Effect of Febuxostat on ambulatory blood pressure in subjects with hyperuricemia and hypertension: A Phase 2 randomized placebo-controlled study

Background--hyperuricemia is associated with hypertension,with elevated serum uric acid levels postulated to have a causal role in the development of hypertension. consequently,serum uric acid reduction may help lower blood pressure (bp). a phase 2,double-blind,placebo-controlled trial was conducted to assess the potential bp-lowering effects of the xanthine oxidase inhibitor febuxostat in subjects with hypertension and hyperuricemia (serum uric acid ≥0.42 mmol/l [≥7.0 mg/dl]). methods and results--subjects (n=121) were randomized 1:1 to febuxostat 80 mg once daily or to placebo. the primary end point was change from baseline to week 6 in 24-hour mean ambulatory systolic bp (sbp). additional end points included the following: change from baseline to week 3 in 24-hour mean sbp and changes from baseline to weeks 3 and 6 in 24-hour mean ambulatory diastolic bp,serum uric acid,mean daytime and nighttime ambulatory sbp/diastolic bp,and clinic sbp/diastolic bp. for the overall study population,there were no significant differences between febuxostat and placebo for changes from baseline to weeks 3 or 6 in ambulatory,daytime or nighttime,or clinic sbp or diastolic bp. however,in a preplanned subgroup analysis,there was a significant decrease in sbp from baseline to week 6 in subjects with normal renal function (estimated glomerular filtration rate ≥90 ml/min) treated with febuxostat versus placebo; least squares mean difference,-6.7; 95% confidence interval -13.3 to -0.0; p=0.049. conclusions--this study suggests that febuxostat may lower bp in hyperuricemic patients with hypertension and normal renal function; further studies should be conducted to confirm this finding. © 2017 the authors.