Fenoldopam, a dopamine agonist, for hypertensive emergency: a multicenter randomized trial. Fenoldopam Study Group.

Abstract

UNLABELLED:

Despite successful therapies for chronic hypertension, hospital admissions for hypertensive emergency more than tripled between 1983 and 1992.

OBJECTIVE:

To examine the safety and efficacy of fenoldopam, the first antihypertensive with selective and specific action on vascular dopamine (DA1) receptors, in a clinical trial involving emergency department patients with true hypertensive emergencies.

METHODS:

Patients with a sustained diastolic blood pressure (DBP) of > or =120 mm Hg and evidence of target organ compromise were randomized in a double-blinded manner to one of four fixed doses of intravenous fenoldopam (0.01, 0.03, 0.1, or 0.3 microg/kg/min) 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 treatment compared with the lowest-dose group.

RESULTS:

One hundred seven participants from 21 centers were enrolled, and 94 patients received fenoldopam. Evidence of acute target-organ damage included new renal dysfunction or hematuria (50%), acute congestive heart failure or myocardial ischemia (48%), and papilledema or grade III-IV hypertensive retinopathy (34%). The DBP decreased in a dose-dependent fashion, with significant differences between the 0.1- and 0.3-microg/kg/min groups compared with the lowest-dose group. Treatment was well tolerated, and there were no deaths or serious adverse events during follow-up, up to 48 hours. All patients were successfully transitioned to oral or transdermal antihypertensives with maintenance of blood pressure control.

CONCLUSIONS:

Fenoldopam safely and effectively lowers blood pressure in a dose-dependent manner in patients with hypertensive emergencies. Observations supporting potential risk factors for hypertensive emergency are discussed.

• Authors: J A Tumlin, L M Dunbar, S Oparil, V Buckalew, C V Ram, V Mathur, D Ellis, D McGuire, J Fellmann, R R Luther
• Journal: Academic emergency medicine : official journal of the Society for Academic Emergency Medicine (Acad Emerg Med) Vol. 7 Issue 6 Pg. 653-62 (Jun 2000) ISSN: 1069-6563 [Print] United States
• PMID: 10905644 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Dopamine Agonists
• Fenoldopam

Topics

• Adult
• Aged
• Analysis of Variance
• Dopamine Agonists (administration & dosage, adverse effects)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Administration Schedule
• Emergency Treatment
• Female
• Fenoldopam (administration & dosage, adverse effects)
• Follow-Up Studies
• Humans
• Hypertension, Malignant (diagnosis, drug therapy)
• Infusions, Intravenous
• Male
• Middle Aged
• Probability
• Prospective Studies
• Reference Values
• Severity of Illness Index
• Treatment Outcome