Fenoldopam, a dopamine agonist, for hypertensive emergency: A multicenter randomized trial

Despite successful therapies for chronic hypertension, hospital admissions for hypertensive emergency more than tripled between 1983 and 1992. Objecti ve: To examine the safety and efficacy of fenoldopam, the first antihyperte nsive with selective and specific action on vascular dopamine (DA,) recepto rs, in a clinical trial involving emergency department patients with true h ypertensive emergencies. Methods: Patients with a sustained diastolic blood pressure (DBP) of greater than or equal to 120 mm Hg and evidence of targe t organ compromise were randomized in a double-blinded manner to one of fou r fixed doses of intravenous fenoldopam (0.01, 0.03, 0.1, or 0.3 mu g/kg/mi n) for 24 hours. The primary endpoint was the magnitude of DBP reduction in each of the three higher-dose groups after four hours of fenoldopam treatm ent compared with the lowest-dose group. Results: One hundred seven partici pants from 21 centers were enrolled, and 94 patients received fenoldopam. E vidence of acute target-organ damage included new renal dysfunction or hema turia (50%), acute congestive heart failure or myocardial ischemia (48%), a nd papilledema or grade III-TV hypertensive retinopathy (34%). The DBP decr eased in a dose-dependent fashion, with significant differences between the 0.1- and 0.3-mu g/kg/min groups compared with the lowest-dose group. Treat ment was well tolerated, and there were no deaths or serious adverse events during follow-up, up to 48 hours. All patients were successfully transitio ned to oral or transdermal antihypertensives with maintenance of blood pres sure control. Conclusions: Fenoldopam safely and effectively lowers blood p ressure in a dose-dependent manner in patients with hypertensive emergencie s. Observations supporting potential risk factors for hypertensive emergenc y are discussed.