relevance to predict cardiovascular disease (CVD) clinical outcome In
this randomised trial conducted on adult subjects with a history of gout, we use surrogate
endpoints to investigate the efficacy of febuxostat compared with allopurinol to predict
(CVD) clinical outcome.
Eligible subjects were randomised in a 1:1 ratio to the following treatment groups:
- Test product: febuxostat 80 mg or 120 mg once daily (120 mg daily, if serum urate was >6
mg/dL after 2 weeks of treatment at 80 mg daily).
- Active comparator: allopurinol 100 mg once daily (up to a maximum dose of 600 mg daily
escalated in 100 mg increments every 2 weeks, if serum urate acid (sUA) was >6 mg/dL
after 2 weeks of treatment at the previous dose).
The study duration was 39 weeks, which included the:
- Run-in/screening period: 1 week (extendable up to a maximum of 30 days according to
variability of sUA levels);
- Treatment period: 36 weeks;
- Safety follow-up period: 2 weeks.