Intravenous nicardipine for the treatment of severe hypertension. A double-blind, placebo-controlled multicenter trial.
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 (diastolic blood pressure less than or equal to 95 mm Hg; systolic blood pressure less than or equal to 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.
Wallin
J D
JD
Department of Nephrology, Tulane University Medical School, New Orleans, La.
Fletcher
E
E
Ram
C V
CV
Cook
M E
ME
Cheung
D G
DG
MacCarthy
E P
EP
Townsend
R
R
Saunders
E
E
Davis
W R
WR
Langford
H G
HG
D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006261:Headache / Q000139:chemically induced; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D007022:Hypotension / Q000139:chemically induced; D007262:Infusions, Intravenous; D007668:Kidney / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009529:Nicardipine / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D010919:Placebos
D010919:Placebos; D009529:Nicardipine