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Biotech / Medical : Myogen (MYOG) -- Ignore unavailable to you. Want to Upgrade?

To: tuck who wrote (3)	11/17/2003 3:11:37 PM
From: tuck	Respond to of 50

>>HEAT-2 Presenter: Roumen Nakuv, MD, International Institute of Thrombosis and Vascular Diseases, Frankfurt, Germany The study: A randomized, placebo-controlled trial of darusentan (an oral endothelin A receptor antagonist) for the treatment of hypertension. After a 2-week placebo run-in phase, a total of 392 patients with hypertension (diastolic blood pressure, 100 to 109 mm Hg) were randomized to placebo or 1 of 3 doses of darusentan (10, 30, or 100 mg/d). Therapy continued for up to 7 weeks. The primary end point was the effect on blood pressure at follow-up. The results: There was a significant, dose-dependent decrease in both systolic and diastolic blood pressure with darusentan. Importantly, this fall in blood pressure was not accompanied by an increase in heart rate. There was a higher incidence of patient-reported adverse events (headache and flushing) in the 100-mg group. Summary: In patients with hypertension, the darusentan produced a dose-dependent decrease in blood pressure that was not associated with an increase in heart rate. The 100-mg group had a higher incidence of patient-reported side effects. << >>Darusentan, an endothelin A antagonist, reduced blood pressure significantly at 3 different doses in the Hypertension Endothelin Antagonist Trial (HEAT-2), said Roumen Nakov, MD, of the International Institute of Thrombosis and Vascular Diseases in Frankfort, Germany. Patients were randomized to 1 of 3 doses of darusentan (10, 30, and 100 mg) or to placebo. The trial, which involved nearly 400 patents, involved a placebo run-in period. Once the medication was started, hypertension decreased over the first week in all the treatment groups. The decrease was dose-dependent, and the greatest drop in blood pressure occurred in those patients who were taking 100 mg of darusentan. There was no change in pulse rate in the groups. "It is important that the reduction in blood pressure is not accompanied by an increase in pulse rate," noted Dr Nakov. However, adverse events occurred in 14.6% of patients in the 100 mg group but only 6.1% of those in the placebo group. The most frequently observed adverse event seen was headache. Others included flushing and peripheral edema, as well as a mild dose-dependent decrease in hemoglobin and red blood cells seen in the first 2 weeks of treatment. The problems reversed when the drug was discontinued, and they were not clinically relevant. The higher incidence of adverse events at the 100 mg dose level warrants further study, said Dr Nakov. However, he thinks that the use of selective endothelin A receptor antagonists holds promise as an effective and safe treatment for hypertension. << Both from the Journal Circulation. It would appear they at least know the MTD. Cheers, Tuck