Gilead Sciences (Gilead) has published data from DAR-311 (DORADO), a phase III clinical trial evaluating the company’s once-daily oral endothelin receptor antagonist (ERA) – darusentan, as an add-on treatment for resistant hypertension. Its defined as the failure to achieve blood pressure goal while adhering to full doses of an appropriate three (or more) drug antihypertensive regimen that includes a diuretic.
The results of the DAR-311 study showed that darusentan was effective at reducing trough sitting and mean 24-hour systolic blood pressure (SBP) and diastolic blood pressure (DBP), after 14 weeks of treatment in patients with resistant hypertension.
DAR-311 is an international phase III double-blind, placebo-controlled parallel group trial, in which 379 patients were randomized to receive once-daily doses of darusentan 50mg, 100mg, 300mg or placebo for up to 14 weeks, as an add-on to existing antihypertensive regimens.
The co-primary efficacy endpoints were change from baseline to week 14 in trough sitting SBP and DBP. Secondary endpoints included change from baseline in mean 24-hour SBP and DBP and percent of patients reaching SBP goal.
Michael Weber, lead study author, said: “The addition of darusentan with optimised diuretic therapy has promise as a new strategy for treating patients with resistant hypertension, a condition for which no standard of care currently exists.
“These findings are important because patients with resistant hypertension are likely to be at increased risk of cardiovascular events including stroke, myocardial infarction and renal failure due to long-standing history of inadequately controlled hypertension, typically in conjunction with other risk factors like obesity, diabetes and chronic kidney disease.”