Postgraduate medicine · 2014
The management of acute hypertension in patients with renal dysfunction: labetalol or nicardipine?
Сравнительное исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Varon Joseph, Soto-Ruiz Karina M, Baumann Brigitte M, Borczuk Pierre, Cannon Chad M, Chandra Abhinav, Cline David Martin, Diercks Deborah B, Hiestand Brian, Hsu Amy, Jois-Bilowich Preeti, Kaminski Brian, Levy Phillip, Nowak Richard M, Schrock Jon W, Peacock W Frank
Аннотация
STUDY OBJECTIVES: To compare the safety and efficacy of U.S. Food and Drug Administration (FDA)-recommended doses of labetalol and nicardipine for hypertension (HTN) management in a subset of patients with renal dysfunction (RD).
DESIGN: Randomized, open label, multicenter prospective clinical trial.
SETTING: Thirteen United States tertiary care emergency departments.
PATIENTS OR PARTICIPANTS: Subgroup analysis of the Evaluation of IV Cardene (Nicardipine) and Labetalol Use in the Emergency Department (CLUE) clinical trial. The subjects were 104 patients with RD (i.e., creatinine clearance < 75 mL/min) who presented to the emergency department with a systolic blood pressure (SBP) ≥ 180 mmHg on 2 consecutive readings and for whom the emergency physician felt intravenous antihypertensive therapy was desirable.
INTERVENTIONS: The FDA recommended doses of either labetalol or nicardipine for HTN management.
MEASUREMENTS: The number of patients achieving the physician's predefined target SBP range within 30 minutes of treatment.
RESULTS: Patients treated with nicardipine were within target range more often than those receiving labetalol (92% vs. 78%, P = 0.046). On 6 SBP measures, patients treated with nicardipine were more likely to achieve the target range on either 5 or all 6 readings than were patients treated with labetalol (46% vs. 25%, P = 0.024). Labetalol patients were more likely to require rescue medication (27% vs. 17%, P = 0.020). Adverse events thought to be related to either treatment group were not reported in the 30-minute active study period, and patients had slower heart rates at all time points after 5 minutes (P < 0.01).
CONCLUSIONS: In severe HTN with RD, nicardipine-treated patients are more likely to reach a target blood pressure range within 30 minutes than are patients receiving labetalol.
CLINICAL IMPLICATIONS: Within 30 minutes of administration, nicardipine is more efficacious than labetalol for acute blood pressure control in patients with RD.
DESIGN: Randomized, open label, multicenter prospective clinical trial.
SETTING: Thirteen United States tertiary care emergency departments.
PATIENTS OR PARTICIPANTS: Subgroup analysis of the Evaluation of IV Cardene (Nicardipine) and Labetalol Use in the Emergency Department (CLUE) clinical trial. The subjects were 104 patients with RD (i.e., creatinine clearance < 75 mL/min) who presented to the emergency department with a systolic blood pressure (SBP) ≥ 180 mmHg on 2 consecutive readings and for whom the emergency physician felt intravenous antihypertensive therapy was desirable.
INTERVENTIONS: The FDA recommended doses of either labetalol or nicardipine for HTN management.
MEASUREMENTS: The number of patients achieving the physician's predefined target SBP range within 30 minutes of treatment.
RESULTS: Patients treated with nicardipine were within target range more often than those receiving labetalol (92% vs. 78%, P = 0.046). On 6 SBP measures, patients treated with nicardipine were more likely to achieve the target range on either 5 or all 6 readings than were patients treated with labetalol (46% vs. 25%, P = 0.024). Labetalol patients were more likely to require rescue medication (27% vs. 17%, P = 0.020). Adverse events thought to be related to either treatment group were not reported in the 30-minute active study period, and patients had slower heart rates at all time points after 5 minutes (P < 0.01).
CONCLUSIONS: In severe HTN with RD, nicardipine-treated patients are more likely to reach a target blood pressure range within 30 minutes than are patients receiving labetalol.
CLINICAL IMPLICATIONS: Within 30 minutes of administration, nicardipine is more efficacious than labetalol for acute blood pressure control in patients with RD.