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Health News

Gilead blood pressure drug works in Phase 3 study

NEW YORK (Reuters) - Gilead Sciences Inc said on Thursday its experimental drug to treat patients whose high blood pressure is not controlled by other medicines met both the primary goals of a late-stage study, sending its shares 5 percent higher.

The drug, darusentan, proved statistically significantly superior to placebo at all three doses tested in goals of change from baseline at 14 weeks in trough sitting systolic blood pressure (SBP) and trough sitting diastolic blood pressure (DBP), Gilead said.

Darusentan is being tested for the treatment of resistant hypertension in patients who failed to achieve blood pressure goals, while taking a three-drug regimen that includes a diuretic.

“In this study, more than half of the patients treated with darusentan achieved goal blood pressure, as compared to approximately one quarter of patients receiving placebo,” Gilead’s research chief Norbert Bischofberger said in a statement.

Failure to control blood pressure increases the risk of heart attack, stroke and heart failure.

Subjects in the 379 patient trial received either 50 milligrams, 100 mg or 300 mg of darusentan, or a placebo.

In the measure of mean trough sitting SBP, the placebo group saw an average reduction of 8.6 mmHg compared with reductions of 16.5 mmHg, 18.1 mmHg and 18.1 mmHg for the three drug doses from lowest to highest.

Reductions in mean trough sitting DBP were 5.3 mmHg on placebo and 10.1 mmHg, 9.9 mmHg and 10.7 mmHg for the darusentan patients.

The most common side effects were mild to moderate fluid retention, which was reported in about a third of darusentan patients compared with 17 percent in the placebo group.

Gilead said it has reached about 90 percent enrollment in a second planned Phase III trial for the drug. Phase III is typically the final stage of human testing before a new drug is submitted to regulators for an approval decision.

Gilead shares rose to $47 in extended trading from their Nasdaq close at $44.70.

Reporting by Bill Berkrot; Editing by Andre Grenon

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