Intravenous nicardipine for the treatment of severe hypertension. A double-blind, placebo-controlled multicenter trial

Abstract

A placebo-controlled, double-blind multicenter trial was conducted in 123 patients with severe hypertension to examine the efficacy and safety of intravenously administered nicardipine hydrochloride in controlling blood pressure. Seventy-three patients were initially randomized to receive nicardipine treatment. This group had an initial blood pressure of 213 .+-. 3/126 .+-. 2 mm Hg. Sixty-seven patients achieved the therapeutic goal (diastollic blood pressure .ltoreq. 95 mm Hg; systolic blood pressure .ltoreq. 160 mm Hg). Fifty patients were randomized to receive placebo solution. Blood pressure in these patients was 216.+-.3/125.+-.2 mm Hg. No patient in this group achieved the therapeutic goal during the "blinded" portion of the study. Forty-four of 49 patients who did not respond to placebo administration responded to subsequent treatment with nicardipine. Patients with end-organ damage were included in the study. These included patients with left ventricular hypertrophy, retinopathy, and renal insufficiency. Patients with and without end-organ damage responded equally well to nicardipine treatment. Serious adverse experiences were infrequent, the most common adverse reaction being headache in 24% of the patients studied.