Pivotal Data Demonstrating Efficacy of Darusentan in Treating Resistant Hypertension Published in The Lancet

Gilead Sciences, Inc. (Nasdaq:GILD) today announced the publication of 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, 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, published online and in an upcoming edition of The Lancet, show 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 50 mg (n=81), 100 mg (n=81), 300 mg (n=85) or placebo (n=132) 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. The most common patient-reported adverse events were edema and/or fluid retention, dizziness, headache and fatigue. Results from this study were presented at the American Society of Hypertension, Inc. Twenty-Fourth Annual Scientific Meeting and Exposition (ASH 2009) in May 2009.

“The addition of darusentan with optimized diuretic therapy has promise as a new strategy for treating patients with resistant hypertension, a condition for which no standard of care currently exists,” said Michael A. Weber, MD, Professor of Medicine at the SUNY Downstate Medical College of Medicine, Brooklyn, New York and lead study author. “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.”

DAR-311 Results

Baseline Demographics

Baseline demographic and clinical characteristics were comparable across treatment groups. The mean patient age was 62 years old. There were nearly equal numbers of women and men in the study and 20 percent of patients were black. The mean body mass index (BMI) was 32 kg/m2, an indication of obesity. Forty percent of patients were diabetic and 25 percent of patients had chronic kidney disease (CKD). At baseline, 58 percent of patients were on four or more antihypertensive medications. Mean baseline trough sitting SBP and DBP measures were 151 mm Hg and 86 mm Hg, respectively.

Primary Endpoint Results

Each of the three darusentan groups experienced statistically significant reductions (versus placebo) in trough sitting SBP and DBP. The mean reductions in SBP/DBP were 17/10 mm Hg with darusentan 50 mg, 18/10 mm Hg with darusentan 100 mg, 18/11 mm Hg with darusentan 300 mg and 9/5 mm Hg with placebo (p

Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Jun 2024 to Jul 2024