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December 1989

Intravenous Nicardipine for the Treatment of Severe Hypertension: A Double-blind, Placebo-Controlled Multicenter Trial

Author Affiliations

From the Department of Nephrology, Tulane University Medical School, New Orleans, La (Drs Wallin and Cook); the Pulmonary Division, Veterans Administration Medical Center, Houston, Tex (Dr Fletcher); the Department of Internal Medicine, University of Texas Health Science Center at Dallas (Dr Ram); the Hypertension Center, Veterans Administration Medical Center, Long Beach, Calif (Dr Cheung); the Hypertension Program, University of Cincinnati (Ohio) Medical Center (Dr MacCarthy); the Renal Division, Allegheny General Hospital, Pittsburgh, Pa (Dr Townsend); the Department of Internal Medicine, University of Maryland Hospital, Baltimore (Dr Saunders); the Department of Internal Medicine, University of South Alabama Medical Center, Mobile (Dr Davis); the Endocrine and Hypertension Division, Department of Internal Medicine, University of Mississippi, Jackson (Dr Langford); the Nephrology Section, Department of Internal Medicine, Louisiana State University Medical Center, New Orleans (Dr DeVault); Pharm Evaluation Services, Englewood Cliffs, NJ (Dr Flamembaum); Department of Internal Medicine, Cedars-Sinai Medical Center, Los Angeles, Calif (Dr Ellrodt); Department of Internal Medicine, Veterans Administration Medical Center, Baltimore (Dr Hamilton); the Division of Cardiology, Southern Illinois University School of Medicine, Springfield (Dr Frank); and the Department of Cardiology, Albert Einstein School of Medicine. New York, NY (Dr Frishman).

Arch Intern Med. 1989;149(12):2662-2669. doi:10.1001/archinte.1989.00390120034008

• 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 95 mm Hg; systolic blood pressure ≤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.

(Arch Intern Med. 1989;149:2662-2669)

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