Safety and efficacy of urapidil and sodium nitroprusside in the treatment of hypertensive emergencies.

Abstract

To assess the safety and efficacy of urapidil compared to sodium nitroprusside in the treatment of hypertensive emergencies. Randomized, prospective clinical study. Emergency department in a 2000-bed inner city hospital. Eighty-one patients with hypertensive emergencies defined as elevation of systolic blood pressure above 200 mmHg and/or diastolic blood pressure above 110 mmHg plus evidence of end-organ damage were included in the study protocol. The efficacy of therapy was defined as 1) blood pressure reduction below 180/95 mmHg within 90 min and 2) no re-elevation of blood pressure during a 4-h follow-up period in primary responders. The safety of both drugs was defined as the number of minor and major side effects during treatment. Patients received either sodium nitroprusside (n = 35; continuous intravenous administration with a starting dose of 0.5 microgram/kg per min; increase in increments of 0.5 microgram/kg per min every 15 min until response to treatment or a maximum of 3 micrograms/kg per min) or urapidil (n = 46; intravenous bolus; starting dose: 12.5 mg; repetitive administration of 12.5 mg every 15 min until response or a maximum dose of 75 mg). Blood pressure was measured every 2.5 min by using a non-invasive oscillometric blood pressure measurement unit. Response to treatment within 90 min was observed in 75 (93%) patients (urapidil: n = 41 [89%]; nitroprusside: n = 34 [97%]; p = 0.18). During the follow-up period 8/34 (24%) patients in the nitroprusside group and 1/41 (2%) patients in the urapidil group exhibited blood pressure re-elevation. Major side effects were observed in seven patients receiving nitroprusside and two patients in the urapidil group (p = 0.04). Urapidil is equally effective, compared to sodium nitroprusside, in the treatment of hypertensive emergencies. Due to a smaller number of adverse events, urapidil is a reasonable alternative to nitroprusside in the treatment of hypertensive emergencies.